Paul A. Ainsworth, a director in Sterne Kessler’s Trial & Appellate Practice Group, is an experienced intellectual property 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 United States Court of Appeals for the Federal Circuit. Paul also regularly represents clients in proceedings before the Patent Trial and Appeal Board (PTAB). Paul’s clients include leading companies in the pharmaceutical, biopharmaceutical, medical devices, chemical manufacturing, and consumer products industries.

Paul is particularly well-known for his work in the firm’s award-winning Hatch-Waxman litigation practice. From pre-litigation strategy through trial, appeal, and/or settlement, he has led teams on more than twenty patent cases for both innovator and generic drug clients. Paul leverages his deep understanding of the IP, regulatory, and business dynamics unique to the pharmaceutical industry to assist his clients in achieving their business objectives.

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 skillfully and successfully represented complainants and respondents in investigations involving their most important product markets.

Paul also has significant experience representing clients, particularly pharmaceutical, biotech, and software companies, in trade secret matters. With uncertainty growing around the ability of U.S. patent law to protect IP portfolios, clients turn to Paul for planning and executing effective trade secret strategies to safeguard what is often their most valuable asset.

Paul is a contributing author of Patent Office Litigation, Second Edition, published in 2017 by Thomson Reuters Westlaw. The book provides a fresh and 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, Second Edition, published in 2018 by the American Bar Association, and ANDA Litigation: Strategies and Tactics for Pharmaceutical Patent Litigators, Third Edition, to be 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.

Hatch-Waxman and Biosimilar Matters

  • 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.) (counsel for IntelGenx in litigation concerning a treatment for major depression—Forfivo®)
  • Helsinn Healthcare S.A. v. Aurobindo Pharma Ltd., (D. Del.) (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 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)

Other

  • Julbo, Inc. v. Oakley, Inc. (N.D. Cal.) (lead counsel for Oakley in litigation concerning goggles)
  • The Kingsford Charcoal Co. v. Creative Spark, IPR No. 2016-01831 (counsel for petitioner in proceeding challenging the patentability of a patent pertaining to charcoal briquets)
  • KAZ USA, Inc. v. Brita LP, IPR2016-01893 (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., IPR 2013-00214, IPR 2013-00215 (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)

  • Best Lawyers, “The Best Lawyers in America®” (2024 – 2023)
  • World Intellectual Property Review (WIPR), “WIPR Leaders” (2023)
  • Super Lawyers, “Super Lawyer – Washington, DC” (2021 – 2017)
  • Super Lawyers, “Rising Star – Washington, DC” (2014)

  • J.D., College of William and Mary
  • B.A., Political Science, The George Washington University

  • District of Columbia
  • Maryland
  • U.S. District Court for the District of Maryland

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

Webinar

ITC Section 337 Year in Review

Virtual, February 28, 2024 2:00 PM - 3:00 PM PST

Webinar

Trade Secrets at the ITC

Virtual, November 15, 2023 1:00 PM - 2:00 PM PST

Webinar

Minimizing Your Risk of Being Sued Before the USITC

July 19, 2023 1:00 PM - 2:00 PM PST

Speaking Engagement

Mitigating Risks and Attracting Rewards – How To Capitalize and Spot Innovation

London, UK, Business Design Centre, May 4, 2023 11:10 AM - 12:00 PM PST

Speaking Engagement

2023 Focus on Pharma

Washington, DC, April 14, 2023 8:30 AM - 6:00 PM PST

Webinar

Drug Development Pathway Series: Intellectual Property Workshop

Virtual, October 28, 2020 4:00 PM - 5:00 PM PST

Webinar

Secondary Considerations: Latest Guideposts

July 30, 2020 2:00 PM - 3:00 PM PST

Speaking Engagement

International IP Skills Summit (IIPSS)

Hyderabad, India, Hyatt Place Hyderabad, February 26, 2020 12:00 AM - 11:59 PM PST

Speaking Engagement

Summit on Biosimilars

New York, NY, New York Marriott East Side Hotel, June 24, 2019 1:30 PM - 2:30 PM PST

