A panel of distinguished lecturers provided thoughts and insights on recent major court cases in the biotech arena — and the decision-making behind them. In a discussion on the effects of Prometheus (and Myriad), the consensus seemed to be that there’s no consensus. On Prometheus, the panel tackled the question of how will the decision effect diagnostic patents?

The decision might be read as rendering much of the innovation in biotechnology, including drug method-of-treatment claims, patent-ineligible. However, Seth Waxman, a lawyer at WilmerHale, felt that the decision will be read narrowly because it was unanimous. Unfortunately, however, the language of the decision creates substantial uncertainty with respect to the patent-eligibility of a large number of issued patent claims in biotech.

Other panel discussions on the topic have showed that the vast majority of companies and venture capitalists are in a tizzy over what this means to investments. With all the uncertainties – clinical trial failure, market failure, etc., and now add this new patent uncertainty — venture capital people may just walk away and “go invest in the 37th iteration of an improved hemorrhoid treatment.”

Others expressed frustration that the Supreme Court never reverses itself, it just makes decisions that can’t be reconciled with earlier decisions. The Court had made an analysis of section 101 as a very broad grant of patentability subject to the further patent rule limitations. That is, 101 sets out very broad array of inventions that are patentable provide and now not true. Here, the Court seems to be skewing patent laws to provide for public policy decisions.

Diagnostic companies should get mobilized over the decision since many diagnostic patents will be challenged to get an interpretation of what is patentable and what is not. The Supreme Court, in declaring all of the claims patent-ineligible in a unanimous decision, emphasizes the role of Section 101 and patent eligibility in guarding against the danger of too broad of patent protection.

In looking at Myriad, the panel noted that isolated DNA has a different structure, different utility compared to the native DNA and lacks lots of things native DNA has. These are markedly different composition with markedly different properties. Such a decision would render taxol unpatentable even though chewing on bark won’t treat cancer while the purified form is incredibly valuable cancer treatment. Myriad is not the model of patent claims — and certainly not the model citizen for biotech companies — but broad rejection of isolated, purified molecules on arguments that not different enough from non-purified state that exists in nature would be detrimental and wrong

Neal Katyal, a lawyer at Hogan Lovells, felt that plenty of cases are unanimous and yet read broadlybroad. He felt the that in reversing the Circuit, the Court wouldn’t have just let Justice Breyer do whatever he wanted. Skepticism about need to patent things to protect economy.

Katyal felt that Myriad is not directly controlled by Prometheus since it deals with a composition and not a process and has both broad and narrow claims. But, it would be wise to consider aspects of Prometheus in terms of uncertainties raised for Myriad.

Earlier, the Court has made plenty of arguments are that section 101 is a broad statute, e.g., Chakrobatry, but it is not that section 101 has no limits. Prometheus suggests that the line has tipped a little towards the not so broad. The Court has noted that its for Congress to decide if limiting of 101 needed – the policy doesn’t need to be decided by the courts.

John Whealan, Associate Dean for Intellectual Property Law, George Washington University Law School, agrees with Waxman. Whealan noted that we can’t just give up on diagnostics. Section 101 cases are impossible to reconcile so it is not an exact test but a matter of degree. In trying to fit what the Court is going to do, look at what the claims trying to do and what is the science.

Kevin Marks, Vice President and General Counsel, Roche Molecular Diagnostics, addressed the question of how businesses may deal with the uncertainty. Companies can use trade secret route but that is very limiting in its protection. The general thought is that we will see diagnostics look to trade secrets more often but they are in a wait and see period. Diagnostic companies are still trying to understand the full impact of the case. How can we craft around the cases? Breyer seems to say that it is not just claims craftsmanship but broader subject matter implications.

Will diagnostic companies decide not do the research in this area because of it? The potential impact is that investors looking for a certain level of return will be turned off. As diagnostics are becoming more like pharmaceutical in the data required for approval, this means that without patents, companies won’t spend that kind of money. This has downstraeam implications since substantial licensing comes out of universities and companies won’t license or pay, without more clear data on how this will be interpreted.

For now, we seem to be in a wait and see period.

