Jason A. Lief

Experience

Jason Lief is a premier patent trial lawyer with 25 years of experience. He has litigated and tried dozens of major patent and other intellectual property cases on behalf of some of the world’s most innovative and dynamic companies, often involving billion dollar products. Applying his legal and scientific training, Jason has established a reputation for winning outcomes and courtroom excellence. 

Jason’s cases include major Hatch-Waxman pharmaceutical litigations (Zantac^®, Wellbutrin^®, Wellbutrin SR^®, Wellbutrin XL^®, Ceftin^®, Intuniv^®, Vyvanse^®, Oxtellar XR^®, Angiomax^®, and Lialda^®), as well as biotech, chemical, and consumer product patent cases. Jason has also litigated trade secret, trademark, copyright, and IP contract disputes. He has argued before the U.S. Court of Appeals for the Federal Circuit and appeared in foreign courts pursuant to the Hague Convention.  Jason has also successfully litigated in the inter partes review (IPR) arena.

Beyond litigation, Jason also counsels clients on various intellectual property issues.

Jason’s approach is to partner with clients to comprehensively understand the scientific, legal and business concerns they face. Listening to clients and asking the right questions is the key to winning. As Jason often says, “litigation is the art of the question.”

Jason’s matters have spanned a range of technologies and industries, including: pharmaceutics, pharmaceutical formulation, sustained-release formulations, pharmacokinetics, biotechnology, organic chemistry, polymers, antibodies, combinatorial chemistry, RNAi, DNA-sequencing technology, antibiotics, anti-depressants, anti-epileptic drugs, anti-retroviral AIDS drugs, ADHD medicines, gastrointestinal and anti-ulcer medicines, asthma medications, nanotechnology, injectables, peptide drug formulation, drug stabilization, advanced battery systems, detergents, dental rinses, deodorants, financial trade secrets and jewelry design.

At Cardozo School of Law, he was Editor of the Law Review.

