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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The 2012 BIO International Convention will feature an educational track devoted to Biotech Patenting and Tech Transfer to discuss legal and legislative developments and how they are likely to impact biotech companies.   Hosted by the Biotechnology Industry Organization(BIO), this year’s global event for biotechnology will take place June 18-21, 2012 at the Boston Convention and Exhibition Center in Boston, MA.

I’ll be in attendance as well as participating in BIO’s blogger network throughout the week. If you’d like to meet up during the conference, drop me a note and we’ll schedule some time to have coffee together. email the Baristas

You can follow Patent Baristas here or @PatentBaristas.  You can get BIO updates from BIOtechNOW, an online portal and newsletter produced by BIO or @BIOConvention.

Session highlights include:

Recent Developments in Patentability: Prometheus, Myriad, Classen and the Patentability of Diagnostic Methods

No, unfortunately this is not about the Charlize Theron movie.  Here, a panel of distinguished patent-law experts and practitioners will discuss the leading cases on patent eligibility of diagnostic methods, focusing on the Prometheus case in the Supreme Court of the United States and the Myriad Genetics and Classen cases in the Federal Circuit. The panel will discuss the implications of these cases for biotech patents and the future of biotech innovation, including personalized medicine.

Tuesday, June 19, 8:30 a.m. – 9:45 a.m.

Moderator: Mark Fleming, Partner, Wilmer Cutler Pickering Hale and Dorr LLP

Speakers: Seth Waxman, Partner, Wilmer Cutler Pickering Hale and Dorr LLP, Kevin Marks, Vice President, Roche Molecular Diagnostics and John Whealan, Associate Dean for Intellectual Property Law, George Washington University Law School

Prior User Rights and Trade Secrets: A New IP Option Replacing Patents to Secure Freedom – to – Operate for Internally Used Innovations in Biotechnology

Trade secret asset management is a strategic imperative as companies develop and market their innovations. The session will help companies answer the question – Is it worth the trouble to patent internally – used technology? Additionally, the panel will discuss whether Prior User Rights, a defense against infringement of a later patent, is a better option for companies.

Tuesday, June 19, 2:00 p.m. – 3:30 p.m.

Moderators: R. Mark Halligan, Partner, Nixon Peabody LLP and Thomas Kelley, Consulting Patent Counsel, Monsanto Company

Speaker: Jason Duncan, Associate General Counsel, EMD, Serono, Inc.

IP Issues Affecting Biomarker Diagnostics and Personalized Medicine

A panel of international will discuss:how and why recent legislation and court decisions defining “patent-eligible” products and methods will impact the patent protection that is available for biomarker diagnostic products and services; scientific issues that impact patent procurement and the scope of patent protection and when the applicant must present the data and cross-border and multi-party (joint) infringement considerations that impact companies’ ability to enforce patents against competitor/copiers.

Wednesday, June 20, 2:00 p.m. – 3:30 p.m.

Moderator: Jan Skouv, Director IPR, Exiqon A/S

Speakers: David Gaas, Partner, Marshall, Gerstein & Borun, LLP;  Thorlakur Jonsson, Director of Intellectual Property, deCODE genetics e; Simon O’Brien, Chartered Patent Attorney, D. Young & Co. and John Tessensohn, Board Member, Shusaku Yamamoto Patent Attorneys

American Invents Act Comes to Campus: the Impact on Commercialization and Technology Transfer Offices

The recently enacted Leahy-Smith America Invents Act 2011 (“Act”) is the most significant change to U.S. patent law in recent decades. Certain provisions of the Act will greatly affect how universities and non-profit research institutions disclose technological information, implement IP strategies, and license their innovations to third parties. This panel will discuss the impact of the Act on the missions and policies of universities and non-profit institutions as well as address new strategies for universities and non-profits.

Thursday, June 21, 8:30 a.m. – 9:45 a.m.

Speakers: Fernando Alberdi, Partner, Honigman Miller Schwartz and Cohn; Charles Niebylki, Senior Intellectual Property Advisor, National Institute of Health (NIH;, Robin Rasor, Director of Licensing, University of Michigan and Christina Sarris, Senior Technology Transfer Policy Advisor, National Institute of Health (NIH)

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It’s day numbah five until BIO 2012 Convention hits beantown in a flurry of activity, Chris Christie, the Republican governor of New Jersey known for his combative style, was named the BIO 2012 Governor of the Year.