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“The relationship between IPRs and biopharmaceutical innovation is together with copyright on the internet perhaps the most contentiously debated topic in the literature.”

~ “Taking Stock: the Gains of Global
Biotechnology Research from IPRs”

Proponents argue that IPRs are essential to pharmaceutical and biotechnological innovation and provide innovators with the necessary incentives to continue to invest in research and to develop new drugs. Critics claim that pharmaceutical IPRs stifle innovation and raise the cost of drug development. In that light, the Biotechnology Industry Organization (BIO) released a report on the contribution of IPRs to the biotechnology ecosystem and economic growth in developed and emerging economies.

The report, titled “Taking Stock: the Gains of Global Biotechnology Research from IPRs,” was unveiled today during the Intellectual Property and Biotechnology – The Way Ahead session.

The report, commissioned by BIO, examines the role played by IPRs in both upstream and downstream phases of the research, development and commercialization of biotechnology products and inventions in developed, emerging and developing economies (particularly as it relates to biopharmaceutical and biotechnological innovation). Upstream being the range of research and development activities which relate to the pre-market and development stages of a product or technology. Downstream being the range of activities that relate to the market and post-market phases (including commercialization) of a product or technology.

In the literature, there is a growing body of evidence suggesting a positive link between economic development and growth, technology transfer, increased rates of innovation and the strengthening of IPRs. This is particularly strong in certain knowledge-intensive sectors such as biopharmaceuticals. Much of the international debate on biopharmaceutical innovation focuses on downstream issues: whether IPRs stand in the way of commercialization and whether they enable or delay access to medicines in developing countries. This discussion is usually placed in the context of the “North-South” divide (i.e. developed vs. developing world) and the extent to which the use of IPRs benefits or damages developing countries.

However, the discussion on the use of IPRs in upstream innovation (or the relationship of IPRs and biotechnology innovation in the context of biotech SMEs and universities) is often theoretical in nature and only at times based on data and collected evidence. Some international debates on IPRs relating to the upstream R&D process also examine the issue of ownership of genetic innovations and biologic materials and so-called research exemptions. There are ongoing concerns about the extent to which the patent system may be used in a manner that slows or hinders access to biotechnological research and innovation.

Based on these findings, the report discusses and explains the impact of IPRs on biotechnological innovation in the upstream process. The report outlines how IPRs have encouraged collaboration between biotechnological entities and, as a result, enabled further research and development of new biotechnologies, specifically in emerging and developing economies. In particular, technology transfer mechanisms such as Bayh-Dole styled frameworks are discussed in the context of emerging and developing economies.

The key findings that have emerged from this report include:

  • IPRs, especially patents, are actively facilitating and contributing to upstream and downstream biotechnology activities in both developed and developing countries.
  • Today, not only mature economies but also major emerging economies are making growing use of the patent system to facilitate biotechnology research and commercialization.
  • Accordingly, biotechnology alliances for research and technology transfer have increased markedly since the early 1990s.
  • Case study analysis suggests that strengthening IPRs and introducing technology transfer frameworks based on IPRs in combination with other reforms can have a positive and sustained impact on innovation, economic development and growth, biopharmaceutical R&D and access to biotech products in emerging economies.

Based on these findings the report makes the following recommendations:

  • Focus the spotlight on upstream phases – Understanding the relationship and interaction between IPRs and the upstream phases of biotech R&D is as important as discussing the role of IPRs in the commercialization of these technologies and products. Therefore, attention should also be devoted to upstream processes, not least in international discussions.
  • A closer look at the nuts and bolts – In this context, we need to deepen our understanding of the mechanics and mechanisms by which IPRs can be used strategically in order to enhance the R&D process.
  • An enhanced architectural mindset – Policymakers should consider the architectural setting and how the use of IPRs during the upstream process can be optimized.
  • The needs of emerging economies – Given the growing positive impact of IPRs in emerging and developing economies, there is a real need to increase our awareness and body of knowledge about frameworks, best practices and specific experiences with the use of IPRs during the upstream phases of R&D.
  • An international observatory of best practices – It is worth creating an international observatory that maps both knowledge as well as instruments that could help galvanize entities around the world to make greater use of IPRs during the upstream phases of biotech R&D.

