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  • Cert. Denied in Eli Lilly v. Sun Pharmaceuticals

    By Kevin E. Noonan —

    Supreme Court Building #1 The Supreme Court refused today to grant certiorari in Eli Lilly & Co. v. Sun Pharmaceutical Industries, Ltd. on the question of obviousness-type double patenting.  In doing so, the Court let stand precedent that seriously expands the scope of the obviousness-type double patenting standard, turning a legal principle that was "clear" to one "distorted by divergent statements[] leading to [a] flawed ruling," according to Judge Newman (joined by Judges Lourie and Linn and Chief Judge Rader) in dissent from denial of Eli Lilly's petition for rehearing en banc.

    To recap, a Federal Circuit panel (opinion by Judge Prost, joined by Judges Gajarsa and Bryson) affirmed the District Court judgment that claims of Eli Lilly's U.S. Patent No. 5,464,826 ("the '826 patent) were invalid for obviousness-type double patenting over another Lilly patent, U.S. Patent No. 4,808,614 ("the '614 patent") (see Patent Docs report).  The '614 patent claims gemcitabine, and methods of using gemcitabine to treat viral infections, while the '826 patent claims methods of using gemcitabine for treating cancer.  Eli Lilly markets the drug GEMZAR®, which contains gemcitabine as the active ingredient, for the treatment of various forms of cancer.  Accordingly, both the '614 and '826 patents were listed in the Orange Book with respect to GEMZAR®.  Sun filed an ANDA in 2006 to market a generic version of GEMZAR®, and filed a declaratory judgment action in 2007, asserting, among other things, that the '826 patent was invalid.  The U.S. District Court for the Eastern District of Michigan granted Sun's motion for partial summary judgment that the asserted claims of the '826 were invalid based on obviousness-type double patenting.

    The history of these patents and their interrelationship were important factors leading to the panel decision.  The '614 patent was a continuation-in-part of a priority patent that disclosed gemcitabine and its antiviral activity.  The application that eventually gave rise to the '614 patent contained additional disclosure regarding the anticancer activities of gemcitabine but contained no claims to this activity.  The '826 patent, in an application filed on the same day as the application that resulted in the '614 patent, both disclosed and claimed this activity and methods for exploiting the anticancer properties of gemcitabine in methods for treating cancer with the drug.  Thus, the '614 patent was entitled to the priority claim to the original patent while the '826 patent was not.

    The panel opinion relied on two earlier cases, Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008) in deciding that the '826 claims were invalid over the '614 patent in obviousness-type double patenting grounds.  These cases can be distinguished, however, since in both cases the specifications disclosed one and only one activity (or use) for the claimed compound, not (as here) an additional, new use.  Also, the panel used what was disclosed, rather than just what was claimed in the '614 patent in making its obviousness-type double patenting rejection of the '826 patent, and this is where the opinion veered significantly from prior precedent.  In doing so, the panel created a per se rule of obviousness-type double patenting that, while promoting certainty also "upsets the settled expectations of the patenting community" by significantly expanding the scope of the obviousness-type double patenting doctrine.

    Specifically, under the rule established by the panel opinion, if the earlier of two co-owned patents includes claims to a compound and discloses one or more uses for the compound in the specification, under the Federal Circuit's ruling any claim(s) in a later patent to any method of use disclosed (but not claimed) in the specification of the earlier patent are per se invalid based on obviousness-type double patenting.  This rule is contrary to prior case law, both in removing flexibility in considering the effect of the later patent on "improperly extending 'protection, beyond the date of expiration of the [earlier] patent, of the very same invention claimed therein . . . or of a mere variation of that invention which would have been obvious to those of ordinary skill in the relevant art,'" In re Kaplan, 789 F.2d 1574, 1579-80 (Fed. Cir. 1986), but also by collapsing the obviousness-type double patenting analysis into obviousness under 35 U.S.C. § 103 (using the patentee's own prior patent as if it were prior art under 35 U.S.C. § 102).  This constitutes a new, non-statutory type of prior art, a patentee's own prior patent application that was not "by another" and did not constitute a statutory bar (i.e., the patentee's own earlier work disclosed more than a year before the later application's filing date).  This is expressly contrary to the Federal Circuit's earlier precedent, e.g., General Foods Corp. v. Studiengesellschaft Kohle mbH, 972 F.2d 1272 (Fed. Cir. 1992), that a commonly owned, prior patent disclosure cited in support of a double patenting rejection cannot be used as though it were prior art.  Specifically, the earlier-filed patent disclosure is not to be considered in making an obviousness-type double patenting rejection.  In re Kaplan, 789 F.2d 1574 (Fed. Cir. 1986).