The Award was presented to Governor Christie at a special ceremony at the State House in Trenton joined by BIO Board Member and Celgene Executive Vice President and Chief Operations Officer Perry A. Karsen and BIO Vice President for Alliance Development and State Government Relations Fritz Bittenbender.

In nominating the Governor, BioNJ cited his leadership in promoting a better business environment for all businesses in New Jersey, his support of the Technology Business Tax Certificate Transfer Program, the doubling of the R&D Tax Credit and the naming of BioNJ to administer the Life Science Talent Network.  His support of the biotechnology industry, along with that of Lt. Kim Guadagno builds on a long tradition of State Government support that has helped to make New Jersey one of the leading bioclusters in the world.

The BIO conference will hit Boston’s convention center on Monday, with 4,000 companies and 15,000 attendees.  While many of the biggest drug names in New Jersey, like Merck and Co., really are pharmaceutical companies, not biotechs, the BIO organization decided in favor of Christie. It could be that New Jersey has seen a massive of jobs over the past few years as big pharma’s blockbuster drugs go off patent.  This starts to make biotech even more appealing.

Christie will be in chowdah-town next week spending time in the state’s pavilion, which is designed to lure new companies to the state.

At least Chistie has shown that he can be the bigger man.

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“The world is shifting to an innovation economy and nobody does innovation better than America. ”
—President Obama, December 6, 2011

On September 16, 2011, President Obama announced that his Administration would release a National Bioeconomy Blueprint as part of his commitment to supporting scientific discovery and technological breakthroughs to ensure sustainable economic growth, improve the health of the population, and move toward a clean energy future. The 2012 National Bioeconomy Blueprint has two purposes: to lay out strategic objectives that will help realize the full potential of the U. S.  bioeconomy and to highlight early achievements toward those objectives.

Technological innovation is a significant driver of economic growth, and the U.S. bioeconomy represents a growing sector of this technology-fueled economy.   According to the USDA, U. S. revenues in 2010 from genetically modified crops were approximately $76 billion.  Beyond agriculture, based on the best available estimate, 2010 U. S. revenues from industrial biotechnology—fuels, materials, chemicals, and industrial enzymes derived from genetically modified systems—were approximately $100 billion.

The growth of today’s U. S. bioeconomy is due in large part to the development of three foundational technologies: genetic engineering, DNA sequencing, and automated high-throughput manipulations of biomolecules.

The National Bioeconomy Blueprint describes five strategic objectives for a bioeconomy with the potential to generate economic growth and address societal needs.

1.  Support R&D investments that will provide the foundation for the future U. S.  bioeconomy.

TCoordinated strategic programs and targeted investments will accelerate progress in biological research and technology areas, and this in turn will drive discovery for an American bioeconomy.

Expand and Develop Essential Bioeconomy Technologies – Multiagency collaborations for emerging foundational technologies such as synthetic biology, biology-related information technologies, proteomics, and others are being fostered in order to grow the bioeconomy.

Integrate Approaches across Fields – The Administration will prioritize additional multidisciplinary efforts to enable biological research at the boundaries of fields, such as physics, chemistry, engineering, computer sciences, and mathematics, that support the bioeconomy.

Implement Improved Funding Mechanisms – Creating or modifying funding mechanisms to support creative, high-risk/high-reward research can enable researchers to pursue daring—and potentially groundbreaking—research that may be constrained by typical funding mechanisms or approaches.

2.  Facilitate the transition of bioinventions from research lab to market, including an increased focus on translational and regulatory sciences.

Accelerate Progress to Market – To capitalize on the promise of the newly reauthorized Small Business Innovation Research (SBIR) program, agencies should evaluate and update SBIR programs. Some relevant objectives include reducing application response times, hiring/training program staff to enhance relevant in-house experience, and increasing the use of industry experts as peer reviewers to evaluate industry proposals.

Enhance Entrepreneurship at Universities –  Integrating entrepreneurship and industry involvement into the university research experience will facilitate the path from research to commercialization and help innovative ideas reach the marketplace. Innovative programs that enhance entrepreneurial activities at universities are needed to help academic discoveries become commercial realities.