You can read the whole report here:  “Taking Stock: the Gains of Global Biotechnology Research from IPRs”

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Patent law is essential to industry and commerce, whether creating new markets and technologies through “creative destruction” and “disruptive innovation” or evolving and improving those that already exist. Cases involving these patents, however, require a judiciary well-informed enough to understand the differences between them. In addition, disruptive innovations in biotechnology can raise questions traditionally addressed by the humanities.

Day 2 of the Bio 2012 Convention brought a panel discussion “Biotechnology on Trial: Scientific Literacy in the Courts and Judicial Reactions to Disruptive Innovations from Life Science.”  Judge Annabelle Bennett, for the Federal Court of Australia, led off a discussion of the scientific knowledge and proficiency of the judges who decide inherently highly technical patent cases.  While Judge Bennett was the only one on the panel with a science background, even she acknowledged that her skill and knowledge cannot be kept up to current, leading edge standards of scientists.

So, the question arises, who should decide technical questions in patent cases, lawyers or experts?  The panel agreed that it is difficult to get an expert that is genuinely unbiased.  Furthermore, even if unbiased, scientific experts can disagree.  Judges work with experts in order to get informed about the technical issues of the case but then run the risk that lawyers can question whether a judge spent too much time with expert. A preferred way to get background information is to first have the parties’ experts offer written, neutral reports.  Another method is “hot-tubbing.”

“Hot-tubbing,” a common practice in Australian courts, is also known as “concurrent evidence.” It means that expert witnesses in a complex, technical trial – such as a patent dispute about biotech, for example – can testify in court together on a panel, rather than one-by-one in the witness box.  This allows lawyers and the judge to question the experts in each other’s presence. It also allows the experts to directly challenge each other’s evidence. Ideally, a judge with only a layman’s knowledge of complex technical matters can more easily pinpoint the key issues in a case.  Some lawyers remain lukewarm to the concept but it could catch on here in the U.S.

Dr. David Bennet, Former Solicitor-General of Australia, Commonwealth of Australia, felt lawyers can do anything and has great faith in trial attorneys.  When litigators must take a case, they have to learn a lot about the particular case and the related science, even if totally unknown.  They specialize in learning.

Hon. William Young Judge agreed with Justice Bennett who said he depends upon advocates to teach him and that is the central attribute of skilled trial lawyer.  He believes that among best trial lawyers are those specializing in IP and this makes judges delighted to get patent cases. While Justice Young likes the concept of hot-tubbing, he indicated that no one will take him up on it so maybe he will need to force the matter.

Young said lawyers often suffer from Admiral Jellicoe syndrome where a loss is too important to risk.  [Winston Churchill – referring to the fact that a German naval victory would have made it impossible for Britain to supply her army in France, or even import food – described Admiral of the Fleet John Jellicoe as “the only man on either side who could lose the war in an afternoon.”]  “Trial lawyers have instincts for the capillaries,” Justice Young indicated.  “That is, the 500 page report on the immaterial while judges are looking for the jugular that will actually solve the case.”

Hon. Roger Hughes, a Judge for the Federal Court of Canada, felt that you are just not going to find judges an expert in the relevant field.  This is not a requirement for job, you want judges to be generalists.

Seth Waxman, a Partner at WilmerHale, summed up things saying “No one wants to hot tub with a litigator.”

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As China positions itself as a major global player in the international biotechnology arena, it has included biotechnology as one of the seven strategic priorities for scientific and technological development in its 12th Five-year Plan.  During the 2012 BIO International Convention, a full-day of program has been devoted to China and will target both Chinese and Western delegations.

As part of China Day, BIO explores questions about the changing landscape for innovation, healthcare reform, global regulatory trends and one of the most pressing questions for many attendees:  What is the right way to partner in China?  Speakers with decades of experience conducting business in the Chinese life sciences sector, such as George Baeder, Partner at Monitor Group Asia, and Li Chen, President and CEO of Hua Medicine, help guide discussions.

