Express Pharma (Vol. 12 No. 12) April 16-30, 2017

VOL. 12 NO. 12 PAGES 64

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CONTENTS MARKET

Vol.12 No.12 April 16-30, 2017 Chairman of the Board Viveck Goenka

COVER STORY

Sr Vice President-BPD Neil Viegas

IPR BUILDING BLOCK OR STUMBLING BLOCK?

Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das,

New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Senior Designer

Graphics Designer

PHARMEXCIL IS ORGANISING 12 BUYER-SELLER MEETS THIS YEAR

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‘WE ARE TRYING TO IMPLEMENT TOTAL AUTOMATION ACROSS THE SUPPLY CHAIN’

With World Intellectual Property Day round the corner, Express Pharma explores the evolving IPR scenario in India and its impact on pharma companies | P18

Mansha Gagneja

Rekha Bisht

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Gauri Deorukhkar

PATENT SYSTEM ONLY WAY TO PROMOTE INNOVATION

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A BALANCING ACT

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TECHNIQUES TO ENHANCE IP VALUATIONS

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ON THE RIGHT TRACK

PACKAGING SPECIAL

Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil

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BOSCH LAUNCHES NEW KLV SERIES FOR LEAK DETECTION OF RIGID CONTAINERS

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AMI POLYMER’S IMAPURE COMPLIES WITH PHARMA STANDARD REQUIREMENTS IN REGULATORY MARKETS

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GELEST PARTNERS WITH NEW MOUNTAIN CAPITAL

MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South

YOGESH PAI Assistant Professor of Law and Co-Director of the Centre for Innovation, Intellectual Property and Competition at National Law University

ASHISH PRASAD Partner, Economic Laws Practice' Delhi

DR GOPAKUMAR G NAIR CEO, Gopakumar Nair Associates

ASHWIN SAPRA Partner, Cyril Amarchand Mangaldas

BIPLAB LENIN Consultant, Cyril Amarchand Mangaldas

Debnarayan Dutta - East Marketing Team

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HEDGING AGAINST UNCERTAINTY IN THE IPR REGIME: CONTRACTUAL PROTECTIONS

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THE BT COTTON SAGA

Ajanta Sengupta Ambuj Kumar E Mujahid Mathen Mathew Nirav Mistry Rajesh Bhatkal PRODUCTION General Manager BR Tipnis Manager

ANAY SHUKLA Lead, Pharma Healthcare team, Nishith Desai Associates

DARREN PUNNEN Member, Pharma Healthcare team, Nishith Desai Associates

VIDYA PHANSE Intern Nishith Desai Associates,

RAJEEV KUMAR Partner, LexOrbis

Bhadresh Valia

Express Pharma®

Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2016-18.

Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at 2nd floor, Express Towers, Nariman Point, Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Express Towers, 1st floor, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) Ltd. All rights reserved throughout the world.

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EXPRESS PHARMA

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April 16-30, 2017

EDITOR’S NOTE

Does IP build or block?

I

ts been 17 years since the World

system

Intellectual Property Organisation (WIPO) started marking April 26 as

investment, rewarding creators, encouraging them to develop their ideas, and ensuring that their new

supports

innovation

by

attracting

World Intellectual Property Day. Themes in the recent past reflect the all pervasive

knowledge is freely available so that tomorrow’s innovators can build on today’s new technology.

But is this supposition true of all countries?

influence of intellectual property rights (IPR) in

Especially developing countries like India?

our lives and reflect how WIPO built on the key message that IPR was, or should be, the cornerstone of civilisation going forward. The first

Therefore as our theme for World Intellectual Property Day, Express Pharma chose to ask if IPR

year, 2001, was about Creating the Future Today, 2002 took this forward with Encouraging

was a building block or a stumbling block? We asked legal experts to analyse issues like why India

Creativity. 2003 focused on Making IP your Business and the next year reinforced this by

is placed second last on the US Chamber's Global Intellectual Property Center (GIPC)'s annual global IP rankings, even though only one compulsory

underlying the Importance of IP for Economic, Social and Cultural Development.

From 2005, we see WIPO involving individuals and joining the dots between IP, ideas and creativity. If 2005 urged people to Think, Imagine, Create, the next year reminded that IP Starts with an Idea. 2007 underlined the Link Between IP and Creativity, and 2008 was about Celebrating Innovation and Respecting IP. In 2009, WIPO moved from the individual to global issues as it focused on Promoting Green Innovation as the key to a Secure Future. The global trend continued in 2010 (Innovation - Linking the World) and 2011 (Designing the Future). In 2012, the focus rightly shifted back to the importance of the individual in the IPR ecosystem, with a celebration of Visionary Innovators.

In 2013, WIPO focussed on Creativity – The Next Generation, and over the next three years, celebrated examples of such creativity. In 2014, it was Movies – A Global Passion, where the spotlight was on IP in movies. IP in Music was centrestage in 2015, with the theme, Get up, stand up. For music. 2016 focussed on yet another creation of next generation creativity, digital creativity and how it was reimagining culture.

This year, 2017 looks at how Innovation (is) Improving Lives. WIPO will explore how innovation is making our lives healthier, safer, and more comfortable, turning problems into progress. WIPO intends to look at how the IP

10 EXPRESS PHARMA April 16-30, 2017

Why is India placed second last on the US Chamber’s GIPC’s annual global IP rankings, even though only one compulsory license has been granted so far?

license has been granted so far and there have been quite a few judgments supporting patent holders.

In fact, one legal eagle wonders if India qualifies for a Guinness World Record for the highest number of ex parte/ ad interim injunctions in patent infringement suits till 2016!

Beyond India, IP laws are evolving and pharma companies need to track regulations in each country that they export to. Aspects like litigation, patentability, revocation, etc are specific to each jurisdiction and are in a constant state of flux. For instance, the Unitary Patent in the European Union calls for new strategies. The 4th Amendment to the Chinese patent law is still pending. New patent regulations in Russia which came into force from August 14 last year and changes in the practices of the Russian Patent Office need more scrutiny.

Like India, many countries are looking at ways to reduce patent prosecution delays but that has not stopped countries like Brazil from implementing a green patent pilot programme.

Now in its fourth phase, the programme promises to examine applications in two years or less if they are related to alternative energy, and similar sectors. Properly regulated, IP is most often a building rather than a stumbling block.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

Pharmexcil is organising 12 buyer-seller meets this year Recently appointed as Director General of the Pharmaceuticals Export Promotion Council (Pharmexcil), Uday Bhaskar's experience spans various government departments and has the unique expertise to understand industry's issues as well as regulatory affairs. In an interview with Usha Sharma, he shares his experience and plans for Pharmexcil

So far you have largely been associated with government departments working on the other side of the fence. What are the learnings you can implement from your past experience to create a more cohesive environment within the Council?

All my earlier assignments with the government were in different capacities to enhance the efficiency of our industry through a different responsibility and enforce the legislation. As a regulator in the state government, I was playing a key role to improve our industry’s regulatory compliance by closely watching the industry and finding ways and means to improve their efficiency and mentor them to adopt such practices to keep pace with developments in regulatory affairs all over the world.

As I was the Secretary General of All India Drugs Control Officers Confederation (AIDCOC) for the past 12 years and President for four years, I know the issues of regulators and industry. I have a vast experience of organising interactive meetings of industry – regulators to update the knowledge on latest development in the regulations. We (AIDCOC) have closely worked with the industry to represent the

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issues of industry and regulators to the government.

With my regulatory background, I can understand the issues of the industry and can coordinate better with regulators in resolving those issues.

Now heading Pharmexcil, my responsibility extends to facilitating India’s exporters to find overseas markets. We take delegations to various markets. In the course of conducting this primary responsibility, Pharmexcil may have to advise the industry to adopt certain changes in the standards of GMPs. Besides, sometimes my role would be to help the industry to reach that stage by playing a liaisonary responsibility between them and government and/or between our exporters and foreign regulatory agencies, to resolve issues, if any, while the industry is adapting to the requirements of our clientele.

What are the new initiatives you intend to commission to boost Indian pharma exports?

Now that the basics of an export systems having been set up, Pharmexcil would look into the newer challenges. Like more joint ventures, and to facilitate more foreign direct investments (FDIs), especially export-oriented ones, to try and find methods to get a

proper breakthrough in certain difficult markets adopting the methods described.

With the support of Department of Commerce, in collaboration with the industry, national research institutions like IICT, NCL, we have also initiated steps to develop strategies to reduce dependence on imports of intermediates, key starting materials (KSMs) and active pharmaceutical ingredients (APIs). Pharmexcil has also established an innovation desk headed by a senior scientist and formed a ‘think tank’ with representatives from BDMA, IDMA, IICT, NCL and senior people from industry.

Till the last financial year, Indian pharma exports were declining. However, in the last quarter, the growth momentum has been revived. What are the factors which have brought about this change?

In the last financial year (201516) our exports has grown by almost 10 per cent. For the most part, we operate in the generic sector of exports. The global generic market during the corresponding period has grown only by four to five per cent. Our generic exports have been continuously growing more than two times the growth rate of global generic

market which indicates that India’s generic share has been continuously improving.

In the financial year 2016-17, our generic exports have just touched the global generic market’s growth rate. This reduced performance is due to the fact that globally generic prices are coming down and many governments are imposing price controls on this sector. In-spite of our exports in terms of volumes has shown considerable growth, we could not register desirable growth by values.

The fact that during the last quarter of the calendar year 2016, India companies have bagged the highest number of ANDAs (almost 34 per cent of the total ANDAs granted in this quarter ) gives a lot of hope that India’s generic exports would be on course in the coming years.

Political uncertainty has created a lot of upheaval in global pharma markets. How will the Council help the industry cope with these challenges to keep up exports?

This would be a temporary phenomenon and most of the issues, except devaluation of currencies of certain countries vis-à-vis the US dollar (for example, Nigeria, and some other petroleum dependent countries of Africa and other continents), do not affect pharma exports. Exceptional growth which we normally experience in big markets like the US and Europe (for example we have registered over 10 per cent growth in exports of generics to the EU even in 2016-17 so far) would offset this decrease and keep a balance in such situations.

Which countries do you think Indian pharma companies should look for growth and why?

On the face of it, Indian pharma companies are looking at the entire global market place for growth in various therapeutic areas. Pharma companies would look for opportunities in finished formulations, APIs and

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intermediates besides emerging areas like excipients, bio-similars and medicals devices.

Let us look at the answer from a different perspective.

The global market place can be divided into three categories.

Highly regulated, regulated

and least regulated ones. The dynamics of regulations moves progressively towards more regulations as factors like emergence of local manufacturing, political sentiments, competition and many other such variables become determinants of the

directions of market forces.

The first way is to look at the market strategies of large companies. These companies look for growth and more consolidation in highly regulated market as the returns are high. The US, presently being the largest

export destination having over 30 per cent share of India’s overall pharma exports, will continue to be the market for growth for large companies in their strategic goals. The top companies would be more keen to introduce new products, joint ventures,

MARKET acquisitions and also opportunities in research and development.

