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  • Docs at BIO: IP Challenges to Personalized Medicine & Diagnostics

    By Kwame Mensah —

    BIO International ConventionA free-flowing panel discussing the potential impact of Mayo Collaborative Services v. Prometheus Laboratories, Inc. on the future of personalized medicine and diagnostic method patents in the United States, and the possible slippery slope that could be encountered if its holding is stretched to the claims in the Myriad case as well as other composition of matter claims, kicked off the IP-related breakout sessions of BIO 2012.  Sitting on the panel were Annabelle Bennett, a judge sitting on the Federal Court of Australia; Hans Sauer, Associate General Counsel for BIO; and Thomas Triolo, Senior Counsel Merck & Co., Inc.  The session was moderated by Jennifer Gordon, a partner at Baker Botts L.L.P.  The panel was highly attended, but somewhat surprisingly, most of the attendees were non-attorneys.  In view of this, Mr. Triolo summarized the claims at issue Prometheus, as well as its holding.  Dr. Sauer then summarized the history of the claimed diagnostic method leading up to the filing of the lawsuit.  This led to a discussion of what is viewed by most patent practitioners as a major faux pas by the Supreme Court; that is bringing novelty analysis into a determination of patentable subject-matter.

    Ms. Bennett went on to thoroughly opine on what she felt the impact of this type of analysis might have on an attorney as well as on judges.  In her view, the patentable subject-matter test should be seen as a threshold test, with novelty and obviousness analyzed after this test is completed, not simultaneously with the test.  She stated that the Supreme Court has seemingly created a new test where novelty is not only analyzed before section 101 analysis, it factors into the determination.  She believes that this could create a situation that makes claim drafting and patent prosecution difficult because "the test has been muddled."  Mr. Triolo noted that the Court stated that one should "take a peek" at novelty and obviousness during the analysis.  Hence, the Court has provided no real guidance for prosecutors to surmise what types of claims will pass muster under section 101.  As for its effect on judges, Ms. Bennett believes that it will be difficult for them to apply the holding to other cases in the future.  For example, was the Court limiting its holding to the facts of Prometheus?  Or should its holding be applied broadly, e.g., to biological composition of matter claims?  She warned that if this is the situation, it would put the U.S. "in a very different place from the rest of the world."

    Ms. Gordon then moved the discussion toward how the USPTO is dealing with Prometheus.  The only guidance that the Office has provided so far is that a claim must encompass significantly more than a natural law (see "USPTO Issues Preliminary Guidance on Mayo v. Prometheus").  The Office makes no mention however, regarding a novelty component in the analysis.  Dr. Sauer commented that the Office is struggling with how to handle currently pending cases in view of the number of cases that have been and are being remanded in view of Prometheus.  He stated later in the session that the prevailing feeling at the Office is one of disappointment in the holding.  He pointed out that the Office has not signed any of the briefs being currently submitted for the Myriad case and is not happy with the Department of Justice's stance on the case.  In a sense, the Office believes that the DOJ's contentions are making it difficult to examine and grant patents.  Regarding ideas for how prosecutors should draft claims going forward, Ms. Gordon stated that it may be necessary to add more specific methodology (which could be interpreted as meaning more "active" steps) to claims to get around the "framework" developed by the Court in Prometheus.

    The discussion then moved to whether the holding in Prometheus will be applicable to the re-hearing of the Myriad case.  Mr. Triolo stated that it was hard for him to find the relevance of the holding to composition claims.  He did however follow up by saying that one could argue that, e.g., an isolated DNA molecule is a product of a natural product, but that was not necessarily an argument he agreed with.  Dr. Sauer stated that it was his belief that the claims at issue in the Myriad case should be reviewed under Chakrabarty because its law is still good law and is controlling for compositions of matter or articles of manufacture.  He does not believe that Prometheus is applicable to compositions of matter.  He hastened to read too much into the GVR of the Myriad case by analogizing it to the time when Chakrabarty was decided; at that time Flook, which encompassed an abstract idea, was good law.  The Court did not use Flook in its analysis in Chakrabarty.

