Paul A. Ainsworth

Overview

Paul A. Ainsworth, a director in Sterne Kessler’s Trial & Appellate Practice Group, is a first-chair trial attorney with a practice focused on patent and trade secret disputes in federal district courts, at the U.S. International Trade Commission (ITC), and before the U.S. Court of Appeals for the Federal Circuit. Paul’s clients include established and emerging leaders in the pharmaceutical, biopharmaceutical, medical devices, chemical manufacturing, and consumer products industries.

Paul has been a leader in the firm’s award-winning Hatch-Waxman litigation practice nearly since its inception. For more than two decades, Paul has represented innovators and generic drug clients in patent litigation. Companies in the pharmaceutical industry understand that the intersection of intellectual property and regulatory exclusivity are critical to their success, and they hire Paul for their most important matters due to his experience and acumen in this area.

Paul is also a leader in the firm’s high-profile ITC practice. Section 337 investigations have a well-earned reputation for being fast-paced, high stakes, and unforgiving. Paul has a proven record of successfully representing complainants and respondents in investigations involving their most important product markets. He is also experienced representing and counseling companies in enforcement activities following the issuance of an exclusion order, including proceedings before the Intellectual Property Rights Branch of the U.S. Customs & Border Patrol.

Further, Paul has significant experience counseling and representing clients in trade secret matters, including under the Federal Defend Trade Secrets Act.  With uncertainty growing around the ability of U.S. patent law to protect IP portfolios, start-up and established businesses turn to Paul for planning and executing effective trade secret strategies to safeguard what is often their most valuable asset. And when clients are faced with allegations of misuse, he has a proven record of delivering results for his clients.

Paul is a contributing author of Patent Office Litigation, Second Edition, published in 2017 by Thomson Reuters Westlaw. The book provides a comprehensive exploration of patent office litigation proceedings, including how the proceedings interact with other aspects of patent procurement and enforcement, while delivering practical analysis and advice. He is also a contributing author of Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, Third Edition, published in 2022 by the American Bar Association and ANDA Litigation: Strategies and Tactics for Pharmaceutical Patent Litigators, Third Edition, published in 2019 by the American Bar Association.

Paul began his legal career as a law clerk for the Honorable Sue L. Robinson, United States District Judge, District of Delaware. In addition to his patent litigation practice, he has also represented leading civil rights organizations on state and federal civil rights issues. In 2011, the National LGBT Bar Association named Paul as one of the “Best LGBT Lawyers Under 40” in recognition of both his accomplishments as an IP litigator and his contributions to the advancement of LGBT civil rights.

When not in the courtroom, Paul is most likely to be found hiking in the Allegheny Mountains with his dog, Rugby.

Representative Matters

Hatch-Waxman and Biosimilar Matters

• Nexus Pharmaceuticals, Inc. v. Somerset Therapeutics (D.N.J.) (lead counsel for Somerset in litigation concerning ephedrine sulfate injections—Emerphed®)
• Catalyst Pharmaceuticals and SERB SA v. Hetero Pharmaceuticals; Catalyst Pharmaceuticals and SERB SA v. Lupin Ltd. (D.N.J) (counsel for Catalyst and SERB in litigation concerning amifampridine—Firdapse®)
• Catalyst Pharmaceuticals v. MSN Labs (D.N.J) (counsel for Catalyst and SERB in litigation concerning perampanel—Fycompa®)
• Catalyst Pharmaceuticals and SERB SA v. Jacobus Pharmaceuticals (D.N.J) (counsel for Catalyst and SERB in litigation concerning amifampridine—Firdapse®)
• Genentech, Inc. et al. v. Sandoz, Inc. et al (D.N.J.) (counsel for Sandoz in litigation concerning rituximab)
• Braintree Laboratories v. Lannett Co. (D. Del.) (lead counsel for Lannett Co. in litigation concerning a bowel prep kit—Suprep®.)
• Adapt Pharma Ops.  v. Teva Pharmaceuticals USA (D.N.J.) (counsel for Teva in litigation concerning a treatment for opioid overdose—Narcan®)
• Insys Therapeutics v. Teva Pharmaceuticals USA (D. Del.) (counsel for Teva in litigation concerning a pain management treatment–Subsys®)
• AstraZeneca AB et al. v. Kremers Urban Pharmaceuticals Inc., (D.N.J.) (lead counsel for Kremers Urban in litigation concerning a treatment for gastroesophageal reflux disease–Nexium®)
• Salix Pharmaceuticals, Inc. v. Novel Laboratories, Inc., (D. Del.) (counsel for Novel Laboratories in litigation concerning a treatment for ulcerative colitis—Apriso®)
• IntelGenx Corp. v. Wockhardt Bio, AG, (D.N.J.) (lead counsel for IntelGenx in litigation concerning a treatment for major depression—Forfivo®)
• Helsinn Healthcare S.A. v. Aurobindo Pharma Ltd., (D. Del.) (lead counsel for Aurobindo in litigation concerning an anti-nausea medication—Aloxi®)
• Alcon Pharmaceuticals Ltd. v. Apotex, Inc., (D. Del.) (counsel for Apotex in litigation concerning a treatment for bacterial conjunctivitis–Vigamox®)
• Galderma Laboratories Inc. et al v. Amneal Pharmaceuticals, LLC et al., (D. Del.) (counsel for Amneal in litigation concerning a treatment for rosacea–Oracea®)
• Medeva Pharma Suisse A.G. et al v. Roxane Laboratories, Inc., (D.N.J.); Medeva Pharma Suisse A.G. et al. v. Par Pharmaceuticals et al. (D.N.J.) (counsel for patentee and licensee in a multi-case litigation concerning a treatment for ulcerative colitis–Asacol®)
• Shire LLC v. Watson Laboratories, Inc., (S.D.N.Y)(S.D. Fla.) (counsel for patentee litigation concerning a treatment for attention deficit hyperactivity disorder – Adderall XR®)