In another session, the World Health Organization (WHO) talked about the Pandemic Influenza Preparedness (PIP) Framework, which established requirements related to the sharing of influenza viruses and access to vaccines and other benefits.  The WHO is now working to implement the PIP Framework internationally.  A panel today, comprised of experts from the WHO and its Member States, the U.S. government, and large and small vaccine manufacturers and developers, discussed implementation progress to date and the broad implications of the Framework for vaccine manufacturers globally.

Recognizing the role of industry as an important contributor to technology innovation and transfer in addressing the challenges of pandemic influenza preparedness and response,

1. ADOPTS, in accordance with Article 23 of the WHO Constitution, the Pandemic Influenza Preparedness Framework, including its annexes;

2. URGES Member States: (1) to implement the Pandemic Influenza Preparedness Framework; (2) to support actively the wide implementation of the Pandemic Influenza Preparedness Framework, and (3) to consider providing adequate resources for its implementation;

3. CALLS UPON relevant stakeholders to give priority to implementing the Pandemic Influenza Preparedness Framework;

4. REQUESTS the Director-General, in consultation with the Advisory Group: (1) to implement the Pandemic Influenza Preparedness Framework; (2) to monitor and review the operation of the Pandemic Influenza Preparedness Framework and all of its components, in accordance with its provisions; (3) to report, on a biennial basis, to the World Health Assembly through the Executive Board on progress in the implementation of this resolution. Tenth plenary meeting, 24 May 2011 A64/VR/10

Meanwhile, smaller biotech’s seem to be stepping up to fill the gap of moving products into treatments and diagnostics for neglected diseases such as tuberculosis, malaria and dengue fever, which because they typically affect impoverished third-world countries have been considered noncommercial markets.

According to David Steinmiller, COO of OPKO Diagnostics LLC of Woburn, part of the challenge is that there is little to no money to be made in neglected diseases, and there is a high cost to get regulatory approvals and to protect intellectual property in multiple countries.

Steinmiller made his comments at a panel centered on a new report by BIO Ventures for Global Health (BVGH) and the Biotechnology Industry Organization (BIO) on participation of small- to medium-sized biotech companies in neglected diseases.

The report found that 134 biotech companies—5 percent of the total number of biotechs—are participating in neglected disease research and development. That translates into 39 percent of the 191 new drugs, vaccines, and diagnostics in development for neglected diseases. Neglected diseases affect more than 1 billion people, according to BVGH CEO Donald Joseph.

By comparison, big pharma participate in 75 of projects, though Joseph pointed out that there are fewer than 20 big pharma companies and their projects are on a larger scale, spending more and running complex clinical trials in multiple countries.

The BIO 2012 convention in Boston, which runs June 18-21 at the Boston Convention and Exhibition Center, expects to attract about 15,500 attendees—one third of them international.

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For the fourth year in a row, BIO is working with bloggers and reporters from around the country (and Canada) to provide attendees with an inside look of what’s happening at the 2012 BIO International Convention in Boston.

Be sure to check out their coverage on BIOtechNOW throughout the event and at their blogs:

Biotech Blog: Yali Friedman & Rolf Taylor

Yali Friedman, Ph.D., is founder of thinkBiotech and chief editor of the Journal of Commercial Biotechnology. His book, Building Biotechnology, is used as a course text in dozens of biotechnology programs. His other books include Best Practices in Biotechnology Education and Best Practices in Biotechnology Business Development. He is also a member of the board of directors and steering group of the Center for Policy on Emerging Technologies, serves on the science advisory board of Chakra Biotech, and also serves as a judge for the Biotech Humanitarian Award and the Maryland Incubator Company of the Year Award.