Speaking Engagement

The Sedona Conference’s Patent Conference: Promoting Invention, Entrepreneurship, Economic Growth, and Job Creation

Washington, DC, Covington & Burling LLP, January 17, 2019

Speaking Engagement

Clinical Innovation: Fair and Effective Incentives for New Uses of Established Drugs

Washington, DC, February 8, 2018 8:30 AM - 5:30 PM PST

Global TEC Forum

October 6, 2016

Related Resources

From Paul A. Ainsworth

Webinar Recordings & Materials

February 28, 2024

ITC Section 337 Year in Review

In the News

February 28, 2024

Jury Awards Wirtgen $12.9M Against Caterpillar in Milling Machine Lawsuit

Equipment World

Firm Announcements

February 27, 2024

Sterne Kessler and Patterson IP Law Team Up to Secure $12.9M Wirtgen Win Over Caterpillar

Sterne, Kessler, Goldstein & Fox

In the News

February 27, 2024

Caterpillar Owes Deere $13 Million in Road-Milling Patent Trial

Bloomberg Law

In the News

February 26, 2024

Caterpillar to Pay Wirtgen $12.9M in Damages After Patent Battle

Construction Briefing

Bylined Articles

February 14, 2024

The Public Interest Impact – Considerations from AliveCor and Masimo

Sterne, Kessler, Goldstein & Fox Davin B. Guinn, Paul A. Ainsworth

Client Alert

February 14, 2024

IP Hot Topic: Sterne Kessler Publishes 2023 ITC Section 337 Year in Review: Analysis & Trends Report

Davin B. Guinn, Paul A. Ainsworth

Reports

February 14, 2024

2023 ITC Section 337 Year in Review: Analysis & Trends

Sterne, Kessler, Goldstein & Fox Multiple Authors

Press Release

February 14, 2024

Sterne Kessler Publishes 2023 ITC Section 337 Year in Review: Analysis & Trends Report

Sterne, Kessler, Goldstein & Fox Multiple Authors

Webinar Recordings & Materials

November 15, 2023

Trade Secrets at the ITC

Multiple Authors

Press Release

November 6, 2023

Sterne Kessler Notches Multiple Rankings in 2024 “Best Law Firms” List

Sterne, Kessler, Goldstein & Fox Multiple Authors

Podcast Recording & Transcript

September 13, 2023

Meat & Potatoes Episode 224: Paul A. Ainsworth, Sterne Kessler

Multiple Authors

Webinar Recordings & Materials

July 19, 2023

Minimizing Your Risk of Being Sued Before the USITC

Multiple Authors

Press Release

July 6, 2023

Six Sterne Kessler Directors Distinguished by World Intellectual Property Review as 2023 WIPR Leaders

Sterne, Kessler, Goldstein & Fox Multiple Authors

In the News

February 28, 2023

Brita Lands Win at ITC Against Water Filter Rivals

Law360 Multiple Authors

Bylined Articles

November 16, 2022

Trade Secrets in the United States

IAM Paul A. Ainsworth, Ryan E. Conkin

In the News

September 12, 2022

Korean Co. Can't Be First To Invent CRISPR, PTAB Told

Law360 Paul A. Ainsworth, Ryan E. Conkin

Press Release

September 9, 2022

Sterne Kessler Wins Hatch-Waxman Impact Case of the Year Award at 2022 LMG Life Sciences Americas Awards

Sterne, Kessler, Goldstein & Fox Paul A. Ainsworth, Ryan E. Conkin

Firm Announcements

August 8, 2022

Sterne Kessler Raises Over $34,000 for the Legal Aid Society of the District of Columbia

Sterne, Kessler, Goldstein & Fox Paul A. Ainsworth, Ryan E. Conkin

Firm Announcements

July 14, 2022

Sterne Kessler Client Catalyst Pharmaceuticals, Inc. Reaches Patent Litigation Settlement