    Despite this disjunction between prior precedent and the panel opinion, the Federal Circuit declined to rehear the case en banc, in a 5-4 ruling from a diminished number of active judges.  Thus, Eli Lilly's only recourse was to appeal to the Supreme Court; however, consideration by the Court was unlikely, for several reasons.  First, the Supreme Court is a generalist court interested in the more significant, "high profile" cases that have characterized the Court's patent jurisprudence for the past decade (including KSR Int'l Co. v. Teleflex Inc., eBay Inc. v. MercExchange, LLC, Quanta Computer, Inc. v. LG Electronics, Inc., Microsoft Corp. v. AT&T Corp., Dickinson v. Zurko).  The obviousness-type double patenting doctrine lies deep in the minutiae of patent law and was unlikely to attract the Court's attention.  The Court also takes interest in patent law questions from the Federal Circuit where the court seems divided (such as Warner-Jenkinson Co. v. Hilton Davis Chemical Co. and Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co.).  This question was important (for the pharmaceutical industry in general) but it will take the Federal Circuit in its entirety to choose a case where the irregularities introduced into this important patent law doctrine will be set straight.

    Patent Docs filed an amicus case in support of certiorari in this case.

  • USPTO Expands First Action Interview Program

    By Donald Zuhn —

    USPTO Seal The U.S. Patent and Trademark Office announced today that it is expanding the Enhanced First Action Interview pilot program to include all utility applications in all technology areas and filing dates.  Like its predecessor programs, under the Full First Action Interview pilot program, an applicant is entitled to a first action interview, upon request, prior to the first Office action on the merits.  The new pilot program is scheduled to run through May 16, 2012.

    The Office initiated the initial First Action Interview pilot program (see "PTO Announces New Program to Reduce Pendency and Improve Patent Quality") in April 2008.  Under the original pilot program, an examiner assigned to a participating application conducted a prior art search and provided the applicant with a pre-interview communication containing a condensed preview of objections or rejections against the claims of the participating application.  Within 30 days from the issuance of the pre-interview communication, the applicant either scheduled a first action interview or decided not to have the interview.  If the applicant chose the latter option, the examiner issued a First Action Interview Office action giving the applicant the longer of one month or 30 days to reply.  If agreement could not be reached during the first action interview, the First Action Interview Office action was issued (with the reply period specified above).

    In October 2009, the Office expanded the First Action Interview pilot program to encompass additional technology areas (see "USPTO Expands First Action Interview Pilot Program").  One year after expanding the program, the Office extended the ending date of the pilot program from April 1, 2010 to October 1, 2010 (see "USPTO Announces Extension of Enhanced First Action Interview Pilot Program").  More recently, the Office revised the eligibility requirements to include utility nonprovisional applications that were filed three months later than the previously listed dates (see "USPTO Extends Enhanced First Action Interview Pilot Program").

    Until today's expansion of the program, biotech and pharma patent practitioners were limited to seeking participation for applications assigned to the 161X (drug, bio-affecting and body treating compositions) and 1795 (chemistry: electrical current producing apparatus, product, and process) art groups.  Under the Full First Action Interview pilot program, however, subject matter and filing date restrictions have been removed.  Other than expanding the program to encompass all technology areas and filing dates, the process remains unchanged from the process used during the Enhanced First Action Interview Pilot Program that ended April 1, 2011.

    In the Office's announcement, it noted that 34% of applications participating in prior iterations of the program were allowed on the first action on the merits as compared with the approximately 11% of applications that are allowed on the first action on the merits on average across all technologies for new non-continuing applications.

    Additional details regarding the Full First Action Interview pilot program can be found in a pre-OG notice issued by the Office.  This notice indicates that applicants wishing to secure a non-discretionary interview before the first action on the merits must electronically file a request (preferably using Form PTO/SB/413C).  Following this request, the Full First Action Interview process would proceed as outlined above for the original program.  To participate in the program, the following requirements must be met:

    (1)  The application must be a non-reissue, non-provisional utility application filed under 35 U.S.C. § 111(a), or an international application that has entered the national stage in compliance with 35 U.S.C. § 371(c).

    (2)  The application must contain three or fewer independent claims and twenty or fewer total claims, and no multiple dependent claims (applicants may file a preliminary amendment in order to comply with this requirement).

    (3)  The claims must be directed to a single invention (if the Office issues a restriction requirement, the application will be removed from the program; if an oral election without traverse is made during a telephone interview, the application will remain in the program).

    (4)  The request for a first action interview must be filed electronically, preferably using Form PTO/SB/413C.

    (5)  The request must be filed at least one day before a first Office action on the merits of the application appears in the Patent Application Information Retrieval (PAIR) system.

