
With nearly two decades of experience, Aziz Burgy has been recognized by several organizations as a leading patent litigator (Top ANDA Litigator - Patexia Intelligence Report 2021; Top ANDA Litigator - Patexia 2020; World's Leading Patent Professional 2020-2021 - IAM Patent 1000; Life Sciences Star 2020 - LMG Life Sciences). Indeed, he was recently recognized in Patexia's ANDA Intelligence Report in the top 3% of the Best Performing ANDA Attorneys Representing Defendants over a four-year period.
He has served as lead counsel to clients in a multitude of venues including U.S. district courts, Patent Trial and Appeal Board (PTAB), U.S. Court of Appeals for the Federal Circuit (CAFC), U.S. Court of Federal Claims, and the U.S. International Trade Commission. Aziz’s practice focuses on the Hatch-Waxman Act, having litigated over seventy such cases in the last ten years. Although many of his cases have focused on pharmaceuticals, he has also represented clients in the banking, medical device, Internet security, robotics, software, and GPS technology industries and has handled other matters beyond patent disputes, including trademark and copyright cases.
Before attending law school, Aziz worked as a research associate at MedImmune, Inc., a leading biotechnology company. During his time there, Aziz worked on the development of a humanized monoclonal antibody (palivizumab) with activity against respiratory syncytial virus and a vaccine consisting of self-assembling, virus-like particles for the prevention of human papillomavirus (HPV) infection of the genital tract and associated cervical cancer. Aziz draws on his industry experience, advanced life sciences coursework, and his vast legal experience to provide him the technical and legal expertise necessary to succeed in scientifically complex matters.
Aziz is a frequent lecturer on U.S. intellectual property rights, with an emphasis on Hatch-Waxman issues. He has also taught classes on intellectual property at George Mason University. Not only is Aziz at the forefront of patent jurisprudence, he has also helped shape legislation related to patent laws. Specifically, Aziz has advised clients and Congress on various patent legislation matters dealing with the America Invents Act (AIA).
Clerkships
- Judicial Intern to the Honorable Arthur J. Gajarsa of the U.S. Court of Appeals for the Federal Circuit
Professional Activities
- Aziz is a member of the Maryland Bar Association, the District of Columbia Bar Association, PTAB Bar Association, the ITC Trial Lawyers Association, the Federal Circuit Bar Association, the American Intellectual Property Law Association, and the American Bar Association.
- UNC Department of Biology Advisory Board Member
Experience
Representative matters:
- Insys Therapeutics, Inc. v. Par Pharm., Inc., 17-cv-01078-LPS (D. Del.). Represented generic drug manufacturer, Par, in Hatch-Waxman litigation involving multiple patents directed to FDA-approved cannabinoid (Syndros®) used to treat anorexia in people with AIDS. Secured dismissal of case based on non-infringement position resulting in Par having the ability to launch upon approval of its ANDA product.
- Noden Pharma DAC v. Anchen Pharm., Inc., 17-cv-00728-MPT (D. Del.). Litigation defenses helped Anchen secure a favorable license to manufacture and commercialize generic version of Tekturna®
- Par Pharm., Inc. v. Horizon Therapeutics, LLC, IPR2015-01127 (P.T.A.B.). Represented Petitioner in review of U.S. Patent No. 8,404,215 directed to nitrogen scavenging drug (Ravicti®) resulting in invalidity of all challenged claims.
- AstraZeneca Pharm., LP v. Sylvia Burwell, 16-cv-01336-RDM (D.D.C.). Represented intervenors Apotex and Par to successfully oppose AstraZeneca’s motion for a temporary restraining order allowing generic versions of blockbuster Crestor® to immediately enter the market.
- Purdue Pharm. Prods. L.P. v. Actavis Elizabeth LLC et al., 12-cv-05311-JLL (D.N.J.) (“Intermezzo”). Represented generic drug manufacturer, Par, in Hatch-Waxman litigation involving two patents directed to the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. The district court invalidated the two patents-in-suit at trial and the Federal Circuit affirmed on appeal.
