European Biotechnology News Science & Industry
May 2013
II Biocapital
SPECIAL 31_EBN5_13_SPECIAL_Cover_Biocapital_tg.indd 27
02.05.2013 14:14:59 Uhr
European Biotechnology Net work
Join the European Biotechnology Network! The European Biotechnology Network is dedicated to facilitating co-operation between professionals in biotechnology and the life sciences all over Europe. This non-profit organisation brings research groups, universities, SMEs, large companies and indeed all actors in biotechnology together to build and deliver partnerships. Do you want to know more about the advantages of a (free) membership? Just have a look at our website: www.european-biotechnology.net
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Nº 5 | Volume 12 | 2013
Euro|Biotech|News
33
Special: Biocapital Intro
Good biocapital access – for a few In an era when payers are increasingly also looking at the economic benefits a new therapeutic has to offer, biotechs have to prove not only safety and efficacy to regulators, but cost-effectiveness to reimbursers as well. Both factors are subject to due dilligence when it comes time to apply for financing. That’s why convincing investors of the value of product portfolios – which are most often developed by biotech innovators – has become a complex task. Market forecasts by Prime Therapeutics/Blue Cross-Blue Shield predict specialty drugs will account for 50% of all drug costs by 2018 (up from 20% in 2009). But the most current Global Biotech Report released by Ernst & Young at the end of April says despite that promising future, just a few large biotechs are benefiting from financing. “As investors, we believe that both clinical and economic benefits are necessary to maximise returns,” says James Healy from Sofinnova Ventures. Europe is ahead of the US in demonstrating benefits for payer systems, he believes. According to the Ernst & Young report, however, this hasn’t yet translated into better performance among European biotech companies in terms of financing. Out of the global revenues totalling US$89.9bn (+8% compared to 2011) that
public biotech companies made in 2012, the 165 public European biotechs earned US$20.4bn, while the 316 public US enterprises took in US$63.7bn. In contrast to US biotechs, which increased both net income (US$4.5bn, +34%) and R&D expenditures (US$19.3bn, +7%), the firstever positive net income year in the European sector was mainly driven by R&D cuts (US$4.9bn, –1%). Ernst & Young believes the cuts reflect European market realities – access to capital is still con-
Table 1: Selected M&As1 and alliances2 with big up-front payments in 2012. Company
Acquisition target1
Partner2
Up-front payment (US$m)
A BMS (US)
Amylin Pharma (US) Inhibitex (US)
5,300 2,500
A Hologic (US)
Gene-Probe (US)
3,800
A GlaxoSmithKline (UK)
Human Genome Sciences (US)
3,600
A AstraZeneca (UK)
Ardea Biosciences (US)
1,260
A Amgen (US)
Micromet (GER/US)
1,160
A GlaxoSmithKline (UK)
Basilea Pharma. (CH)
231
A Abbott Laboratories (US)
Galapagos NV (B)
150
A Merck & Co. (US)
Aicuris GmbH (GER)
141
A J & J (US)
Genmab (DK)
135
A Abbott Laboratories (US)
Action Pharma (DK)
110
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siderably more challenging than it is on the other side of the Atlantic. Although capital raised by European public companies soared by 88% in 2012 to almost US$2.9bn, that was based primarily on large debt financings by just a few firms. In contrast, capital raised by private companies fell by 7%, while IPOs were practically non-existent in Europe (3, –63%). The value of M&As also decreased by 28%, while the volume of transactions sank to its lowest point since 2005. In the US, debt funding plunged by a third, which was the primary cause of the 25% drop in the total amount of cash raised there. However, excluding debt financing, the capital raised increased by 16% compared to 2011. Total financing achieved the second-best score of the decade (US$23.3bn). In contrast to Europe, M&As soared by 5% to US$23.8bn, and IPOs remained at a constant level (11, +10%) for a fourth consecutive year.