Utilize Federal Procurement Authority – To drive the creation and growth of new bioeconomy markets, Federal agencies should prioritize procurement of biobased and sustainable products where appropriate and cost-effective.

3.  Develop and reform regulations to reduce barriers, increase the speed and predictability of regulatory processes, and reduce costs while protecting human and environmental health.

Moving forward: Improved regulatory processes will help rapidly and safely achieve the promise of the future bioeconomy.

Improve Regulatory Processes and Regulations – To reduce costs and impediments to investments but without compromising safety and efficiency, attention should be given to application review times, sequential reviews by multiple agencies should be coordinated to allow parallel reviews, and specific guidance should be issued in response to stakeholder needs.

Collaborate with Stakeholders – Federal agencies should focus on building new, and augmenting existing, stakeholder collaborations to inform efforts, streamline processes, and reduce costs and response times, while preserving safety and ensuring substantive benefit to public

4.  Update training programs and align academic institution incentives with student training for national workforce needs.

Employer-Educator Partnerships – Foster increased industry participation in the development of programs and in training students at all levels for the future bioeconomy workforce.

Reengineer Training Programs – Incentives for academic institutions to enhance entrepreneurship and restructure training programs would better prepare the future bioeconomy workforce, whether individuals are bound for careers in industry or academia.

5.  Identify and support opportunities for the development of public-private partnerships and precompetitive collaborations—where competitors pool resources, knowledge, and expertise to learn from successes and failures.

Catalyze Public-Private Partnerships – Federal agencies are encouraged to broadly pursue opportunities for effective public-private partnerships in health, energy, agriculture, and manufacturing to leverage Federal investments and industry investments and expertise.

See the complete National Bioeconomy Blueprint 2012 here.

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“Behind many extraordinary innovations there are extraordinary human stories.” ~Francis Gurry, Director General of WIPO

On April 26, 2012, WIPO celebrates World Intellectual Property Day.  The theme of World IP Day this year is “Visionary Innovators”.  Behind every great innovation, either artistic or technological, is a human story – a tale in which new pathways open as a result of the curiosity, insight or determination of individuals.

The Wright Brothers’ boyhood fascination with flight leads to a flying machine and travel by air. Louis Pasteur’s inquisitive mind advances the science of disease prevention. Tu Youyou’s dogged analysis of herbal remedies results in a malaria treatment that saves millions of lives. Steve Jobs’ ambition to make digital technology simple and accessible to everyone gives rise to personal computing and – three decades on – a new paradigm for the delivery of entertainment.

The list of visionary innovators is long. It is a catalogue of human ingenuity and creativity. It includes the many artists, writers and musicians who changed the way we see and hear things: Rembrandt and Turner, Picasso and Kandinski, each reshaping our perceptions of light, shape and form; Chekhov and Tagore, Neruda and Mafouz, their writing giving new insights into the human experience; Charlie Parker and Miles Davis, Hendrix and Rostropovich – musicians who challenge the status-quo, and endure.

Why not use World Intellectual Property Day 2011 to fully explore and utilize IP protections for your business?

What you can do

  • Organize an event or activity for World IP Day;
  • Download the official Visionary Innovators poster (28 MB);
  • Browse IP Day activities, posters and photos on our world map;
  • Follow us on Facebook.
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A genius transforms the world by expanding the frontiers of intellect. Intellectual property nurtures genius by protecting products of the mind and intellect for the benefit of society.  ~ Dr. Kalyan Kankanala

Dr. Kalyan C. Kankanala, the founder of SiNApSE Blog and a leading IP expert in India, has published a short e-book entitled, FUN IP, the Fundamentals of Intellectual Property

After giving an overview of the basic concepts, it expounds various contemporary issues and debates around the concepts. Important IP principles have been explained in the book with simple examples and case studies. In summary, the book narrates the IP story of India by weaving together background information, concepts, cases, experiences and public perception.

The book gives a simple chapter by chapter review of the various types of intellectual property and their respective subject matter fro patents and copyrights to trade secrets and traditional knowledge-traditional knowledge.

