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Paul is a shareholder at G&B, and a member of the Pharmaceutical; Biotechnology; Litigation and Trial; Client Counseling; and Patent Prosecution practice groups of Greenblum & Bernstein. His work in these groups includes preparing and supervising the preparation of infringement and validity opinions, Notice Letters, litigation, FDA citizen petitions, and patent prosecution; as well as general counseling, particularly in the pharmaceutical, chemical, and medical arts. Paul is involved extensively in the firm’s pharmaceutical practice and advises drug companies (primarily generics) on strategic planning and new product introduction.  He works extensively with Hatch-Waxman issues and the interface of patent and FDA law.  On the innovator side, Paul prepares and prosecutes patent term extension applications.  Paul also maintains an active patent prosecution docket mostly comprising pharmaceutical, polymer, and medical device technologies. Paul travels throughout the world to meet with current and prospective clients, including regular visits to India.

Notable

  • Studied (Ph.D.) under MacArthur Award recipient Dr. R. Stephen Berry (1986-1993)
  • Regularly travels throughout Europe and India
  • Broad interest in chemical, pharmaceutical, and medical device cases, with a special interest in generic pharmaceuticals and Hatch-Waxman litigation

Experience

  • Filed the nation’s first-ever request for Post-Grant Review (PGR) of a pharmaceutical patent
  • Involved in litigations over more than 25 generic products
  • Invited speaker at international conferences, including International Generic Pharmaceutical Alliance (now International Generic and Biosimilar Alliance), the European generics Association (EGA), and Pharma IPR India

Offices/Professional Activities

  • U.S. Legal Case Law editor, Journal of Generic Medicines

Professional Associations and Memberships

  • American Bar Association (member of Intellectual Property Section and Law Practice Division)
  • American Chemical Society

Representative Publications

  • “A catalyst for change? Orphan drugs and the case of Catalyst v. Becerra”, J. Generic Medicines, vol. 18(3) 194-197 (2022)
  • “A Recent History of Pharma and Biotech Patent Appeals to the U.S. Court of Appeals for the Federal Circuit”, J. Generic Medicines, 17(4), 220-224 (2021)
  • “GlaxoSmithKline v. Teva: Federal Circuit Broadens Induced Infringement to Preclude Marketing Generics for Off-Patent Indications”, J. Generic Medicines, 17(2), 97-101 (2021)
  • “Courts Address Venue for Cases brought under the Hatch-Waxman Act”, J. Generic Medicines, 17, 29-32 (2021)
  • “Biogen v. Banner Lifesciences: The Federal Circuit Narrows the Scope of PTE Patents”, J. Generic Medicines, 16(3), 129-133 (2020)
  • “2018 in Review: Some Recent Developments in US Case Law”, J. Generic Medicines, 15(1), 29-33 (2019)
  • “For PTE’s Sake! Overview and Recent Changes in the Hatch-Waxman Patent Term Extension”, J. Generic Medicines, 14(4), 180-184 (2018).
  • “What companies need to know about FDA’s Final Rule on ANDAs and 505(b)(2) applications”, J. Generic Medicines, 13(4), 214-218 (2017)

Languages

  • Spanish (conversational)