Matthew L. Fedowitz
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Matthew L. Fedowitz

Shareholder

Alexandria, VA
 
 
 

How Matthew Helps Clients

Matthew is a pharmaceutical industry lawyer who focuses his practice on achieving the business goals of clients. This includes patent portfolio development and strategic patent prosecution; counseling with regard to FDA regulatory issues and their intersection with intellectual property; litigation in federal district court; and inter partes proceedings before the Patent Trial and Appeal Board.

Matthew has a particular expertise in the pharmaceutical, life science and medical device fields. He draws on this experience to assist clients in the identification of products as business development opportunities and to obtain and maneuver through intellectual property hurdles by coordinating due diligence, preparing patent validity, freedom-to-operate and non-infringement opinions, and resolving disputes in Federal District Court and before the U.S. Patent and Trademark Office.

Prior to entering private practice at prominent Washington, D.C. firms, Matthew worked at the United States Patent and Trademark Office where he was responsible for patent applications relating heterocyclic organic chemistry in the pharmaceutical and carbohydrate fields. Prior to this, he worked at the U.S. FDA’s Office of Generic Drugs in the Center for Drug Evaluation and Research.

Matthew was selected for inclusion in the IAM Patent 1000 – The World’s Leading Patent Practitioners, 2014-2018; Virginia Rising Stars, 2014-2015; and Washington, D.C. Rising Stars, 2014-2015.

What Clients Can Expect

Matthew brings his legal insight and business instincts to bear for clients. He looks at issues from all perspectives to achieve the most effective and desired outcome for his clients. This is particularly important in today’s competitive business environment where legal strategy must fit within the business goals of a client.

Outside the Office

In his spare time, Matthew is an avid road cyclist and outdoors enthusiast.

Proof Points

  • Represents and advises pharmaceutical manufacturers on strategies regarding REMS (Risk Evaluation and Mitigation Strategies) designated products
  • Represents clients involved in inter partes disputes before the United States Patent and Trademark Office’s Patent Trial and Appeal Board
  • Regularly represents pharmaceutical clients in the review, identification and analysis of patents for potential products
  • Frequently prepares opinions and countless product clearance evaluations as well as representing investors in patent diligence matters for chemical, medical device, life science and pharmaceutical companies

Representative Experience

  • H. Lundbeck A/S et al. v. MSN Laboratories Private Limited et al. Civil Action No.: 1-18-cv-00114 (District of Delaware)
  • Forest Laboratories, LLC f/k/a Forest Laboratories, Inc. et al v. MSN Laboratories Private Limited et al. Civil Action No.: 2-17-cv-10140 (District of New Jersey)
  • Merck Sharp & Dohme Corp. v. MSN Laboratories Private Limited et al. Civil Action No.: 3-18-cv-00675 (District of New Jersey)
  • Bayer Intellectual Property GMBH, et al vs Breckenridge Pharmaceutical, Inc. et al. Civil Action No.: 1:15-cv-00902-SLR (District of Delaware)
  • OSI Pharmaceuticals, LLC et al. vs Breckenridge Pharmaceutical, Inc. and Natco Pharma Ltd. Civil Action No.: 1:15-cv-00772-SLR-SRF (District of Delaware)
  • Ferring B.V., et al. vs Actavis, Inc., et al. Civil Action No.: 2:15-cv-04222-KSH-CLW (District of New Jersey)
  • Otsuka Pharmaceutical Co., Ltd vs Actavis, Inc. Civil Action No.: 1:14-cv-07106 (District of New Jersey)
  • Novartis Pharmaceuticals Corporation and Novartis AG vs Breckenridge Pharmaceutical, Inc. Civil Action No.: 1:14-cv-01043 (District of Delaware)
  • Sanofi and Sanofi-Aventis U.S. LLC v. Alembic Pharmaceuticals Limited, Civil Action No.: 14-424 (District of Delaware)
  • Hospira, Inc. and Orion Corporation vs Intas Pharmaceuticals Ltd. and Accord Healthcare, Inc. USA, Civil Action No.: 1:14-cv-336 (Middle District of North Carolina)
  • Acorda Therapeutics, Inc., et al. v. Accord Healthcare, Inc., et al. Civil Action No.: 1:14-cv-00932-LPS (District of Delaware)
  • G.D. Searle LLC and Pfizer Asia Pacific Pte. Ltd. v. Watson Laboratories, Inc., et al. Case No. 2:13-cv-121 (Eastern District of Virginia)
  • Horizon Pharma AG and Jagotec AG v. Watson Laboratories, Inc., Florida. Case No. 1:13-cv-05124 (District of New Jersey)
  • Gilead Sciences, Inc. et al. v. Cipla Limited. Case No. 1:12-CV-06350 (Southern District of New York)
  • Gilead Sciences, Inc. et al. v. Cipla Limited. Case No. 1:12-CV-06351 (Southern District of New York)
  • Pfizer et al. v. Breckenridge Pharmaceutical, Inc., Alembic Ltd., et al. Case No. 1:12-CV-00810 (District of Delaware)
  • Ferring B.V. v. Watson Laboratories, Inc., Florida. Case No. 3:11-CV-00481 (District of Nevada)
  • Warner Chilcott Company and Warner Chilcott (US), LLC v. Watson Laboratories, Inc., Florida. Case No. 11-5989 (District of New Jersey)
  • Reckitt Benckiser, Inc. v. Watson Laboratories, Inc., Florida, Case No. 09-60609 (Southern District of Florida)
  • In re Brimonidine Patent Litigation, Civil Action No. 07-MD-01866 (District of Delaware)
  • Certain Sucralose, Sweeteners Containing Sucralose, and Related Intermediate Compounds Thereof, Inv. No. 337-TA-604 - Represented six different respondents, including two manufacturers in China, in a case brought by Tate & Lyle alleging infringement of process patents relating to the production of sucralose and certain intermediate compounds. In September 2008, the ALJ issued an initial determination finding no violation by our clients based on non-infringement and other grounds. On April 4, 2009, after a full review of the decision, the commission upheld the ALJ's findings that there was no violation of Section 337, resulting in a complete victory for our clients.
  • Yu et al (Human Genome Sciences, Inc.) v. Browning et al (Biogen Idec) Browning v. Yu, Interference No. 105,485 - Represented Human Genome Sciences in an interference proceeding relating to LymphoStat-B, a human monoclonal antibody that inhibits the biological activity of B-lymphocyte stimulator (BLyS), before the U.S. Patent and Trademark Office Board of Patent Appeals and Interferences
  • Enzo Therapeutics, Inc. v. Yeda Research & Dev. Co., (Eastern District of Virginia) 467 F. Supp.2d 579, 477 F. Supp.2d 699 - Represented Yeda Research and Development Co. in a 146 Action involving interferon-β2
  • DeLucas (Fluidigm Corp.) v. Santarsiero (Takeda San Diego), Interference No. 105,403 - Represented Fluidigm Corp. in an interference where the Board of Patent Appeals and Interferences invalidated more than 400 claims from Takeda San Diego's patents