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  • Three New Biosimilars Pass EMEA Test

        By Donald Zuhn —

    Emea
    Last month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) approved three new follow-on biologic drugs:  Binocrit (Sandoz GmbH), Epoetin alfa Hexal (Hexal Biotech Forschungs GmbH), and Abseamed (Medice Arzneimittel Pütter GMBH & Co.).  The approved biosimilars are generic versions of Johnson & Johnson’s Eprex (marketed as Procrit® in the U.S.), which is based on the human protein erythropoietin (EPO).  Like Eprex, the biosimilars are intended for the treatment of anemia associated with chronic kidney disease and in oncology patients and to reduce blood transfusion requirements in oncology patients and prior to elective orthopedic surgery.

    The European Commission (EC), which usually follows the CHMP’s recommendations, is expected to issue a formal decision on the three biosimilars within two months.  If the EC approves Binocrit, it will be Sandoz’ second approved biosimilar.  Sandoz’ Omnitrope (human growth hormone) was the first biosimilar to be approved in Europe, having received a positive opinion from the CHMP in January 2006.

    For additional information regarding the approval, please see:

    • Outsourcing Pharma’s report

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

  • Merck to Acquire NovaCardia

        By Jason Derry —

    Merck
    Merck has announced an agreement to acquire NovaCardia for $350 million.  NovaCardia, a biotechnology company based in San Diego, has a lead drug candidate, KW-3902, in Phase III clinical trials for treating acute congestive heart failure.  Merck hopes to expand its pipeline for Novacardia
    cardiovascular therapeutics with the purchase of NovaCardia, which has a second compound (K201) currently slated for Phase II clinical trial for treating atrial fibrillation.

    Jason Derry, Ph.D., who graduated with honors from DePaul University
    College of Law, is a molecular biologist and founding author of Patent Docs.

  • USPTO News: New Continuation and Claims Rules to Be Published in Late Summer

        By Donald Zuhn —

    Uspto_seal_2
    The U.S. Patent and Trademark Office (USPTO) announced today (July 25, 2007) that the Office of Management and Budget (OMB) completed its review of the new continuation and claims rules earlier this month.  More importantly, the Patent Office also announced that the continuation and claims rules would be published in the Federal Register sometime in the late summer.  The rules will become effective at least 60 days after publication, and according to the USPTO release, no earlier than October 1, 2007.

    While abstracts of the new continuation and claims rules can be found on the Federal Regulatory Information website, the abstracts provide few clues as to what the final rules will look like.  The abstracts for the continuation and claims rules can be found here:

    • New continuation rule: "Changes to Practice for Continuing Applications, Requests for Continued Examination Practice, and Applications Containing Patentably Indistinct Claims
    • "New claims rule: "Changes to Practice for the Examination of Claims in Patent Applications"

  • USPTO News: Patent Office Sends KSR Training Guidelines to OMB

        By Donald Zuhn —

    Uspto_seal
    Last Friday, the U.S. Patent and Trademark Office (USPTO) announced that it has sent draft obviousness examination guidelines to the Office of Management and Budget (OMB) for review.  The draft training guidelines are to be used by examiners in determining whether a claimed invention is obvious in view of the Supreme Court’s decision in KSR Int’l Co. v. Teleflex Inc.

    The draft guidelines, which the Patent Office did not release, will be posted on the USPTO website after the OMB concludes its review.  According to the USPTO release, however, the Patent Office will begin training examiners "on implementation of KSR" while awaiting the results of the OMB review.

    For additional information regarding the KSR decision, please see:

  • Organon and MRC Technology to Collaborate

        By Jason Derry —

    Organonlogo
    Organon and MRC Technology have announced an intent to collaborate in the development of a humanized antibody for treating various cancers.  Under the agreement, MRC will use its CDR grafting technology to generate a humanized antibody based on one of Mrct_new_logo_2006_email
    Organon’s murine antibodies as a candidate for clinical development.  MRC will receive milestone payments and royalties based on sales of a commercialized product.  Organon is a biopharmaceutical company that is expanding its interest in biotechnology to the fields of immunology and oncology.  MRC Technology performs technology transfer activities for the UK Medical Research Council, and provides chemical and biology tools to assist pharmaceutical and biotech companies in drug discovery.