Rolf Taylor is a development consultant at EASE Fundraising System, a development associate at the American Liver Foundation, and a special projects & vlogger at the Journal of Commercial Biotechnology. He plans and executes communications and development programs to support medical products, devices and diagnostics, association and foundation

The Cross-Border Biotech Blog, Christian Hartmann

Christian Hartmann has worked for the past 3.5 years at Deloitte Canada as an Account Manager supporting the National Life Sciences and Mining Practices. He has worked on large pharmaceutical accounts and works to develop relationships with early stage biotechnology companies. He also represents Deloitte at key industry events including BioFinance and BIO. Christian received his diploma in Biotechnology from Seneca College and has worked in industry as part of the team that developed an early detection kit for Myocardial Infarction at Spectral Diagnostics. He has also owned and operated a business in the Health Food industry gaining approvals from Health Canada, FDA, CRA and CITIES  to import and distribute a novel plant based supplement product for sale in Canada and the U.S.

Fierce Biotech, John Carroll

John D. Carroll is a biotech analyst with 32 years of prize-winning experience in journalism. Appointed editor of FierceBiotech in 2003, he has covered genomics, biotechnology, healthcare and other business topics for Managed Care, American Banker, Small Times, and Local Business.com, He has also contributed stories from Central America and Ireland to the Dallas Morning News and Time and wrote for the Houston Press and other leading publications. He spent six years as editor and publisher of the Dallas Business Journal, was publisher of Texas Business and early in his career was part of a Pulitzer Prize-winning team of reporters and editors at the Kansas City Star & Times. He enjoys hiking, traveling and spending time with his family. John is based in Vermont and Texas.

Genome Alberta, Mike Spear

Mike Spear is Director of Corporate communications at Genome Alberta. After an extensive career in the media as a Producer, Executive Producer, and Program Manager, Mike moved over to other side of the journalists microphone when he joined the non-profit Alberta Beef Producers as Communications and Marketing Manager. After guiding and developing a new marketing plan to lead them through to 2009, it was time to look for a new challenge and he landed here with Genome Alberta in July of 2007. As Director of Corporate Communications Mike is an important part of Genome Alberta’s goal of “taking the Alberta Advantage to the world of international science”.

Life Science Leader, Rob Wright

As the chief editor of Life Science Leader magazine, Rob develops editorial content in the pharmaceutical and biotechnology industries. The focus of their audience is management level decision makers, such as the c-suite and director level, providing information regarding pre-clinical drug discovery and development up to commercialization. Life Science Leader is a B2B publication having 25,000 subscribers in the U.S. and over 50,000 globally via their digital version. Rob has 17 years of pharmaceutical industry experience in variety of roles, including sales, training, and management with OTC and prescription products, medical device, surgical implants and diagnostic tests. Previous publications primarily focused on the post commercialization aspect of the industry. Additional experience includes serving as a speaker at a variety of international marketing and pharmaceutical conferences.

Lillypad, Yasmein Asi & Robyn Orth

Yasmein Asi is a digital government affairs consultant at Eli Lilly and Company. Before being hired full-time in June 2011, she was a government affairs intern at Eli Lilly. She received her BA in Politic Science and Communication in 2008 before receiving her Masters in International Policy & Development.

Robyn Orth is a consultant covering digital government affairs at Eli Lilly and Company. Before being hired full-time, she was an international affairs intern. She received a BA in Latin American Studies and History at Tulane University before earning an MA in Latin American Studies at Georgetown University. Robyn specializes in Latin American studies, networking, administration and research.

MIT Technology Review, Susan Young

Susan Young is the biomedicine editor for Technology Review and looks for stories where technology stands to improve human health or advance our understanding of the human condition. She joined Technology Review in March 2012 after a brief stint in the Washington, D.C., news bureau of the scientific journal Nature.

Patent Baristas, Stephen Jenei

Editor-in-Chief Barista Stephen Jenei is the founder and owner of Patent Baristas. He is also a patent attorney and Owner of the innovative law firm Jenei LLC.  When not serving up patent chat over a cup of java, he’s handling a diverse intellectual property practice in the biotechnology, pharmaceutical and chemical fields for leading universities, research hospitals and research institutes, as well as biotechnology and pharmaceutical companies ranging from start-up to Fortune 500 companies. He works closely with biotechnology and emerging growth companies to brew up successful new business models, execute strategic intellectual property  protection and litigation, and structure and negotiate technology transactions.

