• Kramer Levin’s Life Sciences team combines deep technical and industry knowledge with extensive patent litigation experience to achieve winning results in high-stakes biotechnology, pharmaceutical and medical device patent cases. We represent both emerging and established life sciences companies in patent disputes before the district courts and the Patent Trial and Appeal Board (PTAB), delivering strategic counsel and effective advocacy that enable our clients to focus on improving patients’ lives.

    Our impressive results for clients include:

    • Defeating a $530 million claim of patent infringement of a competitor's recombinant DNA vector patent by obtaining for a biopharma innovator a judgment of noninfringement and the dismissal with prejudice of all claims and discovery sanctions against the patent owner.

    • Obtaining discovery in a Section 1782 proceeding for a pharmaceutical innovator that resulted in the invalidation of an antibody glycosylation patent in the United Kingdom.

    • Success in multiple inter partes review (IPR) trials before the PTAB, defeating validity challenges to Depomed extended-release technology patents

    We have extensive patent litigation experience, including in the following areas:

    • Pharmaceuticals (Hatch-Waxman) — Our Life Sciences patent litigators have protected some of the world’s best-known branded drugs against generic competition in Abbreviated New Drug Application/505(b)(2) cases arising under the Hatch-Waxman Act, achieving repeated litigation successes and favorable settlements involving novel chemical entities, treatment methods and drug formulations.
    • Biotechnology, biologics and biosimilars — We have successfully litigated in the biotechnology arts, including such technologies as nucleic acid labeling, detection and quantitation, monoclonal antibodies, stem cells, vector expression, antibody synthesis, and fusion proteins. We also counsel clients on navigating the Biologics Price Competition and Innovation Act.
    • Medical devices and diagnostics — Kramer Levin lawyers have defended and asserted patents pertaining to a wide variety of medical devices and diagnostics.
    • U.S. Patent and Trademark Office contested proceedings — Our Life Sciences lawyers have handled numerous contested proceedings before the PTAB, including IPRs and patent interferences.

    In addition to handling big-ticket patent disputes, we work with life sciences clients to maximize protection for their innovations through strategic patent prosecution, as well as advise them on the IP aspects of due diligence, licensing and corporate transactions.

    Beyond intellectual property needs, we work in cross-disciplinary teams to assist our life sciences clients with a wide range of matters, including:

    • Corporate transactions, including mergers and acquisitions and joint ventures
    • Capital markets transactions, including initial public offerings and private placements
    • Corporate restructuring and financing transactions
    • Securities litigation and government investigations
    • Commercial litigation
    • Corporate compliance programs and internal investigations
    • Advertising litigation
    • Cybersecurity, privacy and data protection
    • Employment law, including executive compensation and employee benefits
    • Public procurement
    • EU regulatory, in particular relating to bioethics

    Whether our clients face a bet-the-company patent dispute, a government investigation or the need to raise capital, we deliver strategic counsel and effective advocacy that enables them to focus on improving patients’ lives.

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