David Silverstein is a registered patent attorney with nearly twenty years of experience handling legal and regulatory matters, on the generic and the branded side, relating to pharmaceutical and biotech products. David has served as lead counsel in matters before the U.S. district courts, Patent Trial and Appeal Board, and U.S. Court of Appeals for the Federal Circuit. In addition, David’s practice includes performing due diligence, license negotiation, and counseling in connection with complex commercial transactions involving pharmaceutical and biotech products. David is frequently involved in FDA strategy and counseling, including filing or responding to citizen petitions, and coordinating FDA strategy with patent litigation strategy.
David previously practiced in-house at Par Pharmaceutical and, prior to that, at major New York firms. While in-house, David oversaw and managed all aspects of patent, antitrust, unfair competition and trade secret litigation. David also served as Par’s in-house regulatory counsel, advising on regulatory strategies and frequently representing Par before FDA’s Office of Chief Counsel and other regulators.
Together with his graduate training in protein crystallography and structure-based drug design, David combines his courtroom and industry experience to develop strategies that enable his clients to achieve their technical, legal, and commercial objectives simultaneously.
Experience
Representative matters:
- AstraZeneca Pharm., LP v. Sylvia Burwell, 16-cv-01336-RDM (D.D.C.). Represented intervenors Apotex and Par to successfully oppose AstraZeneca’s motion for a temporary restraining order allowing generic versions of blockbuster Crestor® to immediately enter the market.
- Insys Therapeutics, Inc. v. Par Pharm., Inc., 17-cv-01078-LPS (D. Del.). Represented generic drug manufacturer, Par, in Hatch-Waxman litigation involving multiple patents directed to FDA-approved cannabinoid (Syndros®). Secured dismissal of case based on non-infringement position resulting in Par having the ability to launch upon approval of its ANDA product.
- Noden Pharma DAC v. Anchen Pharm., Inc., 17-cv-00728-MPT (D. Del.). Represented generic drug manufacturer, Anchen, in Hatch-Waxman litigation involving multiple patents directed to aliskiren (Tekturna®). Litigation defenses helped Anchen secure, during early discovery, a favorable license to manufacture and commercialize its ANDA product.
- Par Pharm., Inc. v. Horizon Therapeutics, LLC, IPR2015-01127 (P.T.A.B.). Represented Petitioner in review of U.S. Patent No. 8,404,215 directed to nitrogen scavenging drug (Ravicti®) resulting in invalidity of all challenged claims.
- Horizon Therapeutics v. Par Pharm., Inc., 14-cv-384 (E.D. Tex.); Horizon Therapeutics v. Par Pharm., Inc., 18-cv-01224-RGA (D. Del.); Horizon Therapeutics v. Par Pharm., Inc., 17-cv-05901-KM (D.N.J.); Horizon Therapeutics v. Par Pharm., Inc., 16-cv-03910 (D.N.J.); Par Pharm., Inc. v. Horizon Therapeutics, LLC, IPR2018-01550 (P.T.A.B.); Par Pharm., Inc. v. Horizon Therapeutics, LLC, IPR2017-01768 (P.T.A.B.); Par Pharm., Inc. v. Horizon Therapeutics, LLC, IPR2017-01767 (P.T.A.B.); and Par Pharm., Inc. v. Horizon Therapeutics, LLC, IPR2017-01769 (P.T.A.B.). Represented generic drug manufacturer, Par, as the defendant in multiple, simultaneous Hatch-Waxman litigations and as the petitioner in multiple inter partes reviews involving patents directed to nitrogen scavenging drug (Ravicti®). Secured favorable settlement for Par and dismissal of each litigation and IPR.
- Omeros Corp. v. Par Sterile Products, LLC, 15-cv-773-RGA (D. Del). Represented generic drug manufacturer, Par, in Hatch-Waxman litigation involving multiple patents directed to ketorolac tromethamine/phenylephrine HCl (Omidria®). Secured favorable settlement for Par after three-day bench trial.
