Pharmaceuticals and Biotech

  • S. Horowitz & Co. has an outstanding record representing clients on the full range of contentious and non-contentious intellectual property and regulatory issues affecting the pharmaceutical industry. Our work in this field has been recognised by all the major legal directories which have, year on year, ranked us in the top tier for pharmaceuticals and life science - the only major commercial law firm in Israel to receive this distinction.

     

    We act for clients across the entire range of the industry – including both innovative and generic pharmaceutical companies, medical device companies, industry trade associations, medical and healthcare start-ups, founders, academic institutions and other entities that provide services and finance to the sector such as research organisations, hospitals, venture capital funds and financial institutions.

     

    In addition, members of the team have been involved in drafting legislation influencing the entire pharmaceutical and life science industry and have often represented, at both government and local levels, the pharmaceutical industry as a whole.

     

    Our lawyers are specialists with in-depth knowledge of the evolving legal, regulatory and business issues applying to pharmaceuticals, medical devices, healthcare and nutritional supplements and, in particular, the issues that underpin and influence the drug development cycle. Our expertise includes advising on:

     

    • The protection, use and exploitation of intellectual property rights, in particular patent infringement disputes, opposition procedures and patent validity disputes
    • Claims for compensation by current and former employees in respect of patentable inventions created during the course of their employment
    • Parallel import issues surrounding biotechnology and bio-similar products, their relabeling and sale to HMO's and pharmacies
    • Patent licensing and patent licence disputes
    • Compliance matters, including advising on the necessary regulatory approvals required from the Israel Ministry of Health for the importation, production and marketing of pharmaceutical products in Israel
    • Financing and development of pharmaceutical and biotechnology companies
    • The sale, distribution and promotion of pharmaceutical products in Israel
    • Drug development agreements, including research and other collaborative agreements
    • Clinical trial agreements
    • Product liability and regulatory matters relating to product safety with respect to recalls, health professional communications and adverse events
    • Representing Teva, the world’s largest manufacturer of generic medicines, in numerous patent litigation cases in Israel, regarding a wide array of generic versions of various blockbuster drugs (drugs having annual sales in excess of US$ 1 billion) including patent opposition proceedings against:

     

    (i) Merck, in respect of the blockbuster JANUVIA for the treatment of diabetes and in respect of Fosamax Once Weekly (an osteoporosis drug);

    (ii) Novartis, in respect of the blockbuster GLIVEC for the treatment of various types of cancers, and in respect of the blockbuster EXFORGE for the treatment of high blood pressure;

    (iii) Gilead, in respect of the blockbuster TRUVADA and TRIPLA for the treatment of AIDS; and

    (iv) patent opposition proceedings relating to other drugs including LIPITOR, PLAVIX, EFFEXOR and AVANDIA

     

    • Representing Teva on the innovations side of its business, including in connection with its blockbuster COPAXONE (the leading treatment for MS) and others, as well as representing Teva on the enforcement of its patents in the medical device sector, and in providing clearance opinions in respect of all drugs manufactured by Teva in Israel
    • Representing the Israeli pharmaceutical industry as a whole in negotiations between the Governments of the State of Israel and the United States on legislation relating to the protection of clinical test data required to be submitted to the Israeli Ministry of Health to prove safety and efficacy of a new drug and the extent to which generic drug manufacturers may rely on such data in their own marketing applications
    • Representing the Pharmaceutical Division of the Manufacturers’ Association of Israel on various life science matters, including, by way of example:

     

    (i) trademark and copyright aspects concerning the registration of pharmaceutical products with the Israeli Ministry of Health;

    (ii) regulations relating to the packaging and labeling of of pharmaceutical products; and

    (iii) regulations regarding the conduct of pre-clinical experiments on animals.  We also represent this client in legal proceedings:

     

    (a) regarding the Israeli Ministry of Health's policies with respect to the registration of generic pharmaceutical products; and

    (b) before the courts and the Israeli Patent Office in various proceedings relating to IP issues of importance to the entire pharmaceutical industry

     

    • Representing Allergan Inc., the world’s largest specialty pharmaceutical company developing and marketing eye and skin care with brand names such as "BOTOX®" and "LATISSE®", including negotiating the re-assigning of the Israeli BOTOX domain name from its bad-faith registrant to Allergan, and litigating an opposition to an application for the registration of the "ALLERGIKA" trademark before the Israeli Trademarks Office
    • Representing Neurim Pharmaceuticals Ltd. in its successful extension of the period of patent protection for Circadin, a drug that is used to treat insomnia, in two rounds of litigation.  Parallel proceedings were also commenced in the English courts and in the European Court of Justice and in other major jurisdictions in the world
    • Representing Minrav Holdings Ltd. and AstraZeneca plc in their participation in a tender to establish a life science incubator as part of the Office of the Chief Scientist's incubator program
    • Representing Teva in two major patent claims filed against it by Aventis in connection with the anti-allergy drug Telfast/Alegra, claiming losses in the US market in the hundreds of millions of dollars
    • Representing Perrigo Israel Pharmaceuticals Ltd., a subsidiary of the U.S. based Perrigo Company Inc., a major manufacturer in the field of generic pharmaceutical products, in litigation concernng infringement of trademarks and trade names and other IP-related causes of action
    • Representing Mor Research Applications, the technology transfer arm of Clalit Health Services, one of Israel's largest HMOs, including in connection with the following:

     

    (i) preparing the company's intellectual property rules, which regulate, inter alia, the ownership of inventions developed by Clalit employees;

    (ii) representing the company in a dispute with another technology transfer entity and a commercial manufacturer concerning rights in an invention developed by a former Clalit employee, including the preparation of a settlement agreement

     

    • Representing Bristol Myers-Squibb on various corporate and commercial matters relating to the registration, importation, sale, distribution and marketing of its pharmaceutical products
    • Representing Convatec on various corporate and commercial matters relating to the registration, importation, sale, distribution and marketing of its ostomy care products
    • Representing Abic Ltd. in a claim against two manufacturers of veterinary vaccines concerning the breach of a patent covering vaccination
    • Representing Pfizer in defending the patent relating to Viagra, opposed by Bayer, part of the worldwide litigation currently pending against Pfizer relating to the compounds protected by the patent