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  • Court Report – Part II

    By Sherri Oslick —

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

    Bayer CropScience AG v. Dow Agrosciences LLC
    1:10-cv-01045; filed December 3, 2010 in the District Court of Delaware

    Infringement of U.S. Patent No. 6,153,401 ("Microorganisms and Plasmids for 2,-4-Dichlorophenocyacetic Acid (2,4-D) Monooxygenase Formation and Process for the Production of These Plasmids and Strains," issued November 28, 2000) based on Dow's manufacture, use, sale, and offer for sale of transgenic plants and/or seeds resistant to 2,4-D herbicide.  View the complaint here.


    Medicis Pharmaceutical Corp. v. Aurobindo Pharma Ltd. et al.
    1:10-cv-01050; filed December 3, 2010 in the District Court of Delaware

    • Plaintiff:  Medicis Pharmaceutical Corp.
    • Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

    Infringement of U.S. Patent Nos. 5,908,838 ("Method for the Treatment of Acne," issued June 1, 1999) and 7,790,705 ("Minocycline Oral Dosage Forms for the Treatment of Acne," issued September 7, 2010) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of Medics' Solodyn® (minocycline hydrochloride extended release tablets, used to treat acne).  View the complaint here.


    Novartis Pharmaceuticals Corp. v. Aurobindo Pharma Ltd. et al.
    3:10-cv-06283; filed December 3, 2010 in the District Court of New Jersey

    • Plaintiff:  Novartis Pharmaceuticals Corp.
    • Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA, Inc.

    Infringement of U.S. Patent No. 6,162,802 ("Synergistic Combination Therapy Using Benazepril and Amlodipine for the Treatment of Cardiovascular Disorders and Compositions Therefor," issued December 19, 2000) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of Novartis' Lotrel® (amlodipine besylate/benazepril hydrochloride, used to treat hypertension).  View the complaint here.


    Hoffmann-La Roche Inc. v. Apotex Inc. et al.
    2:10-cv-06241; filed December 2, 2010 in the District Court of New Jersey

    • Plaintiff:  Hoffmann-La Roche Inc.
    • Defendants:  Apotex Inc.; Apotex Corp.

    Infringement of U.S. Patent No. 7,718,634 ("Method of Treatment Using Bisphosphonic Acid," issued May 18, 2010) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Roche's Boniva® (ibandronate sodium, used to treat post-menopausal osteoporosis).  View the complaint here.

  • Amicus Briefs in AMP v. USPTO: University of New Hampshire School of Law

    By James DeGiulio —

    Unhlaw In another amicus brief filed in late October in the Association of Molecular Pathology v. U.S. Patent and Trademark Office ("Myriad") case, Prof. J. Jeffrey Hawley and Prof. Ann McCrackin, writing on behalf of amicus University of New Hampshire School of Law, criticize Judge Sweet's District Court decision substantively and procedurally.  Among several concise points, the professors criticize the District Court for overstepping its bounds by implementing a new restriction on patentable subject matter, applying the incorrect standard in the summary judgment ruling, and ignoring its charged duty to uphold controlling federal patent law.

    The brief opens with the argument that the District Court has erroneously established a new limitation on patent-eligible subject matter.  DNA is acknowledged as a result of a "chemical union," which fits squarely within the Chakrabarty definition of a composition of matter.  The brief proceeds to address the "isolated" status of the sequences as distinct from naturally-occurring DNA.  Amicus notes that the criteria for patent-eligibility for compositions of matter, even those derived from naturally-occurring compositions, are that they be new and useful.  Put another way, the claimed subject matter is "markedly different" from the naturally-occurring composition.  Turning to the District Court decision, the brief criticizes the additional imposed exclusion on patent eligibility if the composition of matter "serves as the physical embodiment of the laws of nature."  The brief notes that no Supreme Court decision or Federal Circuit panel has established this limitation, citing the decision in Funk Bros. as the closest decision that can be read in such a way.  Of course, Funk Bros. can be distinguished, for the "new" bacteria at issue did not have a different use than the naturally-occurring bacteria.  Nothing in that decision suggests that if a composition of matter has a "unique characteristic" that "serves as the physical embodiment of the laws of nature" that it is disqualified from patent-eligibility under § 101.