Large companies on the strength of their regulatory compliance would also look towards Japan, presently the third largest market. Japan has opened up its generics market space. By 2018, it strives to increase the share of generics in its healthcare programme to 80 per cent.

The highly developed economy is looking for reducing the public healthcare budget.

Indian companies have a huge opportunity in Japan. They can explore partners for contract manufacturing and joint ventures.

Further, there is immense scope for API manufacturers.

Japan and India signed a Comprehensive Economic Partnership Agreement (CEPA) in December 2011 thereby giving a level playing field for Indian companies at par with Japanese companies.

Pharmexcil, since 2012, has been very aggressively promoting opportunities in the Japanese market besides taking every step to create a

Now heading Pharmexcil, my responsibility extends to facilitating India’s exporters to find overseas markets. In the course of conducting this primary responsibility, Pharmexcil may have to advise the industry to adopt certain changes in the standards of GMPs positive outlook towards Indian companies by engaging with top Japanese innovators, generic companies and regulators. Yes, Indian companies shouldn’t expect relaxation on regulatory compliances in Japan. The companies have to build compliance and capacity for the third largest market.

Countries in the EU shall remain in the strategic landscape for growth of large manufacturers from India in APIs and finished formulations. Areas of biosimilars and new product research will drive growth opportunities. India's exports

to the EU are presently over 21 per cent. In a nutshell, the highly regulated market having 55 per cent share of India’s export will continue to offer opportunities for large companies.

The low-hanging-fruit markets like Africa will be looked at by small and medium-sized companies.

Affordability and accessibility of products will be the dominating factors offering opportunities. Some of the African countries have also attracted investment in local manufacturing from Indian companies.

Top pharma companies are

consolidating their markets in Brazil and Colombia while medium and small companies are getting good opportunities in Central America and other South American markets.

Notwithstanding issues in Vietnam, it will remain a large market for Indian companies in the Eastern part of the world. Philippines too will be an attractive market place for growth. Government of India’s ‘The Look East policy' and formulation of more value integration strategy for CLMV (Cambodia, Laos, Myanmar and Vietnam) will provide immense growth opportunities.

How many buyer-seller meets are planned for this year and in which countries?

During the current financial year 2017-18, the Council is organising 12 buyer-seller meets in North America, Germany, Kenya, Myanmar, Peru, Colombia, El Salvador, Brazil, the UAE, Ukraine, Algeria and Nigeria.

Pharmexcil hosts iPhex in Mumbai every year so why is there a shift in location from Mumbai to Hyderabad this year?

The pharma industry is located mainly in the states of Maharashtra, Gujarat, Telangana and Andhra Pradesh. The Council has been organising iPHEX in Mumbai for the last four years, as it is one of the important cities for the pharma industry.

Government of India felt that it would be ideal to organise iPHEX in those states where pharma has a strong presence with an objective to showcase the Indian pharma capabilities to promote exports. u.sharma@expressindia.com

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MARKET I N T E R V I E W

‘We are trying to implement total automation across the supply chain’ Pharmarack, a health-tech start-up offering a subscription-based solution to revamp pharma industry's upply chain matrix, has caught the interest of marquee VCs like the Patni Group’s Currae Healthtech Fund and Unicorn India Ventures. Pradyumn Singh, Co-founder and CEO, Pharmarack elaborates on his solution’s ability to bring efficiency in the processes of pharma companies, increase their revenue and reduce costs, in an interview with Lakshmipriya Nair In an age of disruptions, how will your solution bring in a paradigm shift in the pharma industry's supply chain?

The entire pharma supply chain has not changed for the last 20 years from the technology perspective. When I say that, it means the last technology used by them was the billing software. So, what we are trying to implement is total automation across the supply chain. All supply chain players are awestruck since

they haven’t seen any techonology improvisation in the last two decades. Our impact/value through our applications is clearly seen on topline and/or bottom line, besides bringing in productivity and efficiency throughout.

What are the three major challenges in India's pharma supply chain? How can Pharmarack provide solutions to these challenges?

The pharma industry has seen

innovation in medicine and cures for deadly diseases through bioscience and medtech. But, if those cutting edge medicines and technologies do not reach the intended users on time, then the whole purpose fails. Even today, in a digital world, a pharma distributor works with the age old method of a pen and paper, which bring in a lot of inefficiency and leakages. We could easily gauge inefficiency in the supply chain. On one side

there are five per cent return goods due to expiry and other reasons while on the other side there are estimates that there is a parallel 25 per cent counterfeit medicine market of the overall India domestic pharma market. Our solutions delivered through technology directly address these challenges.

In an industry which has been wary of change, how has your solution been received?

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MARKET Two years back, when we tested the beta with some common friends in the industry, their feedback was encouraging. We fixed a few bugs, added more features as per the feedback and rolled it out commercially. I’m happy to share that this service didn’t require any large marketing investments from our side because the need for such a product already existed. Our product was lapped up in cities like Pune and Mumbai where we launched first. As we kept signing new users for the platform, it reached a point where educating our customers became a priority. Our customers are accustomed to old ways of maintaining registers to plan their supply

chain. Now we were giving them a technology in an app or a desktop version, so migrating to it and adopting it as a way of business was an organic challenge. We knew that our first few happy customers would convert into getting more on board, so in the early days, my co-founder and I went on client service calls to educate our customers and showed them the various features of our product. This initial legwork actually paved the way for more customer inquiries, whichgot converted successfully. We are now implementing technology solutions to engage with our users.

How are you tackling the

challenges faced from the industry?

The industry hasn’t tried any new technology in past 20 years, so initially it was a bit challenging to bring about a change. However, we feel lucky that we hit the sweet spot at the right time, not too early and definitely not late. We are pioneers in what we are trying to implement and lead this domain so far. Today, we have overcome the resistance phase due to our viral recommendations across India.

We get at least four to five leads daily, not only from India but also from other countries.

We have raised close to a million dollars from Unicorn India Ventures and Currae Health Tech Fund. The funds raised have been used to build our technology stack, making systems more intelligent at the back-end to give intuitive service to its users. We have used the funds to hire more talent, which has helped us expand into new geographies in four states – Maharastra, Gujarat, Andhra Pradesh and Karnataka. Currently, we have close to 800 distributors and 12,000 retailers using our product. Six companies are using our services.

You had raised funding last year, how has it fuelled your growth plans ?

Can you give us the number of subscriptions you have so far?

We have almost 800

distributors on board and we have a trial period for them. We have a pretty decent percentage of active users and subscribed users as compared to the industry standards.

How doesPharmarack enables firms to bring in cost and time efficiencies?

A large Mumbai-based pharma distributor has been with us for over a year. The said distributor has seen his supply chain costs going down by as much as 50 per cent and topline increased by 20 per cent in 9 – 12 months of going live on our platform.

Perhaps, that’s the reason our subscription renewal is 100 per cent. lakshmipriya.nair@expressindia.com

POST EVENT

IPATechnical Seminar emphasises on quality metrics and WHO-GMP The seminar held in Indore was attended by around 100 delegates, managers, corporate heads and entrepreneurs DUE TO economical cost of quality medicines manufactured in India, the US needs India more than India needs the US. This was stated by Ajit Singh, Chairman, ACG Worldwide, at the recently held IPA Technical Seminar in Indore.

The event was organised by Indian Pharmaceutical Association, MP State Branch and Industry Pharmacy division and Department of Pharmaceuticals, Government of India. The conference was attended by 100 delegates, managers, corporate heads and entrepreneurs.

The first day started of the seminar started over the theme, 'Quality metrics- Future need of the pharmaceutical industry for marketing drug products in the US market.

Addressing the delegates, Singh mentioned about various needs of the pharma industry.

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He emphasised the need of quality pharma products at affordable price for lower / middle class population in India.

Shobhit Koshta, Deputy Drugs Controller, FDA MP and Rajneesh Choudhary, State Licensing Authority, FDA MP were present as the Guests of

Honour.

Sanjay Kapadia, President Corporate Quality Assurance, IPCA Laboratories, opined about the importance of quality metrics as a tool to evaluate the pharma quality system. Sanjay Tiwari, VP, Sun Pharmaceuticals and Shantanu Chobhe, As-

sociate Director, Abbott Healthcare at the conference emphasised on the importance of quality culture which needs to be included by Indian pharma units to survive and thrive in international markets.

Vijay Kshirsagar, Director, TRAC Pharma Consulting,

Mumbai spoke about data integrity as an overridding factor for quality metrics. Vipin Sharma talked about US FDA guidelines for elemental impurities in pharma product.

The seminar was conducted and moderated by Sanjay Sinha, President Formulation,

MARKET wished the seminar a grand success. Brijesh Sharma, WHO Advisor, said that the government is working to accept the Indian Pharmacopoeia as book of standard as par with BP & USP by developing nations.

Sanjeev Kumar, Dy Drugs Controller (I), Central Drugs Standard Control Organization Sub Zone, talked in details about

tries regarding WHO-GMP.’ Around 200 participants working in small scale industry, academia and students took part in the seminar.

Dr GN Singh, Drugs Controller General (India) (DCG(I), informed that drug prices are being monitored by PM Office.

The guest of honour, Dr K Bangarurajan, Dy Drugs Controller (I),CDSCO, West Zone, informed that there is no shortage of stunt and the prices are monitored by government. He also talked about need of good laboratory practices and its complicate issues.

Koshta emphasised for better communication between the pharma industry and regulators for quality pharma products at affordable price. Rajneesh Choudhary, State Licensing Authority, FDA MP,

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® Registered trademark, Ashland or its subsidiaries, registered in various countries ™ Trademark, Ashland or its subsidiaries, registered in various countries / ©2016, Ashland AD-13749

IPCA Laboratories.

Sanjay Jain, President IPA, MP State Branch, Anil Kharia, General Secretary, IPA MP State Branch and Dr SB Rijhwani, Vice President, Industry Pharmacy Division also took part in the seminar. The first day of the seminar was conducted by Dr Sapna Malviya, Shivanshu Kharia, Dr Narendra Vyas and Shruti Suraka.

The second day of the seminar had the theme, ‘Expectation of regulators from indus-

the role of CDSCO. Dr SB Rijhwani, VP IPA Industry Pharmacy Division said that if the industry has to survive, regulations and expectations of regulators need to be understood. Anil Khariya delivered the vote of thanks and Dr Sapna Malviya and Shivanshu Khariya conducted the seminar.

Kiran Petkar of Ujjwal Prabha Consultants emphasised about the validation in WHO certification. Amit Saxena (WHO consultant) and Bhart Doshi (Doshi Consultants) elaborated on market complaints and CAPA and up gradation of existing unit for WHO certification respectively.

EP News Bureau

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We are.