    The upcoming months and years will determine the future of personalized medicine in the U.S.  There are several pending cases that will play roles in this determination.  Ms. Gordon opened up the panel by stating that the claims that will be at issue going forward (claims that focus on the importance of biomarkers) highlight the tension between personalized medicine and affordable health care.  In one sense, this debate is viewed in the public as "patent vs. patient."  However, even in view of this somewhat negative perception, many in the patent community believe that patent practitioners should continue to try to get patents for these very important personalized medicine-related inventions.  Patent Docs will continue to bring you updates from BIO 2012 throughout this week.  And if you are at BIO, stop by and see the Docs at booth 1335.

  • Parties and Amici File Briefs in Myriad Case

        By Kevin E. Noonan —

    MyriadThe deadline for filing "supplemental briefs" in Association for Molecular Pathology v. U.S. Patent and Trademark Office ("the Myriad case") was Friday, and in addition to Appellants Myriad (Supplemental Brief for Appellant (Myriad)) and Appellees represented by the ACLU and Public Patent Foundation (here), more than a dozen amicus curiae briefs (at last count) were filed.  Patent Docs will review these briefs and comment on their contents (or at least the ones that provide a frisson of interesting legal theory or patent policy), but for now we provide a list with links to the briefs.

    Two briefs were filed in overt support of the appellants, Myriad Genetics.  The Biotechnology Industry Organization (BIO), joined by the Association of University Technology Managers (AUTM) and the Coalition for 21st Century Medicine filed one of these briefs (here) and the Intellectual Property owners Association filed the other (Brief of Amici Curiae Intellectual Property Owners Association).

    ACLUNot unexpectedly, a motley group of patient advocacy organizations, medical associations, law professors, and public policy alliances filed briefs in support of the plaintiffs.  These include the National Women's Health Network, Reproductive Health Technologies Project, Forward Together, Center for Genetics and Society, Pro-Choice Alliance for Responsible Research, Alliance for Human Biotechnology, Michael Roybal, M.D. and Anne L. Peters. M.D. (Debra Greenfield) (Brief of Amici Curiae The National Women's Health Network, et al.); the American Medical Association, American Society of Human Genetics, American College of Obstetricians and Gynecologists, American Osteopathic Association, American College of Legal Medicine, American College of Embryology, and the Medical Society of the State of New York (Brief of Amici Curiae American Medical Association, et al.); the American Association of Retired People (AARP), Canavan Foundation, Claire Altman Heine Foundation, Facing our Risk of Cancer Empowered, March of Dimes Foundation, National Association for Pseudoxanthoma Elasticum, and Ovarian Cancer National Alliance (Brief of Amici Curiae AARP, et al.); Penn State Law Professor Eileen M. Kane (Brief of Amici Curiae Professor Eileen M. Kane in Support of Plaintiffs-Appellees and Affirmance); and the Knowledge Ecology International and Universities Allied for Essential Medicines (here).

    Several briefs were filed nominally "in support of neither party," but at least some of these advocate a position that, if followed by the Court would favor reversal of Judge Sweet's summary judgment of invalidity for the composition of matter claims (directed to isolated DNA molecules) and method claim 20 (directed to drug screening methods).  These include the New York Intellectual Property Law Association (Brief of Amici Curiae New York Intellectual Property Law Association); the American Intellectual Property Law Association (Brief for Amicus Curiae American Intellectual Property Law Association); Gilead Sciences, Confluence Life Sciences and Euclises Pharmaceuticals (here); Protein Sciences Corporation (here); Law Professor Christopher Holman (here); Eli Lilly & Co. (here); the U.S. Government (here); and Mark J. Gatschet and Richard W. Knight Brief of Amici Curiae Mark J. Gatschet, et al.

    In addition to more in-depth coverage of these briefs, we will update the list and links as additional information on these filings comes available.