Sterne, Kessler, Goldstein & Fox Paul A. Ainsworth, Ryan E. Conkin

In the News

May 6, 2022

Fed. Circ. Rejects Narcan Maker's Redo Bid In Patent Suit

Law360 Paul A. Ainsworth, Ryan E. Conkin

In the News

February 18, 2022

Litigator of the Week Runners-Up and Shout Outs

Law.com Paul A. Ainsworth, Ryan E. Conkin

In the News

February 11, 2022

Federal Circuit Tosses Naloxone Patents

Law Street Media Paul A. Ainsworth, Ryan E. Conkin

In the News

February 10, 2022

Teva Win Invalidating Narcan Patents Upheld by Federal Circuit

Bloomberg Law Paul A. Ainsworth, Ryan E. Conkin

In the News

February 10, 2022

Court Affirms Teva Win in Fight Over Generic Narcan Anti-Overdose Drug

Reuters Paul A. Ainsworth, Ryan E. Conkin

In the News

February 10, 2022

Split Fed. Circ. Won't Restore 4 Narcan Patents

Law360 Paul A. Ainsworth, Ryan E. Conkin

Firm Announcements

August 5, 2021

Sterne Kessler Raises over $25,000 for the Legal Aid Society of the District of Columbia

Paul A. Ainsworth, Ryan E. Conkin

Press Release

July 26, 2021

Sterne, Kessler, Goldstein & Fox Earns 13 Market-Leading Awards for Excellence in the First Six Months of 2021

Sterne, Kessler, Goldstein & Fox Paul A. Ainsworth, Ryan E. Conkin

Press Release

April 27, 2021

Super Lawyers Recognizes 17 Sterne, Kessler, Goldstein & Fox Attorneys as 2021 “Super Lawyers” and “Rising Stars”

Sterne, Kessler, Goldstein & Fox Paul A. Ainsworth, Ryan E. Conkin

In the News

March 30, 2021

Latest Humira Dispute Highlights Biosimilar Trade Secrets Dangers

IAM Paul A. Ainsworth, Ryan E. Conkin

In the News

March 25, 2021

How 2020 ANDA Litigation Played Out – And What to Expect for 2021

Managing IP Paul A. Ainsworth, Ryan E. Conkin

In the News

March 15, 2021

Federal Circuit Backs Caterpillar Rival's Patent Win

Law360 Paul A. Ainsworth, Ryan E. Conkin

In the News

December 18, 2020

Fed. Circ. Agrees That Caterpillar ITC Patent Claim Is Invalid

Law360 Paul A. Ainsworth, Ryan E. Conkin

Press Release

October 8, 2020

Sterne Kessler Client Wins 2020 Nobel Prize in Chemistry for CRISPR-Cas9 Technology

Sterne, Kessler, Goldstein & Fox P.L.L.C. Paul A. Ainsworth, Ryan E. Conkin

In the News

June 23, 2020

Obviousness Doomed Narcan Patents After NJ Bench Trial

Law360 Paul A. Ainsworth, Ryan E. Conkin

In the News

June 5, 2020

Teva Invalidates Opiant Patents In Narcan Suit

Law360 Paul A. Ainsworth, Ryan E. Conkin

Press Release

April 30, 2020

Sterne, Kessler, Goldstein & Fox Attorneys Named 2020 Super Lawyers and Rising Stars

Sterne, Kessler, Goldstein & Fox P.L.L.C. Paul A. Ainsworth, Ryan E. Conkin

Bylined Articles

February 26, 2020

Fed. Circ. Amgen Biosimilar Ruling Raises IP Damages Risk

Law360 Paul A. Ainsworth

In the News

July 23, 2019

Caterpillar Hit With Import Ban In Latest Round Of ITC Battle

Law360 Paul A. Ainsworth

Bylined Articles

May 16, 2019

Proposed BPCIA reforms: More music, same dance

Managing Intellectual Property Paul A. Ainsworth, Lauren A. Watt

In the News

April 22, 2019

Caterpillar Can't Ax Road Milling Machine Patent At ITC

Law360 Paul A. Ainsworth, Lauren A. Watt

Press Release

April 19, 2019

Sterne, Kessler, Goldstein & Fox Attorneys Named 2019 Super Lawyers and Rising Stars