- Jazz Pharm., Inc. v. Par, Pharm., Inc., IPR2015-00548, -00551, & ‑00554 (P.T.A.B.). Served as lead IPR petition counsel orchestrating the drafting of multiple inter partes review petitions for three REMS patents directed to Jazz’s narcolepsy drug, Xyrem®, leading to invalidity of all claims on obvious grounds. The holding was later affirmed by the CAFC.
- Certain Bulk Welding Wire Containers and Components Thereof and Welding Wire, 337‑TA‑686. Represented Respondent accused of infringing six patents related to bulk weld wire containers. After trial, the case resulted in Complainant dropping five patents, invalidation of one claim, and a non-infringement ruling against all accused products. The case was affirmed on appeal to the Federal Circuit.
- Cross Medical Prods., Inc. v. Medtronic Sofamor Danek, Inc., No. 05-1415 (Fed. Cir. Mar. 20, 2007). Represented Defendant Medtronic in a patent infringement case involving six patents directed to spinal implant technology. CAFC reversed the district court’s finding that Medtronic’s modified surgical screw infringed the claimed seat means limitation under the DOE, and affirmed the district court’s grant of summary judgment of noninfringement on a claimed anchor seat.
- Tulip Computers Int’l v. Dell Computer Corp., 00-cv-00981-KAJ (D. Del.). Represented patentee against Dell Computer on a patent involving computer motherboard technology. Case settled for $49.5 million after one week jury trial.
* Includes matters handled prior to joining Axinn
Honors
- Benchmark Litigation – DC Litigation Star: Intellectual Property (2020 – 2023)
- ANDA Litigation Intelligence Report: Best Performing ANDA Attorneys Representing Defendants (2021)
- ANDA Litigation Intelligence Report: Top 100 Most Active ANDA Attorneys (2021)
- ANDA Litigation Intelligence Report: Top ANDA Litigator (2020)
- LMG Life Sciences – Life Sciences Star (2020 – 2021)
- World's Leading Patent Professionals (2020 – 2022), IAM Patent 1000
- Super Lawyers (2020 – 2023)
News
- Axinn Partners Named Life Sciences Stars by LMG Life Sciences
- Axinn Partners Named to Lawdragon 500 Leading Litigators in America
- Axinn Partners Ranked as Litigation Stars in the 2023 Edition of Benchmark Litigation
- Litigator of the Week Honors for Patent Trial Success
- Axinn Achieves Trial Success for Norwich Pharmaceuticals as it Seeks to Market a Generic of Xifaxan®
- View More ›
Thought Leadership
- Solicitor General Urges Supreme Court to Review ‘Skinny Labeling’ and Generic Drug Access, STAT+, March 30, 2023
- Skinny-Label Saga Hangs in Balance as Supreme Court Seeks Input, Generics Bulletin, October 18, 2022
- Pharmaceutical Supply Chain – Patent Considerations, American Bar Association, July 28, 2022
- Patent Cases to Watch in the Second Half of 2022, Law360, July 15, 2022
- Novel Issues Arise With Dismissal of Drugmaker, but not Insurer, From Infringement Case, Legal Dive, June 24, 2022
- PTAB Reform Bill: A 'Reasonable Fine-Tuning', World Intellectual Property Review, June 24, 2022
- Fintiv Denials are Down, but Bill Banning Them Still has Teeth, Law360, June 17, 2022
- Moderna Again Points at US Gov't in COVID-19 Patent Lawsuit, Reuters, May 24, 2022
- Riddle Me This: How Are COVID-19 Vaccines Like Smartphones?, BioWorld, May 12, 2022
- 2022 Forecast: Patent Eligibility, COVID-19, NFTs, World IP Review, January 11, 2022