    (6)  The request for a first action interview must include a statement that applicant agrees not to file a request for a refund of the search fee and any excess claim fees paid in the application after the mailing or notification date of the Pre-Interview Communication (the Office notes that any petition for express abandonment under 37 C.F.R. § 1.138(d), request for a refund of search fee, and any excess claim fees filed after the mailing or notification date of a Pre-Interview Communication will not be granted).

    The pre-OG notice also indicates that:

    • The time period for scheduling an interview following the issuance of the Pre-Interview Communication may be extended for one additional month pursuant to 37 C.F.R. § 136(a).

    • Interviews must be scheduled electronically using the Applicant Initiated Interview Request Form (PTOL-413A).  The applicant must propose an interview date within the longer of two months or 60 days from the filing of the Applicant Initiated Interview Request Form.

    • Amendments filed between the issuance of the Pre-Interview Communication and the interview will not be entered unless approved by the examiner.  At the examiner's discretion, however, an amendment may be entered if it is clearly limited to the cancellation of claims, adoption of examiner suggestions, placement of the application in prima facie condition for allowance, or correction of informalities.

    Additional details regarding the program can be found in the pre-OG notice.

  • Court Report

    By Sherri Oslick —

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

    Elan Corp. et al. v. Teva Pharmaceuticals USA Inc.
    1:11-cv-00367; filed April 25, 2011 in the District Court of Delaware

    • Plaintiffs:  Elan Corp. plc; Elan Pharma International Ltd.
    • Defendant:  Teva Pharmaceuticals USA Inc.

    Infringement of U.S. Patent Nos. 6,228,398 ("Multiparticulate Modified Release Composition," issued May 8, 2001) and 6,730,325 (same title, issued May 4, 2004), licensed to Novartis, following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Novartis' Focalin® XR (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.


    Celgene Corp. et al. v. Teva Pharmaceuticals Usa, Inc.
    2:11-cv-02356; filed April 25, 2010 in the District Court of New Jersey

    • Plaintiffs:  Celgene Corp.; Novartis Pharmaceuticals Corp.; Novartis Pharma AG
    • Defendant:  Teva Pharmaceuticals USA, Inc.

    Infringement of U.S. Patent Nos. 5,908,850 ("Method of Treating Attention Deficit Disorders with d-Threo Methylphenidate," issued June 1, 1999), 6,355,656 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 12, 2002, with a reexamination certificate issued March 27, 2007), 6,528,530 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 4, 2003), 5,837,284 ("Delivery of Multiple Doses of Medications," issued November 17, 1998), 6,635,284 (same title, issued October 21, 2003), and 7,431,944 ("Delivery of Multiple Doses of Medications," issued October 7, 2008) all licensed exclusively to Novartis in certain fields of use, following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Novartis' Focalin XR® (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.


    Genentech, Inc. et al. v. Sandoz Inc.
    1:11-cv-01076; filed April 22, 2011 in the District Court of Colorado

    • Plaintiffs:  Genentech, Inc.; Roche Palo Alto LLC
    • Defendant:  Sandoz Inc.

    Infringement of U.S. Patent No. 6,083,953 ("2-(2-amino-1,6-dihydro-6-oxo-purin-9-yl)methoxy-1,3-propanediol Derivative," issued July 4, 2000) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Roche's Valcyte® (valganciclovir hydrochloride, used to treat cytomegalovirus retinitis and cytomegalovirus disease).  View the complaint here.


    Wyeth LLC v. Nostrum Pharmaceuticals, LLC et al.
    3:11-cv-02280; filed April 21, 2011 in the District Court of New Jersey

    • Plaintiff:  Wyeth LLC
    • Defendants:  Nostrum Pharmaceuticals, LLC; Nostrum Laboratories, Inc.; Enem Nostrum Remedies PVT., Ltd.

    Infringement of U.S. Patent Nos. 6,274,171 ("Extended release formulation of venlafaxine hydrochloride," issued August 14, 2001), 6,403,120 (same title, issued June 11, 2002), and 6,419,958 (same title, issued July 16, 2002) following a Paragraph IV certification as part of Nostrum's filing of an ANDA to manufacture a generic version of Wyeth's EFFEXOR XR® (venlafaxine hydrochloride, extended release, used to treat depression).  View the complaint here.


    AstraZeneca AB et al. v. Dr. Reddy's Laboratories Inc. et al.
    3:11-cv-02317; filed April 21, 2011 in the District Court of New Jersey

    • Plaintiffs:  AstraZeneca AB; AstraZeneca LP; Pozen Inc.
    • Defendants:  Dr. Reddy's Laboratories Inc.; Dr. Reddy's Laboratories Ltd.

    Infringement of U.S. Patent No. 6,926,907 ("Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs," issued August 9, 2005) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of AstraZeneca's Vimovo® (naproxen and esomeprazole magnesium, used to relieve the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of stomach (gastric) ulcers in patients at risk of developing stomach ulcers from treatment with non-steroidal anti-inflammatory drugs (NSAIDs).  View the complaint here.