    Indeed, isolated DNA can acquire many different uses and can serve ends that DNA as it exists in nature cannot provide.  Relying again on Chakrabarty, the brief notes that a similar special exception to patent-eligibility sought in that case was denied.  Specifically, the Supreme Court rejected a proposed special exception to patent-eligibility for living matter.

    The UNH brief presents supporting case law where no "special exception" for living matter was articulated when it was sought, including the In re Bergstrom decision in the C.C.P.A. and the Schering Corp. v. Geneva Pharmaceuticals decision of the Federal Circuit.  The pure prostaglandins in Bergstrom were found to "necessarily differ" from the less-pure natural compounds, thus the "pure" materials were found to be patent eligible.  In Schering, the Federal Circuit noted that a "purified" metabolite would be patent-eligible subject matter.  Metabolites function within the body and could be construed as a "physical embodiment of a law of nature," yet there was no suggestion that this might disqualify the patenting of purified metabolites.

    The second major argument in the UNH brief deals with the summary judgment standard.  UNH argues that there are genuine issues of material fact remaining in the case and thus a summary judgment ruling was improper.  Patent eligibility under § 101 is amenable to summary judgment only in the absence of disputed issues of facts material to the issue.  Thus, the determination of the patent-eligibility of isolated DNA sequences hinges upon facts pertaining to the structure and functions of isolated DNA as compared to the natural DNA in the genome.

    The dispute over the term "isolated" raises issues of material fact.  According to the appellees, isolated DNA is defined as a "fragment of DNA found on chromosome," whereas the appellants have defined isolated DNA as "removed from its naturally occurring environment," requiring "excision from the chromosome."  Clearly, the appellees' definition implies that DNA fragments can be removed without any change in structure or function.  This is not the case, as DNA removed from the genome has several different functions.  Two examples of additional functions for isolated DNA provided by the appellants are its use as probes or primers, rendering isolated DNA suitable for mutation detection, which DNA in its natural environment cannot perform.  The existence of these disputed facts, which must be viewed as evidence in favor of the appellants as the parties opposing the motion, renders the summary judgment finding by the District Court improper.

    The brief's third argument addresses the policy considerations presented in the District Court's summary judgment ruling.  Amicus dismisses all of these policy concerns as irrelevant:  the funding for the tests; enforcement of the patents; impact of the patents on BRCA testing; and impact of gene patents on the advancement of science and medical treatment.  According to UNH, even if these policy concerns were relevant to a summary judgment motion, they should be resolved in a manner favorable to the appellants.  UNH points to Chakrabarty once again, where the Supreme Court determined a similar type of policy inquiry (the inflammatory "parade of horribles" argument) was inappropriate.  Indeed, such policy considerations are better suited for the legislative branch, not the courts.  This same finding was more recently echoed in In re Fisher.

    Next, UNH finds the District Court at fault in failing to uphold the presumption of validity that Myriad's patents should enjoy.  If the District Court is merely going to ignore a binding federal statute, UNH charges the District Court to declare § 282 unconstitutional.  Indeed, the District Court did not cite to legal authority for reasons why the presumption of validity did not apply to this case, but rather cited the statistic that "40% of patents challenged in the courts have been found invalid."  The brief, however, explains away this statistic, stating only the truly close cases make it as far as a judgment on the merits.  A more accurate statistic, according to the brief, should be that the invalidation rates are as high as 40% for cases reaching final judgment, not merely being challenged in court.  Even if the District Court was free to weigh the value of federal statutes, it should not have done so with incomplete data.

    By invalidating Myriad's patents, the District Court committed clear error, since the appropriate clear and convincing standard following the presumption of § 282 was not met.  In applying the "markedly different" test for distinguishing patent-eligible subject matter from products of nature, appellees must prove with a high probability that isolated DNA molecules encoding the BRCA genes are not "product[s] of human ingenuity having a distinctive name, character, and use."  The evidence presented by the appellees was insufficient, merely showing that isolated DNA exists "free-floating" within living cells during transient replication processes.  This evidence does not satisfy the appropriate test, as the appellees failed to produce clear and convincing evidence that isolated DNA does not have distinctive uses, instead contending without evidence that native DNA is certain to enable the same uses as isolated DNA at some undetermined time in the future.