Paul A. Ainsworth, Lauren A. Watt

In the News

March 8, 2019

Senate Patent Bill To Boost Biosimilars Needs Work, Attys Say

Law360 Paul A. Ainsworth, Lauren A. Watt

In the News

December 3, 2018

Zimmer, Stryker Set to Fight Over Huge Damages Award

Bloomberg Law Paul A. Ainsworth, Lauren A. Watt

Press Release

April 23, 2018

Sterne, Kessler, Goldstein & Fox Attorneys Named 2018 Super Lawyers and Rising Stars

Paul A. Ainsworth, Lauren A. Watt

In the News

January 11, 2018

Supreme Court's Ruling in TC Heartland v. Kraft Food on Venue Seen Having Marginal but Meaningful Impact on Nuisance Suits

The Patent Investor Paul A. Ainsworth, Lauren A. Watt

Bylined Articles

August 25, 2017

Strategy Considerations for Biosimilar Applicants after Sandoz v. Amgen

Bloomberg BNA Multiple Authors

Bylined Articles

July 28, 2017

Licensing Considerations After Impression Products v. Lexmark

Bloomberg BNA Michael Q. Lee, Paul A. Ainsworth

Global Patent Prosecution

July 17, 2017

Global Patent Prosecution Newsletter - July 2017

Multiple Authors

Bylined Articles

July 17, 2017

You Can Dance If You Want To

Sterne, Kessler, Goldstein & Fox Multiple Authors

Client Alert

June 12, 2017

The Patent Dance is Optional

Multiple Authors

In the News

June 6, 2017

Appealing PTAB Loss, IV Finds Tough Crowd at Fed. Circ.

Law360 Multiple Authors

Client Alert

May 30, 2017

The Supreme Court Redefines Patent Exhaustion

Michael Q. Lee, Paul A. Ainsworth

Client Alert

May 23, 2017

Practical Issues for the Pharmaceutical and Biopharmaceutical Industry in the Wake of TC Heartland

Michael Q. Lee, Paul A. Ainsworth

In the News

May 23, 2017

High Court’s Venue Ruling Limits Where Generic Drugmakers Can Be Sued

Bloomberg BNA Michael Q. Lee, Paul A. Ainsworth

Press Release

April 11, 2017

Sterne, Kessler, Goldstein & Fox Attorneys Named 2017 Super Lawyers

Michael Q. Lee, Paul A. Ainsworth

Books and Chapters

February 17, 2017

Patent Office Litigation - Second Edition 2017

Thomson Reuters Westlaw Multiple Authors

Bylined Articles

December 16, 2016

Ten Takeaways From the FDA's December 2016 Revisions to its Hatch-Waxman Regulations

Bloomberg BNA's Patent, Trademark & Copyright Journal Paul A. Ainsworth, Chandrika Vira

Client Alert

May 13, 2016

Defend Trade Secrets Act of 2016 Client Advisory

Paul A. Ainsworth

Bylined Articles

April 14, 2016

Trade Secret Pitfalls For The Hatch-Waxman Litigant

Law360 Paul A. Ainsworth

Bylined Articles

April 8, 2016

Acorda Therapeutics v. Mylan Pharmaceuticals: A New Kind of Jurisdiction for ANDA Cases

Bloomberg BNA Pharmaceutical Law & Industry Report Paul A. Ainsworth

In the News

February 16, 2016

Fed. Circ. Backs PTAB Ax Of Gevo Jet Fuel Patent

Law360 Paul A. Ainsworth

Bylined Articles

July 27, 2015

Trade Secret Claim Strategies: ITC Vs. DTSA

Law360 Paul A. Ainsworth

Bylined Articles

March 6, 2015

The Daimler Confusion And Its Impact On ANDA Litigation

Law360 Paul A. Ainsworth

Press Release

June 1, 2014

Sterne, Kessler, Goldstein & Fox Lawyers Named 2014 Super Lawyers

Paul A. Ainsworth

In the News

April 8, 2014

Hospira Can't Get Helsinn Aloxi Suit Dismissed

Bloomberg BNA Pharmaceutical Law & Industry Report Paul A. Ainsworth

Press Release

January 14, 2014

Sterne, Kessler, Goldstein & Fox Announces Election of Four New Directors

Paul A. Ainsworth