•     By Mark Chael

    Seton_hall_law_logo
    On Friday, April 27, 2007 at 9:00 am, the Seton Hall University School of Law (SHU Law) will hold a press conference to announce the establishment of the Center for Health & Pharmaceutical Law.  The mission of the new Center will be "to address the evolving legal and public policy framework of modern drug and device regulation and practice."

    As reported by the Associated Press, the Center will be funded primarily by endowments totaling more than $8 million from Bristol-Myers Squibb, Johnson & Johnson, Sanofi-Avenis, and Schering-Plough.  Bristol-Myers Squibb itself will be donating $5 million to endow a professorship in corporate governance and business.

    The research and policy center will focus on various issues affecting the pharmaceutical and medical device industries, including legal, business ethics, regulatory, enforcement, among others.  According to Ms. Denise Pinney, who is the Assistant Dean of Health, Science, and Technology Law at SHU Law, the research will include not only the view of industry personnel and legal scholars, but also the views of patients, doctors, politicians, and students.

    More information about the press conference can be found here.

  •     By Christopher P. Singer

    Astrazeneca_large
    AstraZeneca PLC announced on Monday that it plans to acquire MedImmune Inc. in a deal estimated to be worth about $15 billion.  AstraZeneca expects that this acquisition, in combination with its earlier acquisition of Cambridge Antibody Technology (CAT) will place it among the top biologics companies in the world, accelerating its biologics strategy.  The company now will be able to approach its research and development strategy through well developed small molecule, biologic, and vaccine technologies.  The acquisition of MedImmune should provide several immediate benefits to AstraZeneca, including adding personnel having experience with the regulatory issues involved with Biologics License Applications; acquiring facilities having large capacity for biologics manufacturing and protein engineering; increasing revenue from sales of existing products including Synagis®, FluMist®, and anticipated sales from Numax®; and expanding its biologics pipeline from 7% to 27%.
    Medimmune_2

       

  •     By Sherri Oslick

    Gavel About
    Court Report:  Each week we will report briefly on recently filed
    biotech and pharma cases, and a few interesting cases will be selected
    for periodic monitoring.


    Breckenridge Pharmaceutical, Inc. v. Cornerstone
    Biopharma, Inc. et. al.

    8:07-cv-01004; filed April 19, 2007 in the District Court
    of Maryland

    Declaratory judgment of invalidity and non-infringement
    of U.S. Patent No. 6,270,796 ("Antihistamine/decongestant Regimens for
    Treating Rhinitis," issued August 7, 2001) based on Breckenridge's sale of
    Allergy DN, a produce comparable to Cornerstone's AlleRx® formulations (used
    to treat allergies and symptoms of the common cold).  View the complaint here.


    PDL Biopharma, Inc. v. Sun Pharmaceutical Industries,
    Ltd.

    4:07-cv-11709; filed April 17, 2007 in the Eastern
    District of Michigan

    PDL Biopharma, Inc. v. Sun Pharmaceutical Industries,
    Ltd.

    2:07-cv-01788; filed April 16, 2007 in the District Court
    of New Jersey

    The complaints in these two cases are substantially
    identical. Infringement of U.S. Patent
    No. 5,164,405 ("Nicardipine Pharmaceutical Composition for Parenteral
    Administration," issued November 17, 1992) following a paragraph IV
    certification as part of Sun's filing of an ANDA to manufacture a generic
    version of PDL's Cardene® I.V.® (nicardipine hydrochloride solution, used
    for the short-term treatment of hypertension).  View the later-filed complaint here.


    MedPointe Healthcare Inc. v. Apotex Inc. et. al.

    1:07-cv-00204; filed April 17, 2007 in the District Court
    of Delaware

    Infringement of U.S. Patent No. 5,164,194
    ("Azelastine Containing Medicaments," issued November 17, 1992)
    following a paragraph IV certification as part of Apotex's filing of an ANDA to
    manufacture a generic version of MedPointe's Optivar® (azelastine
    hydrochloride ophthalmic solution, used to seasonal allergic rhinitis).  View the complaint here.