Financed by Big Pharma While R&D remains the engine of biotech growth, corporate venture capital may be a way out of the financing bottleneck for small companies. At the end of April, GlaxoSmithKline presented a new model for improving the economics of investing in drug discovery. The drug major partnered with life sciences investor Avalon Ventures to inject a total of US$495m into selected pharma biotech startups. The drug-hunter collaboration will be honed into an incubator that will look for new leads in promising disease areas. GSK wants to cherry-pick the ten most promising firms over the next few years and grab options to acquire their assets. “We are going to immediately own the idea if it is successful, and the level of financial exposure is, frankly, quite small,” said GSK’s Head of R&D Moncef Slaoui. The corporate venture capital approach could help both the start-ups – who are desperate to survive the financial valley of death – and drugmakers, who have an insatiable hunger for innovation to help fill lean clinical pipelines. B
02.05.2013 13:39:55 Uhr
34
Nº 5 | Volume 12 | 2013
Euro|Biotech|News
Special: Biocapital financing
Making the right call in early-stage funding Dr. Martin Pfister, High-Tech Gründerfonds, Bonn
The Irish steak was tender, the wine tasty and the conversation enjoyable in the room full of Life Science VCs at the recent Medtech conference in Dublin. But it wasn’t exactly a huge venue. It was a fairly small room that sheltered most of the people instrumental to seed, early and mid-stage life science investments in Europe. One could argue that the focus was Medtech, but that doesn’t change the picture much. The longer-term macro trend is a dwindling number of venture firms active in biotech in Europe, and the number of partners in those firms. If an investor wants to have syndicate partners in the sector, the shrinking available bandwidth of the biotech VC universe is a real concern. The remaining players are busy working on their portfolios and filter thoroughly for the one deal a year. Table 1: German biotech financing rounds in 2012. Company
Month
Financing
Value (am)
A CureVac GmbH
September
private
80.0
A Brain AG
November
private
60.0
A Wilex AG
August
stock market
23.9
A Affimed Therapeutics AG
October
private
22.0
A Probiodrug AG
January
private
15.0
A 4SC AG
June
stock market
12.6
A Wilex AG
January
stock market
9.93
A Apogenix GmbH
January
private
7.50
A Silence Therapeutics AG
August
stock market
6.80
A Proteros Biostructures GmbH
August
private
5.00
A Phenex Pharmaceuticals AG
October
private
5.00
A Subitec GmbH
July
private
4.50
A Algiax Pharmaceuticals GmbH
May
private
4.30
A co.don AG
August
stock market
3.90
A Cevec Pharmaceuticals GmbH
October
private
2.80
A Mologen AG
March
stock market
2.70
A AyoxxA Biosystems GmbH
September
private
2.60
A DermaTools Biotech GmbH
March
private
2.00
A conogenetix biosciences GmbH
April
private
1.50
A t-cell Europe GmbH
May
private
1.45
34-36_EBSIN5_13_SPECIAL_HTGF_tg.indd 34
Dr. Martin Pfister joined the High-Tech Gründerfonds (HTGF) Medtech/Life Sciences team in 2010. He is responsible for deal sourcing, investment and growth of the companies – currently 11 Life Science investments, among them three biotechs. HTGF is one of the largest European seed funds, with about a574 m under management and more than 200 active technologybased portfolio companies with significant growth potential. Pfister has more than 15 years experience in the life sciences industry. Before joining HTGF, he worked in the biotech/diagnostics industry, where he held several management positions in start-ups. He co-founded two companies in the Dx and healthcare services fields, and was also head of the organisation that fostered the Life Sciences/Pharma industry in Saxony (Germany). Pfister studied a combination of medicine, pharmacy and biology in Germany and at New York University, and was granted his PhD in Immunology from the University of Leipzig.
One reason for that small room is that investing has outpaced fundraising. The Silicon Valley Bank (SVB) estimates that since 2005, 25% more cash has flowed out of VCs into biotech companies than has into new VC funds earmarked for biotech. This deficit was destined to impact the sector, and it seems the numbers are starting to reveal it. Recent data from the Bundesverband Deutscher Kapitalbeteiligungsgesellschaften (BVK) support the SVB findings. In 2012, a323m were invested in seed and earlystage companies (Germany, all branches) but funds with an early focus raised only a135m – a net loss of almost a200m. No wonder it’s a world of haves and havenots. Big exits of US venture-capital backed life sciences firms are up from 2005-2011, but are concentrated in the portfolios of relatively few firms. Of 170 big exits since 2005, the top 10 venture funds were involved in about half the deals. The top 20 VCs expand that to 66%. For funds without big exits, fundraising either isn’t likely to happen soon, or is taking longer than expected. How does that fit with the findings that in Germany, 2012 saw twice as much capital raised by biotech companies? Looking beyond the numbers, almost half the capital
30.04.2013 17:28:47 Uhr
Meet Dentons. The new global law firm created by Salans, FMC and SNR Denton. Know the way.
dentons.com Š 2013 Dentons. Dentons is an international legal practice providing client services worldwide through its member firms and affiliates. Attorney Advertising. Please see dentons.com for Legal Notices.