    Novartis AG et al. v. Teva Pharmaceuticals USA, Inc. et al.
    2:11-cv-02289; filed April 21, 2011 in the District Court of New Jersey

    • Plaintiffs:  Novartis AG; Novartis Pharmaceuticals Corp.
    • Defendants:  Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries, Ltd.

    Infringement of U.S. Patent Nos. 6,025,391 ("Enteric-Coated Pharmaceutical Compositions of Mycophenolate," issued February 15, 2000), 6,172,107 ("Entric-Coated Pharmaceutical Compositions," issued January 9, 2001), and 6,306,900 (same title, issued October 23, 2001) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Novartis' Myfortic7 (mycophenolate sodium, used for the prophylaxis or prevention of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids).  View the complaint here.

  • Conference & CLE Calendar

    Calendar

    May 18-19, 2011 – Forum on Freedom to Operate (C5) – Munich, Germany

    May 23-25, 2011 – 6th International Judges Conference on Intellectual Property Law (Intellectual Property Owners Association) – Brussels, Belgium

    June 2, 2011 – EPO Opposition & Appeals — The Case Law (Patent Resources Group and Management Forum) – Chicago, IL

    June 3, 2011 – European Patents — The Case Law (Patent Resources Group and Management Forum) – Chicago, IL

    June 7-8, 2011 – Biosimilars*** (American Conference Institute) – New York, NY

    June 8, 2011 – Biotechnology/Chemical/Pharmaceutical (BCP) Customer Partnership Meeting (U.S. Patent and Trademark Office) – 10:00 am – 4:00 pm (EDT)

    June 21-22, 2011 – 10th Annual Forum on Pharma Patent Lifecycles (C5) – London, England

    July 18-19, 2011 – Hatch-Waxman Boot Camp*** (American Conference Institute) – San Diego, CA

    September 18-20, 2011 – Accelerating Intellectual Property and Innovation in South Africa (South African Department of Science and Technology) – Cape Town, South Africa

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

  • ACI Hatch-Waxman Boot Camp

    San Diego American Conference Institute (ACI) will be holding the next session of its Hatch-Waxman Boot Camp conference on July 18-19, 2011 in San Diego, CA.  ACI faculty will help attendees:

    • Understand the interplay of the PTO and FDA in the patenting of drugs and biologics;
    • Learn about the essentials of the FDA approval process and its link to biopharmaceutical patents;
    • Develop an in-depth and practical knowledge of Hatch-Waxman protocols, including: Orange Book listings, bioequivalency, exclusivities, the 30-month stay, and the safe harbor;
    • Navigate the intricacies of patent term adjustment and patent term extension;
    • Comprehend how recent biosimilars legislation is changing industry dynamics; and
    • Recognize how pre-commercialization concerns relative to CMS approval and Medicare/Medicaid formulary selection are influencing the patenting and approval of drugs and biological products.

    Brochure In particular, ACI's faculty will offer presentations on the following topics:

    • Key agencies overview:  Understanding the jurisdiction and interplay of the FDA and PTO in the patenting of drugs and biologics;
    • Identifying and comprehending pre-commercialization concerns relative to small molecules and biologics;
    • Exploring the link between the FDA approval process and the patenting of drugs and biologics;
    • IP overview for drugs and biologics:  Hatch-Waxman, BPCIA, trade dress, and more;
    • Paragraph IV disputes and litigation;
    • How the dynamics of biosimilars are changing the Hatch-Waxman landscape;
    • Orange Book listings, de–listings, and related challenges;
    • Bioequivalence and the "same active ingredient" vis-a-vis patentability;
    • An in-depth look at 180-day exclusivity;
    • Comprehending the intricacies of non-patent/regulatory exclusivity;
    • Assessing patent protections afforded under the safe harbor; and
    • Examining pharmaceutical patent extensions:  Patent Term Adjustment and Patent Term Extension.

    A post-conference workshop, entitled "Biosimilars: The Law, Interpreting Regulations, and Anticipated Litigation," will be offered from 9:00 am to 12:00 pm on July 20, 2011.  The workshop will provide an overview of the law governing biosimilars, delve into the preparations that should be made in anticipation of litigation, and run through what the first biosimilars litigation could possibly look like.

    The agenda for the Hatch-Waxman Boot Camp conference can be found here.  A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

    ACI - American Conference Institute The registration fee for the conference is $2,295 (conference alone) or $2,895 (conference and workshop).  Those registering by May 20, 2011 will receive a $300 discount and those registering by June 17, 2011 will receive a $200 discount.  Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

    Patent Docs is a media partner of ACI's Hatch-Waxman Boot Camp conference.