    Centocor, Inc. v. Abbott Laboratories

    2:07-cv-00139; filed April 16, 2007 in the Eastern
    District of Texas

    Infringement of U.S. Patent No. 7,070,775
    ("Recombinant A2-Specific TNF? Specific Antibodies," issued July 4,
    2006) based on Abbott's manufacture and sale of Humira® (adalimumab, used to
    treat arthritis, ankylosing spondylitis, and Crohn's disease).  View the complaint here.


    Ariad Pharmaceuticals Inc. et. al. v. Amgen Inc. et. al.

    1:07-cv-00202; filed April 13, 2007 in the District Court
    of Delaware

    Infringement of U.S. Patent No. 6,410,516 ("Nuclear
    Factors Associated with Transcriptional Regulation," issued June 25, 2002)
    based on defendants' manufacture and sale of Enbrel® and Kineret®
    (etanercept and anakinra, respectfully, both used used to treat arthritis).  View the complaint here, and a more in depth
    report here.


    Exela Pharmsci, Inc. v. Allergan, Inc.

    1:07-cv-00338; filed April 6, 2007 in the Eastern
    District of Virginia

    Declaratory judgment of non-infringement and invalidity
    of U.S. Patent Nos. 5,424,078 ("Aqueous Ophthalmic Formulations and
    Methods for Preserving Same," issued June 13, 1995), 6,562,873
    ("Compositions Containing Therapeutically Active Components Having
    Enhanced Solubility," issued May 13, 2003), 6,627,210 ("Compositions
    Containing alpha-2-Adrenergic Agonist Components," issued September 30, 2003),
    6,641,834 (same title, issued November 4, 2003), and 6,673,337 (same title,
    issued January 6, 2004) in conjunction with Exela's filing of an ANDA to
    manufacture a generic version of Allergan's Alphagan® P (brimonidine tartrate
    ophthalmic solution, used to treat glaucoma).  View the complaint here.

  •     By Donald Zuhn

    Novartis_2
    Last Thursday, Novartis AG announced that it had signed an exclusive license with Antisoma PLC for the worldwide rights to the cancer therapeutic AS1404.  AS1404 is a member of a class of compounds known as small molecule vascular disrupting agents (VDAs).  VDAs, which selectively disrupt established blood vessels supporting tumor growth, differ from angiogenesis inhibitors, which inhibit the formation of new tumor blood vessels.

    Asmln
    AS1404 is set enter Phase III clinical trials in patients with squamous non-small cell lung cancer in 2008 after showing positive results in Phase II trials; the compound extended median survival by five months in patients with non-small cell lung cancer when used in combination with paclitaxel and carboplatin.  With the licensing of AS1404, Novartis now has seven cancer therapeutics in its pipeline, including: RAD001, for treating multiple tumors; SOM230, for treating Cushing’s disease/refractory carcinoid tumors and acromegaly; LBH589, for treating chronic myeloid leukemia/cutaneous T-cell lymphoma; Tasigna, for treating chronic myeloid leukemia; EPO906, for treating ovarian cancer; and PKC 412, for treating acute myelogenous leukemia.

    In its release, Novartis stated that it would make an upfront payment of US $75 million to Antisoma, with additional payments of US $380 million, contingent on developmental milestones and approvals, and up to US $325 million, contingent on future sales performance.  The agreement also calls for Antisoma to receive sales royalties, and involves an option for Novartis on a back-up compound to AS1404 that could net Antisoma another US $110 million.

    Forbes reported that that deal, worth a potential US $890 million, would be the second largest for the British biotechnology industry.  According to Forbes, the Antisoma-Norvartis agreement trails last month’s Oxford BioMedica and Sanofi-Aventis deal, previously reported by Patent Docs, now believed to be worth a potential US $1 billion.  Forbes also noted that Roche handed the rights to AS1404 back to Antisoma last June amid concerns about patent protection.  According to a Guardian Unlimited report, Roche was worried that U.S. patent protection for AS1404 would expire in 2012 despite assurances from Antisoma that several patents covering AS1404 combination therapies would not expire until 2021.  Antisoma has not identified the serial numbers of the relevant U.S. patents.

