FDA Practice Group

AV&H’s FDA Practice Group provides counseling and litigation services relating to the approval, development and marketing of new and generic drug products.  The firm actively represents clients before the Food and Drug Administration – both informally and formally through the Citizen Petition process and in litigation.  By coupling the firm’s knowledge of the regulatory landscape with the firm’s in-house scientific capability and patent litigation expertise, the firm offers a comprehensive team to enable companies to bring drug products to market in the most efficient, competitive and profitable manner.

The firm’s FDA Practice Group specializes in navigating the intricacies of the Hatch-Waxman Act.  Areas of particular focus include:

• ANDA requirements
• Patent listing and certification issues
• Paragraph IV certifications and notice letters
• 180-day generic marketing exclusivity
• Forfeiture of the exclusivity period under the 2003 Medicare Modernization Act
• 30-month stays
• Bioequivalence
• Pediatric exclusivity
• New Chemical Entity and New Dosage Form exclusivity
• Patent term extensions
• Labeling carve-outs and requirements

In addition to its activities representing clients before FDA, AV&H also litigates cases involving food and drug law.  For example, AV&H successfully obtained a temporary restraining order from the U.S. District Court for the District of Columbia against the FDA’s award of generic marketing exclusivity in connection with Purepac Pharmaceutical Company’s development of an extended-release metformin product.  Purepac successfully negotiated a settlement of the case shortly thereafter.  Representative examples of other litigation involving FDA issues include: Mylan Laboratories, Inc. v. FDA, No. 07-579 (D. D.C.) (representing third-party intervenor) and Ranbaxy Labs, Ltd. v. FDA, No. 04-0869 (D.D.C.) (representing third-party intervenor).

Attorneys in AV&H’s FDA Law Group are on the cutting edge of developments in the pharmaceutical industry.  These attorneys frequently speak and write about issues relating to the Hatch-Waxman Act and pharmaceutical patent litigation.  The Chair of the FDA Practice Group, Chad Landmon, also serves on the Editorial Advisory Board of Generic Line, a publication of FDAnews.