  • Ocean Tomo Study Highlights Importance of Patents and Inventors to Corporate Value

    By Donald Zuhn —

    Ocean Tomo A study released earlier this year by Ocean Tomo highlights the emergence of intellectual capital and how the U.S. has transitioned to an innovation-based economy over the past 35 years.  The company's Intangible Asset Market Value study indicated that in 2010, 80% of company value (for the S&P 500) was comprised of intangible assets, and that physical and financial accountable assets constituted only 20% of company value.  The study also showed that a significant portion of the intangible value was represented by patented technology.  The relative value of intangible and tangible assets has completely flipped since 1975, when 83% of corporate value was due to tangible assets and only 17% was derived from intangible assets.

    OceanTomoChart In a separate report — the Ocean Tomo Patent Quality Inventor study — the IP financial products company focused on the importance of inventors on corporate value by identifying the top inventors within four technology sectors:  biotech, industrials, semiconductors, and wireless.  Inventor ranking was based on the average patent IPQ® score for each inventor's 2010 issued and active U.S. patents within noted U.S. Patent Office Classifications.  In the biotech sector, the report awarded the top spot to Dr. Travis Mickle, who has received 16 patents falling within the 435 (Chemistry: Molecular Biology and Microbiology) and 436 (Chemistry: Analytical and Immunological Testing) classes that have an average IPQ score of 185.1 (where the median score is 100).  The report noted that this average placed Dr. Mickle's patents, which are directed to abuse-resistant amphetamine prodrugs, in the top 1% of all active U.S. utility patents.  The 16 patents are:  7,723,305; 7,718,619; 7,713,936; 7,700,561; 7,687,467; 7,687,466; 7,678,771; 7,678,770; 7,674,774; 7,671,031; 7,671,030; 7,662,788; 7,662,787; 7,659,254; 7,659,253; 7,655,630.

  • European Court of Justice Considers Embryonic Stem Cell Ban

        By Kevin E. Noonan —

    European Court of Justice The European Court of Justice (ECJ) is poised to make a decision regarding the patent-eligibility of human embryonic stem cells (hESCs) in Europe, and that decision will be "no" if the court follows the recommendation of the court's advocate general.

    The case began in 2004, when Greenpeace sued in German federal court over a German patent to the University of Bonn involving methods for deriving neural cells from hESCs (DE 197568664 C1).  While German laws regarding stem cell research have been characterized as the "most restrictive in Europe," such research is permitted provided that it is performed with pluripotent (rather than totipotent) cells, using cell lines imported from abroad and only cell lines that were made prior to May, 2007.  Nevertheless, Greenpeace argued that claims to methods for using hESCs were "immoral and against public order," provisions of European law generally that define subject matter not eligible for patent (there is no corresponding provision under U.S. law).

    The German federal court ruled for Greenpeace in 2006, and the university appealed to the German supreme court.  That court decided that it needed to refer the question to the ECJ, since German law was closely patterned on European Union guidelines for biotechnology patenting.

    On March 17, 2011, the ECJ advocate-general, Judge Yves Bot, rendered an opinion that stem cell patents were "contrary to ethics and public policy" because they required "industrial use" of human embryos.  This is not a final decision of the ECJ, which will now consider the matter before the entire 13 judges of the court and render an opinion in the next several months.  However, it is expected that the court will agree with the advocate-general, since it is rare that such preliminary opinions are overruled, according to a court spokesman.

    Cover_nature This possibility prompted several stem cell scientists in Europe to send a letter to the court, published in Nature on April 28th, setting forth the case for stem cell patenting.  In the letter, the scientists expressed their "profound concern" in the capacities as "coordinators of multinational European stem-cell projects."  They contend that stem cells are cell lines, not embryos, and that they were derived from "surplus in vitro fertilized eggs donated after fertility treatments" that could not be maintained "indefinitely."  The existence of "more than 100" established stem cell likes make concerns about embryos "misplaced," they assert, and warn that it may be "premature to suggest that human embryonic stem cells can be replaced" (by iPS cells, for example) in developing stem cell therapies.  A stem cell ban in Europe will prevent scientists from "deliver[ing] clinical benefits without the involvement of biological industry," and such companies "must have patent protection as an incentive" to do their work in Europe.  This will result, these scientists predict, in "European discoveries [being] translated into applications elsewhere, at a potential cost to the European citizen."