  • Calendar April 27, 2007 – Patent Claim Construction Workshop (Law Seminars International) – Atlanta, GA

    May 6-9, 2007 – BIO International Convention – Boston, MA

    June 26-28, 2007 – Euro-Biotech Forum 2007 – Paris, France

  • "Biotech/Pharma" Top 50 (+1)

        By Donald Zuhn

    Ipo_1
    On Monday, the Intellectual Property Owners Association (IPO) released its annual list of the top 300 organizations receiving U.S. patents in 2006.  The IPO’s release of the list comes three months after the U.S. Patent & Trademark Office (PTO) announced that it would no longer release an annual list of top patent recipients in order to "discourag[e] any perception that we believe more is better."  The IPO stated that while it did not want "to encourage organizations to obtain more patents merely for the sake of obtaining more patents," it would continue to publish its annual list of top recipients because the list was "currently one of the few objective measures of the patent system."  The IPO compiled its list by counting the number of utility patents granted during 2006 on which an organization or its subsidiary was listed as the owner on the face of the patent.  The IPO noted that 173,771 patents were issued in 2006.

    From the IPO’s list of the top 300 patent holders, Patent Docs compiled a list of the Top 51 "biotech and pharma" companies and organizations receiving U.S. patents in 2006.  Each organization’s IPO top 300 ranking is indicated in parentheses.  Please note that some of the companies and organizations listed below may be involved in non-biotech or non-pharma work, and therefore, that a portion of the patents granted to these companies may be directed to other than biotech and pharma-related inventions.  In addition, our list is a little inclusive in that we included medical device companies.

    1 (38) — E. I. du Pont de Nemours and Co. — 531 patents
    2 (40) — Johnson & Johnson — 516
    3 (41) — Boston Scientific Corp. — 514
    4 (49) — Agilent Technologies, Inc. — 469
    5 (54) — Regents of the University of California — 410
    6 (62) — Procter & Gamble Co. — 359
    7 (65) — Pfizer Inc. — 345
    8 (80) — Industrial Technology Research Institute, Taiwan — 255
    9 (89) — Medtronic Inc. — 233
    10 (99) — Bristol-Myers Squibb Co. — 201
    11 (107) — Sanofi-Aventis Deutschland GmbH — 178
    12 (115) — GlaxoSmithKline — 163
    13 (126) — Bayer AG — 148
    14 (128) — Genentech, Inc. — 146
    15 (132) — Rohm and Haas Co. — 142
    16 (134) — Massachusetts Institute of Technology — 139
    17 (145) — Merck & Co., Inc. — 130
    18 (151) — Council of Scientific and Industrial Research — 123
    19 (152) — U.S.A., Health & Human Services — 122
    20 (153) — Battelle Memorial Institute — 121
    21 (158) — Schering Corp. — 117
    22 (160) — Wyeth — 116
    23 (161) — California Institute of Technology Corp. — 115
    24 (169) — AstraZeneca AB — 109
    25 (175) — University of Texas — 107
    26 (187) — Amgen Inc. — 102
    26 (189) — Sumitomo Chemical Co., Ltd. — 102
    28 (190) — Novartis AG — 101
    28 (192) — Wisconsin Alumni Research Foundation — 101
    30 (194) — Merck Patent GmbH — 100
    31 (195) — Pacesetter, Inc. — 99
    32 (196) — Stanford University — 98
    33 (201) — Commissariat a l’Energie Atomique — 92
    34 (203) — Johns Hopkins University — 91
    35 (207) — Degussa AG — 90
    36 (211) — Dow Chemical Co. — 89
    37 (225) — Boehringer Ingelheim Pharmaceuticals, Inc. — 81
    38 (238) — Applera Corp. — 75
    39 (244) — Abbott Laboratories — 72
    40 (250) — University of Michigan — 69
    41 (251) — Advanced Cardiovascular Systems, Inc. — 68
    42 (264) — Fraunhofer-Gesellschaft zur Foerderung der  Angewandten Forschung E.V. — 65
    43 (267) — Becton, Dickinson and Co. — 64
    43 (271) — Monsanto Technology, LLC — 64
    43 (272) — Shimadzu Corp. — 64
    46 (275) — Baxter International Inc. — 63
    47 (281) — Japan Science and Technology Agency — 62
    48 (286) — Cornell Research Foundation Inc. — 61
    48 (291) — Stine Seed Farm, Inc. — 61
    50 (292) — Kaneka Corp. — 60
    50 (294) — University of Florida Research Foundation, Inc. — 60

    Readers:  If you discover any omissions or inaccuracies, we ask that you please notify us so that we can update and/or correct the list. 