We are passionate, tenacious solvers who thrive on developing practical, innovative, and elegant solutions to complex problems in drug delivery, always pushing the boundaries of what’s possible, and advancing the competitiveness of our customers. ashland.com/pharma

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efficacy usability allure integrity profitability™

cover)

IPR BUILDING BLOCKOR STUMBLING BLOCK?

With World Intellectual Property Day round the corner, Express Pharma explores the evolving IPR scenario in India and its impact on pharma companies

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(

THE MAIN FOCUS

Patent system only way to promote innovation Yogesh Pai, Assistant Professor of Law and Co-Director of the Centre for Innovation, Intellectual Property and Competition (CIIPC) at National Law University, Delhi counters the argument that the patent system is ‘broken’ by pointing out that although patents may not be necessary for innovation per se, they facilitate market-based transactions for converting useful ideas into products and help markets to value the entitlements by way of bargaining in the shadow of property rights

T

hat intellectual property protection - specifically patents, are extremely relevant in the context of global innovation, although heavily contested, is a foregone conclusion. The global R&D-based pharmaceutical firms by continuing to innovate new and useful medicines have helped reduce human suffering and increase the average global life expectancy. Similarly, the hitech industry has been extremely innovative in ushering the digital-tech revolution that we are all witness to. While it may be argued that the patent system may raise input cost for rival firms engaging in different kinds of technical innovation or that it may raise barriers for static price competition in healthcare thereby hindering access to the needy, it is difficult to conclude that the so-called ‘broken’ patent system has actually ‘harmed’ innovation per se. At least, such claims are often made by scholars and pundits who have criticised the patent system for impeding innovation- much in contrast to the objectives it seeks to foster!

So much has this narrative been mainstreamed over a period of time that a popular news paper The Economist did a cover story in August 2015 focussing on how the patent

system is a ‘rotten way’ of rewarding ideas! It can’t be anyone’s claim that the patent system is the only way to promote innovation. Also, to claim that patents are important to exante incentivise innovation is overstated in some industries.

However, the function of the patent system has been grossly misunderstood.

Patents as property rights help markets allocate optimal innovation incentives since price is the only signalling mechanism to facilitate exchange in the marketplace of ideas. Certain inventions are valued more than others in this process. Although patents may not be necessary for innovation per se, there is an important ex-post rationale for the existence of patents as property rights. They facilitate market-based transactions for converting useful ideas into products. The existence of patents does help markets to value the entitlements by way of bargaining in the shadow of property rights.

To replace property rules for valuing entitlements that currently forms the foundation of the patent system with any other system would require of us to make important choices of imposing forced coordination and non-market-based valuation of patented entitlements. As suggested by some scholars shifting pricing of as-

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Yogesh Pai, Assistant Professor of Law and Co-Director of the Centre for Innovation, Intellectual Property and Competition at National Law University

sets from an informed marketplace to uniformed regulators and by disturbing the organisational choices made by firms to facilitate market exchange of assets (thereby pushing them to become vertically integrated) are only among few consequences. In other words, men- bureaucracy, regulators and judges- will play ‘God’ to generate a pre-determined outcome (by both overcompensating or under- compensating inventors) instead of a rule-based market allocated outcome!

And yet, some scholars seem fascinated with the idea to replace the current private property-based patent system with a ‘regulatory type’ patent

system (and whatever that entails). The oft quoted criticisms against the patent system are that the high propensity to patent does not lead to correspondingly higher innovation and that many unclear parcels of property rights (patent thickets) operate to raise cost for rivals through litigious waste. Such patents are often enforced by Patent Assertion Entities (PAEs- pejoratively referred to as ‘trolls’) to generate monopoly rents as against ‘true’ innovators and manufacturers by engaging in opportunistic conduct such as patent hold-up (i.e. disproportionately claiming beyond the economic value of the actual contribution made by a patented technology) and royalty-staking (i.e. cumulative royalties for different patents leading to exorbitant prices for end products).

A constant concern in biotech has been the so-called phenomenon ‘anti-commons’, where it is claimed that innovation in the bio-drug industry could suffer due to coordination breakdown leading to socially sub-optimal innovation. Not that these claims could not be theoretically made. But there is little evidence to show that these issues are pervasive in the patent intensive industries.

This is also because markets

have shown resilience by engaging in private ordering and by relying on transactional solutions to help reduce such coordination breakdown. It is difficult to argue that such markets actually experienced any reduction in innovation or output notwithstanding the intensity of patenting activity.

Of course, one may always claim that in a ‘but for patents’ world, there could be ‘x’ amount of innovation, much higher than the marketallocated outcome. But the question is how would that be economically efficient outcome?

This is not to suggest that some firms may not wish to engage in heavy patenting behaviour. Or even when they do, they would enforce patents defensively or strategically rather than offensively to generate royalties. The incentives for such firms may be generated purely through secrecy, first-mover advantage or network-effects-often seen in platform markets. In fact, some firms may choose to voluntarily forfeit their assets by pledging patents. In the now famous article titled ‘The Hosts Dilemma’ published in the Harvard Law Review (2011), Prof Jonathan M Barnett has articulated that firms engage in a trade-off between Continued on Page 20

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cover ) Abalancing act Ashish Prasad, Partner, Economic Laws Practice Delhi, analyses IPR in India, elaborates on the need to evolve an effective IPR policy to encourage innovation without compromising public interest

Patent system only way to...

Continued from Page 19

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nnovation is integral to the lives of individuals as it has over the years turned complications into progress, thereby improving standards.

It has found a cure to diseases to which no cure was available, made tasks easier, found simpler solutions to problems, improved our knowledge, made our lives healthier, safer and more comfortable by improving availability of crops, drugs, medical procedures, appliances etc. To put it generally, innovation is developing a novel idea or concept to cause an improvement over existing knowledge or product to resolve problems faced by humans.

The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) which came into force on January 1, 1995 sets the minimum standards for Intellectual Property Rights protection for all members of the World Trade Organisation (WTO). It provides a framework for granting legal protection to new creations, innovations and technological advancements, thus incentivising innovators to invest in research and development of new products and processes.

The National IPR policy of India by promoting amongst others, innovation, licensing, technology transfers, patent pooling, cross sector partnerships, reducing API imports by incentivising manufacture of API in India etc. follows the TRIPS framework and attempts to provide for an enabling structure for new innovations.

At the same time, over the years there have been considerable debates amongst econ-

20 EXPRESS PHARMA April 16-30, 2017

Ashish Prasad, Partner, Economic Laws Practice Delhi

omists and policymakers regarding the development of the Intellectual Property Rights (IPRs) regime in order to balance public interest and the rewards to be accorded to the innovator. The pharma industry illustrates this conflict the best; need for the state to ensure that medicines are available and affordable by all and the interest of the pharma industry in engaging in continuous research and development for the invention of new drugs and medicines.

In India, this conflict of interest is manifested in the tussle between innovated drug manufacturers and manufacturers of generic/follow on products. Indian law and policy is designed to encourage generic drug manufacturers to develop and market follow-on drugs so that fruits of innovation are available to the masses at lower costs.

It is but natural therefore, that developed countries are calling for stricter implementation of tougher and more restrictive conditions in the

patent laws of the developing economies in the form of TRIPS-Plus provisions to curb the manufacture of generic drugs. One of the most prominent examples is pushing for protection under Article 39.3 on data exclusivity which disallows clinical trial data that is generated by the innovator company to be used by another company for obtaining approvals to market the generic versions of the drug for which the trial had been conducted.

Acceding to this provision can considerably delay the market approval as well as availability of generic versions of medicines for many years since this would require generic manufacturers to conduct clinical trials afresh. This would increase the cost of production of generic medicines leading to a higher price burden on the consumers.

As the tussle continues, multinational innovator companies have often knocked the doors of the judiciary seeking protection of their IPRs. The judiciary has in turn taken a nuanced stand and walked the fine line between the interest of the innovator and public interest. Recently, the Delhi High Court, while dealing with the first case on bio-similar approvals in India, between Roche and The Drug Controller General of India and well known Indian drug manufacturers (Mylan & Biocon) in its decision disallowed the right to question the approval granted by the DCGI in an appeal before division bench. The interim decision by the single judge had earlier denied the Indian manufacturers to market their product as a bio-similar to the drug innovated by

Roche. With another battle for bevacizumab already in courts, it appears that we are about to see the same pattern that was seen during the rise of the generic manufacturers. This decision has a far reaching impact on the pharma industry of India as the generic drug/biosimilar manufacturers would be encouraged to innovate and develop substitutable products in the interest of public. On March 8, 2017 in the case of Bayer v. Union of India the Delhi High Court held that export of drugs for the purposes of clinical trial was covered under the exemption as provided under Section 107 A of the Patents Act, 1970. The Indian judiciary has by far been able to set a well-reasoned standard, maintain equilibrium of obligations under the TRIPS, Patents Act and the social interest of the country.

It is now well known that the innovator pharma companies, in the interest of protecting their legitimate IP rights, adopt various strategies including delaying of the introduction of bio-similar/generic versions though litigation tactics. They have now realised the opportunity vesting with the generic market and have now sought to enter the generics’ market.

President Trump’s decisions to withdraw the TPP may have temporarily jolted the existing negotiations undertaken during President Obama’s regime. However, it may not be long before when India will be asked the same question again i.e. to give its consent to incorporate the TRIPS-plus provisions which would then affect the Indian pharma industry, especially the generic segment.

open and closed IP policies by being able to sustain revenues within the total consumption bundle of platforms and complementary goods and services. In his view, the markets reward generosity where ‘to win a platform race, the clever host must leave a substantial portion of total revenues to third parties that provide complementary goods. Conversely, the market punishes the selfish host that keeps too large a portion of market revenues for itself.’ Clearly, calibrating firm’s IP policies depending on the nature of the market to self-maximise is actually an efficient marketbased outcome. How far these conclusions support the pitch for substantial ‘reforms’ in the patent system in an attempt to ‘fix it’ by analogising it with some imaginative ‘regulatory’ mechanism is anybody’s guess!

Of course, this is not to suggest that the patent system is perfect. In fact, it has miserably failed to facilitate R&D in neglected diseases that disproportionately affect the developing world. We do need government interventions on a massive scale to support R&D in such cases. Perhaps we shouldn’t stop trying non-market based alternatives to the patent system like prizes, subsidies etc... Again, whether the state-supported R&D will replicate the success of the market in innovation without recourse to patents and market exchange is a difficult question. However, it is important to note that these alternative measures can only be in addition to the patent system and not by undermining it!

(Views are personal)

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Techniques to enhance IP valuations Dr Gopakumar G Nair, CEO, Gopakumar Nair Associates, gives an insight on why IP systems must support innovations by creating a conducive environment to attract investments, and must reward inventions with IP protection in return for disclosures

www.pharmalab.com

‘J

allikattu’ controversy can wait, IPR appears to be the new arena for the “bulls and bears.”