Patent Docs, Kevin Noonan & Don Zuhn

Kevin Noonan has extensive experience in biotechnology and the chemical arts. Dr. Noonan brings more than 10 years of experience as a molecular biologist working on high-technology problems to his legal work. He has wide experience in all aspects of patent prosecution, interference, litigation, and client counseling on validity, infringement, and patenting strategy matters. He represents pharmaceutical and biotechnology companies both large and small, and he is particularly experienced in representing university clients in both patent prosecution and licensing to outside investors.

Don Zuhn has more than a decade of experience in all aspects of patent prosecution, litigation, counseling, and licensing. He represents a variety of clients, including biotechnology and pharmaceutical companies both large and small, and universities.  Don joined MBHB in 1998. He maintained a full-time position as a law clerk while attending law school at night until his graduation in 2002.

Snapshot, Betsy Raymond Stevenson

RaymondStevenson Healthcare Communications’ client roster includes leading pharmaceutical and biotechnology companies. Prior to founding RaymondStevenson in 2007, Betsy worked with Pfizer Inc’s Corporate Communications group, where she developed strategy and directed international and top-tier media relations for the company’s Oncology and Central Nervous System portfolios and served as media counsel for Pfizer’s Chief Medical Officer and Senior Vice President Worldwide Development. Betsy led the team that developed Pfizer’s U.S. Research and Development communications and re-branding strategies for the company’s Warner-Lambert merger and Pharmacia acquisition.

Trade Secrets, Brady Huggett

Brady Huggett is Managing Editor for BioWorld Today, BioWorld Financial Watch, BioWorld Week and BioWorld International, and serves as overseer for the organization’s sourcebooks and BioWorld Phase III Report.

Xconomy, Luke Timmerman

Luke is an award-winning journalist specializing in life sciences. Before joining Xconomy, he was the U.S. biotechnology reporter for Bloomberg News, based in San Francisco. There, he led coverage of major medical meetings and broke news about the industry’s top companies. His stories appeared in The New York Times, Los Angeles Times, Boston Globe, and International Herald Tribune. Before that, his passionate coverage of biotechnology won many awards for The Seattle Times.

While at the Times, Luke was the lead reporter on an investigation of doctors who leaked confidential information about clinical trials to investors. The story won the Scripps Howard National Journalism Award, the Sigma Delta Chi prize from the Society of Professional Journalists, the Society of American Business Editors and Writers award, an honorable mention Gerald Loeb Award, and was nominated for the Pulitzer Prize in public service. At Xconomy, he was honored in 2012 as a finalist for the Gerald Loeb Award, and received a SABEW award for biotech columns.

Now, let’s get to down to business.

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Former Secretary of Health and Human Services to Lead Panel at 2012 BIO International Convention Panel Calls for the Urgent Need to Better Fuel the Biotechnology Pipeline with a Diverse Workforce

WHAT:                Thought leaders of industry, education, and government will gather to discuss fostering and recruiting a more diverse workforce in the biotechnology industry at the Diversity Summit, a special program on Monday, June 18 at 3:00 p.m. The event will be featured at the 2012 BIO International Convention, the global event for biotechnology, taking place June 18-21, 2012 at the Boston Convention and Exhibition Center in Boston, MA.

The 2012 Diversity Summit – Fueling our Industry Pipeline: An Eye on Education will consist of a panel of experts discussing the importance of recruiting and fostering a diverse workforce in the biotechnology field.

WHO:                  Moderator: Dr. Louis W. Sullivan, Former Secretary of Health and Human Services, President Emeritus, Morehouse School of Medicine

·       Dr. Brandi Kaye Freeman, Pediatric Fellow, Trustee to the Board of Trustees of the National Medical Association, Chairperson of the Post-Graduate Physician Scientific Section
·       Dr. Norbert G. Riedel, Corporate Vice President, Chief Science and Innovation Officer of Baxter International Inc.
·       Dr. Eugene M. DeLoatch, Dean and Full Professor of the Clarence M. Mitchell Jr. School of Engineering, Morgan State University

WHEN:                Monday June 20th
3:00 pm

WHERE:              Room 211

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The Biotechnology Industry Organization (BIO) will take the wraps off some findings from a report on the role of Intellectual Property Rights (IPRs) in encouraging upstream R&D and downstream commercialization in biotechnology at the 2012 BIO International Convention in Boston.