    In its last argument, amicus attacks the District Court's determination that Myriad's method claims fail the machine-or-transformation test.  Preliminarily, the brief notes that this is not the only test for subject matter eligibility.  UNH then follows by charging the Supreme Court with defining "abstract idea."  UNH recognizes that Bilski provides some clues about patent-eligibility, but finds these guidelines to be insufficient.

    In an intriguing section of the brief, UNH proposes the following definition for an abstract idea:

    A claim recites only an abstract idea when the claim describes the idea only in terms of results without specifying how to achieve the results.  Even if the claim specifies how to achieve the results, the claim is still abstract if the claim is wholly directed to an algorithm.  The result itself may be specified explicitly or implicitly; however, the manner by which the result is achieved must be explicitly recited in one or more steps.

    After introducing a proposed definition of abstract ideas, the brief analyzes a representative process claim in one of Myriad's patents and declares the claim to recite patent-eligible subject matter.  The claim examined in the brief is claim 1 of U.S. Patent No. 5,710,001, which recites:

    1.  A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises gene comparing a first sequence selected faun the group consisting of a BRCA1 gene from said tumor sample, BRCA1 RNA from said tumor sample and BRCA1 cDNA made from mRNA from said tumor sample with a second sequence selected from the group consisting of BRCA1 gene from a nontumor sample of said subject, BRCA1 RNA from said nontumor sample and BRCA1 cDNA made from mRNA from said nontumor sample, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said tumor sample from the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said nontumor sample indicates a somatic alteration in the BRCA1 gene in said tumor sample.

    No abstract idea is claimed here, according to the brief.  The claim describes a process to screen a tumor sample, which produces a result by comparing a sequence of the BRCA1 gene from the tumor with a sequence from the non-tumor sample in order to detect a somatic alteration in the BRCA1 gene from the tumor sample.  Thus, the claimed process specifies how to screen the tumor, by using a very specific DNA sequence, and is therefore not directed to an abstract idea.

    For additional information regarding this and other related topics, please see:

    • "Amicus Briefs in AMP v. USPTO: Rosetta Genomics & George Mason University," December 8, 2010
    • "Academic Amici Refute ACLU Falsehoods in Gene Patenting Debate," December 7, 2010
    • "Amicus Briefs in AMP v. USPTO: Genetic Alliance," November 10, 2010
    • "BIO and AUTM File Joint Amicus Brief in AMP v. USPTO," November 9, 2010
    • "AIPLA Submits Amicus Brief in AMP v. USPTO," October 3, 2010
    • "IPO Files Amicus Brief in AMP v. USPTO," November 2, 2010
    • "AMP v. USPTO — Briefing Update," November 1, 2010
    • "DOJ Tries to Be All Things to All Constituencies in Myriad Amicus Brief," October 31, 2010
    • "Myriad Files Appeal Brief in AMP v. USPTO," October 28, 2010

  • Court Report

    By Sherri Oslick —

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

    Shire LLC, Supernus Pharmaceuticals, Inc. et al. v. Impax Laboratories, Inc. et al.
    3:10-cv-05467; filed December 2, 2010 in the Northern District of California

    • Plaintiffs:  Shire LLC; Supernus Pharmaceuticals, Inc.; Amy F.T Arnsten; Pasko Rakic; Robert D. Hunt
    • Defendants:  IMPAX Laboratories, Inc.; Watson Pharmaceuticals, Inc.; Watson Laboratories, Inc.-Florida; Watson Pharma, Inc.; Anda, Inc.

    Infringement of U.S. Patent Nos. 5,854,290 ("Use of Guanfacine in the Treatment of Behavioral Disorders," issued December 19, 1998), 6,287,599 ("Sustained Release Pharmaceutical Dosage Forms with Minimized pH Dependent Dissolution Profiles," issued September 11, 2001), and 6,811,794 (same title, issued November 2, 2004) based on Impax's filing of an ANDA to manufacture a generic version of Shire's Intuniv (guanfacine, used to treat attention-deficit hyperactivity disorder).  View the complaint here.