    This action is the latest in a series of initiatives by individuals and groups with philosophical objections to patents involving biological materials, particularly material derived from human beings.  These include the Public Patent (PubPat) Foundation's attempts to invalidate the Thomson hESC patents in the U.S. (unsuccessful with regard to U.S. Patent Nos. 5,843,780 and 6,200,806 and currently pending against U.S. Patent No. 7,029,913) as well as PubPat and the ACLU's challenge to human gene patenting in the AMP v. USPTO (Myriad) case.  Opponents of such patents voice various arguments and rationales against patenting products of human biology, but ultimately the argument is the one raised in Europe, that there are moral objections to the practice.  Such objections are sincerely held by many and it is neither possible nor productive to make arguments on these grounds:  as it is in many public policy debates, these positions tend to be absolutes for some, not subject to merely reasoned argument.  Perhaps the best rejoinder of the argument is to posit the situation if patent opponents prevail (which also comprises a part of the scientists' argument in their letter).  Lack of patent protection will have two concrete and predictable consequences:  lack of financial investment to translate basic scientific discoveries to useful commercial products, and (where possible) reducing or eliminating public disclosure of inventions (and where not possible, investment in other technologies).  Neither outcome is conducive to reducing human morbidity or mortality or improving the human condition.  It is hard to understand how advocating such an outcome can be considered the more moral position.

    The Nature letter was signed by the following scientists:

    • Austin Smith EuroSyStem Project, Wellcome Trust Centre for Stem Cell Research, Cambridge, UK
    • Peter Andrews ESTOOLS Project, Centre for Stem Cell Biology, University of Sheffield, UK
    • Clare Blackburn EuroStemCell Project, MRC Centre for Regenerative Medicine, University of Edinburgh, UK
    • Anders Björklund NeuroStemcell Project, Wallenberg Neuroscience Center, Lund University, Sweden
    • Elena Cattaneo NeuroStemcell Project, University of Milan, Italy
    • Giulio Cossu OptiStem Project, Stem Cell Research Institute, San Rafaelle Institute of Milan, University of Milan, Italy
    • Juergen Hescheler ESNATS Project, Institute of Neurophysiology, University Hospital of Cologne, Germany
    • Olle Lindvall NeuroStemcell Project, Lund Stem Cell Center, Lund University, Sweden
    • Marc Peschanski STEM-HD, Institute for Stem Cell Therapy and Exploration of Monogenic Diseases, INSERM, Evry, France
    • Daniel Pipeleers BetaCellTherapy Project, Diabetes Research Centre, Free University of Brussels, Belgium
    • David Sassoon EndoStem Project, University of Paris VI/INSERM, Pitié Salpêtrière Medical School, Paris, France
    • Anna Veiga hESCreg Project, Centre of Regenerative Medicine, Barcelona, Spain
    • Catherine Verfaille HemiBio Project, Stem Cell Institute, K. U. Leuven, Belgium

  • Patent Reform News Briefs

    By Donald Zuhn —

    H.R. 1249 Could Reach House Floor in June

    IPO #2 In Friday's IPO Daily News, the Intellectual Property Owners Association (IPO) reported that "[m]any observers" believe the House version of the America Invents Act (H.R. 1249) will reach the House floor for a vote sometime in June.  While the House Judiciary Committee ordered an amended version of the bill to be reported last month, only the introduced version of the bill is currently available on the Library of Congress' THOMAS site.  The IPO report also indicated that House Judiciary Chairman Lamar Smith (R-TX) expects to propose additional amendments to the bill when it comes to the floor for a vote, and will likely craft a bill that the Senate would be willing to accept.


    Delaware Senator Encourages House to Move Quickly on H.R. 1249

    Coons, Chris Delaware Senator Chris Coons (D), writing in The Huffington Post earlier this month, used the postponement of the prioritized examination (or Track I) portion of the Enhanced Examination Timing Control Initiative to push House leadership to bring H.R. 1249 to the floor for a vote ("Shortchanging Our Inventors Is Slowing Our Economic Recovery").  Noting that the recently delayed Track I program would have brought in an additional $40 million in patent fees (10,000 applications x $4,000 prioritized examination fee), Sen. Coons (at right) explained that the Track I program would have allowed "[i]nventors with time-sensitive applications . . .  obtain faster consideration without slowing down the processing of applications on the normal track."  The Senator reflected on his own experience, stating that "[a]fter working for eight years at a manufacturing company where patents were the lifeblood of our business, I know that Track One would have made a real impact on our economic recovery and the workforce-in-waiting of engineers, tradespeople, laborers, and others ready to get to work."

    According to Sen. Coons, however, Congress got in the way of the Track I program by funding the U.S. Patent and Trademark Office at its 2010 level, thereby "shortchanging the agency by $85 to $100 million and forcing [Director] Kappos to pull the plug on the Track One program."  By denying the USPTO its 2011 budget request, which included $40 million to implement the Track I program, Sen. Coons noted that the $40 million the program would have created would have been diverted to the Treasury.  The Senator suggested that the America Invents Act would eliminate this problem by ending fee diversion.  He concluded by expressing his hope that "Speaker Boehner move[] quickly to bring H.R. 1249 up for a vote on the House floor," adding that "[e]very day we fail to act is another day that hundreds of thousands of innovations — and the millions of jobs they can create — remain nothing more than unread good ideas on paper in someone's inbox."