Intellectual property right (IPR) has come a long way since Paris Convention and other early treaties and conventions. The fundamental ratio, unanimously accepted, has always been a fine balance of rights (to inventors) and obligations (to users and the state). In recent years, post 1980s in particular, there has been intensive efforts and initiatives to exploit IPR to the hilt in favour of inventors (or assignees) often to the detriment of users.

Uruguay Round was conceived by the developed nations as an extension of this bull run, to use IPR as a trade barrier to rein in the trade growth potential of the third world countries.

The transformation of General Agreement on Tariffs and

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cover ) Trade (GATT) to World Trade Organisation (WTO) and incorporation of Paris Convention in trade-related aspects of IPRs, linking to WTO, was considered a smart move to control global trade. However, the emergence of BRICS and resurgence of Asia and Africa post WTO has cautioned the developed nations that mastering of IPs and working around IPRs are within the technological feasibility and reach of developing countries, such as India.

Intensive initiatives and techniques to enhance IP valuations and prolong the life of patents has been on the increase in last few decades, such as ever greening. Even though, exceptions/exemptions for healthcare and nutrition, encompassing pharma industry, generic alternatives for affordable access were incorporated in TRIPs Articles 7 and 8, these measures had not received adequate attention, till Doha Declaration of 2001. However, the Doha declaration itself was side-lined as not statutory till recently when in 2016, the Article-31bis has been introduced by WTO through an amendment of TRIPs. It is still considered too little, too late and too cumbersome to address affordable access to life saving medicines in third world countries. The first and only amendment of TRIPs (affordable access) was notified on December 6, 2005, and is available on https://www.wto.org/english/trato p_e/trips_e/wtl641_e.htm.

In the meantime, grant of a Compulsory Licence (CL) in India to Nexavar (Sorafenib), an anticancer drug for treatment of advanced renal cell carcinoma, generated a lot of heat and dust globally. The controversy gripped both groups for and against, so much so the CEO of Bayer (the innovator) stated in 2014 (post the grant of CL by India in 2012) that Nexavar was developed for “western patients who could afford it� and not for poor patients in India and other under developed countries.

This leads us to the cause

22 EXPRESS PHARMA April 16-30, 2017

and cost of innovation and drug discovery. Over the years, with increasing pharmacovigilance and Adverse Drug Resistance(ADR), the FDA has been raising the bar for approval of new drugs. Newly elected US President, Donald Trump has promised to bring down the drug approval costs and ease the norms in return for voluntary price reduction by USbased big pharmas. However, none of these are likely to happen. US FDA is not likely to drop or dilute safety-efficacyADR norms. Big pharma is not likely to voluntarily and drastically reduce costs.While admitting and advocating for adequate financial motivation through attractive returns for drug discovery research, it is essential to explore ways and means to strike an equitable balance. It can be done by evolving a voluntary parallel pricing mechanism for the poor patients of third world countries. Concerns of cross-border osmotic sales work against such options. By strategically evolving trade norms, parallel pricing models for patented essential medicines can be designed.

Medicines Patent Pool (MPP), backed public health initiative fully funded by UN had come up with an excellent model for addressing this vexatious affordable access concern. While MPP is currently reported to be managing over 100 HIV pharma projects globally, the MPP licensing is being extended to anti TB drugs and hepatitis C treatment. The recent voluntary licensing initiative in India by Gilead had used the MPP vehicle, initially for ART drug combinations and more recently for Sofosbuvir and others for hepatitis C treatment. Non-exclusive licence of Sofosbuvir (Sovaldi) by Gilead, to 11 Indian companies, is a welcome model.

Drug discovery and healthcare-based innovations are essential and need strong support and appreciation at all the levels. IP systems must support innovations by creating conducive environment to at-

Dr Gopakumar G Nair, CEO, Gopakumar Nair Associates

tract investments, to reward inventions with IP protection in return for disclosures. At the same time, taking the benefits of such breakthrough innovations to the needy patients is equally important.

Currently, the trend in patent protections are through excessive monopolies, exclusive global licensing and prohibitive uniform pricing, insensitive to the diversity and variance in patent populations spread across the globe and their purchasing power parity and economic status of communities.

India has been following its own model over the years. Being a leader in generic medicines, a large number of developing countries and least developed countries (LDCs) have been looking up to India to provide healthcare support and affordable access to life saving essential medicines in their countries. India, from the outset, during negotiations on the Dunkel Draft Treaty as well as in implementing the TRIPs flexibilities through WTOTRIPs compliant amendments to the (Indian) Patents Act, 1970, cleverly and compliantly incorporated all the available TRIPs flexibilities into the thrice amended Patents Act, 1970.

While Compulsory Licence (CL) is a globally accepted terminology which finds a place in almost all Patent Acts/ Statutes/ Code of Nations,

practicing of CL in the pharma/biotech healthcare fields have been receiving strong and aggressive counterreactions from big pharma and developed nations. Even though India had granted only one CL, India continues to be ranked lowest but one in the Global IP rankings by GIPC (This leaves a bad taste and poor impression not on India but on GIPC). Such bias and preconceived reverse-engineered approach towards India is also reflected in the Super 301 Report from US, year after year.

All this, in spite of the fact that between 2010 and 2016, India has created a world record (may be eligible for Guinness) in grant of ex parte / ad interim injunctions in patent infringement suits. Indian courts, especially Delhi High Court, has been liberally granting ex parte injunctions till 2016, just for the asking. In spite of the research exemption in Sec.107(A)(a), till recently no defendant was successful in preventing grant of injunction, simply because a Drug Approval Application has been filed with Drugs Controller General of India (DCGI)/CDSCO (Central Drugs Standard Control Organisation). The prima facie validity of the patent or a prima facie verification of infringement of the product or process is ignored or done away with while granting injunctions in patent infringement suits, exceptionally in India. A patent on tablet with multiple layer coating and at least 40 per cent of the solvent in the core (an impossibility) succeeded repeatedly against uncoated multi-layer tablets in the market place to obtain injunction and infringement status. A very narrow composition of iron complex infusion is being enforced against every generic dosage form of iron complex infections in the market place in a country where anaemia or iron deficiency especially among women and children is identified as the biggest healthcare concern. Currently, patent enforcement is at a record high

in India, even compared to US and Europe. In spite of all this, India is at the bottom of the IPR ladder, what a contradiction. On the contrary, the scenario differs in trade marks.

The current proposal from the Health Ministry to market generic medicines through Jan Aushadhi Stores and to bring new labelling and prescribing norms to emphasise generic names, substantially erodes the brand concepts for medicines and is irrevocably diluting value of trade marks and brands. To add insult to injury, leading globally recognised Indian brands like Cipla have been facing brand erosion and trade mark dilution. In a recent case, Cipla failed in invalidation against a copycat Cipla Engineering, while Cipla is a globally well-known mark. In conclusion, India had started well to enjoy full TRIPs flexibilities post WTO/TRIPs since 1995.

However, over the years, partly due to legal indoctrination and partly due to built-up fear of Super 301 and other threats, India has been going overboard in patent enforcement through liberal ex parte injunctions.

While India has been very worried about TPP, it is heartening to note that the Trump Administration has resolved the concern by burying the TPP. India has also been adversely affected by the data integrity issues, which of course, is not related to the data exclusivity conundrum and allegations of big pharma. India need to seek more liberal voluntary licensing of essential medicines on non-exclusive basis. If licensing is the order of the day in copyrights, trademarks and other forms of IP, why not in pharma patents?

Why not consider pharma patents in third world countries as Standard Essential Patents (SEPs) for healthcare and affordable access to life saving medicines for poor patients in developing countries and LDCs? Of course on fair, reasonable, and non-discriminatory terms (FRAND) terms of adequate remuneration and equitable royalty to the innovator.

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On the right track Ashwin Sapra, Partner, and Biplab Lenin, Consultant, Cyril Amarchand Mangaldas, give an insight on how adequate research and development, intellectual property protection protocols and enforcement strategies in place, the Indian pharma industry is expected to achieve new heights

I

nnovation is the root of success in the competitive world of today. Creativity that stems from the intellect manifests itself into new ideas and technologies. New technologies when adopted make life easy. This could not hold greater truth than for the pharmaceutical industry.

With the Indian pharma industry en route to becoming a major player in the global market by 2020, the sector currently shows significant promise and opportunity domestically as well as internationally. The industry is expected to become a $55 billion and exports are likely to touch $20 billion by 2020, as per a joint study by Associated

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cover ) Chambers of Commerce & Industry of India (ASSOCHAM)TechSci Research. Indian drug companies have played their part and have established their presence on the global stage.

There is increased activity in terms of investments in research and development, access to world class healthcare at affordable rates for the public at large and a renewed focus on development in the rural markets. The market is huge and has unlimited potential. The government has also played its role in terms of actions take with respect to relaxing approval requirements for foreign investment in brownfield entities (by allowing 74 per cent foreign direct investment under the automatic route), the forecast is for an increase in the number of associations between domestic and foreign players in the sector. The sectoral outlook has never been more positive.

Innovation leads to progress. That is a good thing.

However, an inventor of a new product or a process would stand to lose if his/ her invention is not afforded the right level of IP protection. An IP right granted under law gives the inventor the right to derive commercial benefit from his/her efforts. Though patent law in India has existed over the years, jurisprudence related to pharma patents, is still developing. From granting product patents, to specifically identifying patentable subject matter and incorporation of provisions for compulsory licensing, the law has come a long way since its inception.

With India’s accession to TRIPS, a conscious effort has been made to ensure that our laws are TRIPS compliant while supporting a larger initiative to ensure that life saving medicines are available at affordable prices (compulsory licensing, price control etc.).

While disputes between patent owners and infringers abound, courts in India are getting increasingly sensitive to the complex and technical issues that form the pith and

24 EXPRESS PHARMA April 16-30, 2017

Ashwin Sapra, Partner, Cyril Amarchand Mangaldas

Biplab Lenin, Consultant, Cyril Amarchand Mangaldas

substance of complex pharma patent litigation. Patent litigation turns on opinion of experts and evidences, which are often absent at the preliminary stages of litigation especially the interim injunction stage and as such the practice of passing ex-parte interim injunctions has given way to a more rational and balanced approach, wherein questions of prima facie infringement, balance of convenience and irreparable injury of the parties are weighed, analysed and rationalised along with a larger public interest perspective.

Parties are going guns blazing at the interim injunction stage with a view towards hitting each other where it hurts the most i.e putting a roadblock in the opponent’s business and then strategising systematic delays to ensure that the hurt caused never heals. The Supreme Court has time and again insisted that patent matters should be handled on an expedited basis especially where issues of public health, access of life saving drugs and commercial interests are involved and that matters should expeditiously head to trial.

Courts are thankfully paying heed to this. Times are changing.

Though India has been accused of judicial pronouncements that are pro generic and anti innovator, the accusation

is not largely true given that there have been instances where the courts have supported the patent owners, however, such cases have turned mostly on technicalities. The law is still developing and there is hope that the courts would balance enforcement of statutory rights, socio-economic requirements and existing law with international obligations and the current push for greater investment in the sector. In the last decade, particularly after formation of the Intellectual Property Appellate Board (IPAB), we have seen a number of cases filed and adjudicated in India particularly relating to invalidation of granted patents, although, the number of cases are low when compared to the developed nations.