  •     By Robert Dailey —

    Novozymes
    Novozymes and Genencor (Danisco) reached a settlement involving Genencor’s infringement of U.S. Patent No. 6,867,031.  The patent covers alpha-amylases useful in the manufacture of fuel-grade ethanol.  As previously reported by Patent Docs, Novozymes had prevailed over Genencor in an infringement trial and subsequently proved that Genencor’s infringement had been willful.

    Genencor_international
    According to news reports and a Novozymes press release, the settlement includes a $15.3 million cash payment.  This amount includes damages for infringement and attorneys’ fees.  Both companies also waived rights to appeal the district court decision.  Further details of the settlement remain secret.  Therefore, it is unclear whether the agreement also includes an ongoing license of the Novozymes technology.

    The settlement is awaiting approval by the U.S. District Court in Delaware.

    For additional information regarding this case, please see:

    Robert Dailey, Ph.D., is a physical chemist and a third-year law
    student at the University of North Carolina at Chapel Hill.  Dr. Dailey
    was a member of MBHB’s 2006 class of summer associates, and is a
    regular Patent Docs contributor.

  •     By Kevin E. Noonan

    Dojlogo_rgb150
    On Tuesday, the U.S. Department of Justice (DOJ) and Federal Trade Commission (FTC) released an extensive (218 page) report on their analysis of the relationship between antitrust law and patent law (see "Antitrust Enforcement and Intellectual Property Rights: Promoting Innovation and Competition").  And in what may come as a surprise to many patent practitioners, the report contains mostly good news.

    Ftc
    From the beginning of the Introduction to the Report, the tone is positive for patent holders.  The Report acknowledges that in the past, antitrust law and patent law were seen as being in conflict, but that the more enlightened view is to consider them both to be concerned with encouraging innovation and enhancing consumer welfare.  The Report states that patent "monopolies" are not inherently antithetical to the antitrust regime, and that "it is well understood that exercise of monopoly power, including the charging of monopoly prices, through the exercise of a lawfully gained monopoly position will not run afoul of the antitrust laws," citing Verizon Commc’ns Inc. v. Law Offices of Curtis V. Trinko, LLP, 540 U.S. 398, 407 (2004).  Further, "antitrust doctrine does not presume the existence of market power from the mere presence of an intellectual property right."  Ill. Tool Works Inc. v. Indep. Ink, Inc., 126 S. Ct. 1281, 1284 (2006).

    The Report focuses on patent licensing behaviors, including unilateral, unconditional refusals to license;   extracting increased licensing royalties as the result of standard-setting and patent-pooling; grantbacks and reach-through royalties; and tying arrangements.  The Report opines that refusal to license, without more, is not an antitrust violation.  The Report expressly rejects the Ninth Circuit’s reasoning in Image Technical Services, Inc. v. Eastman Kodak Co., 125 F.3d 1195 (9th Cir. 1997), which focused on the patentees’ subjective intent, as being impractical and "out of step" with antitrust analyses based on "objective economic evidence."  However, the Report also rejects the view that 35 U.S.C. § 271(d)(4) provides an exemption from antitrust liability for refusal to license.  Conditional refusals, i.e., refusals containing a condition that can be met vel non and influence the decision to license, may implicate antitrust liability when coupled with market power and competitive harm.

    With regard to standard-setting situations, the Report acknowledges that such standards can have pro-competitive and pro-consumer effects.  However, the Report acknowledged the Scylla and Charybdis of anticompetitive activities of standard-setting organizations (SSOs) in standard setting and the anticompetitive activities of patent holders whose intellectual property has increased value due to coverage of the standards set.  The Report encourages transparency from patent holders participating in standard setting, and ex ante agreements to license under reasonable and non-discriminatory terms.  The Report recommends that activities of both SSOs and patent holders be evaluated under the rule of reason.  Specifically, unilateral announcement of licensing terms or price terms would not violate the Sherman Act, nor would bilateral licensing negotiations raise antitrust concerns without additional indicia of anticompetitive behavior.

