Axinn provides in-depth counseling and litigation services to clients in the pharmaceutical industry relating to patent, FDA and antitrust issues. In particular, the firm advises clients on patent issues relating to the development and commercialization of drug products.
Axinn's role often begins before product formulation, evaluating whether the patent risk is worth the expense of development. For example, the firm evaluates proposed drug formulations, prepares opinions of counsel and assists in the preparation of Paragraph IV Notice Letters.
Axinn possesses substantial experience handling all aspects of pharmaceutical patent infringement litigation. The firm aggressively defends clients against infringement lawsuits initiated by patent holders. Axinn is also especially active in matters involving the intersection of antitrust and patent in the pharmaceutical industry, drawing upon the firm’s extensive counseling experience and litigation skills in both fields. The firm actively counsels clients regarding antitrust issues arising from the settlement of patent and Hatch-Waxman exclusivity disputes, the licensing of critical technology and the formation of joint development agreements. In addition to providing advice regarding such issues, Axinn has also represented clients during FTC investigations involving such agreements.