The Supreme Court’s judgement in the Novartis case gave rise to a general perception that India is no longer a country that respects and protects patent rights of innovators. India has time and again argued that it is fully TRIPS compliant and advocated against TRIPS PLUS provisions. India has done what any developing nation would do – amend its laws to comply with its international obligations under TRIPS to a degree whereby its compliance is exact. Not more, not less, but exact. India is TRIPS compliant in the background of the need to provide cheap and

readily available drugs to the public at large. The move has been welcomed by most developing nations as they now look at India as an example of how domestic laws can be tweaked to ensure international compliance obligations whilst ensuring that domestic requirements are kept at a priority.

This has caused many innovators to seriously rethink their India strategies and also take their woes to international forums where India’s presumed anti innovator patent regime has been a subject matter of many debates. These debates continue at a national and international level and raise significant questions on the issue of balancing national interests against the backdrop of the current trend of economic reforms which are increasingly looking at attracting foreign investment into India. Will the government’s push for increased foreign investment shadow its responsibility towards the citizens or will it tow a median path? A question that is pertinent.

The Trump administration has hinted that free and open trade will be pursued cautiously. Though India is yet to specifically figure in any particular policy document or comment in terms of IP rights, given the administrations focus to keep America first, one can expect a tightened outlook towards protecting US interests in as far as IP rights are concerned. However, it would most likely be a median line drawn given the administrations objective at giving cheap medicines to the American people which would be a welcome sign for Indian generics given that they are still amongst the cheapest in the world in terms of drug pricing. All that remains to be seen is whether President Trumps IP policies will be India inclusive or India exclusive.

The UK shook the world with its decision to exit from the EU. This has gives rise to concerns for players from the India pharma sector given large interests in the form of

acquisitions, research and development agreements, supply and distribution agreements and some manufacturing arrangements with UK-based partner companies. The Indian pharma industry, being one of the major exporters to the UK, will certainly be affected. It is, however, largely dependent on the success of this move as the UK will have two years to negotiate its exit, during which key issues would be visited and renegotiated. Uncertainty looms, however, given that the UK has a government funded public health system, the focus is likely to be on cheaper drugs, cheaper R&D processes as the UK looks out for economical collaborations.

A report published by the Global Intellectual Property Center, US Chamber of Commerce places India on the 43rd position out of 45 countries. India continues to make up the bottom end of the list given its tough stand on not allowing incremental innovations, focus on providing cheap drugs and its slow legal system. A stumbling block? Or factor driven by need? As a developing nation, India is also carving out exceptions when it comes to need of the public at large and any urgency situations. Also, being a developing nation, affordable healthcare will continue to play a vital role in the near future.

India has updated all its IP laws to comply with its international obligations and has also invested in infrastructure at the four patent offices in India to accommodate such changes and facilitate faster and smoother patents prosecution.

There have been many cases and precedents in the last few years wherein courts in India have protected interests of patent owners and granted injunctive reliefs in infringement related cases. However, cases where public interest has been considered paramount are also present. It is a mixed bag. With a view towards reducing the burden on the courts, the government has introduced, The Commercial Courts, Commercial Division and Commercial

( Appellate Division of High Court Act, 2015(CC Act). Intellectual property disputes have been categorised as commercial disputes. The law lays down strict timelines so as to reduce the overall litigation timeline and it is expected that that proceedings before such commercial courts would take significantly less time. The rights moves are being made.

With adequate research and development, intellectual property protection protocols

the pharma sector should derive comfort from the fact that the genesis of the Patents Act in India is in consonance with international practices and enforcement strategies in place, the Indian pharma industry is expected to achieve new heights. With the initiatives like ‘Make in India’ campaign, the Indian government is pushing reforms in the innovation domain. Also, the Government of India has approved the ‘The National Intellectual Property Rights (IPR) Policy’ which aims at ‘Creative India; Innovative India.’ We have recently seen few measures such as appointment and training of patent examiners and more pro-active amendments and actions by the patent office on issues concerning applicants and attorneys.

With all these positive measures, the pharma industry and healthcare at large is gaining momentum to consolidate its existing position and record unprecedented growth.

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With more than 3000 pharma companies, India is slowly making its presence and emerging as a significant player in the world market. India has already positioned itself to compete with the coun-

terparts of developed nations.

As a take home, the pharma sector should derive comfort from the fact that the genesis of the Patents Act in India is in consonance with international practices. Even though public

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interest and access to healthcare has become the mainstay of policy formulation and judicial interpretation, the balancing act of adopting international practices and standards for protection of patents and

promoting innovation has gone a long way in maintaining India’s reputation of being the 'Pharmacy of the World' and its international obligation and commitment of being a level player in a level playing field.

cover) Hedging against uncertainty in the IPR Regime: Contractual protections Anay Shukla, Lead, Pharma Healthcare team, Darren Punnen, Member, Pharma Healthcare team and Vidya Phanse, Intern, Nishith Desai Associates, discuss contractual strategies that companies engaged in IP-oriented businesses may employ to exploit their IP, without fearing its unauthorised use by a business partner

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ndia is certainly witnessing a change in its intellectual property (IP) policy and regulatory framework. The government published its National Intellectual Property Rights Policy in 2016, which formalised the government’s intention to push Intellectual Property Rights (IPR) as a marketable financial asset. Contrary to popular perception, it was not just lip service. The government walked its talk by introducing a slew of reforms over the last year as well as this year. For instance, it amended the Patent Rules, 2003 and allowed 'Tatkal' or expedited patent examination, which should significantly reduce the overall time-frame for grant of a patent. Similarly, the Trade Mark Rules, 2017 have adopted rationalised procedures such as e-service of documents, which should significantly reduce time required to obtain a trade mark.

Despite consistent efforts of the government, India does not score high on international scale for IP recognition and protection. For instance, India has reportedly remained almost at the bottom of the U.S. Chamber of Commerce-International Intellectual Property Index for four years in a row. Similarly, the Global Intellectual Property Centre (GIPC) index on IP standards has placed India at the bottom of 45 countries. The official US government statement on the state of IPR protection and enforcement in India reportedly reads as follows: “India also remains on the Priority Watch List this year (2016) for

26 EXPRESS PHARMA April 16-30, 2017

Anay Shukla, Lead, Pharma Healthcare team, Nishith Desai Associates

Darren Punnen, Member, Pharma Healthcare team, Nishith Desai Associates

Vidya Phanse, Intern, Nishith Desai Associates,

lack of sufficient measurable improvements to its IPR framework despite more robust engagement and positive steps forward on IPR protection and enforcement undertaken by the Government of India.”

This apparent contradiction may cause uncertainty in the mind of the reader about whether or not to trust the IP framework of India for doing IP oriented business in India.

One way to overcome the apparent uncertainty regarding protection and enforcement of IPR is to use the time-tested contractual law framework. In this article, we will be discussing some contractual strategies that companies engaged in IP-oriented businesses may employ to exploit their IP, without fearing its unauthorised use by a business partner.

The most important contractual strategy is the use of a non-compete provision. A noncompete provision essential stops a party to a contract from

competing in the field of business of another party. In the context of this article, this provision could come handy in a scenario where a company fears that its patent may not be recognized or invalidated during the term of the agreement. In such a situation, a non-compete provision enables such a company to restrain the contracting party, which has signed a non-compete agreement, from conducting business in the field of the company.

However, it should be remembered that non-compete provisions have their own limitations. They have been proven to be enforceable during the term of the agreement. However, enforcement of non-compete provisions after the expiry of the term of the agreement may or may not be successful depending on the facts of the case. If the intention is to restrain a company after expiry of term, then it is recommended to ensure that the other company

has accepted that the information, that is essential to exploit the IP, is confidential to the company. It may be possible to prevent the contracting party from transferring or disclosing such confidential information to third parties after expiry of term, provided such information was not known to the other company prior to the contract and is not known to the public.

Another limitation of the non-compete provision is reasonability. It is to be remembered that a non-compete provision is not an agreement to refrain from doing profitable business in its entirety, but simply an agreement not to compete with the existing business of the company. Therefore, noncompete provisions should always be limited in scope, necessary in requirement and tight in language. Unreasonable noncompete provisions are not enforceable.

A common contractual strategy to negate the effect of invali-

dation of patent or trademarks is to define IP as broadly as possible. Therefore, even if one of the corresponding IPR is invalidated, unenforceable or found to be non-existent by a Court, a company can rely on IPRs emanating from other IPs. For instance, an Indian court has held that royalties cannot be collected once a patent has expired or has ceased to exist. In addition, Indian patent law allows a licensee of a patent that has seized to be in force, to conclude the license arrangement after giving the licensor three months’ notice. In such as case, defining IP under any agreement to be limited to only the 'patent', would effectively end the ability of the company to legitimately be paid. However, if the IP is defined broader to include other IPs such as knowhow which will survive invalidation of the patent, the contracting party would be obligated to pay the company for the use of its IP despite invalidation of its patent.

There are many other such innovative contractual strategies that pharma and medical device companies are employing today to successfully do business in India, in order to hedge against the uncertainties in its IPR framework. In this way, even as the IPR regime in India continues to evolve for the better, companies can ensure that they can continue to optimally conduct business in India.

As it is commonly said, “when a door closes, look out for the window that opens!”

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THE MAIN FOCUS

The Bt cotton saga Rajeev Kumar, Partner, LexOrbis provides a commentary on the facts and questions of law that are raised in the current Bt. cotton patent infringement suit filed by Monsanto against its ex-licensee Indian seed companies

T

here have been extensive the registered trademarks by the discussions in India redefendants amounted to infringelated to genetically modiment of its IPR. The main issue fied plants, especially that was addressed by the plainwith respect to their acceptabiltiffs was the infringement of the ity within Indian agro ecosystem patent 214436, especially claims 25and on environmental impact.

