Pharmaceutical Product Development

  • Provides regulatory counseling regarding: pre-clinical and clinical development strategies; bioequivalence and therapeutic equivalence standards; Abbreviated New Drug Application (ANDA) and 505(b)(2) New Drug Application (NDA) strategies; product classification and regulatory approval pathways; strategic use of FDA meeting opportunities; dispute resolution; labeling negotiations; and appeals of adverse FDA review decisions

Drug Marketing and Promotion

  • Served as outside counsel on the promotional review committees of several prominent pharmaceutical companies
  • Regularly advises clients on compliance with laws governing drug promotion and marketing practices, including rules enforced by the FDA, the FTC, the Securities & Exchange Commission (SEC) and the Health and Human Services' Office of Inspector General (HHS/OIG)
  • Counsels and trains pharmaceutical companies on all manifestations of pharmaceutical marketing and education, including: professional detail aids; managed care marketing; DTC advertising; pharmacy and patient support programs; press releases and other corporate disclosures; medical conference sponsorship; financial relationships with health care practitioners; and the permissible boundaries of the dissemination of "off-label" information for prescription drugs
  • Represents companies in response to government investigations of alleged off-label marketing and civil and criminal prosecutions under the False Claims Act, the Stark anti-kickback law, and the Food, Drug and Cosmetic Act

Hatch-Waxman

  • Handles matters arising under the Hatch-Waxman Amendments, providing strategic advice regarding: regulatory exclusivities; patent listings; patent challenges; patent term extensions; 180-day generic exclusivity; and lifecycle management strategies
  • Has served as lead counsel in numerous administrative petition proceedings and judicial challenges arising under Hatch-Waxman

International Trade

  • Advised pharmaceutical companies on negotiation and implementation of international trade agreements
  • Advises companies on the laws governing the importation and exportation of pharmaceuticals and food products

Intellectual Property

  • Counsels clients on issues such as Orange Book patent listing requirements and limitations and the role of IP rights in delineating the scope and timing of generic entry
  • Assists innovator companies to develop and enforce IP rights via the regulatory process, including by the use of Citizen Petitions, interactions with the FDA's Center for Drug Evaluation and Research (CDER), the Office of Regulatory Affairs, the Office of Generic Drugs and the Office of the Chief Counsel. Antitrust
  • Counsels clients in advance of potential pharmaceutical patent settlements and in litigation and investigations involving consummated settlements

Corporate

  • Provides regulatory counseling and advice in connection with corporate and commercial transactions, all stages of venture financing, and public offerings
  • Provides strategic counseling on deal terms (regulatory-based milestones, regulatory responsibilities in joint ventures, defining the scope of licensed rights based on regulatory classifications/fields of use), as well as regulatory due diligence

Securities Law

  • Advises FDA-regulated entities on the regulatory and securities law ramifications of corporate disclosures

Reported Cases

  • Merck KGaA v. Integra LifeSciences, 545 US 193 (2005) (FDA counsel to Merck in favorable 9-0 Supreme Court of the United States decision interpreting the drug development-patent infringement safe harbor provisions of the Hatch-Waxman amendments)
  • Granholm v. Heald, 544 US 460 (2005) (counsel to amicus curiae WineAmerica in support of successful constitutional challenge to state wine shipment restrictions)
  • Teva Pharmaceuticals v. FDA, 182 F.3d 1003 (D.C. Cir. 1999) (as appellant); on further appeal, 2000 US App. LEXIS 38667 (D.C. Cir., 2000) (argued two appeals in the DC Circuit successfully challenging FDA's refusal to approve client's generic drug application)