International Summit on Biosimilars and Originator Biologics - DS

Main

Park,

ç Comprehend how global affairs are transforming the development and commercialization of biologics and biosimilars

ç Analyse the global legal and business ramifications of the EMA and FDA biosimilar regulatory pathways

ç Understand the significance of regulatory exclusivities in biosimilar development from the perspectives of both originators and biosimilars

ç Evaluate the impact of the current SPC landscape and the implementation of the UPC

ç Traverse the complexities of U.S. market entry: naming, labeling, and marketing concerns

ç Implement winning strategies to prevent compliance breaches of EU competition law

ç Learn how AI and data mining accelerate drug discovery and development

2022 Co-Chairs:

Dr. Christine Berndt

VP, Global Head Development

Arzneimittel AG Sharada F. Devarasetty Head of Patents –

PRE-CONFERENCE

–12:00

A | Patenting mRNA, CRISPR, and Emerging Modalities: Harnessing IP Protections to Ensure Successful Commercialization of New Biotechnologies 13:00–16:00

B | Working Group on Innovator Biologics and Biosimilars in the U.S.: The BPCIA, aBLAs, The Patent Dance and The Purple Book

Theglobal biosimilars industry is evolving at an unprecedented rate. These changes give rise to a multitude of complex legal and regulatory shifts impacting bioligics and biosimilar companies, their funding, and their support teams.

Understanding the regulatory framework, the potential adaptation of competition law, and the impact of the Unified Patent Court will be essential to biosimilar manufacturers as they develop new strategies to overcome barriers to market entry. Additionally, they need to take stock of new complications in the patent landscape and include commercial considerations, to take advantage of growth opportunities.

C5 will bring you the forces transforming the global biopharmaceutical legal and regulatory landscape. On 1–2 December, join leading industry stakeholders as well as your clients and colleagues for a meeting of the minds at C5’s International Summit on Biosimilars and Originator Biologics in Munich. Attend and learn how IP and regulatory changes are impacting the business of biosimilars — not just in Europe — but across the globe. Our faculty of diverse thought leaders will provide practical advice and winning strategies for biopharmaceutical companies seeking to navigate this multifaceted legal and regulatory atmosphere and benefit from the amazing opportunities that this new landscape presents.

SECURE YOUR SPOT

Simplified regulatory pathways, a new court system for member states, and the application of competition law will make 2023 the most transformative year for originator biologics and biosimilars in Europe since the framework was established in 2005.

Interesting mix of interconnected topics related to biosimilars. Excellent speakers. Good networking opportunities.

Associate General Patent Counsel, UCB

Distinguished Faculty

CO-CHAIRS:

Sharada F. Devarasetty

Head of Patents – Biopharmaceuticals Sandoz

Dr. Christine Berndt

VP, Global Head Development Specialty/Biosimilars STADA Arzneimittel AG

Excellent content and very good speakers.

SPEAKERS:

Dominic Adair Partner

Bristows LLP

Kirsten Bauch

Head of ADR Services European Union Intellectual Property Office Thorsten Bausch Partner

HOFFMANN EITLE Laëtitia Bénard Partner

Allen & Overy LLP

Richard Bonneau

Executive Director

Prescient Design

Dr. Sabrina Duschner

Vice President Patent Litigation Strategy

Intellectual Property Management Fresenius Kabi

Katherine A. Helm Partner

Dechert LLP

Martin Herzog Patent Attorney

Herzog IP Patentanwalts GmbH

Willem Hoyng Partner

Hoyng Rokh Monegier

Siddharth Kusumakar Partner

Powell Gilbert LLP

Loïc Lemercier

Partner Dentons

Sergio Napolitano Legal Affairs and Trade Director Medicines for Europe

Kevin E. Noonan Partner

McDonnell Boehnen Hulbert & Berghoff LLP

Director Strategy, Portfolio, and Project ManagementPolPharma Biologics

Bert Oosting Partner

Hogan Lovells LLP

Ioana Ratescu Senior Legal Counsel

Novartis Pharma AG

Alexander Roussanov Partner

Arnold & Porter Kaye Scholer LLP

Robert Smyth, Ph.D. Partner

Morgan, Lewis & Bockius LLP

Richie Paul

VP & Head of Intellectual Property Alkermes

Lincoln Tsang Partner

Ropes & Gray LLP

Workshops are available for in-person delegates only.