  • Court Report

    By Sherri Oslick —

    Gavel About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

    Janssen Products, L.P. et al. v. Hetero Drugs, Ltd., Unit III et al.
    2:12-cv-03570; filed June 13, 2012 in the District Court of New Jersey

    • Plaintiffs:  Janssen Products, L.P.; Janssen R&D Ireland; G.D. Searle, LLC
    • Defendants:  Hetero Drugs, Ltd., Unit III; Invagen Pharmaceuticals, Inc.

    Infringement of U.S. Patent No. RE42,889 ("α- and β-Amino Acid Hydroxyethylamino Sulfonamides Useful as Retroviral Protease Inhibitors," issued November 1, 2011) following a Paragraph IV certification as part of Hetero's filing of an ANDA to manufacture a generic version of Janssen's Prezista® (darunavir, used to treat human immunodeficiency virus (HIV-1) infection).  View the complaint here.

  • Conference & CLE Calendar

    Calendar

    June 18-21, 2012 – BIO International Convention (Biotechnology Industry Organization) – Boston, MA

    June 19, 2012 – Post-Grant Proceedings after the AIA (Law Seminars International) – 3:00 – 4:00 pm (Eastern)

    June 20-21, 2012 – International Forum on Pharma Patent Lifecycles*** (C5) – London, England

    July 23-24, 2012 – Patent Cooperation Treaty Seminar (American Intellectual Property Law Association) – Alexandria, VA

    June 24-26, 2012 – IP Business Congress (Intellectual Asset Management (IAM) magazine) – Cascais, Portugal

    June 25-26, 2012 – Hatch-Waxman Boot Camp*** (American Conference Institute) – San Diego, CA

    July 11-13, 2012 – Fundamentals of Patent Prosecution 2012: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – San Francisco, CA

    July 12, 2012 – Inducement to Infringe in Hatch-Waxman Litigation:  Lessons from Bayer Schering v. Lupin and AstraZeneca v. Apotex for Pharma Patents (Strafford) – 1:00 – 2:30 pm (EDT)

    July 17-19, 2012 – Product and Pipeline Enhancement for Generics*** (marcus evans) – Washington, DC

    July 30-31, 2012 – Freedom to Operate*** (American Conference Institute) – Philadelphia, PA

    July 30 to August 1, 2012 – Intensive Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

    ***Patent Docs is a media partner of this conference or CLE

  • Meet the Docs at BIO 2012

    BIO International ConventionThe Biotechnology Industry Organization (BIO) will be holding its annual BIO International Convention next week in Boston, MA.  Founded in 1993, BIO is a nonprofit association seeking supportive biotechnology policies on behalf of more than 1,100 biotechnology companies, state and international affiliates, and related organizations, as well as providing business development services for many emerging biotech companies.

    As part of the Convention, more than 1,800 biotech companies, organizations, and institutions are expected to participate in the BIO Exhibition.  Patent Docs authors Donald Zuhn and Kevin Noonan, and contributors Sherri Oslick, James DeGiulio, Andrew Williams, and Kwame Mensah will also be attending BIO as part of the MBHB contingent, and will be participating in BIO's blogger network throughout the week. Patent Docs readers who may be attending BIO this week are encouraged to stop by Booth 1335 – Hall A to meet the Docs, at the times indicated below, and talk a little biotech patent law.

    Monday, June 18
    12:00 – 2:30 pm — Sherri Oslick
    2:30 – 5:00 pm — James DeGiulio

    Tuesday, June 19
    10:00 am – 12:00 pm — Donald Zuhn & Kwame Mensah
    12:00 – 2:00 pm — Kwame Mensah
    2:00 – 4:00 pm — Donald Zuhn
    4:00 – 6:30 pm — Sherri Oslick & James DeGiulio

    Wednesday, June 20
    10:00 am – 12:00 pm — James DeGiulio
    12:00 – 2:00 pm — Sherri Oslick, James DeGiulio & Kwame Mensah
    3:30 – 5:00 pm — Donald Zuhn & Andrew Williams

    Thursday, June 21
    10:00 – 11:30 am — Donald Zuhn & Kevin Noonan
    11:30 am – 1:00 pm — Kevin Noonan & Andrew Williams