- Only in Your Dreams: Patent Stakeholders Share Their IP Wishes for the New Year, IPWatchdog, January 1, 2022
- Vermont Senator Patrick Leahy to Retire, Intellectual Property Magazine, November 18, 2021
- From Fintiv to Arthrex, New USPTO Chief Will Have Full Plate, Law360, November 1, 2021
- Industry Reacts to Kathi Vidal Nomination, IPWatchdog, October 27, 2021
- Happy 10th Birthday, Intellectual Property Magazine, September 27, 2021
- Celebrating (?) the America Invents Act: Ten Years On, Many IP Stakeholders Say it’s Time for a Second Look, IPWatchdog, September 16, 2021
- GSK Redo Doesn't Cure Generics' "Skinny Label" Uncertainty, Law360, August 9, 2021
- U.S. Advances Four Bills Targeting Patent System Abuses, Intellectual Property Magazine, August 3, 2021
- USPTO’s Arthrex Guidance Offers Window into Agency’s Thinking, World IP Review, July 26, 2021
- SCOTUS Decides Arthrex: Much Ado About Inter Partes Reviews, Bloomberg Law, July 15, 2021
- PTO Changes to Follow Supreme Court's Arthrex Ruling, Attorneys Predict, Westlaw Journal IP, June 30, 2021
- Arthrex Finds That APJs are Unconstitutionally Appointed, Intellectual Property Magazine, June 22, 2021
- U.S. Supreme Court Hands PTO Director the Authority to Review Patent Board Determinations, BioWorld, June 22, 2021
- New Arthrex Powers Put Spotlight on USPTO Director Search, Law360, June 21, 2021
- Supreme Court’s New Patent Power for PTO Director Likely Limited, Attorneys Say, Thomson Reuters, June 21, 2021
- Will Skinny Labelling Survive?, Intellectual Property Magazine, March 25, 2021
- Supreme Court's Appointments Clause Ruling Will Keep PTAB Intact, Lawyers Predict, Westlaw Journal IP, March 4, 2021
- This Week in IP: Illinois TM Cases Soar, IP Rights Bring Riches, Skinny Label Case Revived, Managing IP, February 12, 2021
- Top 10 IPR Pitfalls at the Institution Stage, ABA Landslide magazine, Vol. 13, No. 2, November / December 2020 Issue
- Lawyers Keenly-Awaiting Arthrex Showdown, World IP Review, October 14, 2020
- Virus Delays, Few Approvals Dry Up Generic Drug Lawsuits in 2020, Bloomberg Law, September 9, 2020
- PTAB Limits on Amendment Rejections Spur Quality Worries, Law360, July 13, 2020
- IPR: The End of the Road for Fifth Amendment Challenges?, World IP Review, July 6, 2020
- SCOTUS Opts Not to Hear Three AIA IPR Cases, Intellectual Property Magazine, June 24, 2020
- SCOTUS Passes on Three IPR Petitions for Cert, but Arthrex Petition Still in Play, BioWorld / BioWorld MedTech, June 24, 2020
- SCOTUS Expands PTAB’s ‘Unchecked’ Power Over Patent Reviews, World IP Review, April 21, 2020
- SCOTUS Says PTAB Time-Bar Rulings Are Not Appealable, Thomson Reuters Westlaw, April 21, 2020
- Fed. Circ. to Air Live Audio of Oral Arguments Amid COVID-19, Law360, April 1, 2020
- Attys Prep for Phone Hearings As Fed. Circ. Braces for Virus, Law360, March 12, 2020
- Biogen Loses Bid to Block Rival’s Multiple (1), Bloomberg Law, February 27, 2020
- Method of Treatment Eligibility, Intellectual Property Magazine, January 9, 2020
- Amgen Kidney Drug Ruling May Expand Patent Protection, Bloomberg Law: Pharmaceutical & Life Sciences News, January 8, 2020
- Amgen, Sanofi’s Cholesterol Drug Spat a Turning Point on Patents, Bloomberg Law, December 27, 2019
- 3 Strategies to Manage Case Scope in ANDA Patent Litigation, Law360, December 10, 2019