PRE-CONFERENCE WORKSHOPS | WEDNESDAY, 30TH NOVEMBER

13:00–16:00 (Registration begins at 12:30)

A | Patenting mRNA, CRISPR, and Emerging Modalities: Harnessing IP Protections to Ensure Successful Commercialization of New Biotechnologies

Harnessing new capabilities such as AI, automation, and data analytics, as well as the manipulation of mRNA and CRISPR technologies are critical to how companies will commercialize innovation and ensure success of the business unit. Securing IP rights to these technologies and leveraging or licensing these rights appropriately is essential to successful commercialization, growth, and future development of these innovations.

This workshop will examine recent IP controversies with new technologies such as mRNA and CRSPR and provide an insightful exchange on addressing patent rights in this new era which has been dubbed “the New Biotech Revolution.

Points of discussion will include:

• Survey and analysis of current mRNA and CRSPR patent challenges

• Looking at future uses of mRNA and CRISPR technologies, while being cognizant of current and potential IP challenges

• Analyzing the future market opportunities and emerging biotechnological trends on a global level

• Being mindful of freedom to operate parameters with these technologies as well as peripheral patent rights

• How to appropriately leverage patent rights for new biotech inventions: when does a license make sense over a lawsuit?

• Selecting a delivery method for new inventions

• Deciding whether to in-license lipid nanoparticle (LPN) technologies v. patent protection on novel technologies

• Reviewing the regulatory pathways for these technologies

• Exploring the changing landscape relating to regulatory evaluation, drug development and commercial strategy

• Understanding how the multi-stakeholder approach can be used to support efficient implementation

B | Working Group on Innovator Biologics and Biosimilars in the U.S.: The BPCIA, aBLAs, The Patent Dance and The Purple Book

This intimate working group will cover the regulatory framework governing innovator biologics and biosimilars in the U.S. Our industry thought leaders will explain the differences between the BPCIA and related pathways relating to patent protection and litigation, recent BPCIA court cases, and IPR activities linked to biologics.

Points of discussion will include:

• An introduction to biologic drugs, biosimilars, the Biologics

• Price Competition and Innovation Act (BPCIA) abbreviated approval pathway, and statutory language

• Discussing the FDA Draft Guidance documents on biosimilar product development

• Making predictions for the future of biotech patents and biosimilar product development in the U.S.

• Reviewing BPCIA cases at the Federal Circuit and District Court levels

09:00–12:00 (Registration begins at 08:30 – breakfast will be served)

THE INTERNATIONAL REGULATORY THINK TANK

DAY ONE THURSDAY, 1ST DECEMBER

07:00 Registration and Breakfast

07:45

Opening Remarks from the Conference Co-Chairs

Microphone-alt Sharada F. Devarasetty, Head of Patents – Biopharmaceuticals, Sandoz

Dr. Christine Berndt, VP, Global Head Development Specialty/Biosimilars, STADA Arzneimittel AG

08:00

The Unitary Patent and the Unified Patent Court: A Guide to Ratification, Implementation, and Strategies for Biosimilars and Originator Biologics

The Unitary Patent and the Unitary Patent Court were designed to achieve a simpler, cost-effective means of protecting and enforcing patents in Europe. While it is certain that the UPC’s decisions will have pan-European effect, it is less clear how the UPC could impact biosimilar medicines. This session will analyze the changes under the UPC and UP and provide attendees with a handbook for the future. Topics of discussion will include:

• Considering the costs and benefits of the system for biologic patent applications

» Weighing the decision to opt out

• Monitoring competitor patents toward launching UPC revocation actions

• Strategically using divisional applications during the transition period

• Understanding the territorial scope of protection and the role protocols play in the biologics space

• Predicting the impact to litigation and legal certainty

• Detailing the non-exclusive jurisdiction for all national validations of European patents and biologics patents in particular

9:00

PART I: Anticipating the Impact of EU Regulatory Change on Biosimilars and Originator Biologics

Recent and ongoing European regulatory changes will affect every originator and biosimilar company that currently sells or sponsors products in the European Union and the UK. The regulatory landscape is transforming so rapidly that that companies must track and monitor these developments or risk the license-to-operate.

While timelines continue to waver, manufacturers, distributors, providers, and counsel must consider the implications of these regulations and take a proactive approach to dealing with regulatory change.

