BioMedical Practice Group

Utilizing the firm’s extensive experience in patent and antitrust law, AV&H has an active BioMedical practice group, which focuses on numerous facets of the development and marketing of drug products.  The firm provides in-depth counseling and litigation services to clients in the pharmaceutical industry relating to patent, FDA and antitrust issues.  James Veltrop heads this practice group and works closely with William Rubenstein, James Doyle, Chad Landmon, Michelle Seagull, Lee Hebert and Brennan Price.  Antitrust counseling and patent and FDA litigation services are also provided by Lauren Albert, Michael Keeley, Mark Alexander, Nick Gaglio, Eric Beal and Elizabeth Timkovich.

In particular, AV&H advises clients on patent issues relating to the development and marketing of new and generic drug products.  The firm’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 and determines whether such formulations would infringe valid patents or whether there are design-arounds that would overcome the patent risk.  AV&H also prepares opinions of counsel relating to the infringement and validity of patents.

AV&H handles all aspects of any ensuing patent and other litigation.  Utilizing the firm’s significant experience with many types of complex litigation, AV&H aggressively defends clients against any infringement lawsuits initiated by the patent holders.  The firm’s knowledge of the Hatch-Waxman regulatory regime also enables AV&H to handle any exclusivity or automatic stay issues associated with such litigation.

AV&H is very active in litigation and counseling involving the Hatch-Waxman Amendments, including numerous issues regarding the generic exclusivity period.  The firm has an intimate knowledge of the statutory and regulatory provisions relating to the generic drug approval process, including the significant changes made by the 2003 Medicare Prescription Drug Improvement and Modernization Act.  AV&H assists pharmaceutical clients in navigating the Hatch-Waxman regulatory regime and developing the most efficient strategy for launching a new or generic drug product.  For example, the firm assists clients in devising the most appropriate strategy for obtaining the generic exclusivity period, for overcoming the brand’s patent or regulatory exclusivity and for defeating the generic exclusivity period awarded by FDA to a competitor.

AV&H is also especially active in matters involving the intersection of the antitrust and patent laws in the pharmaceutical industry, drawing upon the firm’s extensive counseling experience and litigation skills in both fields.  AV&H actively counsels clients regarding antitrust issues arising from the settlement of patent and Hatch-Waxman exclusivity disputes, the licensing of critical technology and the formulation of joint development relationships.  In addition to providing advice regarding such issues, AV&H has also represented clients during FTC investigations involving such agreements.