    The Convention also offers more than 125 breakout sessions.  A program listing all of the sessions can be found here.  Among the sessions that may be of interest to Patent Docs readers are:

    Monday, June 18
    • Access to and Uptake of Biosimilars: The European Experience — 10:00 – 11:30 am
    • IP Challenges to Personalized Medicine & Diagnostics — 2:00 – 3:30 pm
    • The New World: Post-Grant Review in the United States — What Can We Learn from Past Experiences in Europe, Japan, India and Australia — 2:00 – 3:30 pm
    • Cross–border Intellectual Property Challenges in Strategic Research Collaboration between Canada and California (Cancer Stem Cell Case Study) — 3:00 – 3:45 pm
    • Successful IP Strategies for Biotech Platform Technologies — 3:45 – 5:00 pm

    Tuesday, June 19
    • Options for Generic Biotech Crops: An "Accord" on Responsibility and Data Compensation for Expiring Patents and Overseas Approvals — 8:30 – 9:45 am
    • Recent Developments in Patentability: Prometheus, Myriad, Classen and the Patentability of Diagnostic Methods — 8:30 – 9:45 am
    • Beyond Borders: Ernst & Young’s Annual Biotechnology Industry Report (Super Session) — 10:00 – 11:30 am
    • Prior User Rights and Trade Secrets: A New IP Option Replacing Patents to Secure Freedom-to-Operate for Internally-Used Innovations in Biotechnology — 2:00 – 3:30 pm
    • Burrill State-of-the-Industry Report (Super Session) – 2:00 – 3:30 pm
    • FDA Town Hall — 2:00 – 3:30 pm
    • International Leaders Share Their Worldview: Scientific American's Regional Bio-Innovation Scorecard (Super Session) — 3:45 – 5:15 pm

    Wednesday, June 20
    • Patenting Under the America Invents Act in Comparison with European Patent Practice — 10:00 – 11:30 am
    • IP Issues Affecting Biomarker Diagnostics and Personalized Medicine — 2:00 – 3:30 pm

    Thursday, June 21
    • Enactment of the Leahy-Smith America Invents Act 2011 (AIA): How Changes to Patent Law in the United States Will Impact Commercialization and Technology Transfer Offices — 8:30 – 9:45 am
    • Challenges and Opportunities of Protecting and Managing IP Assets in Emerging Markets — 10:00 – 11:30 am

    MBHB EventIn addition, the Docs will be attending the MBHB reception at Black Rose Pub, 160 State Street, from 9:00 pm to 1:00 am on Tuesday, June 19.  Additional information about the reception, including invitations for the event, can be picked up at the MBHB booth (Booth 1335 – Hall A) on Monday or Tuesday.

  • CLE on AIA Post-Grant Proceedings

    LSI - Law Seminars International - redLaw Seminars International (LSI) will be offering a one-hour telebriefing on the "Post-Grant Proceedings after the AIA" on June 19, 2012 from 3:00 – 4:00 pm (Eastern).  Wab P. Kadaba of Kilpatrick Townsend & Stockton LLP will moderate a panel including Wilson White, Associate Litigation Counsel of Google Inc., who will provide an in-house perspective and Mitchell G. Stockwell of Kilpatrick Townsend & Stockton LLP and Cyrus A Morton of Robins, Kaplan, Miller & Ciresi L.L.P., who will provide the private litigator's perspective.  The panel will discuss the practical implications of implementation of inter partes review and post-grant review to post-grant proceedings in the wake of the AIA, offering participants practical and strategic insights about how best to prepare for the post-AIA landscape.  Among the topics to be covered are:

    • Practical impacts of new Patent Office procedures, including post-grant and inter partes review;
    • Strategic and tactical considerations for challenging third party patents;
    • The impact of the estoppel provisions on later challenges to the same patent;
    • Potential effects on patent litigation and patent trials; and
    • Potential pitfalls and how to avoid them.

    A Q&A will follow the presentation and last for up to 30 minutes.