    Momenta Pharmaceuticals, Inc. et al. v. Teva Pharmaceuticals Industries Ltd. et al    .
    1:10-cv-12079; filed December 2, 2010 in the District Court of Massachusetts

    • Plaintiffs:  Momenta Pharmaceuticals, Inc.; Sandoz Inc.
    • Defendants:  Teva Pharmaceuticals Industries Ltd.; Teva Pharmaceuticals USA, Inc.

    Infringement of U.S. Patent Nos. 7,575,886 ("Analysis of Sulfated Polysaccharides," issued August 19, 2009) and 7,790,466 ("Evaluating Mixtures of Low Molecular Weight Heparins By Chain Profiles Or Chain Mapping," issued September 17, 2010), both licensed to Sandoz, based on Teva's expected manufacture and sale of generic Lovenox® (enoxaparin sodium, used for the prophylaxis of deep vein thrombosis, and for treatment of acute deep vein thrombosis).  View the complaint here.


    Monsanto Co. et al. v. Sauceda
    4:10-cv-02249; filed December 2, 2010 in the Eastern District of Missouri

    • Plaintiffs:  Monsanto Co.; Monsanto Technology LLC
    • Defendant:  Zeferino Sauceda

    Infringement of U.S. Patent Nos. 5,352,605 ("Chimeric Genes for Transforming Plant Cells Using Viral Promoters," issued October 4, 1994) and RE39,247 ("Glyphosate-tolerant 5-enolpyruvylshikimate-3-phosphate Synthases," issued August 22, 2006) based on defendants' use of saved Roundup Ready® or Bollgard® seed.  View the complaint here.


    Cellectis S.A. v. Precision Biosciences Inc.
    1:10-cv-01033; filed November 30, 2010 in the District Court of Delaware

    Infringement of U.S. Patent No. 7,842,489 ("Use of Meganucleases For Inducing Homologous Recombination Ex Vivo and In Toto In Vertebrate Somatic Tissues and Application Thereof," issued November 30, 2010) based on Precision's use of its Directed Nuclease Editor technology.  View the complaint here.


    Regents of the University of California v. Kappos
    1:10-cv-02031; filed November 29, 2010 in the District Court of the District of Columbia

    Reversal of the decision of the BPAI in upholding the examiner's rejection of certain claims in the ex parte reexamination of U.S. Patent No. 5,916,912 ("Dietary Composition for Enhancing Metabolism and Alleviating Oxidative Stress," issued June 29, 1999).  View the complaint here.


    Hoffmann-La Roche Inc. v. Watson Laboratories, Inc. et al    .
    2:10-cv-06206; filed November 29, 2010 in the District Court of New Jersey

    • Plaintiff:  Hoffmann-La Roche Inc.
    • Defendants:  Watson Laboratories, Inc.; Watson Pharmaceuticals, Inc.; Watson Pharma, Inc.; Cobalt Pharmaceuticals Inc.; Cobalt Laboratories, Inc.

    Infringement of U.S. Patent No. 7,718,634 ("Method of Treatment Using Bisphosphonic Acid," issued May 18, 2010) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Roche's Boniva® (ibandronate sodium, used to treat post-menopausal osteoporosis).  View the complaint here.


    Astrazeneca Pharmaceuticals LP et al. v. Mylan Pharmaceuticals Inc. et al    .
    1:10-cv-00199; filed November 29, 2010 in the Northern District of West Virginia

    • Plaintiffs:  Astrazeneca Pharmaceuticals LP; Astrazeneca UK Ltd.
    • Defendants:  Mylan Pharmaceuticals Inc.; Mylan Inc.

    Infringement of U.S. Patent Nos. 4,879,288 ("Novel Dibenzothiazepine Antipsychotic," issued November 7, 1989) and 5,948,437 ("Pharmaceutical Compositions Using Thiazepine," issued September 7, 1999) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of AstraZeneca's Seroquel® XR (quetiapine fumarate, used to treat schizophrenia and bipolar disorder).  View the complaint here.


    Alza Corp. et al. v. Impax Laboratories Inc. et al    .
    1:10-cv-01024; filed November 24, 2010 in the District Court of Delaware

    • Plaintiffs:  Alza Corp.; Ortho-McNeil-Janssen Pharmaceuticals Inc.
    • Defendants:  Impax Laboratories Inc.; Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.