    For additional information regarding this collaboration, please see:

    Jason Derry, Ph.D., who graduated with honors from DePaul University
    College of Law, is a molecular biologist and founding author of Patent Docs.

  • Mergers and Acquisitions Are Preferred Over IPO’s

        By Baltazar Gomez —

    The biotech industry needs lots of capital for research, new product development, and lots of funds for daily operations.  The current trend of mergers and acquisitions in the biotech industry arises in order to satisfy the needs of the industry.  Many biotech firms have promising technologies and low stock prices, making such firms excellent takeover candidates.  For large firms, mergers address excess capacity resulting from anticipated patent expirations and gaps in product pipelines.  For small firms, mergers are excellent exit strategies and opportunities to have access to larger markets and more money.

    An article by Katie Weeks of the San Diego Business Journal explores mergers and acquisitions from the perspective of investors (see "Mergers, Acquisitions Leading ‘Exit Strategy’ For Biotech Companies").  Investors and biotech companies favor mergers and acquisitions over initial public offerings (IPO) because this is a way to gain value quickly.  Consequently, the number of IPO’s have declined in recent years.  The decline is partly due to the increasing interest by large pharmaceutical companies to acquire new products through mergers, rather than to develop products from ground zero.  The incentive to acquire new products comes from the urgent need to have backup revenue as old products go off patents.  Thus, private biotech companies opt to merge with large pharmaceutical companies to take advantage of biotech’s innovative treasure chest to fill the drug pipelines of the large pharmaceutical companies.

    Sdbj_logo

    For additional information on this topic, please see:

  • Ortho-McNeil and Par Pharmaceutical Settle Patent Suit

        By Sherri Oslick —

    Orthomcneil_2

    Ortho-McNeil, Inc.     announced late last week that it has settled its lawsuit against Par Pharmaceutical Companies, Inc. and its subsidiaries, Par Pharmaceutical, Inc. and Kali Laboratories, Inc., over the patent covering Ortho’s Ultracet® (tramadol hydrochloride and acetaminophen, used to treat acute pain).

    As part of the settlement agreement, Par/Kali entered into a consent judgment admitting to infringement and conceding that the patent-in-suit, RE39,221, is valid and enforceable.  Ortho will Logo_par_2
    receive a lump sum for past damages, and Par will pay royalties going forward until November 15, 2007, the date on which the parties agreed Par/Kali will exit the market.

    Ultracet
    Ortho filed its suit against Par/Kali on July 31, 2006 in the District Court of New Jersey (2:06-cv-03533) based on defendants’ manufacture and sale of a generic version of Ultracet®.  Par/Kali’s ANDA, including a Paragraph IV certification, was approved by the FDA on April 21, 2005.

    On the day before announcing its settlement with Par/Kali, Ortho filed suit against Apotex for infringement of RE39,221 based on Apotex’s recent ANDA filing seeking approval to market generic Ultracet®, as reported here.  RE39,221 will expire on August 9, 2011.

  • European Medicines Agency Releases Paper on Biosimilar Medicines

        By Donald Zuhn —

    Emea
    Last month, the European Medicines Agency (EMEA) released a paper entitled "Questions and Answers on biosimilar medicines (similar biological medicinal products)," in which the EMEA provided answers to a number of questions concerning the authorization of biosimilars.  The European biosimilar regulatory pathway was established in 2004.  In view of recent attempts by Congress to enact biosimilar legislation (see "Senate Commitee Passes Biologics Legislation"), the EMEA paper is informative.

    In the paper, the EMEA defines a "biological medicine" as a medicine whose active ingredient is made by or derived from a living organism (such as recombinant insulin produced by a bacterium carrying the insulin gene), a biological reference medicine" as an authorized biological medicine, and a "biosimilar medicine" as a medicine that is similar to the biological reference medicine.  In describing the similarity between a biological reference medicine and a biosimilar medicine, the EMEA noted that, in general, both would be used "at the same dose to treat the same disease," but that because the two "are similar but not identical, the decision to treat a patient with a reference or a biosimilar medicine should be taken following the opinion of a qualified healthcare professional."

    With regard to the authorization of biosimilars, the EMEA stated that such medicines could only be marketed after a suitable regulatory authority – such as the EMEA – had conducted a scientific evaluation of the efficacy, safety and quality of the medicine.  The EMEA also noted that those seeking to market biosmilar medicines would be allowed to do so only after the expiration of "a period of data protection following the pharmaceutical legislation."