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Nº 5 | Volume 12 | 2013
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Special: Biocapital was devoted to just two deals, and doesn’t involve institutional VCs. With its first two products entering the market in 2020, CureVac raised a80m from one investor – financier Dietmar Hopp (see table). BRAIN raised capital from the MIG Fonds, a firm that collects money from hundreds of private individuals. For the first year since the HTGF was founded, major contributions from follow-on rounds in 2012 didn’t come primarily from German VCs, which were outperformed by private investors and VCs from abroad. Private investors have discovered a “new” asset class, and are investing their money in start-ups directly. It might help that European biotechs in particular are considered ‘undervalued’ by Big Pharma and other investors – and not only those from outside Europe.
Handbook to the up-side Overall, two-thirds of all life science financings were “up-rounds” last year, a healthy percentage of rounds with step-ups in valuation and the highest level in five years. But that is a two-edged sword. The Cooley Venture Financing Report revealed Series A premoney valuations in 2012 are off from 2008 by between 20% and 30% (around US$5-6m in 2012). That’s the lowest level in the past five years. This suggests that the companies that have been raising new money had previously priced lower rounds in the past, giving them headroom on valuations to support the higher frequency of step-up rounds. The good news is that in most dimensions, the deal terms (evaluation, tranching, full ratchet, etc.) are improving for startups and reverting to pre-2009 financial crisis levels. Surprisingly, it has been the early-stage investors that cashed in: SVB analyses showed that companies that receive Series A venture investments at the pre-clinical stage have made up the majority of biotech big exits over the last six years. Another surprise was that about half of the assets were preclinical or Phase I-II at the time of exit. An example for that got lots of press last year: the acquisition of German company Cor immun by US healthcare group Johnson & Johnson. Corimmun develops peptide drugs aimed at the tailored treatment of heart failure and arteriosclerosis. Just a13m in capi-
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tal had been invested in the firm before the exit, and its main candidate COR-1 was still in clinical Phase II. The sell-off was quite lucrative for the investors, among them HTGF. As it turns out, biotechs on a broader basis that are looking to out-license assets are generally less satisfied with potential Big Pharma partners. A recent BCG study (and my own experience) have also shown that smaller companies that give sell-siders make a positive impression. The report names Celgene and Novo Nordisk as the most popular bio tech partners for Big Pharma on the lookout for collaborations.
R&D path’s impact That brings us to what topics are interesting for VC and strategic partners. The list no longer includes cancer drug targets. A significant percentage of nearly 1,000 (!) active drug programmes are chasing the same targets. When we see this kind of cancer pipeline concentration, it makes it hard to argue better bets on what diseases, what targets, and what approaches the scarce industry capital should ploughed
into. The crowded field unites Big Pharma/ Biotech (90% of spending) and smaller bio tech (90% of the companies). It is only fair to wonder if that is what promises a return on investments. Instead, it may be wiser to follow an R&D path in areas that pharma is fleeing or that have been neglected, among them: – Gene therapy: once massively hyped, it’s had a comeback with the first drug approved by the EMA (Glybera, Amsterdam Molecular Therapeutics/uniQure) and interesting recent deals (BI Venture Funds investment in Eyevensys, Novartis Venture Fund fueling GenSight Biologics) – Neuroscience: both symptomatic and disease-modifying therapies address real unmet needs in neuroscience, and both are benefiting from the accelerating pace of scientific progress. – Antibacterials: treatments to fight hospital-acquired infections like MRSA – Heart failure: new modalities like micro RNA, stem cells, and other novel small and large molecule targets offer real promise to change the heart failure landscape (see Corimmun example above). – Obesity/metabolism: while pharma has been generally hesitant over the past five years amidst this uncertainty, smaller bio techs have stepped up. OD status is still what many biotechs are aiming at, and yes – smaller budgets do help speed things up. Bringing your indication through the committees also helps start-ups gain experience with the EMA/FDA. As an early-stage investor focused on company creation, we think it’s less about the total amounts of money flowing into the system, and more about how to make sure the right kind of money is lined up at the right time for the right ideas: grants, venture, (strategic)partners. We need intelligent biotech corporate structures and flexible infrastructures to make financing more efficient. With smaller, mostly milestone-based rounds, we have to make sure companies have a pre-defined and tightly-titrated capital intensity and virtual development efficiency. CEOs shouldn’t be wasting time looking for the next cash infusion, but instead seeking to create value in the Life-Science oriented VC’s portfolio. With that, LP interest in the asset class might return. B
30.04.2013 17:28:52 Uhr
Nº 5 | Volume 12 | 2013
Euro|Biotech|News
37
Special: Biocapital Interview
EU rules for better access to finance A brand-new EU regulation on European Venture Capital Funds is predicted to remove significant obstacles to Venture Capital when it comes to cross-border fundraising. EuroBiotechNews spoke with Peter Homberg, partner at the freshlyfounded company Dentons, about the implications of the changed rules, financing trends, and the merger that resulted in the creation of his new global law firm.
