Orange Book Blog

At the intersection of Patent and FDA Law

Recent Posts

  • IIR “8th Annual Generic Drugs Summit” Conference, Washington D.C., Sept. 17-19

    The Institute for International Research will be holding its 8th annual “Generic Drugs Summit” at the Fairmont Hotel in Washington, D.C., September 17-19.  According to IIR, this is “the leading independent forum for addressing business and legal concerns impacting the Generics marketplace.”

    The conference features three pre-event symposia and workshops on September 17:

    • Full day: Generic Biologics: Understanding the Scientific, Legal, Regulatory, Economic and Marketing Implications
    • Morning: Strategies for Filing Successful Paragraph IV Certifications
    • Afternoon: Understanding How to Submit Quality ANDAs Based on ObR to Reduce Approval Time

    The agenda highlights for the main program, September 18-19, are impressive:

    • Q&A with Congressman Henry A. Waxman on Hatch-Waxman reform
    • Update and Q&A with Senator Debbie Stabenow on hurdles that slow generics from coming to market
    • Update on legislative developments
    • Current antitrust actions affecting the generics industry
    • An executive roundtable
    • A view from Wall Street
    • A debate on authorized generics

    Additionally, each afternoon will split into two separate tracks: one covering intellectual property and legal issues, the other covering business trends and strategy.

    For further information and to register, please visit the conference website.

    Orange Book Blog is a media partner of this conference.

  • Forest Labs’ Lexapro Patent Withstands Teva’s Appeal at Federal Circuit

    Forest Labs. v. Ivax Pharms. and Cipla, No. 2007-1059 (Fed. Cir. 2007)

    In an opinion released today, the Court of Appeals for the Federal Circuit affirmed a district court decision that upheld the validity of Forest Labs’ U.S. Reissue Patent 34,712, which covers (+)-citalopram, the active ingredient in Lexapro.  Teva, seeking to market a generic version of Lexapro before the ‘712 patent expires in 2012, challenged the patent’s validity in a paragraph IV filing.

    Teva’s lead argument (which took up the entire 30-minute oral argument in May) was that the claims of the ‘712 patent were anticipated by a prior art reference that predicted that one enantiomer of the racemate, citalopram, would be more active than the other.  The Federal Circuit affirmed the district court’s conclusion that the prior art reference was not enabled, and therefore not anticipating.

    Teva’s second argument was that the claims of the ‘712 patent were obvious in light of racemic citalopram and known techniques of separating enantiomers from their racemates.  The Federal Circuit dismissed this argument in less than a paragraph, stating: " As with their arguments on anticipation, Ivax and Cipla mainly emphasize the evidence that is favorable to their desired outcome without addressing the evidence favorable to Forest."

    Forest earns more than $2 billion annually on U.S. sales of Lexapro.  If today’s decision sticks, Teva won’t be able to sell a generic version until 2013, when Forest’s pediatric exclusivity on the drug expires.

    RELATED READING:

  • Pharma News Briefs

    • Novartis announced last week that European regulators have approved its follow-on biologic epoetin alfa, which is biosimilar to J&J’s Eprex.  Pharmalot posted this story today about J&J’s reaction.
    • The WSJ Health Blog had this interesting post last week reporting that more clinical trials are now under way in China than in India.
    • Adams Respiratory Therapeutics is facing a patent challenge by Perrigo over its Mucinex cough medicine.  Bloomberg recently published this report; MarketWatch.com had this one.
    • The Wall St. Journal published this interesting article (subscription) a couple weeks ago about a drug development partnership between Eli Lilly and Chi-Med, a Chinese biotechnology company.
    • FDA Law Blog had this post last month about impending FDA enforcement action on marketed unapproved drugs.
    • Finally, a couple oldies but goodies from Pharma’s Cutting Edge: Ariad v. Lilly patent litigation; response to Richard Epstein’s Overdose.

  • ACI “Pharma/Biotech Patent Boot Camp” Conference, San Francisco, Sept. 18-19

    American Conference Institute will be holding its Pharma/Biotech Patent Boot Camp conference in San Francisco, September 18-19.

    According to ACI, the conference “has been designed to give new patent attorneys and patent attorneys who are new to the life sciences industries–as well as business executives in pharma and biotech companies–a strong working knowledge of essential IP and regulatory competencies relative to life sciences patents.”

