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Hatch Waxman: Generic & Proprietary

An Abbreviated New Drug Application (ANDA) contains data which when submitted to the Food and Drug Administration (FDA), provides for the review and ultimate approval of a generic drug product.  Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.

We counsel clients in matters arising at the interface between patent law and the FDA approval process. Our practice includes:

  • Patent Validity & Infringement Analyses
  • Exclusivity Strategies
  • Preparation of Patent Certifications for ANDA's & 505(b)(2) Applications
  • ANDA & 505(b)(2)-related Litigation
  • Prepare & file Patent Term Extension Applications
  • Orange Book Listing Strategies
  • Appeals before the Court of Appeals for the Federal Circuit

(3) Sterne Kessler Welcomes Litigators John Christopher Rozendaal & Michael Joffre to the Firm

Sterne Kessler Welcomes Litigators John Christopher Rozendaal & Michael Joffre to the Firm
A Case Study:

Sterne Kessler Welcomes Litigators John Christopher Rozendaal & Michael Joffre to the Firm

Sterne Kessler is pleased to announce that John Christopher (J.C.) Rozendaal and Michael Joffre have joined the firm as directors.

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