    The registration fee is $125 per caller and $50 each additional person on the same line who desires continuing education credit.  Those interested in registering for the telebriefing, can do so here.

  • The Aussies Are At It Again

        By Kevin E. Noonan —

    Australia Coat of ArmsLast year, the Australian Senate rejected a call for banning patents on human genes in Australia.  This result came after almost a decade of debate, resulting in several Reports (including the 2011 ACIP Report on Patentable Subject Matter, the Senate Gene Patents Report, issued November 24, 2010, and the 2004 Australian Law Reform Commission's Report on Genes and Ingenuity: Gene Patenting and Human Health (ALRC 99 Report) (see "News from Abroad: The Gene Patents Debate in Australia — An Update").  On November 23, 2011, the Australian government released a combined report (that can be accessed here).  And the Australian Senate determined that the Australian Patent Act of 1990 should not be amended to exclude human genes as patent-eligible subject matter, pursuant to a 124-page report that recommended against passage of the Patent Amendment (Human Genes and Biological Materials) Bill 2010, which was introduced by Senators Helen Coonan, Bill Heffernan, Rachel Siewert, and Nick Xenophon (see "Australian Senate Committee Issues Recommendation on Gene Patenting Bill").

    Undaunted, another Member of Parliament (Melissa Parke, the Labor representative from Fremantle, Western Australia), is reported (by Intellectual Asset Management, "Gene patent opponents take the fight back to Parliament") to be ready to introduce a bill to amend Section 18(2) of the Patents Act, as follows:

    18(2)  The following are not patentable inventions:
            (a)  human being, and the biological processes for their generation;
            (b)  genetic materials that exist in nature, or are the same as or not markedly different from those existing in nature whether such materials are in situ, isolated or purified;
            (c)  any method that involve the mere comparison of genetic materials or genetic sequences in the provision of a diagnosis for a human being.
    18(2)(A)  A reference in subsection (2) to genetic materials includes, but is not limited to, DNA or RNA whether in whole or part or in fragments, however made.

    While wrongheaded, this proposal has a few advantages over judicial solutions that may arise in the U.S., for example.  First, it is expressly limited to genetic material, and so avoids the risk of determining that "products of nature" are somehow patent ineligible.  While this bill shares the infirmity with Congressman Becerra's thrice-rejected (or maybe more correctly, ignored) bill to ban "gene patenting" in that it encompasses more than human DNA (thus threatening cucumber or tomato gene patents as well as human ones), it does avoid the risk of finding the antibiotics, anticancer drugs, improved lubricants or silicon formulations, or antibodies (the most common form of biologic drug) would become unpatentable.  It also permits any such ban to be considered by Australia's elected representatives, rather than judges without any particular expertise in technology (some of whom are comfortable overturning the opinions of judges that do have such "special expertise").

    But unlike earlier proposals (including last year's), this bill would also ban "applications" of genetic technology, albeit only those that "mere[ly] compar[e]" genetic sequences.  Such claims have already been held unpatentable in the U.S. under the Bilski and AMP v. USPTO precedent.  It is unclear whether claims further reciting other affirmative steps in identifying a sequence would fall within the scope of the proposed ban.  Also precluded from patent protection would be synthetic DNA including oligonucleotide fragments (while blessedly being devoid of a reference to a "magic microscope" as justification for the ban).  It is unclear whether cDNA would be considered "markedly different" under the bill, although this would depend on whether the chemical or informational properties of DNA are considered.

    The prospect of the bill being introduced is another testament to the persistence of the anti-gene patenting proponents on the issue, reminiscent of other motivated political factions.  Whether this bill gains sufficient traction to have a chance of passage, or whether political fatigue or indifference prevent its passage will be closely monitored, here and anywhere the issue is seriously considered.