    Patent Reform Result of "Fierce" Lobbying

    Washington Post An article in The Washington Post reports that the Senate's passage of the America Invents Act was the result of more than 100 lobbying firms representing 267 different organizations ("Patent Reform Measure Ignited Fierce Lobbying Effort").  According to the piece, the first-inventor-to-file provision has generated the most interest among the organizations lobbying Congress.  Among the most active lobbyists, the article pointed to the Coalition for 21st Century Patent Reform, which gave more than $1.4 million to the lobbying firms Akin Gump Strauss Hauer & Feld and the Palmetto Group, and the Coalition for Patent Fairness, which spent more than $2 million on lobbyists from Elmendorf Ryan; Fierce, Isakowitz & Blalock; the Franklin Square Group; Mayer Brown; and Patton Boggs.

  • FDA Seeks Comment on Biosimilar User Fee Proposal

    By Donald Zuhn —

    FDA On Monday, the U.S. Food and Drug Administration published a notice in the Federal Register (76 Fed. Reg. 27062) requesting comments related to the development of a user fee program for biosimilar and interchangeable biological products under the approval pathway for biosimilar biological products established by the Patient Protection and Affordable Care Act (PPACA).  In a press release, the FDA noted that the PPACA mandates that the agency develop recommendations for a user fee program for fiscal years 2013-2017, and that such recommendations must be presented to Congress by January 15, 2012.

    In the Federal Register notice, the FDA states that the fee for a biologics license application (BLA) is currently the same regardless of whether the application is submitted under the new 351(k) approval pathway created by the PPACA or the preexisting 351(a) approval pathway.  In working towards a user fee program for the 351(k) approval pathway, the FDA's notice outlines the agency's principles for developing the program, its proposal for a user fee program, and proposed performance goals for 351(k) applications for FY 2013-2017.

    With regard to the FDA's principles for developing a user fee program, the agency seeks comment regarding the following proposed guiding principles:

    (1) A user fee program must provide the FDA with sufficient review capacity in order to prevent unnecessary delays in the development and approval of biosimilar and interchangeable biologics.

    (2) At least between 2013 and 2107, 351(k) user fees should remain comparable to 351(a) user fees.  The notice explains that "at least initially, review to determine biosimilarity or interchangeability of a proposed product in a 351(k) application is expected to be comparably complex, technically demanding, and resource-intensive as review of a proposed 351(a) application."

    (3) The 351(k) user fee program should provide funding to support activities that occur early in the biosimilar and interchangeable product development cycle.

    (4) Because the same expert scientific teams at the FDA that conduct review of 351(a) applications will typically be involved in the review of 351(k) applications, the 351(k) user fee program should ensure adequate resources for the review of 351(k) applications, so that critical resources for 351(a) review are not redirected from innovator drug review to biosimilar products.

    Based on the above principles, the FDA has proposed a user fee program consisting of two fees for 351(k) applications in the premarket phase (i.e., Biosimilar Product Development and 351(k) Marketing Application fees) and two fees for marketed 351(k) products (i.e., Establishment and Product fees).  A detailed discussion of these fees can be found in the FDA's Federal Register notice.  With regard to the premarket phase fees, the notice indicates that "the FY 2013 annual Biosimilar Product Development fee amount would be on the order of $150,000," and that the 351(k) Marketing Application fee would be set equal to the 351(a) marketing application fee (from which accrued annual Biosimilar Product Development fees would be deducted).

    In the third section of its notice, the FDA describes two categories of 351(k) applications (noting that the biosimilars approval pathway prohibits applications from being submitted until 4 years after the reference product was first licensed, and prohibits the FDA from approving such applications until 12 years after the reference product was first licensed).  The two categories include:  (1) applications submitted 10 or more years after the date of first licensure of the reference product, which would be eligible for approval in 2 years or less, and (2) applications submitted between 4 and 10 years after the date of first licensure of the reference product.  While the notice sets forth performance goals for the first category of applications, the FDA, noting that the agency "is concerned about committing resources to meet performance goals that might ready an application for approval years before it could be approved, necessitating updating of the application, new reviews, and new inspections of facilities shortly before the application becomes eligible for approval under the section 351(k)(7)," seeks public input regarding the second category of applications.  To guide public comment on the latter category, the FDA poses several questions on page 27066 of the Federal Register notice.