27. Claim 25 of IN 214436 is diBt. cotton, however passed rected to a nucleic acid sequence, through those tests and by 2002 which when expressed in a plant it was the only genetically modi- Rajeev Kumar, cell, exhibits bollworm resistance fied crop that was allowed for Partner, LexOrbis trait. The infringement is alleged commercialisation by the because the seeds produced and Supreme Court in India. The result of in- sold by defendants contain the patented troduction of Bt. Cotton, particularly the nucleic acid. integration of the Bt. trait in locally develThe questions raised by the defendant oped proprietary cotton varieties devel- seed companies before the Delhi High oped by the Indian seed companies was Court were twofold. One, whether the terphenomenal. Today, the Bt. cotton crop mination of the sub-license agreement by forms almost 95 per cent of cotton grown Monsanto on the ground of non-payment in India. of the agreed trait value by the defendant Monsanto, the developer of the Bt. trait was legally tenable in view of the fixation in the US, through its joint venture in In- of the trait value by respective state govdia Mahyco Monsanto Biotech (India) Ltd. ernments, and secondly, whether the de(MMBL), sub-licensed the Bt. trait to velopment and sale of a cotton variety many Indian seed companies to develop (containing a nucleic acid), wherein a variand sell local varieties which contained the ety /seeds are barred from patent, can still said trait. For this purpose, Monsanto pro- be considered as infringing a claim on the vided 50 seeds of Bt. cotton variety to the nucleic acid contained in those seeds. The sub-licensee companies in consideration finer question is, can the patent rights be of an upfront payment and also bound the extended (directly or indirectly) to provide said companies to pay trait value on sale protection over those subject matters of Bt. cotton hybrid seeds in India. The which were expressly excluded from the trait value, thus payable by the seed com- purview of patent protection. panies to Monsanto significantly inThese issues would be decided if and creased the price of cotton seeds in India when the case moves to full trial. But at the leading to the intervention of the state interim stage, on March 28, the Single governments. Several state governments Judge Bench of the Delhi High Court has enacted laws and issued notification to fix found that the termination of the sub-lithe maximum selling price of cotton seeds, cense agreement by MMBL was illegal and keeping in consideration of trait value, arbitrary. The Single Judge accordingly, payable by seeds companies to Monsanto. modified its earlier order of injunction, and Disputes arose between the parties with directed for restoration of the sub-license regard to trait value and Monsanto termi- agreement between the parties with modnated the sub-license agreements of the ification of trait fee payable by the defendefendants and filed the civil suit C.S. dants to MMBL. (Comm.) No. 132 OF 2016 on the cause of Monsanto appealed the decision of the actions for infringement of its patent and Single Judge and a Division Bench of the trademark and passing off.

Delhi High Court on April 10, stayed the Monsanto contended that, once the restoration of the sub-license agreement. sub-license agreement has been termi(As the case is sub judice, the article is a nated, the use of patented invention and commentary on facts and not a view point)

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EXPRESS PHARMA

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April 16-30, 2017

RESEARCH UPDATES

Sanofi’s Toujeo shows reduction in blood sugar and hypoglycemia: Study In the DELIVER 2 study, after six months, patients who switched to Toujeo experienced 33 per cent fewer hypoglycemic events versus those who switched to other basal insulins, without compromising blood sugar control

S

anofi announced the presentation of a new observational study1 in real-world clinical practice demonstrating significantly lower risk of hypoglycemia without compromising blood sugar control in patients with type II diabetes (T2D) using basal insulin who switched to Toujeo (insulin glargine 300 Units/mL) when compared to other basal insulins. The results of the study were presented at the Endocrine Society 2017 Annual Meeting (ENDO 2017) in Orlando, FL, US. A previous real-world observational study2 (DELIVER 1) assessed the change in HbA1c (average blood sugar levels) and occurrence of hypoglycemia in 881 patients, based on electronic medical records up to six months after switching to Toujeo from another basal insulin. This new observational study (DELIVER 2) analysed electronic medical records for 1,894 patients in two matched cohorts.

The comparative study assessed the HbA1c change, occurrence of hypoglycemia (identified by ICD-9-CM/ICD10-CM and/or plasma glucose level = 70 mg/dL) and hypoglycemic events related to inpatient or emergency department (ED) visits with Toujeo versus other basal insulins (insulin glargine 100 Units/mL, insulin detemir and insulin degludec).

In the DELIVER 2 study, after six months, patients who

28 EXPRESS PHARMA April 16-30, 2017

switched to Toujeo experienced 33 per cent fewer hypoglycemic events (event rate per 100 patient-months: 5.32 vs. 7.98, respectively; p<0.01) versus those who switched to other basal insulins, without compromising blood sugar control. In addition, patients who switched to Toujeo showed a 48 per cent reduction in hypoglycemic events related to inpatient or ED encounters (event rate per 100 patient-months: 1.97 vs. 3.82, respectively; p<0.01) versus other basal insulins.

“With these DELIVER 1 and 2 studies conducted in a real-world setting, we see treatment with Toujeo leading to less hypoglycemia without compromising blood glucose control,” said Lawrence Blonde, MD, Director of the Ochsner Diabetes Clinical Research Unit, in the Frank Riddick Diabetes Institute at the Ochsner Medical Center-Jefferson Highway, New Orleans, LA, US and a co-author of DELIVER 2. “Of particular importance is the lower observed rate of hypoglycemic events related to inpatient or emergency department encounters.”

“Hospital visits are a major contributor to the overall cost of care for people with diabetes, so the lower rate of related hypoglycemic events is particularly interesting.

These consistent results increase the body of evidence on the use of Toujeo in people with type II diabetes from ob-

Sanofi is conducting a programme, unique in diabetes, of three randomised, prospective real-life clinical studies with Toujeo

servational studies. While randomised clinical trials provide the highest level of evidence, comparative data from real-world observational studies can be relevant for payors and other organisations evaluating how findings from clinical trials can translate into routine clinical practice,” said Riccardo Perfetti, Head of Global Diabetes Medical Team, Sanofi. “Sanofi is committed to going beyond traditional models to conduct further studies to assess Toujeo, combining the broad populations, and type of interaction between healthcare professionals and patients seen in routine care with the rigorous methodology of clinical trials.

The randomised Real Life

Study programme will provide further evidence that directly reflects Toujeo’s performance in standard clinical practice.”

Complementing these observational studies in routine clinical practice and the EDITION programme of Phase 3 clinical trials, Sanofi is conducting a programme, unique in diabetes, of three randomised, prospective real-life clinical studies with Toujeo.

These studies, called Achieve Control, Reach Control and Regain Control, involve more than 4,500 people with type II diabetes across the US and Europe who are starting basal insulin treatment or switching from another basal insulin. In addition to clinical measures,

the studies will also collect patient feedback on treatment satisfaction and their experience of hypoglycemia, along with impact on healthcare resource utilisation. Initial results are anticipated later in 2017.

The DELIVER 2 retrospective observational study used data from the Predictive Health Intelligence Environment (PHIE) database of US real-world electronic medical records (representing 26 integrated health delivery networks). Included patients were adults with type II diabetes using basal insulin, with data for 12 months prior to (baseline) and 6 months after (follow-up) switching to either Toujeo or other basal insulins.

The study used a matched cohort model, based on baseline demographics and clinical characteristics, and analysed outcomes for 947 patients who switched to Toujeo alongside 947 who switched to other basal insulins (insulin glargine 100 Units/mL, insulin detemir or insulin degludec). Outcome assessments included reduction in HbA1c from baseline, HbA1c goal attainment (<7.0 per cent and <8.0 per cent) and incidence and event rate of hypoglycemia (identified by ICD-9CM/ICD-10-CM and/or plasma glucose level = 70 mg/dL).

These findings represent actual prescribing patterns and clinical outcomes outside the confines of a clinical trial, which might include drug use outside FDA-approved prescribing information. As a result, reporting of hypoglycemia at baseline and in both treatment arms were not based on self-monitored blood glucose, which could result in less severe events not being reported by patients.

Mean baseline HbA1c was 8.89 per cent in the Toujeo cohort and 8.91 per cent in the other basal insulin cohort, and levels decreased significantly to 8.42 per cent and 8.50 per cent, respectively, during the six-month follow-up period (p<0.01 for both).

After six months, patients who switched to Toujeo experienced 33 per

cent fewer hypoglycemic events (event rate per 100 patient-months: 5.32 vs.

7.98, respectively; p<0.01) versus those who switched to other basal insulins (difference: -2.67 events per 100 patient-months; p<0.01) A similar trend was observed for hypoglycemia related to inpatient or emergency department (ED) encounters (event rate per 100 patientmonths: 1.97 vs. 3.82, respectively; p<0.01).

Significantly lower hypoglycemia risk was also seen at three months of follow-up among patients who switched to Toujeo.

References 1. Zhou FL et al, Lower Risk of Hypoglycemia after Switch to Insulin Glargine 300 U/Ml (Gla-300) Vs Other Basal Insulins in Patients with Type II Diabetes (T2D) on Basal Insulin in Real-World Clinical Settings (DELIVER 2 study), Poster presentation LB SUN 81, Endocrine Society 2017 Annual Meeting [ENDO 2017], Orlando, FL, US. 2. Ye, F et al, Real-World Assessment of Patient Characteristics and Clinical Outcomes of Early Users of the New Insulin Glargine 300U/mL, Poster presentation 943-P, American Diabetes Association 76th Scientific Sessions, New Orleans, LA, US Saturday, June 11, 2016.

EP News Bureau

Teva wins FDA approval for Huntington’s drug FDA approval was based on results from a latestage study of the drug, Austedo, in reducing chorea in patients with Huntington's disease ISRAEL-BASED Teva Pharmaceutical Industries said the US Food and Drug Administration had approved its drug to treat chorea stemming from Huntington's disease, a fatal degenerative disorder.

Chorea is an abnormal, involuntary writhing movements disorder that occur in 90 per cent of Huntington’s disease patients at some point in the course of their illness.

The company recently said that the FDA approval was based on results from a late-stage study of the drug, Austedo, in reducing chorea in patients with Huntington's disease.

Huntington's disease is an inherited condition that causes the progressive breakdown of nerve cells in the brain, resulting in a gradual decline in motor control, cognition and mental stability.

Analysts forecast annual sales reaching $850 million by 2023 for Teva’s Austedo, according to Thomson Reuters data.

Teva, the world's largest generic drugmaker, said on May 31 that approval for the drug had been held up by US regulators seeking further blood study.

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Reuters

EXPRESS PHARMA

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April 16-30, 2017

RESEARCH

Vaccinating pregnant moms protects Drug spun off newborns from whooping cough byAstraZeneca Babies whose mothers got the Tdap booster vaccine for tetnanus, diphtheria and pertussis were 91 per cent less likely to get whooping cough during the first two months of life THE BACTERIA Bordetella pertussis causes whooping cough, which gets its nickname from the sounds patients make as they gasp for air during intense coughing fits. Pertussis is highly contagious and easily spread when an infected individual coughs or sneezes.

About half of babies under age one who catch pertussis require hospitalisation for serious complications like pneumonia or brain disorders.

For the study, researchers examined data on almost 149,000 infants born in California from 2010 to 2015.

They found babies whose mothers got the Tdap booster vaccine for tetnanus, diphtheria and pertussis were 91 per cent less likely to get whooping cough during the first two months of life, a critical period before US infants typically get their first dose of the pertussis vaccine.

“It’s very important for pregnant women to get vaccinated,” said lead study author Dr Nicola Klein, Kaiser Permanente Vaccine Center in Oakland, California.

“It’s an extremely effective vaccine to protect babies before they are able to get vaccinated on their own,” said Klein.

Health officials in many countries recommend vaccination during pregnancy, as well as a series of three shots for infants starting sometime between six weeks and three months of age.

Some countries also recommend that women get vaccinated during each pregnancy because effectiveness of the shot wanes over time.