- Alcon Pharms. Ltd. et al. v. Par Pharm. Inc., 15-cv-7240 (D.N.J.). Represented generic drug manufacturer, Par, in Hatch-Waxman litigation involving multiple patents directed to ciprofloxacin/dexamethasone (Ciprodex®). Secured dismissal of case based on non-infringement position resulting in favorable settlement for Par.
Honors
- World's Leading Patent Professionals (2020-2021), IAM Patent 1000
News
- Axinn and IP Partners Ranked by IAM Patent 1000: The World’s Leading Patent Professionals
- Axinn and IP Partners Ranked by IAM Patent 1000: The World’s Leading Patent Professionals
- Axinn Secures IPR Victory for Par in Challenge to Horizon’s Ravicti Patent
- Axinn Defeats TRO, Enabling Immediate Launch of Generic Versions of AstraZeneca’s Blockbuster Crestor
- Axinn Expands IP and Regulatory Practice with Partners David Silverstein and Aziz Burgy
- View More ›
Thought Leadership
- Pharmacy Times Interviews, Pharmacy Times, May 26, 2021
- U.S. Backs COVID IP Waiver - Industry Reacts, World Intellectual Property Review, May 7, 2021
- U.S. Support for Patent Waiver Unlikely to Cost Covid-19 Vaccine Makers in Short Term, The Wall Street Journal, May 7, 2021
- President Biden Urged to Waive Vaccine IP Rules, Intellectual Property Magazine, April 20, 2021
- Exploring the COVID-19 Vaccine IP Waiver Proposal at the WTO, Pharmaceutical Technology, March 15, 2021
- Axinn IP Update: Where is the Federal Circuit Heading in the Skinny Labeling Case?, Axinn Update, March 4, 2021
- A Look at What’s Ahead in the Rapidly Growing Cell Therapy Landscape, Pharmacy Times, February 25, 2021
- Axinn IP Update: Federal Circuit Agrees to Reconsider Controversial “Skinny Label” Decision, Axinn Update, February 10, 2021
- Moderna Won't Enforce COVID-19 Patents During Pandemic, Law360, October 8, 2020
- Surveying the Landscape, Intellectual Property Magazine, September 29, 2020
- Pfizer Appears Slightly Ahead of Moderna in COVID-19 Vaccine Race, Pink Sheet, September 17, 2020
- Regulating Advanced Therapies: Q&A with Patent Lawyer David Silverstein, Pharmaceutical Technology, August 26, 2020
- Opioid Epidemic Taking a Toll on Drug Development and Patients, BioWorld, February 19, 2020
- IPR Proceedings Survive Constitutional Challenge in 7-2 Supreme Court Ruling, BioWorld, April 24, 2018
- Scope of Patent Review, Deference At Issue, Westlaw Journal Intellectual Property, December 5, 2017
Events
- ACI 12th Annual Summit on Biosimilars & Innovator Biologics
- ACI Paragraph IV Disputes Virtual Conference
- ACI 13th Annual Paragraph IV Disputes Conference
- ACI 12th Annual Paragraph IV Disputes Conference
- ACI 8th Annual Paragraph IV Disputes Conference
- ACI 6th Annual Paragraph IV Disputes Conference
- IQPC 6th Annual Summit on E-Discovery for Pharma, Biotech, and Medical Device Industries
- ACI 5th Annual Paragraph IV Disputes Conference
Education
- JD – Duke University (2003)
- MS, Chemistry – Cornell University (1999)
- BS, Chemistry, magna cum laude – University of Georgia (1997)
Admissions
- New York
- New Jersey
- US Court of Appeals for the Federal Circuit
- US District Court Northern District of New York
- US District Court Southern District of New York
- US District Court Western District of New York
- US District Court District of New Jersey
- US Patent and Trademark Office