    The following talks sound particularly informative:

    • Pre-Patent Considerations Relative to Product Development, Commercialization and Life Cycle Management
    • Freedom to Operate: Analysis and Opinions for Pharma and Biotech Patents
    • Finding Safe Harbors for Life Sciences IP: Assessing Protections and Identifying Infringing Activities Relative to Third-Party Patents
    • The Nature of the Approval Process for Drugs and Biologics: What Every Life Sciences Patent Attorney Should Know
    • Patent and IP Overview for Drugs and Biologics: Hatch-Waxman, Trade Dress and More
    • Patent and Non-Patent Exclusivity
    • Bioequivalence and the “Same Active Ingredient” vis-a-vis Patentability
    • Exploring Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration

    The co-chairs of the conference are MaCharri R. Vorndran-Jones (patent counsel, Eli Lilly and Co.) and Thomas J. Kowalski (partner, Frommer Lawrence & Haug LLP).  Additional details and registration information are available at the conference website.

    Orange Book Blog is a media partner of this conference.

  • USPTO To Present Webcast On New Claims and Continuation Rules Thursday, August 23, 1 p.m.

    The USPTO contacted me yesterday and requested that I post the following announcement:

    The U.S. Patent and Trademark Office (USPTO) will hold a special webinar on Thursday, August 23, 2007, at 1:00 p.m. (EST) on new claims and continuations rules that will allow the agency to continue to make the patent examination process more effective and efficient by encouraging applicants to use greater clarity and precision in describing the scope of their inventions.  The new rules will be published in the Federal Register available at www.uspto.gov after noon on August 21, and will be effective on November 1, 2007.

    During this live, two-hour webcast, USPTO officials will explain the new rules and answer questions.  The presentation and audio for this event will be streamed over the Internet.  All participants need is a computer with an Internet connection, sound card, speakers and the ability to view Windows Media presentations.

    To register for this free webcast, click on the following link:  https://uspto-ls.webex.com/uspto-ls/onstage/g.php?d=664144307&t=a

    An advance copy of the presentation will be made available to registrants prior to the event.

    If you would like to receive regular updates from USPTO on its eCommerce initiatives, please register by clicking on the following link:  http://uspto.websurveyor.net/mail/register.aspx

  • U.S. Patent Office Issues Initial Rejection of Pfizer’s Reissue Patent Application on Lipitor

    As The Wall Street Journal reported last week, the U.S. Patent and Trademark Office has issued an initial rejection of Pfizer’s application for a reissue patent of U.S. Patent No. 5,273,995–one of two Pfizer patents covering Lipitor.

    In a decision last August, the Court of Appeals for the Federal Circuit upheld one Pfizer patent on Lipitor (U.S. Patent No. 4,681,893) and invalidated another (the ‘995 patent).  Specifically, the court invalidated claim 6 of the ‘995 patent, covering the hemicalcium salt of atorvastatin acid (the active ingredient in Lipitor), because it failed to specify a further limitation to the claim from which it depended.  Pfizer sells about $12 billion worth of Lipitor annually.  The ‘995 patent (if valid) was set to expire more than a year later than the ‘893 patent will expire, so naturally Pfizer filed a reissue patent application to try to correct the ‘995 patent.

    In a preliminary amendment filed as part of its reissue application in January, Pfizer amended claim 6 of the ‘995 patent to be an independent claim, and indicated that "this was one of the options . . . approved by the Federal Circuit in its decision."

    Ranbaxy–the first ANDA filer for generic Lipitor and the defendant in the patent litigation decided by the Federal Circuit–filed a protest against Pfizer’s reissue application in May.  Among Ranbaxy’s arguments was that the defect in claim 6 is not correctable through a reissue patent.

    The Patent Office mailed a first Office Action on Pfizer’s reissue application last Thursday.  While the Patent Office stated that the defect in claim 6 is in fact correctable through a reissue application, the Office rejected all 14 claims of Pfizer’s reissue application on grounds of anticipation, obviousness, or obviousness-type double patenting.  In particular, the Office rejected claim 6 for obviousness-type double patenting in view of U.S. Patent Nos. 6,605,729 and 5,969,156.