    Infringement of U.S. Patent No. 6,930,129 (same title, issued August 16, 2005) following a Paragraph IV certification as part of Impax's amendment to its ANDA to manufacture a generic version of Alza's Concerta® (methylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

    Abbott Laboratories et al. v. Impax Laboratories Inc.
    1:10-cv-01029; filed November 24, 2010 in the District Court of Delaware

    • Plaintiffs:  Abbott Laboratories; Abbott Respiratory LLC
    • Defendants:  Impax Laboratories Inc.

    Infringement of U.S. Patent Nos. 6,129,930 ("Methods and Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia at Night," issued October 10, 2000), 6,406,715 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique Urinary Metabolite Profiles," issued June 18, 2002), 6,676,967 ("Methods for Reducing Flushing in Individuals Being Treated with Nicotinic Acid for Hyperlipidemia," issued January 13, 2004), 6,746,691 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique Biopharmaceutical Characteristics," issued June 8, 2004), 7,011,848 ("Hydrophobic Component Free Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued March 14, 2006), 6,818,229 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia," issued November 16, 2004), 6,080,428 ("Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued June 27, 2000), and 6,469,035 ("Methods of Pretreating Hyperlipidemic Individuals with a Flush Inhibiting Agent Prior to the Start of Single Daily Dose Nicotinic Acid Therapy to Reduce Flushing Provoked by Nicotinic Acid," issued October 22, 2002) following a Paragraph IV certification as part of Impax's filing of an ANDA to manufacture a generic version of Abbott's Simcor® (niacin extended release / simvastatin tablets, used to treat hypercholesterolemia).  View the complaint here.


    Jazz Pharmaceuticals, Inc. v. Roxane Laboratories, Inc.
    2:10-cv-06108; filed November 22, 2010 in the District Court of New Jersey

    Infringement of U.S. Patent Nos. 6,780,889 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued August 24, 2004), 7,262,219 (same title, issued August 28, 2007), 7,668,730 ("Sensitive Drug Distribution System and Method," issued February 23, 2010), and 7,765,106 (same title, issued July 27, 2010) following a Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy).  View the complaint here.


    Daiichi Sankyo Inc. et al. v. Impax Laboratories Inc. et al    .
    1:10-cv-00997; filed November 19, 2010 in the District Court of Delaware

    • Plaintiffs:  Daiichi Sankyo Inc.; Genzyme Corp.
    • Defendants:  Impax Laboratories Inc.; Glenmark Generics Inc. USA; Glenmark Generics Ltd.; Glenmark Pharmaceuticals Ltd.

    Infringement of U.S. Patent Nos. 5,607,669 ("Amine Polymer Sequestrant and Method of Cholesterol Depletion," issued March 4, 1997) and 5,693,675 ("Alkylated Amine Polymers," issued December 2, 1997) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of plaintiffs' Welchol® (colesevelam hydrochloride, used to treat primary hyperlipidemia and type 2 diabetes mellitus).  View the complaint here.


    Abbott Laboratories et al. v. Roxane Laboratories Inc.
    1:10-cv-00998; filed November 19, 2010 in the District Court of Delaware

    • Plaintiffs:  Abbott Laboratories; Wisconsin Alumni Research Foundation
    • Defendants:  Roxane Laboratories Inc.

    Infringement of U.S. Patent No. 5,587,497 ("19-nor-Vitamin D Compounds," issued December 24, 1996) following a Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of Abbott's Zemplar® (paricalcitol, used to treat secondary hyperparathyroidism in patients with kidney failure).  View the complaint here.


    Merck & Co., Inc. et al. v. Hetero Drugs Ltd., Unit III et al    .
    2:10-cv-06111; filed November 19, 2010 in the District Court of New Jersey

    • Plaintiffs:  Merck & Co., Inc.; Merck Sharp & Dohme Corp.
    • Defendants:  Hetero Drugs Ltd., Unit III; Hetero USA Inc.