  • BIO International Convention 2012 Preview – Part III

    BIO and the America Invents Act

    By Andrew Williams —

    BIO International ConventionThe 2012 BIO International Convention begins in Boston next week.  Patent Docs has been highlighting a few sessions, in thematic fashion, to help you navigate your way through the convention.  Today, in this final installment, we review a few opportunities for those interested in learning how the Leahy-Smith America Invents Act will impact U.S. patent practice, with the use of patent systems from other countries to serve as a guide.  Please note, however, that even though we have highlighted several sessions from a spectrum of disciplinary tracks over the past week, we have only begun to scratch the surface of opportunities available at the BIO convention.  Of course, if you want to share your favorite session with us, or let us know how the America Invents Act is going to affect you or your company (or for that matter, any other topic that is on your mind), the Patent Docs authors and contributors will be present at BIO as part of the MBHB contingent, and you are encouraged to stop by the MBHB booth to meet us (#1335 – Hall A).  We will be posting a schedule shortly to let you know when your favorite Patent Docs author or contributor will be at the booth.

    As Patent Docs readers know, one of the biggest stories from the past year for U.S. patent practice was the passage of the Leahy-Smith America Invents Act ("the AIA").  Of course, Patent Docs has been covering the AIA for years, and is continuing to follow the U.S. Patent Office's implementation of various provisions of the new law.  There has been no shortage of opportunities to learn about and discuss the AIA, but the BIO International Convention provides some unique opportunities that are not necessarily found elsewhere.  Specifically, the U.S. can look to how patent systems throughout the world have been dealing with provisions that are analogous to sections of the AIA.  Because of the strong international presence at the conference, U.S. patent practitioners can learn from their international colleagues.  And, hopefully, it will also give the non-U.S. patent practitioners a chance to learn about how the new U.S. law will affect them and their companies or clients.

    As a perfect example, the Biotech Patenting and Tech Transfer Track will be presenting "Patenting under the America Invents Act in Comparison with European Patent Practice" on Wednesday, June 20, between 10:00-11:30 am.  This session will include speakers from the European Patent Office and the U.S. Patent and Trademark Office, as well as patent practitioners from these two jurisdictions, who will be able to provide insight on the America Invents Act and how it compares to European practice.  The session promises to review the changes in patentability in the U.S., such as the first-to-file system, the grace period, prior art, and post grant review, and assess patentability in Europe, including its first-to-file system, prior art, and opposition practice.  These two systems will be compared and contrasted for perspectives on global strategies.  For example, the differences in the grace periods related to the two first-to-file systems will be examined, including how they might impact prosecution strategies.  The speakers of this session include Wenfang Chen, Patent Counsel for Danisco U.S. Inc./Dupont; Sally Mannion, Head, Pharma & Nutrition Team at Avidity IP; Enrique Molina Galán, Director, European Patent Office; and Mary Till, Legal Advisor with the U.S. Patent and Trademark Office.  This session will be moderated by Thomas Kowalski, Shareholder at Vedder Price.

    Another example of a session that will look to other jurisdictions, this time for a specific topic, is "The New World: Post-Grant Review in the United States — What Can We Learn from Experiences in Europe, Japan, India and Australia," which is being presented on Monday, June 18, between 2:00-3:30 pm.  The AIA made significant changes to the U.S. post-grant review system, allowing parties the opportunity to challenge the validity of patents on prior art and disclosure grounds within nine months of grant.  There will be a newly titled "Patent Trial and Appeal Board" that will hear these challenges, and the Federal Circuit will only be able to review decisions under the substantial evidence standard.  The speakers for this session are a panel of international experts who will be able to explain their countries' histories with post-grant review, including the growing pains they experienced developing their respective systems.  They promise to assess the pros and cons of post-grant review and coordinated global approaches to the subject.  The session includes Pravin Anand, Managing Partner at Anand and Anand; Katrina Howard, Member, Selborne Chambers; Hans-Rainer Jaenichen, Partner at Vossius & Partner; and Shusaku Yamamoto, Founder of Shusaku Yamamoto Patent Attorneys.  The session will be moderated by James F. Haley, Partner at Ropes & Gray LLP.