    The Report also recognized the value of patent pools in overcoming "patent thicket" problems, but cautioned against "anticompetitive effects if the arrangements result in price fixing, coordinated output restrictions among competitors, or foreclosure of innovation."  Patent pooling requires more antitrust scrutiny than portfolio cross-licensing, based on increased potential for collusion and collective pricing.  Patent pools were characterized as being generally pro-competitive, although the Agencies will evaluate them under the rule of reason on a case-by-case basis.

    Licensing restraints generally received less positive consideration, due to the higher likelihood of anticompetitive effects.  The Repoort recommends that non-assertion clauses, grantbacks, and reach-through royalty arrangements be reviewed under the rule of reason to determine whether the pro-competitive effects outweigh any anticompetitive effects.

    Tying and bundling arrangements were also viewed as raising (or being more likely to raise) antitrust concerns due to anticompetitive effects.  The Report recommends continued surveillance of these arrangements, and to consider them illegal when the patent holder has market power, the arrangement has an anticompetitive effect on the market for the tied product, and justification of the tying arrangement on efficiency grounds do not outweigh the anticompetitive effects.

    Surprisingly, the Report did not condemn outright agreements that extended the term of patent royalty payments to periods after expiration of the underlying patents.  The Report recognized that such arrangements could have pro-competitive effects, such as requiring lower royalties over a more extended period of time.  The Report also noted that such arrangements themselves only implicate antitrust concerns when the patent confers market power.

    In sum, the Report reaffirmed the Agencies’ approval of and continued reliance on the Intellectual Property Antitrust Guidelines while affirming the pro-competitive effects of the current patent regime.  The Report’s recommendations suggest that the "rule of reason" has now extended to these agencies the recognition of the positive effects that patents have on innovation and U.S. competitiveness, features that have been recognized elsewhere.  See "Science Fiction in The New York Times" and "The Continuing Value of Biotech Patenting."

  • Life Sciences Institute The University of Michigan's Life Sciences Institute is sponsoring a symposium for presentations and discussions relating to the latest in stem cell biology research.  The symposium, entitled "Frontiers in Stem Cell Biology," will be held May 9, 2007 at the Biomedical Sciences Research Building Auditorium at the University of Michigan.  More information, including the schedule of speakers, can be found here.

  •     By Sherri Oslick

    Ariad
    In a recent press release, ARIAD Pharmaceuticals, Inc. announced that it has filed suit against Amgen Inc., certain Amgen affiliates, and Wyeth for infringement of U.S. Patent No. 6,410,516 ("Nuclear Factors Associated with Transcriptional Regulation," issued June 25, 2002).  The ‘516 patent is directed to certain aspects of the NF-kB transcription factor pathway.  ARIAD’s complaint alleges that Amgen’s products Enbrel® (etanercept, a TNF blocker) and Kineret® (anakinra, an IL-1 receptor antagonist), both Wyeth_logo_sm
    used to treat arthritis, infringe the ‘516 patent.  Both drugs were developed by Amgen and are marketed by Amgen and Wyeth.

    Amgen_4
    The suit, filed in the District Court of Delaware, is directly related to an earlier suit filed in the same court.  In April 2006, Amgen filed an action for declaratory judgment of invalidity and non-infringement (based on the manufacture and sale of Enbrel® and Kineret®) of the ‘516 patent.  The complaint was later amended to include a count of declaratory judgment of unenforceability.  In its answer to the original complaint, ARIAD denied Amgen’s claims, but did not file any counterclaims.  As set forth in a scheduling order in that case, the parties had until April 13, 2007 to join parties and amend or supplement the pleadings.

    As noted in letter authored by ARIAD’s counsel to the Court in the declaratory judgment action, out of concern for the possibility of waiving its right to pursue an affirmative claim of infringement in view of Amgen’s indication that it would oppose ARIAD’s efforts to add an infringement counterclaim, ARIAD filed the separate infringement action on April 13th as a precautionary measure.  Shortly after ARIAD’s filing, Amgen filed an amended complaint, immediately after which ARIAD answered, adding counterclaims of patent infringement.  ARIAD has asked the court to either consolidate the actions or to dismiss the infringement action without prejudice in view of ARIAD’s filing of an infringement counterclaim in the declaratory judgment action.

    ARIAD’s claim for infringement is case number 1:07-cv-00202, pending in the District Court of Delaware.  Amgen’s original declaratory judgment suit is 1:06-cv-00259, also pending in the District Court of Delaware.