Sharon K. Gagliardi

sharon-gagliardi

Sharon K. Gagliardi

Associate

Philadelphia | Cira Centre, 2929 Arch Street, Philadelphia, PA 19104-2808
+1 215 994 2278 | +1 215 994 2222

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Sharon K. Gagliardi represents clients in intellectual property and complex commercial litigation, primarily involving patent and trade secret claims. Her practice spans a wide spectrum of technology areas, with a particular focus on life sciences.

Ms. Gagliardi has managed a significant number of patent litigations in federal courts throughout the United States for various multinational companies, including Endo Pharmaceuticals, GlaxoSmithKline, Pfizer, Baxter, Hitachi, PepsiCo, and others. She has extensive experience litigating Hatch-Waxman Act ANDA infringement actions on behalf of branded pharmaceutical companies, and has handled all phases of litigation including drafting complaints and answers, preparing infringement contentions, managing electronic discovery, Markman briefing and hearings, working with infringement and validity experts, drafting motions and declarations, taking and defending fact and expert depositions, supervising pretrial filings, and managing trial teams. Moreover, in 2014, Ms. Gagliardi was honored with Dechert’s Exceptional Teacher Award for her commitment to training and developing associates.

In addition to her extensive patent litigation practice, Ms. Gagliardi also has substantial experience in the areas of trade secrets, trademarks, copyrights, cyberlaw, non-competition agreements, and the intersection of antitrust law and patent law. Ms. Gagliardi also has substantial experience representing companies and individuals involved in criminal and other government investigations and related civil litigation, including investigations and litigation under the False Claims Act, the Federal Food, Drug and Cosmetic Act, and the Anti-Kickback Statute.

Ms. Gagliardi maintains an active pro bono practice, defending the rights of victims whose civil liberties have been violated and assisting individuals in immigration and family law matters. In 2007, Philadelphia Volunteers for the Indigent Program (VIP) honored Ms. Gagliardi as Philadelphia VIP’s November Volunteer of the Month. Additionally, the National Center for Missing & Exploited Children presented Ms. Gagliardi an Award of Merit for her work in successfully returning a child to his father in a case brought pursuant to the Hague Convention on the Civil Aspects of International Child Abduction.

Ms. Gagliardi has served as a member of the Philadelphia Intellectual Property Law Association and the American Chemical Society. She served as a Steering Committee Member for the Wake Forest Friends of Chemistry from 2010-2013. During law school, Ms. Gagliardi interned for the Honorable Stephen M. Orlofsky of the United States District Court for the District of New Jersey. Prior to attending law school, Ms. Gagliardi completed a National Science Foundation research fellowship at the University of Pennsylvania in Materials Science.

Significant Representations

  • Endo Pharmaceuticals Inc. vs. Teva Pharmaceuticals USA, Inc., et al. (U.S. Dist. Ct. Del.). Trial counsel representing Endo in a Hatch-Waxman patent infringement case regarding Endo’s Opana® ER controlled-release oxymorphone product against seven generic pharmaceutical manufacturers. Case ongoing.
  • Endo Pharmaceuticals v. Teva, et al. (U.S. District Court, Southern District of New York). Trial counsel for Endo Pharmaceuticals in Hatch-Waxman Act case filed against a dozen ANDA filers involving Endo's OPANA ER® product. Following a five-week trial, the court ruled in Endo's favor, finding its patents valid and infringed. Currently representing Endo on appeal.
  • Endo Pharmaceuticals Inc., et al. v. Watson Laboratories, Inc., Mylan, Noven and TWi (D. Del.). Trial counsel for Endo Pharmaceuticals Inc. and Teikoku Seiyaku Co. Ltd. in ANDA litigation against Paragraph IV filers, involving the Lidoderm® patch. Following a six-day bench trial against Watson, the first-filer, that case was settled. Other related cases settled before trial.
  • Endo Pharmaceuticals v. Impax, Actavis, Barr, Sandoz, Watson and Roxane (U.S. District Court, District of New Jersey). Represented Endo Pharmaceuticals Inc. in Hatch-Waxman Act ANDA cases filed against six generic companies involving Endo’s branded oxymorphone extended release tablet (OPANA ER®), two of which went to trial. Case settled during trial.
  • Stiefel Laboratories v. Perrigo (D. Del.) Represented GlaxoSmithKline entities in an ANDA case relating to ROGAINE® Foam. Case settled. 
  • In re Paxil Antitrust Litigation; BCBS of Minnesota v. GlaxoSmithKline. Represented a Fortune 100 research-based pharmaceutical company in these companion monopolization and attempted monopolization class action and opt out cases based on allegations of sham patent litigation and unlawful intellectual property strategies. All of the cases were settled. 
  • Pfizer, Inc. Represented Pfizer, a pharmaceutical company, in patent matters relating to Pfizer’s animal health business, one of the largest in the world.
  • U.S. ex rel. Piacentile v. SmithKline Beecham Corporation d/b/a GlaxoSmithKline. Ms. Gagliardi represented SmithKline Beecham Corporation d/b/a GlaxoSmithKline in this FCA case, where after GSK filed its motion to dismiss, the plaintiff voluntarily agreed to dismiss his complaint with prejudice.  
  • Confidential Client. Ms. Gagliardi represented a pharmaceutical manufacturer in a government investigation of its sales and marketing practices, including issues relating to off-label promotion and alleged violations of the Anti-Kickback Statute. 
  • Confidential Client. Ms. Gagliardi represented a number of individuals in connection with a government investigation of off-label marketing practices by a pharmaceutical manufacturer.
Education
  • Wake Forest University, B.S., Chemistry, 1998, summa cum laude, Phi Beta Kappa
  • Rutgers School of Law - Camden, J.D., 2004, Highest Honors (top 3 students), Westlaw Award for Academic Excellence, Hunter Moot Court Top Ten Brief
    Dean's Merit Scholarship
Admissions
  • Pennsylvania
  • New Jersey
  • Supreme Court of the United States
  • United States District Court for the District of New Jersey
  • United States Court of Appeals for the Federal Circuit
  • United States District Court for the Eastern District of Pennsylvania
Memberships
Philadelphia Intellectual Property Law Association