Euro|BioTech|News
?
Corporate financing is especially difficult for European biotechs. What regulations are hampering access to VC in Europe compared to the US or emerging markets?
! Homberg There are a number of issues in Europe that are currently preventing venture capital funds from investing in European biotech star t-up companies. The main issue is that there is no common framework for the use of “EuVECA” for qualifying venture capital funds. Europe needs consistent rules for the portfolio of funds that operate under the “EuVECA” designation, including for their eligible investment targets, the investment tools and the categories of investors that are eligible to invest in them. In addition, in Germany the current tax laws relating to the lapse of the use of losses carried forward in start-ups in case of an exit need to be addressed by the legislative body. Euro|BioTech|News
?
How have EU policymakers tried to improve the situation, and how did the markets respond?
! Homberg On 12 March 2013, the European Parliament agreed on a Regulation on Eu-
37-38_EBSIN5_13_SPECIAL_Interview_Homberg_tg.indd 37
ropean Venture Capital Funds (“EuVECA-R”). It’s predicted the new regulation will remove significant obstacles to crossborder fundraising by venture capital funds – something that a number of our clients are concerned about. But the full impact on the markets will only become clear when EuVECA-R becomes applicable in July.
Euro|BioTech|News
?
Which current trends in financing and access to venture capital or corporate venture capital have you noticed at the new law firm Dentons?
! Homberg A number of our US-based venture capital fund clients have already recognised that there are investment opportunities in Europe, and in particular in Germany. These funds are currently analysing and evaluating interesting biotech projects, and we believe that this trend will grow in the future. Firstly, there are a number of scientifically interesting projects that are currently not funded or are underfunded, and thus secondly, investment into these projects carries a relatively low price tag. It will be interesting to see how this develops. Euro|BioTech|News
?
Dentons resulted from a kind of crossborder merger between three law firms.
Peter Homberg is a partner in Dentons’ Frankfurt office. He specialises in life sciences, IP and corporate law, especially in IP transactions, R&D transactions and financings. He became a partner at Salans in 2012, and has moved with the firm to the new global entity Dentons. From 2010-2012 Homberg led the German Life Science practice at Raupach & Wollert-Elmendorff. Prior to that, the former Deputy Head of the Legal Department at Roche Diagnostics GmbH headed the German and European Life Sciences Practice from 2001-2009 at Jones Day. What can you tell us about the details of that deal?
! Homberg Dentons is a new top ten global law firm created by the March 2013 combination of Salans, FMC and SNR Denton. Our aim is to provide our clients with a competitive edge required by an increasingly complex and interconnected marketplace. With more than 2,500 lawyers and professionals in 79 locations in 52 countries, we are driven to challenge the status quo in legal services by delivering consistent and uncompromising quality. Euro|BioTech|News
?
What different expertises in the life sciences sector did the different partners bring in?
02.05.2013 13:41:05 Uhr
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Nº 5 | Volume 12 | 2013
Euro|Biotech|News
Special: Biocapital ! Homberg We are able to provide our clients unrivalled breadth and depth of expertise in life sciences in all the markets they require. In particular, we have a very strong presence in the two key life sciences markets, the US and Europe. In Germany, our portfolio of advice comprises transactions, license agreements, all IP and antitrust related questions, issues of regulatory, products, classification as well as dispute resolution.
Euro|BioTech|News
?
Euro|BioTech|News
Euro|BioTech|News
Are you seeing any synergy effects from the merger? Which ones exactly?
! Homberg Whilst our combination is still very new, we have already seen positive growth in cross-regional collaboration, and we expect this to continue in the future.
?
Does the resulting law firm have a preferred geographic focus?