    The proceedings over Pfizer’s reissue patent application are far from over.  Pfizer will certainly file a response to last week’s Office Action, after which the Patent Office might issue a final Office Action.  If Pfizer is unsatisfied at that point, it might request continued examination or file an appeal to the Patent Office Board of Appeals.  If rebuffed there, Pfizer could appeal to the Federal Circuit.  Given how much money is at stake, Pfizer is likely to pursue all its options before giving up on the reissue application.

    RELATED READING:

  • Informa Life Sciences “European Pharmaceutical Law Forum” Conference, Washington D.C., October 23-25

    Informa Life Sciences will be presenting a unique conference entitled "European Pharmaceutical Law Forum" in Washington, D.C., October 23-25.  The conference will provide an invaluable introduction to the laws and regulations governing the pharmaceutical, biotech and generics industries in Europe.

    At this premier global event you will be brought up-to-date with the key European cases shaping international pharmaceutical law and hear the latest regulatory and legal developments governing drug development, registration and commercialization in Europe.  Leading European lawyers, in-house counsel and representatives of the European Commission and the Federal Trade Commission will present crucial information to help optimize your international legal strategy.

    Informa Life Sciences is offering Orange Book Blog readers a $200 discount on registration (use promotional code CQ50270E).  For additional details or to register, please visit the conference website.

    Orange Book Blog is a media partner of this conference.

  • ACI “FDA Boot Camp” Conference, Chicago, Sept. 25-26

    American Conference Institute’s popular "FDA Boot Camp" returns to the University of Chicago’s Gleacher Center in downtown Chicago on September 25-26.  ACI expects a sell-out of this conference and recommends early registration.

    The conference is designed to give patent lawyers, product liability lawyers, and life sciences investment and securities experts a strong working knowledge of core FDA regulatory competencies.  It features FDA regulatory and patent law experts from pharmaceutical companies and outside law firms.

    Presentations on the agenda include:

    • The Basics: Understanding and Working with the FDA–Jurisdiction, Functions, Organization, and Operations
    • The Nature of the Approval Process
    • Patent and IP Overview for Drugs and Biologics: Hatch-Waxman, Trade Dress, and More (I’ll be on this panel, speaking about Hatch-Waxman)
    • Drugs and Biologics: Labeling
    • Non-patent Exclusivity
    • Bioequivalence: What Patent Lawyers Need to Know
    • Follow-on Biologics
    • Medical Devices: Classification and the Essentials of the Device Premarket Review Process

    The co-chairs of the conference are Coleen Klasmeier of Sidley Austin LLP and Erika Lietzan of Covington & Burling LLP.  Additional details and registration information are available at the ACI FDA Boot Camp web site.

    Orange Book Blog is a media partner of this conference.

  • Pharma News Briefs

    • The Wall St. Journal Health Blog had an interesting post Thursday on how Genzyme’s struggle to produce enough Myozyme heightens worries about generic biotech drugs.
    • The New York Times published an interesting article Wednesday on the recent "tidal wave" and the coming "golden era" of generic drugs.
    • Novartis lost its challenge to India’s drug patent law on Monday (see New York Times; Business Week; WSJ Health Blog).  PhRMA reacted in this press release.
    • The Spicy IP blog has been providing a thoughtful, in-depth perspective on the Novartis India case.
    • FDA Law Blog reported Monday that the House passed an FDA appropriations bill with a provision allowing for reimportation of prescription drugs.
    • MarketWatch.com had this interesting article Monday on recent growth in pharmaceutical R&D in China and India.

  • Pharma News Briefs

    • FDA Law Blog had a post Thursday about "The Dog Ate My Homework Act," which would give a reprieve to companies that miss the deadline for filing a patent term extension request.
    • Pharmalot had this post Wednesday, reporting that Congress has delayed the FDA bill until September.
    • Patently-O reported Wednesday on the Federal Circuit’s decision on Washington, D.C.’s drug price law.  PhRMA made a press release on the decision.  The Washington Post published this article on the case.
    • Tuesday, Wyeth announced a deal with Teva and Sun concerning generic Protonix.  Today, Teva announced that FDA approved its ANDA for Protonix.
    • Investor’s Business Daily had an interesting article last week, "RNAi Stirs Excitement in Big Pharma."
    • The Patent Prospector had a neat post last week, "Dealing with KSR."