    The final session that we are highlighting will explore the consequences, whether intentional or unintentional, of one of the provisions of the AIA — the Prior User Rights.  This session is entitled "Prior User Rights and Trade Secrets: A New IP Option Replacing Patents to Secure Freedom-To-Operate for Internally Used Innovations in Biotechnology," and will be presented on Tuesday, June 19, and 2:00-3:30 pm.  This section of the AIA allows a company to maintain a new technology as a trade secret, while providing a defense against future infringement of a later patent.  As such, the Prior User Rights could change the patent landscape for externally marketed products and internally used technologies used to produce them.  This session promises to assess the merits and risks of the choice between patents and prior user rights to secure freedom-to-operate for these internally used technologies.  It will also explore how a prior user paradigm might best benefit you or your clients company.  The speakers for this session include Brian Barrett, Associate General Patent Counsel for Eli Lilly & Company; Mary Ann Dillahunty, Vice President, Intellectual Property for Oncolytics Biotech, Inc.; Jason Duncan, Associate General Counsel of EMD Serono, Inc.; and Andrew Torrance, Visiting Professor at MIT Sloan School of Management.  The moderators will be Thomas Kelley, Consulting Patent Counsel of Monsanto Company and R. Mark Halligan, Partner at Nixon Peabody LLP.

  • Federal Circuit Declines Invitation to Reconsider Standing Question

    By Kevin E. Noonan —

    MyriadThe Federal Circuit today denied Defendant Myriad Genetics' motion, styled as "Appellant's Suggestion of Mootness, or, in the Alternative, Motion to Remand," seeking to reopen the question of whether Dr. Harry Ostrer continues to have standing to bring the lawsuit (see "Myriad Files Motion 'Suggesting' Mootness or Seeking Remand in AMP v. USPTO").  As will be recalled, the Federal Circuit held that only Dr. Ostrer among all the named plaintiffs had standing, because he asserted he was “ready, willing and able” to practice the claimed BRCA genetic diagnostic methods should the Court affirm the District Court's decision invalidating the claims at issue.  Myriad contended that Dr. Ostrer's change in academic affiliation stripped him of the ability to perform genetic diagnostic tests for the BRCA mutations, and thus that the Court should either dismiss the case or remand for a determination by the District Court on Dr. Ostrer's status.

    Of course, even that eventuality might have proven unavailing for having the case dismissed, since plaintiffs had also asserted unconstitutionality claims (under the First and Fourteenth Amendments) based on the USPTO granting patents that interfered with a woman's ability to obtain information about her genetic health.  A motion to dismiss by the PTO was denied on the grounds that the women had no other recourse to a remedy other than the lawsuit.  The District Court avoided addressing that issue, however, and dismissed the USPTO from the case when making its decision, under the principle that constitutional questions should be avoided if the matter can be resolved by applying the appropriate statute (or, as here, deciding that the government action was contrary to the statute).

    Opening party briefs and briefs by any amici remain due on June 15th.

  • BIO International Convention 2012 Preview – Part II

    BIO and Biosimilar Regulations throughout the World

    By Andrew Williams —

    BIO International ConventionThe 2012 BIO International Convention in Boston begins next week.  If you are planning on attending, Patent Docs is highlighting a few sessions, in thematic fashion, to help navigate your way through the Convention.  Last week, we highlighted three sessions on how the Supreme Court's Prometheus case is impacting the BIO community.  Today, we present opportunities for those interested in learning more about how the biotech industry is adjusting to the new biosimilar framework in various jurisdictions.  Of course, Patent Docs authors and contributors will be present at BIO as part of the MBHB contingent, and Patent Docs readers are encouraged to stop by the MBHB booth (#1335 – Hall A) to discuss the FDA's draft guidance documents on the new biosimilar approval pathway (or whatever other topic is of interest to you).