! Homberg What makes this combination so special is that Dentons is truly polycentric in nature. This means that we embrace the diversity of our geography, cultures and legal traditions. With nearly 80 offices in over 50 countries across four continents, we are uniquely positioned to serve clients wherever they are. ?
What are the benefits for your clients?
! Homberg Our combination is a direct response to our clients’ demands for a global law firm that can provide agile legal counsel and inventive business solutions to clients of all sizes, across border and practice
disciplines and in key industry sectors. It’s our job to connect our clients to more lawyers and services in more places, in a way that reflects the changing practice of law worldwide.
?
Euro|BioTech|News
What is your strategy for the future? In which segments and areas do you want to grow?
! Homberg The first half of 2013 will be characterised by simply becoming Dentons, and by the launch of the new brand – which will naturally enhance our competitiveness and attractiveness. Our goals concerning the second half of 2013 are currently being developed. I assume that the significant growth potential – especially in areas like Life Sciences – will lead to a utilisation of the opportunities arising from the new Dentons perspective. B
More up-to-date than ever before! www.eurobiotechnews.eu The latest … | News os | Pictures & Vide | People | Special Topics | Service e! | and much mor
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30.04.2013 17:29:49 Uhr
Sure we’re proudSure of Rembrandt. we’re But we prefer proud of Rembrandt. modern art. But we prefer modern art.
The modern art of Investment Banking. modern art of FromThe Amsterdam, Holland. Investment Banking. From Amsterdam, Holland.
39_EBSIN5_13_Kempen.indd 1
03.05.2013 14:19:22 Uhr
40
Nº 5 | Volume 12 | 2013
Euro|Biotech|News
Special: IP The Myriad Case
Moment of truth for pharma innovations Dr. Ute Kilger, Dr. Markus Engelhard, Dr. Jan Krauss, Boehmert & Boehmert, Berlin
Dr. Ute Kilger (Boehmert & Boehmert, Berlin) studied chemistry at Germany’s University of Merseburg. Since completing her doctorate in bio chemistry at the Freie Universität Berlin, she has worked for more than a decade in the patent departments of large pharmaceutical companies, including Boehringer Mannheim, Roche and Schering. Her fields of interest are molecular biology, immunology, biochemistry and pharmacology.
Oral arguments for the Myriad case, which may shape the future of medical patents, were held before the US Supreme Court in mid-April. A final decision is expected in June. Myriad Genetics holds patents on two human genes that correlate to the risk of developing breast cancer or ovarian cancer. The genes are known as BRCA1 and BRCA2. Myriad’s patents claim every naturallyo ccurring version of those genes, including mutations. In particular the patents claim isolated human genes, “man-made” complimentary DNA that mimics the naturally-occurring sequence (cDNA), methods for obtaining said DNA and methods for diagnosing the predisposition of contracting breast cancer. It was a laborious task to identify these genes, as well as a major investment, and it has led to a medical breakthrough that has saved lives. The Court of Appeals for the Federal Circuit (CAFC), the highest patent court in the US, decided the case (again) in August 2012, and found genes to be patent-
Myriad headquarters
40-42_EBSIN5_13_Special_Boehmert&Boehmert_tg.indd 40
able subject matter. Despite the “valuable insights” provided by the earlier US Supreme Court case Mayo Clinic vs. Prometheus, Judge Lourie’s opinion came to the conclusion that isolated DNA molecules are not found in nature, do not represent products of nature, and are therefore patent-eligible subject matter. This case is now before the Supreme Court, and the question to be looked at by the Court is the following:
Are human genes patentable, or are they a law of nature? In the above-mentioned oral arguments, the petitioner (the opponent of Myriad) stated: “One way to address the question presented by this case is what exactly did Myriad invent? And the answer is nothing. Myriad unlocked the secrets of two human genes. These are genes that correlate with an increased risk of breast or ovarian cancer. But the genes themselves … where they start and stop, what they do, what they are made of, and what happens when they go wrong … are all decisions that were made by nature, not by Myriad.” … and further regarding cDNA: “What the scientist does who’s creating the cDNA is they take the mRNA out of the body and then they simply have the natural nature-driven nucleotide binding processes complement the mRNA.
Dr. Markus Engelhard (Boehmert & Boehmert, Munich) studied biology, chemistry and biochemistry in Frankfurt/Main, WittenHerdecke and Cambridge (UK), where he also completed his doctorate. His interests lie in IP protection in the areas of biochemistry, molecular biology and pharmacology.