    Merck & Co., Inc. et al. v. Hetero Drugs Ltd., Unit III et al.
    2:10-cv-05370; filed November 19, 2010 in the Eastern District of New York

    • Plaintiffs:  Merck & Co., Inc.; Merck Sharp & Dohme Corp.
    • Defendants:  Hetero Drugs Ltd., Unit III; Invagen Pharmaceuticals, Inc.

    These complaints are substantially identical.  Infringement of U.S. Patent Nos. 5,571,817 ("Methods of Treating Androgenic Alopecia with Finasteride [17β-N-mono-substituted-carbamoyl-4-aza-5-α-androst-1-en-ones]," issued November 5, 1996), 5,547,957 ("Method of Treating Androgenic Alopecia with 5-α Reductase Inhibitors," issued August 20, 1996), and 5,886,184 ("Finasteride Processes," issued March 23, 1999) following a Paragraph IV certification as part of Hetero's filing of an ANDA to manufacture a generic version of Merck's Propecia ® (finasteride, used to treat androgenic alopecia).  View the New Jersey complaint here.

  • Conference & CLE Calendar

    Calendar

    December 16, 2010 – "The Role of Intellectual Property in Development" (World Bank Legal Vice Presidency) – Washington, DC

    January 1-5, 2011 – 28th Annual National CLE Conference (Law Education Institute, Inc.) – Vail, CO

    January 12, 2011 – "New USPTO Guidelines and the Obviousness Standard for Patents" (Strafford) – 1:00 – 2:30 PM (EST)

    January 26-27, 2011 – The Life Sciences Lawyer's Guide to Patent Term Adjustment and Patent Term Extensions*** (American Conference Institute) – New York, NY

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

  • Webinar on Obviousness Guidelines

    Strafford #1 Strafford will be offering a webinar entitled "New USPTO Guidelines and the Obviousness Standard for Patents" on January 12, 2011, from 1:00 – 2:30 PM (EST).  Karen Canaan of CanaanLaw will provide a review of the USPTO's new post-KSR guidelines and how the courts and the USPTO are applying the obviousness standard, and will discuss best practices for avoiding obviousness rejections and defending patent validity.  The webinar will review the following questions:

    • What insights into how the USPTO will perform obviousness analyses do the new USPTO Guidelines provide?
    • Under what circumstances has the obvious-to-try standard supported a finding of obviousness — and when has it worked to nullify such a finding?
    • What are the steps that patent applicants can take to stand up to obviousness rejections?

    An interactive Q&A session will follow the presentation.

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by December 17, 2010 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

  • LEI National CLE Conference

    Skiing Law Education Institute, Inc. (LEI) will be holding the 28th Annual National CLE Conference on January 1-5, 2011 in Vail, Colorado.  The Intellectual Property program of the conference, which will be held at the Vail Marriott Resort & Spa, will offer presentations on a number of topics, including:

    • The state of inequitable conduct;
    • Continued importance and use of opinions of counsel post-Seagate and Broadcom;
    • Strategic use of the joint infringement defense;
    • Legal research made easy with WestlawNext;
    • Legal ethics can be fun:  Lawyers on TV and in the movies;
    • Unglamorous but deadly — Invalidity under Section 112;
    • A dialogue between Bench and Bar on the Federal Circuit;
    • Patent corporate counsel panel:  What keeps corporate counsel awake at night;
    • What hath Bilski v. Kappos wrought:  Fallout in the courts and the USPTO;
    • Insurance coverage for IP disputes; and
    • Patent markets.

    Law Education Institute (LEI) An agenda and list of speakers for the Intellectual Property program of the conference can be found here.

    The registration fee for the conference is $645.  Those interested in registering for the conference can do so by calling either 1-303-860-0608 or 1-888-860-2531, by faxing a registration form to 1-303-860-0624, or online here.

  • BIO Announces Return to Chicago for 2013 and 2016 Conventions

    BIO International Convention The Biotechnology Industry Organization (BIO) recently announced that it will be holding both its 2013 and 2016 International Conventions in Chicago, the site of BIO 2010 this past May and BIO 2006 four years earlier.  The Convention attracts more than 15,000 industry leaders from 48 states and 60 countries and highlights the latest advancements in biotechnology.