Unlike many books that provide an overview of IP, Fun IP provides an excellent section on Traditional Knowledge.  That is, the knowledge, wisdom and information in possession of indigenous communities that has been passed to them from their ancestors:

The Biodiversity Law in India affords protection for knowledge related to biological resources with the objective of safeguarding biodiversity in the country. The law lays down a benefit sharing mechanism for utilization of traditional knowledge relating to biological resources. It provides that benefits acquired from intellectual property developed based on traditional knowledge relating to biological resources must be shared with the communities possessing the knowledge. In other words, if any person develops intellectual assets from biological resources, he will be able to acquire intellectual property protection over it only if he agrees to share benefits with communities, who provided him the knowledge with respect to the resources. For example, if a pharma company isolates active ingredients from a plant that is being used by an indigenous community in Kerala for treatment of diabetes, it can file and acquire patent protection only if it agrees to share benefits with the community that holds knowledge about the plant.

While comprehensive treatment of even a single subject covered by Fun IP would require many volumes, this e-book does provide a good overview of all the types of intellectual property protection.

I  recommended this book for those not well versed in intellectual property who are looking for a comprehensive overview.  The details of the e-book are available here.  The book  will also be made available shortly for download on i-books, Kindle and other readers.

About the Author

Dr. Kalyan C. Kankanala is a founding Partner of Brain League, National Expert on IP, United Nations Industrial Development Organisation (UNIDO), and Visiting Faculty, National Law School of India University, Bangalore.  Dr. Kalyan specializes in helping companies extract and maximize business  value from intellectual assets. During his illustrious career as an IP professional, he has worked closely with technology driven companies on IP Protection, Strategic IP Analysis, IP Audits, Management of IP, Strategic Alliances, Licensing and Risk Mitigation.  SiNApSE Blog is an initiative of Brain League, created with an idea of showcasing the diversity of approaches towards Intellectual Property.

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As reported in the Atlantic, applicants to law school are down 15.6 percent for the year. Bigger problem? The wrong students may have stopped applying.
The smallest drop in applications (4.3%) was among test takers who scored below a 144. Meanwhile, applicants in the 170-174 range are down by more than 20 percent. The Law School Admission Council released figures on the one-year drop in applicants at ABA-accredited schools based on numbers collected through the end of March.

Best quote:

“So, the smart kids got the memo.  Law school is largely a losing game, and they’re not going to play, even though they can probably count on a better hand than most. Meanwhile, the number of laggards applying has barely budged.”

What does that mean?  I’m not sure if it means anything but it could mean that (a) the smartest applicants are pursuing careers in other areas and (b) the quality of law grads could decrease.  Only time will tell how that plays out but it could be good news for career paths that need more qualified people.

ABA Journals’ note here.

Lawyers Against the Law School Scam

 

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What:

Known by many names within the industry – non-practicing entity (NPE), patent assertion entity (PAE) and most infamously as “patent trolls” – NPEs over the past few years have single-handedly spawned a sub-specialty of patent litigation.  It’s certainly big business.  It’s estimated that the average patent suit involving NPEs results in $122 million in lost wealth for the defendant,  not to mention the millions of dollars often spent in litigation costs, lost work hours and time-consuming negotiations.

Offered as a one-day event to minimize time spent out of the office and in contrast to more general IP litigation events, American Conference Institute’s NPE Litigation conference provides an opportunity for attendees to network with colleagues while engaging in an open discussion with peers who are also being confronted with the same issues.

Presenting practical strategies for:

  • Approaching settlement and license negotiations with an NPE – How to Obtain Favorable Results from Your Settlement and License Negotiations
  • Utilizing reexam, motion practice, claim construction and the Markman hearing to preemptively address weak IP
  • Effectively asserting key defenses – divided or joint infringement, prior commercial use laches and patent pools
  • Making the decision of whether or not participate in a patent pool, defensive patent aggregation group or joint defense agreement Gain and discuss best practices for successfully defending against this new breed of patent infringement claim and walk away with practical tips and proven strategies for ensuring your client achieves success in its next action involving an NPE.

When:

Tuesday, June 12, 2012

Where:

Millennium UN Plaza
New York, NY

How:

Seats at this event are expected to go quickly given the great interest in this topic. Reserve a space now for a member of your IP and litigation departments by calling 1-888-224-2480; faxing your registration to 1-877-927-1563 or registering online at www.AmericanConference.com/NPE.

PatentBaristas.com is a Media Sponsor of this event.  Readers of Patent Baristas are entitled to $200 off the current conference price tier.   The discount code you will need for this is: PB 200.

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