“Taking Stock: the Gains of Global Biotechnology Research from IPRs”

The report, titled “Taking Stock: the Gains of Global Biotechnology Research from IPRs,” will bring together experts to discuss how IPRs have affected innovation and the development of new biotechnologies and whether they contribute to growth in partnerships and other models of collaboration between biotechnology R&D actors such as universities, small and medium sized entities (SMEs) and pharmaceutical manufacturers.

The session will unveil a new report, titled “Taking Stock: the Gains of Global Biotechnology Research from IPRs,” which focuses on the extent to which intellectual property rights play a role in encouraging upstream R&D and downstream commercialization in biotechnology in developed and developing countries.

BIO International Convention, Boston Convention & Exhibition Center, Room 259A

Tuesday, June 19, 2:00 pm – 3:30 pm

This report will highlight the need for intellectual property rights and the importance for developing countries to advance in the biotechnology field. In order for countries to build a strong and thriving biotech sector, strong intellectual property protection is a must.

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With four days left until BIO 2012 in Boston, EvaluatePharma’s World Preview 2018 warns of excessive R&D spending, but patent cliff may “liberate” drug companies.  EvaluatePharma released a report on the pharmaceutical industry entitled “World Preview 2018: Embracing the Patent Cliff,” whcih includes analysts’ forecasts on which companies and products will come out as winners in the years ahead.

This report is critical for everyone in the pharma arena.  Lots of great info! The forecasts are based on EvaluatePharma’s coverage of the world’s largest 3,500 pharmaceutical and biotech companies.

The market for prescription drugs, based on the consensus forecast for the leading 500 pharmaceutical and biotechnology companies, will grow by 3.1 percent per year between 2011 and 2018 to reach $885 billion, according to World Preview 2018.

EvaluatePharma’s analysis shows that more than $290 billion of prescription drug sales are at risk from patent expirations during that time frame. As companies have worked to rebuild their pipeline, the pharmaceutical industry has spent $1.1 trillion over the last 10 years on research and development, according to the report.

“It is often said there is an R&D productivity issue, but is it just poor portfolio strategy and investment choices? Is too much money being spent chasing too few quality R&D projects?” asks Anthony Raeside, Head of Research. “The patent cliff in its own right may not be the problem, but rather the way management reacts to it.”

The World Preview 2018 report will be officially released at the 2012 BIO International Convention, held June 18-21 in Boston. A hard-copy Executive Summary of World Preview 2018 will be available at EvaluatePharma’s Booth 1421.

In addition to assessing forecast trends in prescription drug sales and R&D spending, World Preview 2018 also looks at therapy area growth and the performance of marketed and pipeline products. Among this year’s key findings:

Novartis will emerge as a clear leader in 2018, with sales forecast to reach $51.3 billion by that year. That’s $3 billion ahead of its closest competitors, Pfizer and Sanofi.

Gilead Sciences is set to climb the most positions within the top 20, moving up seven places to number 15 with prescription sales of $15.1 billion in 2018, thanks in large part to the company’s strong HIV franchise and impressive forecasts for GS-7977, its recently acquired development stage hepatitis C product.

Looking at which products will top the sales charts, Merck & Co.’s Type 2 diabetes therapy franchise, Januvia/Janumet, will reign with sales forecast showing a 10 percent compound annual growth rate between 2011 and 2018 to reach $9.7 billion in sales.

Gilead’s potential new hepatitis C polymerase inhibitor, GS-7977 — forecast to achieve $5.4 billion in sales in 2018 — is the highest ranked R&D product in 2018.

In this year’s report, EvaluatePharma has added, for the first time, a geographic analysis looking at the performance of the U.S., Europe and Japan pharmaceutical markets in 2011. The analysis reveals major market growth flat-lining in 2011, with little or no growth in the U.S., a decline in Europe, and modest growth in Japan.

Complimentary copies of World Preview 2018 are available for download here.

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