    Upcoming Conventions are scheduled for Washington, DC (June 27-30, 2011), Boston (June 18-21, 2012), Chicago (April 22-25, 2013), Philadelphia (June 15-18, 2015), and Chicago (May 2-5, 2016).  A location and dates for BIO 2014 has yet to be finalized.

    Founded in 1993, BIO is a nonprofit association seeking supportive biotechnology policies on behalf of more than 1,100 biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations, as well as providing business development services for many emerging biotech companies.

  • Symposium on Role of Intellectual Property in Development

    World Bank The World Bank Legal Vice Presidency will be hosting a Symposium on "The Role of Intellectual Property in Development" on Thursday, December 16, 2010 from 12:30 to 4:15 pm at its headquarters in Washington, DC.  The Symposium is being coordinated by Ms. Akiko Ogawa, a former Visiting Scholar to Chief Judge Rader, in the Vice Presidency of the World Bank.

    The Symposium, which has been organized in collaboration with the Legal Department of the International Finance Corporation (IFC), the Economic Policy and Debt Department of the Poverty Reduction and Economic Management Network (PREM) and the World Bank Science and Technology Innovation Global Expert Team (STI GET), will focus on the current debate about the role of intellectual property in development.  The goal is to address key issues on how to employ intellectual property in investment and decision making processes to develop legal frameworks that promote economic growth.  The speakers will address the following questions:

    • What is the effect of strong IP laws on the rate of innovation and economic growth?

    • Does a shift to stronger intellectual property rights promote foreign direct investment and technology transfer into developing countries?

    • Does strong IP protection favor northern economies over southern economies or alternatively is it a means to ultimately level the playing field?

    • Do national measures that require the involuntary transfer or withdrawal of IP rights achieve the long-term developmental goals of developing countries?

    • Should the World Bank factor intellectual property into its investment and decision making processes to incentivize legal frameworks that promote economic growth, and if so, how?

    • How can public agencies acknowledge and reward private initiatives that use know how or intellectual property to address needs for which there is an insufficient commercial market?

    The agenda for the Symposium is as follows:

    • 12:30-12:40 — Welcome Remarks — Hassane Cisse, Deputy General Counsel, Knowledge and Research, Legal Vice Presidency, World Bank

    • 12:40-1:00 — Introduction (Moderator) — Sherry M. Knowles, Knowles Intellectual Property Strategies, Former Chief Patent Counsel, GlaxoSmithKline

    • 1:00-1:30 — Can Innovation help the Developing World Achieve Economic Goals?  Collaboration between US and Developing Countries — David J. Kappos, Under Secretary of Commerce and Director of the US Patent and Trademark Office

    • 1:30-2:30 — Economic Perspectives on Effect of IP on Developing Countries — Dr. Carlos Braga, Director of Economic Policy and Debt, Poverty Reduction and Economic Management Network, World Bank; Dr. Lee Branstetter, Associate Professor of Economics and Public Policy, Carnegie Mellon University

    • 2:30-2:45 — Coffee Break

    • 2:45-3:45 — Case studies: Effect of National IP Frameworks on Development and Commercialization — McLean Sibanda, Group Executive for Commercialization, Technology Innovation Agency of South Africa; Carl Horton, Chief Intellectual Property Counsel, General Electric

    • 3:45-4:15 — Closing Remarks: Judicial Observations on Development of IP Regimes in Developing Countries — Hon. Chief Judge Rader, U.S. Court of Appeals for the Federal Circuit

    • 4:30-5:30 — Reception

    The Symposium will have as the primary audience the World Bank Group staff, but will also have limited availability for external attendees.  Anyone interested in attending the event should send an e-mail to LJDevelopment@worldbank.org with their contact information (name, organization, email, telephone) by Monday, December 13, 2010.

  • HHS Denies Request to Exercise Bayh-Dole “March-in” Rights for Fabrazyme

    By James DeGiulio —

    Department of Health & Human Services On August 2, patients with the rare Fabry disease petitioned the Department of Health and Human Services to exercise the "march-in" powers under the federal Bayh-Dole Act, and issue an open license to use patents needed to manufacture Genzyme's enzyme replacement drug Fabrazyme (see "Genzyme's Manufacturing Issues with Fabrazyme Prompt Patients to Petition HHS Secretary to Exercise Bayh-Dole "March-in" Rights").  Not surprisingly, in a letter to the patients' attorney C. Allen Black, Jr., the NIH denied the petitioners' request.  Despite recognizing the situation as grave, the NIH found there is no manufacturer situated to readily acquire FDA approval to manufacture Fabrazyme even under a march-in license.