Dr. Jan Krauss (Boehmert & Boehmert, Berlin) studied biology at the Freie Universität Berlin. After finishing his training as a patent attorney, he worked with a large US law firm in Frankfurt/Main. His fields of interest include molecular biology, immunology, plant genetics and biotechnology.
So that if the mRNA has a C, the scientist just puts the corresponding nucleotide in there and nature causes them to bind up. The scientist does not decide.“ These arguments have interesting consequences. If one follows this line of debate, and agree that thus (human) genes are not patentable, what will happen to (human) proteins, hormones, antibodies, and naturally-occurring substances – including small molecules? They would no longer be patentable as well! What about other inventions in the life sciences? Not patentable! All of a sudden, everything
02.05.2013 13:41:49 Uhr
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Ins_210x275_MESSEN_2013.indd 1 41_EBN5_13_LISA.indd 1
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Nº 5 | Volume 12 | 2013
Euro|Biotech|News
Special: Biocapital
This can’t be the answer Providing compound protection for molecules that were isolated and thus made available for use for the very first time is an absolute must for the life sciences industry. So-called ‘use and method’ patents, as well as purpose-bound compound pro tection and second medical use claims, cannot provide enough legal certainty for the investing industry, and such patents can be circumvented too easily, e.g. by crosslabel use if several indications are approved for a drug. Medical practitioners may also prescribe a medication comprising an active drug for any approved use of said drug. And the health insurance company will reimburse it, regardless of whether or not
60 40
10
20
5
0
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
0
Year of first generic entry
Fig. 1: Percentage of new drugs experiencing Pharagraph IV challenges and average time from launch to first challenge (1995-2008).
the specific manufacturer holds a license for said specific approved use. Cross-label use is one reason for the need for absolute compound protection in the life sciences, including for molecules that may be found in nature. The enormous difficulties in proving patent infringement for use and method patents is yet another reason absolute compound protection is vital. Many believe that an ‘absolute’ scope of protection for DNA patents would hamper research, as well as further development. However, specific exemptions are available for research and for performing clinical trials. Compulsory licenses are also available. There are therefore sufficient tools for preventing any (alleged) misuse of patents. And more importantly, naturallyoccurring molecules are not ready to use simply because they already exist. They can be used because somebody invested in the research that went into finding them, isolating them, and thus providing them. Such investments must be incentivised, and until today, those incentives have been largely based on patent protection.
© DKFZ, Heidelberg
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15
© Health Affairs, 30, 2011 p 2157-66
Share of new drugs experiencing Paragraph IV challenges Average time from brand-name launch to Paragraph IV challenges
Years from brand-name launch to first challenge
20
80 Share of new drugs
would be considered a law of nature – especially in the life sciences – and consequently this argument could be used to basically challenge any – even pre-existing – patent in this field. If absolute compound protection was no longer available for proteins, hormones, antibodies, and naturally-occurring substances (including small molecules) what would that mean for an innovative industry? What would provide the incentives to continue to look for the “secrets” of nature and make them useful for mankind? The petitioner had a very interesting answer to that question as well, saying that scientists are curious anyway, and would pursue research in order to try to win a Nobel Prize. He also suggested that taxpayers may sponsor such work. Thus, the overall message is: “Don’t worry about investments. They’ll come no matter how this ruling goes!”
Right now, it is difficult enough for investors in the pharma and life science businesses to obtain a sufficient return on investment. When you look at the facts, more and more money now has to be invested before a drug hits the market. According to Nature Reviews Drug Discovery (2012,11, 191200) more than 20 drugs were launched per billion US$ spent for R&D in 1950. In contrast, the same amount of money was not sufficient to bring even one drug to market in 2010 (around 0.8 drugs per billion US$ spent on R&D). Thus, the costs for bringing a single drug to market have constantly and significantly increased in the past, and are continuing to do so. Rising costs are due to more requirements for approval and stricter regulations, which in turn require higher investments in drug development – for example, in clinical trials. At the same time, there is increased pressure coming from generics makers. Fig. 1 reveals that today, generic challenges start earlier, and involve a constantly increasing percentage of innovative drugs. Adequate patent protection is therefore a must for the innovative industry. The multifaceted problems in this area were even recognised some years ago by the US Supreme Court, which in one of its brighter moments stated in the Festo Decision (2002): “Courts must be cautious before adopting changes that disrupt the settled expectations of the investing community.” One can only hope that the Justices who now make up the court will remember to listen to the wise advice they gave the American public back then. B
03.05.2013 14:20:46 Uhr