    In addition to soliciting public comment regarding user fees, the FDA states that it plans to hold public meetings with public and industry stakeholders on the issue.  Those interested in participating in the public meetings should send their complete contact information to BiosimilarsUserFeeProgram@ fda.hhs.gov by June 3, 2011.  Written comments are due by June 9, 2011, and can be submitted by regular mail addressed to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, or electronically at http://www.regulations.gov.  Additional information regarding the public meetings and submission of written comments can be found in the FDA's Federal Register notice.

    In other biosimilar news, according to reports by Reuters and FierceBiotech, the director of the Center for Drug Evaluation and Research at the FDA, Dr. Janet Woodcock, has indicated that a full set of biosimilar guidelines will be released by the FDA later this year.

  • Federal Trade Commission Issues Report on Reverse Settlement Agreements in FY2010

    By Kevin E. Noonan —

    Federal Trade Commission (FTC) Seal Under the Medicare Prescription Drug, Improvement and Modernization Act of 2003, settlements between innovator drug companies and generic competitors must be filed with the Federal Trade Commission (FTC).  On May 3rd, the Commission released a compilation of the statistics relating to these settlements.  Consistent with its long-time concern with and vendetta against settlements between innovator and generic drug companies, the Report highlights what it views as an increase of settlements where a generic company is compensated for staying off the market for longer than would be the case if it won ANDA litigation against the innovator.  Viewing the same data a different way suggests that the frequency of such "pay-for-delay" agreements are in fact decreasing (while at the same time suggesting that the wastefulness associated with ANDA litigation is beginning to be appreciated by innovators and generic drug makers alike).

    First, the stats.  For the 2010 fiscal year (October 1, 2009 to September 20, 2010), there were 113 "final resolutions of patent disputes" between innovator and generic drugmakers (in the context of ANDA litigation).  Thirty-one of these settlements involved both "compensation" to the generic manufacturer and an agreement that the generic drugmaker not market its product for a term longer than would have resulted from successful ANDA litigation.  These settlements involved drugs having a combined U.S. sales of about $9.3 billion.  In another 66 settlements, the FTC stated that there was a restriction on the ability of a generic drugmaker to sell generic versions of a drug, without any "explicit compensation."  A little more than one half (36) of these settlements were with generic drugmakers who were not the first ANDA filers (and thus were not eligible for the 180-day exclusivity for a first ANDA filer under the Hatch-Waxman Act).  The Report recognizes that these settlements involved "restrictions on entry in exchange for the ability to market the relevant product for some period prior to patent expiration" (i.e., earlier than the generic drugmaker would have been able to market its product if unsuccessful in challenging Orange Book-listed patents).  Finally, a total of 16 settlements had no restrictions on market entry for the generic drugmaker.

    All of the settlements between innovators and first ANDA filers had restrictions on time of market entry, and about half (26/49) also had compensation from the innovator to the generic drugmaker for market entry delay.

    Comparing fiscal year 2010 with prior years, the Commission's Report states that it witnessed:

    [A] significant increase in the number of final settlement agreements filed, as well as the number of settlements potentially involving pay-for-delay.  The number of final settlements filed in FY 2010 is almost double the amount received in any previous year.  Similarly, the number of potential pay-for-delay (PFD) settlements and the number of potential pay-for-delay settlements involving first filers (FF) substantially increased over any previous year.

    These statements were supported by the following table:

    Table 1
    A more expanded table might have been more informative:

    Table 2
    These numbers suggest that, while the absolute number of settlements having either market entry restrictions, compensation, or both have increased, this increase must be considered in the context of the overall increase in ANDA litigation settlements.  Whether due to the scrutiny occasioned by FTC displeasure over the practice, or because of the threat of antitrust litigation (from state as well as private "attorneys general"; see "Second Circuit Denies En Banc Reconsideration in Cipro® Case"), "reverse settlement" agreements ("pay-for-delay" in FTC parlance) appear to be becoming less popular.  This trend is essentially the same for first filers as well as other ANDA filers, and is not significantly more pronounced for first filers, who stand to lose the 180-day exclusivity benefit if they settle ANDA litigation.

    The Report is accompanied by copies of settlements over Humira® (between Centocor and Abbott Labs), fentanyl (Cephalon and Watson), and gemcitabine (Eli Lilly & Co. against a number of foreign generic drug companies), among others.  While the trend towards settling ANDA cases seems to support those who argue, inter alia, that the Hatch-Waxman ANDA regime is wasteful of resource that might better be spent addressing deficiencies in the pharmaceutical pipeline (see "Maybe Hatch-Waxman Data Exclusivity Isn't So Good For Traditional Drugs After All"), within that trend is a declining likelihood to settle ANDA litigation with agreements that provide monetary compensation to generic drugmakers in exchange for delayed market entry.  This trend should be more welcome to the FTC than the latest Report seems to indicate.