    Genzyme Genzyme, which produces Fabrazyme under an exclusive license from Mount Sinai Medical Center, has been unable to produce enough drug to treat the U.S. Fabry disease market since 2009 due to various manufacturing issues.  Initially, Genzyme's bioreactors were contaminated by a virus, and later, vials for injection were produced containing foreign contaminates.  Once the supply got so low that patients were rationed to only 30% of the recommended dosage and no newly diagnosed patients were eligible for therapy, the petition was brought by Fabry patients who asked HHS to grant an open license to U.S. Patent Nos. 5,356,804 and 5,580,757.

    National Institutes of Health Francis Collins, the Director of the NIH, signed off on the determination opinion in the Fabrazyme case.  The opinion presents a primer on the process for bringing a biological product to market, which requires "substantial time, effort, and resources, irrespective of any patent rights."  A manufacturer must procure clinical materials, gather preclinical data, and ensure safety before FDA will approve an Investigational New Drug Application to authorize beginning clinical trials.  Following sufficient clinical trials, the Biologic License Application must be approved by the FDA, whose review can take ten months at minimum (six with priority status).  In light of the regulatory hurdles that another manufacturer would have to overcome even with a license to the Genzyme patents, the NIH determined that exercising march-in rights at this time would not address the lack of Fabrazyme supply because it would simply take too much time for FDA approval.  Further, Genzyme has indicated that it expects the production of Fabrazyme to be back to full levels in the first half of 2011, which should address the shortage.  The NIH has agreed to monitor the situation, and has requested that Mount Sinai provide monthly reports on Genzyme's manufacturing process, and will reconsider its opinion upon receiving any unfavorable updates.

    Mount Sinai has also agreed with the NIH not to seek injunctions against any infringers of the Fabrazyme patents.  Nonetheless, the petitioners plan to appeal the NIH decision and argue that the HHS approved the FDA rules that block companies from manufacturing the drug in a timely manner under Bayh-Dole, even thought the HHS controls the FDA and the NIH.  If history is any indication, there may be something to the irony of their argument.  This month marks the 30th anniversary of the Bayh-Dole Act, and the march-in provision has yet to be exercised in the three decades of the legislation's existence.

  • USPTO Recognizes 30th Anniversary of Bayh-Dole Act

    By Donald Zuhn —

    USPTO Seal Earlier today, the U.S. Patent and Trademark Office commemorated the 30th anniversary of the Bayh-Dole Act with a special program at its headquarters in Alexandria, VA.  The program featured congressional leaders who were instrumental in the passage of the legislation, including former Senator Birch Bayh (D-IN) and former Representative Robert Kastenmeier (D-WI).  The Bayh-Dole Act, which passed on December 12, 1980, created a uniform patent policy among the many federal agencies that fund research, enabling small business and non-profit organizations — including universities — to retain title to inventions made under federally funded research programs.  According to a statement issued by the Office, "[t]he legislation is credited with the creation of thousands of new companies and billions of dollars of direct benefits to the U.S. economy."

    Mr. Bayh noted that "[a] handful of determined men and women made the law a reality and have preserved it for 30 years," and added that "[n]ow we need new hands to help carry the message of how valuable Bayh-Dole is to the continued health and wealth of the United States."  Mr. Kastenmeier said that the legislation takes advantage of "a unique American cycle of innovation," wherein "[w]ith the help of federal funding, university researchers discover and create solutions that open new opportunities for technology transfer."  He added that "[t]he Act is constructed on the solid foundation of intellectual property to stimulate economic growth and job creation for the benefit of society at large."  USPTO Director David Kappos observed that "[o]ver the past thirty years since its passage, Bayh-Dole has managed to spark innovation and capture the value of federally funded research on university campuses across the country."  He also noted that the legislation's benefits "reaffirm the basic understanding rooted in our Constitution that the issuance of patent rights promotes advancements in both science and commerce."