Topics of discussion will help you:

• Understand legislative reforms that will impact biosimilar regulation within Europe

• Learn how companies can adapt their processes and systems to these new systems in order to comply

• Appreciate which innovative process and technology solutions can help you achieve readiness success

10:00 Morning Networking Break

10:15

PART II: Comparing Global Biosimilar Regulation, the EMA, FDA and Their Approval Processes

There are fundamental differences in both the regulatory processes and the market dynamics of the U.S. and the EU that account for much of the discrepancy in the uptake of biosimilars. As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S. and European markets in the coming years.

This session will dissect the BPCIA, compare it with the European approach, and consider near and medium scenarios for biosimilars in the United States.

Topics of discussion will include:

• Exploring the basics of the BPCIA

• Comparing the European and American approaches

• Considering near and medium scenarios for biosimilars in the United States

11:15

European Supplementary Protection Certificates: What Every Regulatory and IP Attorney Needs to Know About the Evolving Framework Governing SPCs

The introduction of the SPC manufacturing waiver which went into effect on 2 July 2022 addressed a significant disadvantage that European producers of biosimilars had compared to non- European rivals. Under the new system, the UPC will have jurisdiction over SPCs unless the opt-out provision is invoked or if they originate from an already opted out European patent. This session will detail the rights conferred by the SPC.

Topics of discussion will include:

• Whether an SPC under the current national SPC laws can be based on a unitary patent

• Outlining the implications of the rules of origin on the biopharmaceutical industry

• Detailing the scope, relevant marketing authorization, and which patents can be used to obtain an SPC

• Considering areas where clarification from CJEU may still be required

• Preparing for the EU Commission’s prospect of introducing a unitary SPC

12:15

Medical Uses of Known Biological Products and Drug Repurposing: Reconciling Infringement and Enforcement

As originators become more active in the business of biosimilars, and biosimilar manufacturers have entered the arena of creating their own new biologics, the importance of second medical uses for individual companies as well as the global industry is of growing importance.

Topics of discussion will include:

• Understanding second medical use patents & carve out strategies

» Clarifying the patentability of further medical use inventions

• Whether eliminating an indication claimed by a second medical use patent from the product label does or does not alone save the generic from a finding of infringement and a consequent injunction

• Assessing the implications of second use patents for:

» Regulatory

» Market Access

» Legal

• Outlining the implications

• What form can second medical use claims take?

• What must be established for a second medical use patent to be infringed?

• How do you enforce a second medical use patent?

• Can you prevent off-label use?

13:15 Networking Luncheon

INTERNATIONAL DEVELOPMENTS TRANSFORMING BIOLOGICS AND BIOSIMILARS IN EUROPE

14:30

Plausibility, Sufficiency, and Inventive Step: Deliberations for Formulation and Combination Patents

Plausibility in the context of the inventive step and sufficiency requirements are a contentious issue. To discern whether an invention is purely speculative, the Boards of Appeal of the EPO developed the doctrine of “plausibility” in the context of sufficiency of disclosure as well as inventive step.

As we await the Board of Appeal to issue the written decision, this session will consider in what situations post-published evidence can be considered to support the effect of the invention. Topics of discussion will include:

• Understanding in what situations post-published evidence can be considered to support the effect of the invention

• Overcoming the key challenges and hurdles currently being faced in obtaining formulation, combination and second medical use patents in Europe (as related to showing plausibility, sufficiency and inventive step)

• Incorporating the latest EPO and national case law into your strategies for procuring, maintaining and enforcing these types of patents

• Striking the balance between securing an early filing date and overcoming the plausibility hurdle

15:30

Proportionality, Preliminary Injunctions & Damages: The Ability to Deny, Grant, or Tailor Injunctive Relief

• Considering the Boards of Appeal’s decision in Amgen v. Sanofi, how great an influence is potential invalidity when it comes to a preliminary injunction application?

• Assessing when may preliminary injunctions be denied, regardless of if a patent is valid or infringed upon

• How important is the role of an infringement assessment in preliminary proceedings?

