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Michael J. Freno

Partner
+1.206.370.7947
Fax +1.206.623.7022

Michael Freno is a partner in the firm’s Seattle office. He counsels clients on intellectual property matters and specializes in intellectual property litigation and opinions relating to validity and infringement. 

Based on 15 years of litigation experience, Mr. Freno advises pharmaceutical companies on federal Hatch-Waxman litigations and Patent Office proceedings, including Inter Partes Review and Post-Grant Review. His litigations have involved all kinds of small molecule pharmaceuticals, dosage forms, and methods of use, including anti-HIV agents, beta-blockers, atypical anti-psychotics, chemotherapeutic agents, oral contraceptives, antidepressants, calcium-channel blockers, nitrogen scavenging drugs, hypothyroidism treatments, ADHD and ADD drugs.  

Mr. Freno also counsels clients on all aspects of the regulatory and litigation strategy for successfully launching pharmaceutical products. Starting with product selection, Mr. Freno advises clients on design-around opportunities, performs patent landscape analyses, provides non-infringement and invalidity opinions, and counsels clients on FDA regulatory hurdles.

In addition to his pharmaceutical practice, Mr. Freno has successfully litigated IP cases across the United States, including patent cases of various technologies, including biologics (antibodies against the DR5 death receptor), polymers (fluoroelastomers), mechanical products (fiberglass reinforced doors) and electrical engineering technology (organic light emitting diodes and LCDs). Mr. Freno also has extensive experience in unfair competition, false advertising, and trademark infringement.

Professional Background

Prior to joining K&L Gates, Mr. Freno was partner at another Seattle law firm, and before that, he worked in New York for 11 years, specializing in complex patent litigation matters.

Before law school, Mr. Freno taught logic as a graduate student at both The Ohio State University and the University of Wisconsin-Milwaukee. He also developed methods to test the stability of novel drug formulations for two years as an analytical chemist at G.D. Searle in the1990s.

Professional/Civic Activities

  • American Intellectual Property Law Association
  • Washington Biotechnology & Biomedical Association
  • Lead counsel for Par Pharmaceutical, Inc. as an intervenor in an action against FDA by a brand pharmaceutical requesting a reversal of FDA’s decision to approve Par’s dexmedetimodine hydrochloride product.
  • Lead counsel for Par in a patent infringement case against Par’s zoledronic acid product.
  • Lead counsel for Par in a Hatch-Waxman case involving Par’s levothyroxine product.
  • Lead counsel for Par in a Hatch-Waxman case involving Par’s methylphenidate hydrochloride product. 
  • Lead counsel for Par in a Hatch-Waxman case involving Par’s calcium acetate oral solution product.
  • Lead counsel for Par in a Hatch-Waxman case involving Par’s saxagliptin product.
  • Lead counsel for Par in a Hatch-Waxman case involving Par’s glycerol phenylbutyrate product.
  • Lead counsel for Par in a Hatch-Waxman case involving Par’s memantine hydrochloride and donepezil hydrochloride product.
  • Lead counsel for Par in a Hatch-Waxman case involving Par’s posaconazole product.
  • Lead counsel for Par in a false advertising case involving Par’s epinephrine product.
  • Lead counsel for Par in a false advertising case involving Par’s vasopressin product.
  • Counsel for Teva in Hatch-Waxman case involving emtricitabine, tenofovir disoproxil fumarate, and efavirenz.
  • Counsel for Teva in Hatch-Waxman case involving gemcitabine. 
  • Counsel for Teva in Hatch-Waxman case involving aripiprazole.
  • Counsel for Watson in Hatch-Waxman case involving ethinyl estradiol, norethindrone, and ferrous fumarate.
  • Counsel for KV Pharmaceutical in Hatch-Waxman case involving metoprolol succinate.
Publications and Lectures
  • American Conference Institute's 8th Annual Paragraph IV Disputes, The Gauntlet Rethrown: The Paragraph IV Certification and Notice Letter, New York, New York, April 28, 2014.
  • Freno, Michael J., Valuing Trademarks, Business Valuation, Wolters Kluwer, vol. 14, Issue No. 2 (April 2013).
  • Kaplan, Dana & Michael J. Freno, The Intricacies Involved in Choosing a Pharmaceutical Trademark, IP Value 2008, 72–75 (2008).
  • Freno, Michael J., Trademark Valuation: Preserving Brand Equity, 97 The Trademark Reporter 5, 1055–72 (Sep.-Oct. 2007).
  • Nicholson, Joseph & Michael J. Freno, Trademarks for Color Wear Many Shades, New York Law Journal (Jul. 29, 2002).
  • Nicholson, Joseph & Michael Freno, Database Legislation: Why It Needs a Compulsory License, The Licensing Journal, 13–15 (Feb. 2001).
  • Nicholson, Joseph & Michael Freno, Trademarking Single Colors in Europe, 8 The Intellectual Property Strategist 12 (Sep. 2002).
  • Nicholson, Joseph & Michael Freno, Protecting the Content of Databases, IP Litigator, 8–10 (Jan. 2001).
  • Freno, Michael, Database Protection: Resolving the U.S. Database Dilemma with an Eye Toward International Protection, 34 Cornell Int’l L.J. 165 (2001).