    On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act ("the Act"), which amended the Public Health Service Act to create an abbreviated approval pathway for biological products that are either biosimilar to or interchangeable with an already approved biological product.  While the fate of the Act has yet to be determined by the Supreme Court, the U.S. is almost certain to begin seeing biosimilar drugs approved in the near future.  In fact, in February of this year, the FDA issued three guidance documents that provided its thinking on key scientific and regulatory factors that will be involved in submitting applications for biosimilar products to the agency (see "FDA Publishes Draft Guidelines for Biosimilar Product Development").  However, the U.S. is not the first jurisdiction to consider a biosimilar pathway, and in fact Europe has already approved several biosimilar drugs via an abbreviated registration process.  Of course, the subject of biosimilars is of great interest to the biotech community, and this year provides several opportunities for BIO attendees to attend sessions on the development of biosimilars regulatory schemes both here and outside the U.S.

    Europe has led the way in creating a biosimilar approval pathway, and was the first to approve biosimilar drugs.  Some of the key factors driving this process were patent expirations, cost containment measures, ageing populations, and supporting legislations.  On Monday, June 18, between 10:00-11:30 am, the Health Policy and Reimbursement Track will present "Access to and Uptake of Biosimilars: The European Experience."  This session promises to focus on market opportunities for both innovator companies and the generic industry in Europe.  It will evaluate the challenges for the policy makers and payers in terms of pricing and reimbursement of biosimilars, as well as the challenges of providing patients, healthcare professionals and payers with adequate information.  The panel for the session consists of Thomas Bols, Vice President Health Policy & Market Access, EuropaBIO; Paul Greenland, Biosimilars and Proprietary Marketing Director, EGA; and Steffen Thirstrup, Chief Medical Officer of the Danish Medicines Agency (DKMA).  The session will be moderated by Thomas Heynisch, Deputy Head of Unit Healthcare, Biotechnology, of the European Commission, DG Enterprise and Industry.

    Of course, Europe isn't the only area outside of the U.S. that has been establishing a biosimilar regulatory framework.  Countries in Latin America have been actively making plans to become global leaders in biotechnology.  Argentina published a dedicated biosimilar regulation in late 2010 and 2011, and Brazil developed new biologics regulations in the same timeframe, with product-specific guidelines for biosimilars.  In addition, Mexico recently updated the Regulation of Health Supplies (RIS) in terms of biological medicine.  To discuss these advances, the Global Innovations and Markets Track will present "Biologics and Biosimilars in Latin America: Are New Regulations and Guidelines in Brazil, Mexico, and Argentina a New Model for Drug Regulation?" on Wednesday, June 20 from 8:30-9:45 am.  The panel promises to discuss the regulatory framework in Brazil and Mexico, because, in 2012, Brazil is finalizing its guidelines for biosimilar monoclonal antibodies, and Mexico is implementing it new biologics regulation.  It is an objective of this session to distinguish the framework in these two countries from other emerging markets, and how the respective governments were able to achieve this change in regulatory framework.  It is also an objective to learn from company executives working within these regulatory frameworks what matters most when deciding to enter and/or invest in a country.  Currently, the session presenters are Dirceu Barbano, Director Chairman of ANVISA, National Health Surveillance Agency, and Laura Hamill, Vice President, Latin America for Amgen.

    As a final example of a learning opportunity about biosimilars, the Achieving Regulatory Approval and Compliance Track is presenting "Interchangeable Biosimilars: Distinguishing between Aspiration and Achievement" on Thursday, June 21 from 8:30-9:45 am.  The U.S. may not be the first jurisdiction to create a biosimilar regularity pathway, or approve biosimilar drugs, but they are the only one to require an evaluation of interchangeability.  In fact, Canada has explicitly rejected the notion of interchangeability.  This session promises to summarize the state of the science of biotechnology, specifically with regard to a determination of interchangeability as defined by the U.S. law.  Also, the panelists will discuss the challenges of implementing such a system, and how it will affect manufacturers, health care providers, patients and payers.  Finally, they will look at the key public policy considerations involved.  The panel will include Joseph Miletich, Senior Vice President, Research and Development for Amgen; Gregory Schimizzi, Co-founder of Carolina Arthritis, Coalition of State Rheumatology Organizations; Jan Wyatt, Patient Advocate for the Arthritis Foundation; and Richard Kingham, Partner at Covington & Burling LLP.  The session will be moderated by Ramsey Baghdadi, Senior Editor of The RPM Report.