• Analyzing Article 3(2) of the IP Enforcement Directive 2004/48

16:30

Alternative Dispute Resolution in the Biologics arena: The Shift from Ordinary Proceedings Towards ADR

• Understanding how BoA and the EUIPO helps with ADR

» ADRs in the EUIPO Boards of Appeal

» Assisted Negotiation and Expert Determination

» Effective Dispute Resolution (EDR)

» Co-mediation mechanisms

» ADR Cooperation Initiatives

• Detailing why parties should consider using EUIPO ADR mechanisms

• Combining parallel disputes at national and international levels into one resolution

» Avoiding complex litigation proceedings

» Achieving quicker, more efficient outcomes in a cost-effective way

17:30 Day One Adjourns

11:00

TWO FRIDAY, 2ND DECEMBER

08:45

Co-Chairs’ Recap of Day One and Opening Remarks

Microphone-alt Sharada F. Devarasetty, Head of Patents – Biopharmaceuticals, Sandoz

Dr. Christine Berndt, VP, Global Head Development Specialty/Biosimilars, STADA Arzneimittel AG

THE IMPACT OF BIOSIMILAR COMPETITION IN EUROPE

09:00

Special Keynote: Tracking Changes in Competition Law

10:00

Balancing Innovation and Competition: Patent Thickets, Continued Litigation, and New Economic Considerations for Settlements

This session will consider the economic implications of biosimilar reverse payment litigation globally, including competitive effects, and economic damages. Topics of discussion will include:

• Understanding settlement strategies between innovator biologic companies and biosimilar applicants

• Whether developing a patent thicket is an antitrust violation

» UFCW Local 1500 Welfare Fund v. AbbVie Inc. (7th Cir. Dec. 28, 2020)

ƒ Reviewing what is deemed “anti-competitive activities”

• Whether you need to prove that all the patents in the ‘thicket’ around a drug are invalid

• Highlighting the state legislation directly addressing “reverse payment” patent settlements

» When biologic manufacturers should expect antitrust scrutiny

• Reviewing the proper standards of antitrust review and the rising call for a legislative response

» Analyzing the current legislative and regulatory framework

» Mergers, acquisitions and exclusive licenses

» Anticompetitive agreements

Morning Networking Break

COMMERCIAL STRATEGIES FOR THE ORIGINATOR AND BIOSIMILARS MARKETPLACE

11:30

The Economics of Biosimilars: Improving Market Access and Sustainable Pricing Across Europe

• Evaluating the clinical pipeline by company, indication and phase

» Analyzing the market share for biosimilars in various regions

» Target drugs with highest spending

» Current market dynamics and considerations for biosimilar adoption

» Comparing the European Union biosimilar experience

• Considering the implications of insurers placing biosimilars on “primary tiers” and what that means for the future

• Incentivizing providers to adopt biosimilars

12:30 Networking Luncheon

14:00

GLOBAL STRATEGIES: From Patent Protection to Cost and Market Access in The U.S., the EU, and Asia

Our panelists of global thought leaders will contemplate where the EU fits in the global biosimilars marketplace.

• Assessing regulatory and legislative developments impacting the biopharmaceutical industries in each region

• Understanding the economics and market influences

» Considerations for market access, sustainable pricing and reimbursement policies

» Market uptake of biosimilar products

» Biosimilar v. biosimilar litigation in a crowded market

» Abuse of dominance

» Life cycle management and contracting

» Pricing strategies

• Avoiding costly litigation and associated penalties by effectively complying with the law

15:00

The Business of Biologics: Calling Attention to Products Coming Off-Patent and Devising Forward-Thinking Portfolio Strategies for Maximizing Global Success

• Identifying approved and marketed biologics coming off patent while looking ahead and considering clinical insights, pricing and dosages

• Predicting what problems future competitors may run into with respect to their IP profiles

• Forecasting which segments or regions will drive market growth

• Reviewing key sustainability tactics adopted by leading market players

• Evaluating the impact of off-patent drugs on competition and growth strategies

• Developing techniques for an accurate assessment of the current value of your portfolio while devising forward-thinking product strategies

16:00

Artificial Intelligence, Data and Drug Development: Accelerating Biopharmaceutical Discovery and Development

• Understanding how AI and data mining can accelerate drug discovery and development

• Analyzing the extent to which data might be mined from previous clinical trials toward finding new uses for known drugs

• Taking stock of the role of artificial intelligence in this process

• Preparing for the challenges that exist for patents

17:00 Conference Concludes

Related Events

About us:

I attend over a dozen conferences a year, and C5 events are among my favorite to attend. This one in particular was unique in that it connected a number of very important non-traditional topics that I think are critical to the area of biosimilars, not the least of which is bringing together the global perspective on the legal, regulatory and economics challenges face by biologics and biosimilars around the world and providing a forum for us all to discuss new ideas on how to address these global challenges. Keep up the terrific work!

Partner, Venable

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