    Since the active substance in the biological reference medicine and the biosmiliar medicine may differ slightly as a result of the methods of production, those seeking to market biosimilar medicines must perform studies specified by the European biosimilar legislation in order to ensure the similarity, safety, and efficacy of the biosimilar medicine.  Such studies must establish that there are "no meaningful differences" between the safety and efficacy of the biological reference medicine and the biosimilar medicine.  Submission of information regarding the corresponding biological reference medicine is not required.

  • Court Report

        By Sherri Oslick —

    Gavel_23
    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.


    Ortho-McNeil Pharmaceutical, Inc. v. Apotex, Inc.
    1:07-cv-04050; filed July 18, 2007 in the Northern District of Illinois

    Infringement of U.S. Patent No. RE39,221 ("Composition Comprising a Tramadol Material and Acetaminophen and Its Use," issued August 1, 2006) following a paragraph IV certification as part of Apotex’s filing of an ANDA to manufacture a generic version of Ortho-McNeil’s Ultracet® (tramadol hydrochloride and acetaminophen, used to treat acute pain).  View the complaint here.


    Shire US Inc. et al. v. Johnson Matthey Inc. et al.
    2:07-cv-02958; filed July 18, 2007 in the Eastern District of Pennsylvania

    Declaratory judgment of noninfringement of U.S. Patent No. 6,096,760 ("Solid alpha-Phenyl-2-Piperidine Acetate Free Base, Its Preparation and Use in Medicine," issued August 1, 2000) based on Shire’s manufacture and sale of its Daytrana (methylphenidate transdermal system).  View the complaint here.


    UCB Societe Anonyme et al v. Cobalt Pharmaceuticals, Inc.
    1:07-cv-01630; filed July 13, 2007

    Infringement of U.S. Patent No. 4,943,639 ("(S)-Alpha-Ethyl-2-Oxo-1-Pyrrolidineacetamide," issued July 24, 1990) following a paragraph IV certification as part of Cobalt’s filing of an ANDA to manufacture a generic version of UCB’s Keppra® (levetiracetam, used to treat epilepsy).  View the complaint here.


    Sepracor Inc. v. Barr Laboratories Inc.
    1:07-cv-00438; filed July 12, 2007

    Infringement of U.S. Patent Nos. 5,362,755 ("Method for Treating Asthma Using Optically Pure (R)-albuterol," issued November 8, 1994), 5,547,994 (same title, issued August 20, 1996), 5,760,090 (same title, issued June 2, 1998), 5,844,002 ("Method for Inducing Bronchodilation Using Optically Pure R(-) albuterol," issued December 1, 1998), and 6,083,993 ("Method for Treating Bronchospasm Using Optically Pure R(-) albuterol," issued July 4, 2000) following a paragraph IV certification as part of Barr’s filing of an ANDA to manufacture a generic version of Sepracor’s Xopenex® inhalation solutions (levalbuterol hydrochloride, used to treat asthma).  View the complaint here.


    Novartis Corp. et al. v. Dr. Reddy’s Laboratories, Inc. et al.
    2:07-cv-03221; filed July 12, 2007 in the District Court of New Jersey

    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 Dr. Reddys’ filing of an ANDA to manufacture a generic version of Novartis’ Lotrel® (amlodipine besylate/benazepril hydrochloride, used to treat hypertension).  View the complaint here.


    Novo Nordisk A/S v. Sanofi-Aventis U.S. LLC et al.
    3:07-cv-03206; filed July 10, 2007 in the District Court of New Jersey

    Infringement of U.S. Patent No. 7,241,278 ("Injection Device," issued July 10, 2007) based on defendants’ sale or anticipated sale of its SoloStar prefilled disposable insulin injection device ("pen") for use by patients in the treatment of diabetes.  View the complaint here.

  • Conference & CLE Calendar

    Calendar_22
    September 18-19, 2007 – Pharma/Biotech Patent Boot Camp (American Conference Institute) – San Francisco, IL***

    September 26-27, 2007 – Advanced Forum on Biotech Patents (American Conference Institute) – Boston, MA***

    ***Patent Docs is a media sponsor of this conference or CLE.