Kaiser Permanente, where all the babies in the study were born, started encouraging Tdap vaccinations for pregnant women in 2010 after a whooping cough outbreak in California. In early 2013, the US Centers for Disease Control and Prevention recommended that all pregnant women get the Tdap shot, regardless of whether they previously had received this vaccine.

From 2006 to 2008, before these recommendations came out, less than one per cent of babies at Kaiser hospitals had mothers who got vaccinated during pregnancy, the study found.

30 EXPRESS PHARMA April 16-30, 2017

Health officials in many countries recommend vaccination during pregnancy, as well as a series of three shots for infants starting sometime between six weeks and three months of age

At the start of the study in 2010, about 12 per cent of babies had vaccinated mothers. By 2015, 87 per cent of infants had vaccinated mothers.

Babies whose mothers got the vaccine during pregnancy had a 69 per cent lower risk of whooping cough in their first year of life, even after accounting for the effects of whooping cough vaccines the infants got starting at two months of age, researchers report in Pediatrics.

The study wasn’t a controlled experiment designed to prove that the vaccinating pregnant mothers protects babies from whooping cough, the authors note. Because most women who did get shots during pregnancy received them around the same time, the study also can’t help determine the optimal point in pregnancy to vaccinate mothers.

Still, this is the first study to provide very strong evidence that vaccinating pregnant women protects their babies, especially during that critical first two months of life when infants haven’t received their own dose of the vaccine, said Dr Yvonne Maldonado, a paediatric infectious disease researcher at Stanford University School of Medicine in California, who wasn’t involved in the study.

In addition, the findings should ease concerns that vaccinating women during pregnancy might make the infants’ vaccinations at two, four and six months less effective, Maldonado said by email.

“This study demonstrated that this was not the case, and in fact there appears to be a benefit from maternal Tdap even after infant immunisation,” Maldonado said.

Not all women are getting this vaccine during pregnancy, and if their doctor doesn’t offer it they should ask, said Julie Leask, a public health researcher at the University of Sydney in Australia who wasn’t involved in the study. “The data further strengthen the case for pregnancy vaccination as the ‘first dose’ of vaccination in babies,” Leask said by email.

Reuters

shows promise in hot flashes The new drug targets receptors in the brain and offers a different, non-hormonal approach AN EXPERIMENTAL drug spun off by AstraZeneca last year to an unlisted US biotech firm could cut menopausal hot flashes by nearly three-quarters, according to results from a small midstage clinical trial.

The British drugmaker licensed rights to the medicine, which is given as a pill, to Millendo Therapeutics as part of its strategy to divest non-core drug development.

Findings published recently in the Lancet medical journal suggest the arrangement is working well for Millendo, which is backed by venture capitalists. AstraZeneca also holds a stake in the company.

The drug, known as MLE4901, works in a novel way by blocking a chemical called neurokinin B. Hot flashes or flushes, also known as vasomotor symptoms, have been a problematic field for drug research.

Hormone replacement therapy can help some women but the therapy can increase the risk of breast cancer and blood clots.

The new drug targets receptors in the brain and offers a different, non-hormonal approach.

The Phase II study funded by Britain’s Medical Research Council and the National Institute for Health Research, found 28 women who suffered seven or more hot flashes a day could cut episodes by up to 73 per cent with MLE4901, as well as reducing their severity.

Researchers now need to see if the drug, which is also being tested for polycystic ovary syndrome, is safe and effective over the long term in a larger group of patients.

Reuters

RESEARCH

Anorexia nervosa diagnosis more common in women with celiac disease Anorexia nervosa is an emotional disorder that involves an obsessive desire to lose weight by refusing to eat WOMEN WITH celiac disease may be more likely to also be diagnosed with the eating disorder anorexia nervosa, researchers suggest. In a nationwide study, a diagnosis of anorexia nervosa was more likely both before a celiac disease diagnosis, and afterward.

“Before this study, there have been published a few small ‘case reports’ of patients with celiac disease developing eating disturbances after their celiac disease diagnosis,” said lead study author Dr Karl Marild, a researcher at the University of Colorado in Aurora.

“This, however, is the first large study to show an association between celiac disease

and anorexia nervosa,” Marild said by email.

Anorexia nervosa is an emotional disorder that involves an obsessive desire to lose weight by refusing to eat.

Celiac disease is an autoimmune disorder in which consumption of the gluten protein in wheat, barley or rye leads to damage of the small intestine and problems with absorption of nutrients from food.

The two disorders sometimes share similar symptoms, like fatigue, abdominal problems, discomfort after eating, excessive weight loss and an inability to absorb certain nutrients.

For the study, researchers examined data collected from

1987 through 2009 on almost 18,000 Swedish women diagnosed with celiac disease and roughly 89,000 women around the same age who didn’t have the autoimmune disorder.

After a celiac disease diagnosis, women were 46 per cent more likely to be diagnosed with anorexia nervosa, researchers report in Pediatrics. After an anorexia diagnosis, women had twice the odds of a later diagnosis of celiac disease.

More specifically, each year during the study period, a new diagnosis of anorexia nervosa was made in about 0.03 per cent in women with a diagnosis of celiac disease, compared to about 0.02 per

cent in women without celiac disease.

Also, the researchers report, nearly 0.2 per cent of women with celiac disease had been previously diagnosed with anorexia nervosa, compared to only about 0.1 per cent of women in the study who didn’t have celiac disease.

The study wasn’t a controlled experiment designed to prove that celiac disease causes anorexia, or that the reverse is true, the authors note.

It’s possible that at least some patients were initially misdiagnosed with one disease when they had the other disorder, the researchers point out. At least some of the

overlap in diagnoses of both conditions might be explained by what’s known as 'surveillance bias,' or the fact that women being closely monitored due to one issue with eating might be more likely to be evaluated for another foodrelated health problem.

In addition, dietary restrictions prescribed for celiac disease might trigger an obsessive eating pattern that leads to anorexia, Marild said. The potential for misdiagnosis may be particularly important in treating teens, Dr Neville Golden, an adolescent medicine researcher at Stanford Children’s Health in California writes in an accompanying editorial.

Reuters

PACKAGING SPECIAL PRODUCTS

Bosch launches new KLVseries for leak detection of rigid containers CCI portfolio completed

T

he Bosch subsidiary Pharmatec supports customers with suitable equipment during biotechnological drug production. The pilot fermenter on show at Interpack is suited for both laboratory and industrial manufacture of pilot batches for cell cultivation, for instance for the use in cancer medication. Thanks to different mixing technologies, it processes batches between eight and 50 litres.

Via scale-up, batch sizes can even be increased to 200 litres.

New ALF 5000 standalone version for vials For production-scale filling and closing of liquid pharmaceuticals, Bosch showcases the ALF 5000 vial version for the first time. To date, customers could fill either ampoules or vials and ampoules on one machine. Now the proven platform is also available for vials only. The machine shown at Interpack is equipped with 100 per cent in-process control and a carrying rake transport system, which provides an even gentler handling. The ALF 5000 achieves an output of up to 600 containers per minute and can be combined with different barrier systems â&#x20AC;&#x201C; a competence, which Bosch also demonstrates at interpack.

Comprehensive barrier competence Apart from proven isolator technology and open Restricted Access Barrier Systems (RABS), closed RABS and the newly developed return air filter for highly potent products now complete the

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The KLV 1360 for vials. The platform is suited for inspection of up to 600 standing glass containers per minute

When it comes to the inspection of filled containers, Container Closure Integrity Testing (CCIT) is becoming increasingly important. With the KLV 1360, Bosch presents a new development for vacuum leak detection of rigid containers, which combines the highest inspection accuracy with maximum output.

Together with fully automated solutions for high-volume leak detection and laserbased headspace analysis (HSA), Bosch can now offer an entire portfolio of CCI technologies. Benchtop devices for visual inspection, HSA and vacuum leak detection provide an additional overview of the broad inspection portfolio.

End-of-line assembly and packaging technology

The KLV 1360 achieves its maximum performance thanks to special inspection chambers, where the containers can be tested either individually or in groups

portfolio. In contrast to the commonly used safe change filters, which are situated in the technical area, the new return air filters are integrated into the machine. This saves time and facilitates cleaning, because the highly potent substances are already filtered at point-of-use. Moreover, the filter exchange is particularly easy and safe: there is no contact between the operator and the contaminated filter medium.

Containment and operator safety are also the focus of the downflow booth. Usually, the booth is used for manual weighing and dosing of powders. By supplying fresh air from the ceiling and drawing dust away from the operator, he can work with the substances in the closed space without safety concerns. As a tradeshow highlight, the downflow booth is converted into a meeting room for customers.

The semi-automated MSA from the Bosch subsidiary Moeller & Devicon is designed for the assembly of multi-part single-use auto injectors or pens, which are used for the treatment of autoimmune diseases or in emergency care. With its compact and hygienic design, the MSA platform is suited for the assembly of small volumes between five and 15 pieces per minute. Thanks to standardised modules it can also be upgraded for larger batches and fully automated production, offering drug producers the flexibility to adapt quickly to new market demands.

Further technologies, such as product and equipment sterilisation from the Bosch subsidiary Schoeller-Bleckmann Medizintechnik (SBM) complete the equipment port-

folio for liquid pharmaceuticals. These lines can be further extended by adding secondary packaging solutions, as well as platforms and industry 4.0 technologies for serialisation and aggregation.

Customised services for all maintenance strategies A comprehensive range of services to improve machine efficiency and productivity completes Boschâ&#x20AC;&#x2122;s line competence. The focus is on solutions for preventive maintenance as well as services to eliminate unwanted machine conditions as quickly as possible. To this end, Bosch provides a worldwide service network with qualified field service technicians who offer regional support. Thanks to digital services such as Remote Service, which is now supported by a visualisation and chat feature, or the mobile version of the E-Portal, which will be presented at Interpack 2017, customers receive targeted support regardless of their location.

Bosch will further showcase the versatile training portfolio of the Bosch Packaging Academy. Apart from new assistance solutions, Bosch will demonstrate virtual training concepts enabling manufacturers to acquire demand oriented know-how for machine operation and maintenance.

Bosch will also illustrate how Preventive Maintenance Parts Kits and tailor-made maintenance agreements help to proactively minimise unplanned downtime.

Contact details Christian Treitel Phone: +49 7951 402-875

Ami Polymerâ&#x20AC;&#x2122;s Imapure complies with pharma standard requirements in regulatory markets

IMAPURE IS platinum cured silicone tubing designed for peristaltic pump and fluid transfer in pharmaceutical and biotech applications. Imapure is translucent silicone tubing known for its ultra smooth bore to prevent any particle entrapment. It is especially designed to comply with requirements of critical food and pharmaceutical standards of regulatory markets.