- Curing the Drug Label as Prior Art Malady at the PTAB, IPWatchdog, November 13, 2019
- Discretionary Denials at Patent Court Thwart Generic Drugmakers, Bloomberg Law, November 1, 2019
- Courts Beat Back AIA Constitutional Challenge, Put Compounders in Their Place, BioWorld, August 7, 2019
- Challenging University Patents Just Got a Whole Lot Easier, BioWorld Today, June 18, 2019
- SCOTUS Decision Limits Govt’s Ability to Defend Itself in Patent Suits: Lawyers, World IP Review, June 11, 2019
- High Court Leaves Gov't With Few Patent Challenge Options, Law360, June 10, 2019
- Patent Owners May Not Like PTAB Claim Construction Change, Law360, May 10, 2018
- Increased Patent Review Fees Could Impact Litigation, Corporate Counsel, December 4, 2017
- Slow Down Before Accelerating: Litigation Ramifications of Accelerated Examination Procedure on Nanotechnology, The SciTech Lawyer (Vol. 4, No.1), Summer 2007
Events
- ACI 9th Annual Paragraph IV Disputes Master Symposium
- ACI 14th Annual Summit on Biosimilars & Innovator Biologics
- LSPN North America Conference 2023
- ACI 8th Annual Paragraph IV Disputes Master Symposium
- ACI 15th Annual Paragraph IV Disputes Conference
- ACI Summit on Biosimilars & Innovator Biologics Virtual Conference
- Introduction to Patent Law
- ACI 10th Annual Summit on Biosimilars Conference
- ACI 13th Annual Paragraph IV Disputes Conference
- ACI 12th Annual Paragraph IV Disputes Conference
Seminars & Classes
- "Biosimilar Biological Products," FDLI's Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies Course; March 8, 2023
- Guest Lecturer, ECON327, The University of North Carolina, Chapel Hill, North Carolina; February 25, 2021
- Guest Lecturer, ECON327, The University of North Carolina, Chapel Hill, North Carolina; February 13, 2020
- “Harnessing the Power of Covered Business Method Patent Review,” ACI’s inaugural conference on Post-Grant PTO Proceedings; New York, NY; March 25-26th, 2015
- “Combating Patent Trolls," Texas Bankers Association 130th Annual Meeting; Colorado Springs, CO; May 8, 2014
- “Patent Wars: The Impact of Patent Trolls on Financial Services,” NACHA Counsel Mega Meeting; Reston, VA; October 3, 2013
- “Patents: Industry Strategy and Response,” American Bankers Association; Washington, DC; May 17, 2013
- “Dealing with Non-Practicing Entities,” American Bankers Association Community Bankers Council Spring Meeting; Tucson, AZ; April 28, 2013
- “Receiving a Cease and Desist Letter from a Non-Practicing Entity: Top Ten Things to Know,” American Bankers Association; Washington, DC; January 10, 2013
- Guest Lecturer, George Mason University, Fairfax, VA (Spring 2011, Spring 2012, Spring & Fall 2014)
- “Protecting Assets Through Trade Secrets,” The Business of Intellectual Property Conference, Technology Council of Maryland; March 27, 2008
Education
- JD, magna cum laude – University of New Hampshire School of Law (2003); Editor, IDEA: The Journal of Law and Technology
- MS, Biotechnology – Johns Hopkins University (2000)
- BS, Biology – University of North Carolina at Chapel Hill (1996)
Admissions
- District of Columbia
- Maryland
- US Court of Appeals for the Federal Circuit
- US Court of Federal Claims
- US District Court District of Columbia
- US District Court District of Maryland
- US District Court Northern District of Ohio
- US Patent and Trademark Office