ITC

• In re Certain High-Performance Gravity-Fed Water Filters and Products Containing the Same, 337-TA-1294 (lead counsel for Complainant Brita in an ITC Investigation pertaining to pour-through water filters)
• In re Certain Electronic Nicotine Delivery Systems and Components Thereof, 337-TA-1139 (counsel for Complainant Juul Labs, Inc. in an ITC Investigation pertaining to electronic nicotine delivery systems)
• In re Certain Electronic Nicotine Delivery Systems and Components Thereof, 337-TA-1141 (counsel for Complainant Juul Labs, Inc. in an ITC Investigation pertaining to electronic nicotine delivery systems)
• In re Certain Road Construction Machines and Components Thereof, ITC Investigation No. 337-TA-1088 (counsel for Respondents Wirtgen GmbH, Wirtgen America, and Joseph Vögele AG in an ITC investigation pertaining to road construction equipment)
• In re Certain Road Milling Machines and Components Thereof, ITC Investigation No. 337-TA-1067 (counsel for Complainant Wirtgen American in an ITC investigation pertaining to road construction equipment)
• In re Lithium Silicate Materials and Products Containing the Same, ITC Investigation No. 337-TA-911 (counsel for Complainant Ivoclar Vivadent AG in an ITC investigation pertaining to lithium silicate-based dental prostheses)
• In re Certain Motorized Self-Balancing Vehicles, ITC Investigation No. 337-TA-1000 (counsel for Respondent Powerboard in an ITC investigation pertaining to personal transport vehicles)
• In re Certain Overflow and Drain Assemblies for Bathtubs and Components Thereof, ITC Investigation No. 337-TA-993 (counsel for Complainant WCM Industries in an ITC investigation pertaining to screwless bathtub drain assemblies)
• In re Certain Video Game Machines and Related Three-Dimensional Pointing Devices, ITC Investigation No 337-TA-658 (counsel for respondent Nintendo in an ITC investigation concerning television interactive program guide and 3D pointing device technologies)

Trade Secrets

• Pharmazam, LLC v. Thermo Fisher Scientific, Inc. (M.D. Fla.) – Represented Thermo Fisher Scientific in an allegations relating to trade secret misappropriation. Plaintiff voluntarily dismissed complaint after Sterne Kessler filed a motion to dismiss for failure to state a claim.
• Sonatype, Inc. Takari, Inc. (D. Md.) – Filed a complaint alleging that the company’s founder misappropriated, copied, and wrongfully disclosed Sonatype’s intellectual property and trade secrets after separating from the company. Sterne Kessler achieved a favorable settlement shortly after filing the complaint.
• Confidential matter. Represented a pharmaceutical company in a trade secret dispute related to the misappropriation of trade secret information involving a former business development partner. Former development partner used confidential business information in an effort to extort a license to certain intellectual property. Conducted an internal investigation that led to evidence of misappropriation. Negotiated a favorable resolution for our client.
• Confidential matter. Represented a biotechnology client in a dispute with a former founder and chief scientific officer. Conducted an internal investigation that led to evidence of breaches of the former founder’s employment and separation agreements.  Negotiated a favorable resolution for our client.

Other

• Wirtgen America v. Caterpillar (Del.) (counsel for Wirtgen America in litigation concerning road milling machines)
• University of California v. Broad Institute (PTAB) (counsel for The Regents of the University of California, University of Vienna, and Emmanuelle Charpentier in an interference proceeding relating to CRISPR technology)
• Julbo, Inc. v. Oakley, Inc. (N.D. Cal.) (lead counsel for Oakley in litigation concerning goggles)
• The Kingsford Charcoal Co. v. Creative Spark (PTAB) (counsel for petitioner in proceeding challenging the patentability of a patent pertaining to charcoal briquets)
• KAZ USA, Inc. v. Brita LP, (PTAB) (counsel for patent owner in proceeding challenging the patentability of a patent pertaining to water filters)
• 1-800-CONTACTS, d/b/a/ glasses.com v. DITTO Technologies, Inc. (D. Utah) (lead counsel for plaintiff glasses.com in litigation relating to systems for virtual display and modeling of eyewear)
• Naraka Intellectual Property LLC v. Atlassian, Inc. (M.D. Pa.) (lead counsel for defendant in litigation relating to videoconferencing systems)
• Ivoclar AG v. Glidewell Laboratories, (D. N.J.) (counsel for Ivoclar in litigation pertaining to lithium-silicate dental prostheses)
• Intellectual Ventures v. Ericsson (Fed. Cir.) (appellate counsel for patent owner in appeal from an inter partes review relating to wireless communications systems)
• Butamax Advanced Biofuels LLC v. Gevo, Inc., (PTAB) (counsel for petitioner in proceeding challenging the patentability of certain biofuel manufacturing patents)
• Automated Tracking Solutions, LLC v. Awarepoint Corp., (E.D. Va.); Automated Tracking Solutions, LLC v. Teletracking Technologies, Inc. et al. (E.D. Va.) (counsel for patentee in multi-case litigation relating to radio frequency identification (RFID) technology)

Education

• J.D., William & Mary Law School
• B.A., Political Science, The George Washington University

Clerkships

• U.S. District Court for the District of Delaware