Imapure is manufactured by using PLC-controlled latest Extrusion Technology & Advance Grade Platinum Cured Silicone and manufactured & packaged in Clean Room Class of ISO7, ISO 9001 QMS and ISO 14001 & OHSAS 18001 certified facility. It is inspected by laser online inspection device to maintain critical dimensional consistency and laser etched for traceability. It complies with FDA 21 CFR, USP Class VI & ISO 10993. It has excellent transparency with no odour and taste. It has extractable study available upon request and excellent

biocompatibility due to inertness to tissues and cells. It is sterilisable by using different techniques like autoclaving, ethylene oxide and gamma radiation. It is also available with FDA compliant colour coding for ease of identification and custom dimension, hardness and length size also available. Another most important part of tubing is its extractables and leachables data can be provided upon request and by signing with NDA procedures.

Contact details Ami Polymer 319, Mahesh Industrial Estate, Opp Silver Park, Mira-Bhayander Road, Mira Road (E), Thane â&#x20AC;&#x201C; 401104, Maharashtra Tel: +91 22 28555 107 / 631 / 914 Cell: +91 86910 13935 Email: mktg@amipolymer.com Web: www.amipolymer.com

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April 16-30, 2017

PACKAGING SPECIAL

OVEN Industries’5R7-001 temperature controller finds its way into customer’s high efficiency chilling device OVEN INDUSTRIES, experts in precision temperature and sensor applications, offers standard and custom designs.

The affordable 5R7-001 was chosen for this high efficiency chilling device produced

by Customer, Custom Chill, which is located in Philadelphia PA, US. Custom Chill is a Philadelphia-based designer and manufacturer of state-of-the-art thermoelectric chillers. Based on solid state cooling technology, Custom Chill’s chillers have been designed and manufactured with the highest performance and customer satisfaction in mind. Custom Chill has a proven track record of providing innovative solutions

that customers have seamlessly integrated into their systems, whether these applications are medical, photonics, industrial, or technology based.

Custom Chill has an outstanding reputation for providing reliable, safe, solid state thermal systems to some of the most technologically advanced and innovative companies in the world.

Oven Industries (OI) was founded in 1964 and specialises in the development of custom electronic temperature controllers and sensors along with extensive turnkey Contract Manufacturing capabilities and International Sourcing. OI also carries a full line of standard products, purchasable online,

Gandhi Automations: Doors with innovative and creative engineering GANDHI AUTOMATIONS India’s entrance automation and loading bay equipment company offers high speed doors. The high speed doors designed and manufactured by Gandhi Automations are sturdy, dependable and are the ideal solution for medium and large entrances. The doors are manufactured with European collaboration and technology with innovative and creative engineering. Fast moving functional and reliable doors are needed in industrial and commercial contexts.

Gandhi designed and manufactured high speed doors are versatile and solid ensuring long-lasting reliability. The modular structure of the curtains, assembled and joined by anodised aluminium extrusions, provides for a wide range of polyester sections available in a variety of colours. Wide, full-width window panels ensure a safer traffic and allow more light in. Their fast and easy replacement, in case of accidental tearing, saves money and time. The alternating metal tubular structure there inserted ensures high wind-resistance.

Prime high speed doors are the ideal solution for internal and external entrances and effectively operate in any situation, even when strong winds are blowing and in rooms with high volume traffic.

Sturdy and dependable, prime is the intelligent door for medium and large entrances.

High speed doors for external entrance are equipped with spring steel wind lock in curtain

34 EXPRESS PHARMA April 16-30, 2017

pocket that ensures silent door travel, higher wind loads and curtain stability.

Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W), Mumbai – 400064, India Off: +91 22 66720200 / 66720300(200 Lines) Fax: +91 22 66720201 Email: sales@geapl.co.in, Website: www.geapl.co.in http://geapl.co.in/high-speed-doors.html

including temperature controllers and sensors, power supplies, heat sinks, thermistors and thermocouples. OI supplies precision electronic devices that serve an array of clients not limited to these industries; aerospace, automotive, biomedical, defence markets, medical and semiconductor. With a superior design engineering staff and complete production facilities, the company is a leading technology and development company.

Contact details 434 Railroad AveCamp Hill, PA 17011United States (877) 766-OVEN(717) 766-0721(717) 766-4786 – faxsales@ovenind.com

PACKAGING SPECIAL

Romaco to unveil four news products at interpack 2017

AT THE upcoming interpack 2017 to be held in Dusseldorf/Germany from May 4 to 10, 2017, Romaco will show several product innovations in a new corporate industrial design. For the first time, the line compatibility of the Kilian, Siebler, Noack and Promatic brands will also be visually emphasised – an impressive demonstration of the group’s innovative vitality With four new machines in a corporate industrial design, Romaco will take advantage of interpack 2017 to draw attention to the functional unity of its technologies and underline its status as a single-source supplier to the pharmaceutical industry. For the first time, Kilian, Noack, Siebler and Promatic brand innovations will also visually communicate Romaco’s application focussed solution strategy. The exhibit will comprise the Noack NBP 950 blister packaging machine, the Promatic PCI 915 cartoner and the Kilian KTP 590X tablet press in line with the Siebler STF 120 tube filler.

The company has led the field in the

effervescents sector for several years now, notably with its Kilian and Siebler brands. At this year’s interpack, Romaco will unveil a system concept for tableting and packing effervescent tablets in tubes which is both technologically and visually integrated.

Horizontal lines are the dominant theme of Romaco’s new corporate industrial design, which aims to stress the ‘line’ character of the manufacturer’s system solutions for the pharma industry.

Optimising the OEE (overall equipment effectiveness) is a key priority in all Romaco development projects. Availability plays a crucial role in this context. The faster a machine can be changed over and cleaned, the more effectively its capacity can be utilised. Higher productivity is especially decisive for contract pharma players against the background of global cost pressures. The new design mirrors Romaco’s claim of first-class quality and reliable processes. The dark-tinted branding zone of the new Noack, Siebler, Promatic and Kilian machines adds visual impact to this product promise.

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EXPRESS PHARMA

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April 16-30, 2017

PACKAGING SPECIAL Noack NBP 950 blister packaging machine

Siebler STF 120 rigid tube filler

The Romaco Noack NBP 950 blister packer has acquired more than just a new design; increased ease of use was likewise a development objective. This rotary sealing machine is very easy to change over and clean.

Format changes can be completed in next to no time. The fully interchangeable QuickFeed unit speeds up product changes by making a second unit available while QuickAdjust – the automatic station control system – adjusts the sealing, coding and perforation processes. This saves time and materials during the run-in following a job change. With a maximum output of 500 blisters per minute, the Noack NBP 950 is the ideal solution for small to medium-sized batches. The blisters can be arranged either lengthwise or crosswise to the running direction, enabling numerous blister layouts with different cavity geometries. This extraordinary flexibility as regards the format design opens up countless possibilities for manufacturers of blister packaging.

Romaco’s new product line for filling effervescent tablets into tubes will be on show to industry professionals for the very first time. The launch of the Siebler STF 120 rigid tube filling machine will expand the company’s packaging portfolio for effervescent products. This redesigned system meets all requirements for quick and easy cleaning of the tube filler. The tablet conveyor belt in the feeding area, for instance, can be replaced in a matter of minutes.

The fact that only a small number of compact format parts are necessary typically simplifies retooling. Many settings are completely independent of specific formats, like the adjustment of filling volumes or the ability to adapt to different tube lengths. The pick and place system for transferring tubes enables controlled feeding, filling and discharge processes. Even very short tubes no more than 5 mm in length can be processed reliably in this way and safe handling of sensitive aluminium tubes is easily possible. The Romaco Siebler STF

120 achieves a maximum output of 120 tubes per minute because the tubes are transferred to the filling station in clusters. Fragile effervescent tablets are filled extremely gently according to the rotation principle, which is suitable for all tablets with a hardness down to 40 Newtons.

Promatic PCI 915 intermittent motion cartoner The Promatic PCI 915 intermittent motion cartoner strengthens Romaco’s position in the secondary packaging sector.

With its small footprint and maximum output of 150 cartons a minute, this machine represents the low-to-medium performance class. Flexibility is particularly important here: frequent product and format changes call for an ergonomic design as well as optimal access to all components. For the first time, the containers for rejected leaflets and cartons are freely accessible on the Promatic PCI 915 and can be removed and emptied without interrupting operation. Furthermore, the compact cartoner’s cGMP compliant balcony architecture greatly simplifies line clear-

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Kilian KTP 590X rotary press for bi-layer and effervescent tablets The Kilian KTP 590X rotary press is the newest model in Romaco Kilian’s successful KTP series. The iF award-winning KTP design inspired Romaco to develop a corporate industrial design to be applied to further machines. The Kilian KTP 590X, Romaco’s first singlesided rotary press specifically for compressing bi-layer and effervescent tablets, will be launched at interpack. Two large, standard fill shoe modules

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VENDOR NEWS

Gelest partners with New Mountain Capital New Mountain will provide Gelest with significant financial and strategic resources to support future growth initiatives and better serve its customers GELEST, A leader in customised, highly specialised organosilicon compounds, metal-organic compounds, and silicone materials, has partnered with New Mountain Capital, a growth-oriented investment firm that currently manages approximately $15 billion in assets. New Mountain is providing Gelest with significant financial and strategic resources to support future growth initiatives and better serve its customers.

Headquartered in Morrisville, PA, Gelest has been an innovator, manufacturer, and supplier to healthcare and advanced technology markets

36 EXPRESS PHARMA April 16-30, 2017

for over 25 years. Recognised by the industry for the high quality of its products and innovation, Gelest provides focussed technical development and application support to a diverse set of markets, including life sciences, medical materials, pharmaceutical synthesis, diagnostics and separation science and personal care.

In India, Gelest is represented by Gautavik International, a Mumbai-based company headed by Dr Vasanti Yadav, as the exclusive distributor of Gelest’s complete line of silane, metal-organics and silicone products for advanced

technology applications in sectors ranging from pharmaceuticals, aerospace, coating, composite, adhesive and sealant, cosmetic, bioscience, dental, medical device and agricultural industries. Gautavik has well established logistics and a technically trained staff with the ability to service diverse customer requirements.

Gelest serves its customers through a materials sciencedriven approach, and is uniquely positioned due to its best-in-class manufacturing and synthetic formulation capabilities as well as a proprietary product portfolio. The

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New Mountain, a New York-based private equity firm, identified Gelest through a proactive focus in the life sciences and speciality materials sectors.

“New Mountain is the ideal partner to help Gelest execute on its growth plans,” said Barry Arkles, President, Gelest. “New Mountain is known for its focus on business building, and Gelest will have deep resources at its dis-

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“Gelest is the high quality leader in its space, and we are excited to partner with the Gelest team to support the next phase of growth,” said Andre Moura, MD, New Mountain Capital.

Matt Holt, MD, New Mountain Capital, added, “Gelest is the leader in one of the most attractive segments of highly specialised materials. We see an opportunity to continue to build on Gelest’s leadership position through investments in new products, new capabilities, and acquisitions.”

EP News Bureau

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