Representative Court Decisions

• Eagle Pharm., Inc. v. Slayback Pharma LLC, Civil Action No. 21-1256-CFC-JLH, 2022 U.S. Dist. LEXIS 193941 (D. Del. Oct. 25, 2022) (took trial testimony in dramatic trial victory for defendant Slayback, wherein Chief Judge Connolly ruled from the bench, finding non-infringement, after the first day of trial and cancelled the rest of the trial).
• Medical Diagnostics Labs. LLC v. Protagonist Therapeutics, Inc., 298 F. Supp. 3d 1241 (N.D. Cal. 2018) (participated in victory dismissing plaintiff’s case based upon the statutory safe harbor from patent infringement). 
• Supernus Pharms. Inc. v. Actavis Inc., 2016 U.S. Dist. LEXIS 14111 (D.N.J. Feb. 5, 2016) (wherein Jason took the winning trial cross-examination of defendant’s obviousness expert in a case regarding Oxtellar XR^® as well as the successful direct examination of one of Supernus’s expert – the patent was found non-obvious and that issue was not appealed).
• Coalition For Affordable Drugs II LLC v. Cosmo Technologies Ltd., 2016 Pat. App. Lexis 13255 (Bd. Pat. App. & Interferences Oct. 5, 2016) (wherein Jason’s examination of the Petitioner’s expert was quoted by the Board against Petitioner when upholding the validity of the patent regarding Lialda^®). 
• The Medicines Co. v. Mylan Inc., 72 F. Supp. 3d 837 (N.D. Ill. 2014) (wherein Jason took the winning trial cross-examination of defendant’s obviousness expert in a case regarding Angiomax^® – the patent was found non-obvious and that issue was not appealed). 
• Glaxo Wellcome, Inc. v. Pharmadyne Corp., 32 F. Supp. 2d 265 (D. Md. 1998) (wherein Jason crafted the winning trial cross-examination of defendant’s obviousness expert in a case regarding Zantac^®; the cross revealed the expert’s “monstrous error” of chemistry – the patent was found non-obvious and there was no appeal). 
• Shire Dev. LLC. v. Mylan Pharmaceuticals, Inc., 2015 WL 1345322 (M.D. Fla. Mar. 23, 2015) (wherein Jason successfully argued the Markman hearing regarding claim construction of U.S. Patent 6,773,720 before trial in a case regarding Lialda^®). 
• Shire Dev. LLC. v. Mylan Pharmaceuticals, Inc., 235 F. Supp. 3d 1298 (M.D. Fla. Jan. 27, 2017) (wherein Jason took the then-winning direct examination of Shire’s main expert at trial in a case regarding Lialda^®; and Mylan’s main expert was withdrawn at trial before Jason’s cross-examination – the case was reconsidered by the Court after an adverse Federal Circuit claim construction ruling in a related case).
• Shire Dev. LLC v. Watson Pharmaceuticals, Inc., 932 F. Supp. 2d 1349 (S.D. Fla. 2013) (wherein Jason successfully briefed Shire’s opposition to summary judgment of non-infringement regarding a generic version of Lialda^®).
• Shire Dev. LLC v. Watson Pharmaceuticals, Inc., 2013 WL 1912208 (S.D. Fla. May 9, 2013) (wherein Jason took the winning direct trial examination of Shire’s expert on melting point and the winning trial cross-examination of Watson’s expert on that same issue; the ruling in Shire’s favor regarding melting point was never appealed – the victory was reversed on appeal on other grounds and remanded).
• Shire Dev. LLC v. Watson Pharms., Inc., 2016 U.S. Dist. LEXIS 40360, 2016 WL 1258885 (S.D. Fla. 2016) (a second trial victory regarding Lialda^®, wherein Jason took the winning direct trial examination of Shire’s main expert and the winning cross-examination of Watson’s main expert – ultimately reversed on appeal on claim construction).
• Shire LLC v. Sandoz Inc., 2012 U.S. Dist. LEXIS 161964, 2012 WL 5494944 (D. Col. 2012) (wherein Jason participated in the successful Markman briefing and hearing in a case regarding Intuniv^®).
• Shire LLC v. Teva Pharmaceuticals USA Inc., 2012 WL 12974072 (D. Del. Aug. 1, 2012) (wherein Jason briefed the successful opposition to a Daubert motion against Shire’s expert regarding Intuniv^®).
• Glaxo Wellcome, Inc. v. Andrx Pharmaceuticals, Inc., 344 F.3d 1226 (Fed. Cir. 2003) (wherein Jason participated in the successful appellate briefing, on behalf of plaintiff Glaxo in a case regarding Wellbutrin SR^®, resulting in a reversal of summary judgment of non-infringement).
• Andrx Pharmaceuticals, LLC v. GlaxoSmithKline, PLC, 236 F.R.D. 583 (S.D. Fla. 2006), aff’d., 2006 WL 2403942 (S.D. Fla. 2006) (wherein Jason successfully briefed and argued motions on behalf of Glaxo, resulting in opposing counsel being denied access to confidential information in a case regarding Wellbutrin XL^®).
• Eyal R.D. Corp. v. Jewelex New York Ltd., 784 F. Supp. 2d 441 (S.D.N.Y. 2011) (wherein Jason successfully briefed and argued federal copyright law preemption of state law claims in a case involving jewelry design).
• Concat LP v. Unilever, PLC, 350 F. Supp. 2d 796 (N.D. Cal. 2004) (wherein Jason participated in the successful briefing that sent the case to arbitration).
• University of Minnesota v. Glaxo Wellcome, Inc., 58 F. Supp. 2d 1036 (D. Minn. 1999) and 44 F.Supp.2d 998 (D. Minn. 1999) (wherein Jason crafted the winning arguments on behalf of Glaxo that maintained the case in Federal Court over supposed Eleventh Amendment objections; the case involved a licensing dispute over the AIDS drug Ziagen^®).
• Glaxo Group Ltd. v. Apotex, Inc., 130 F. Supp. 2d 1006 (N.D. Ill. 2001) (wherein Jason participated in crafting the winning arguments on behalf of Glaxo that maintained a novel declaratory judgment action for future infringement in Federal Court for a non-Hatch-Waxman antibiotic Ceftin^®).
• Glaxo Wellcome, Inc. v. Ben Venue Labs., 1998 WL 965993 (N.D. Ohio Jul. 31, 1998) (wherein Jason crafted the winning cross-examination of the opposing expert that overcame non-infringement and obviousness arguments in a case regarding Zantac^®).
• Pfizer, Inc. v. Perrigo Co., 988 F. Supp. 686 (S.D.N.Y. 1997) (wherein Jason, on behalf of Pfizer, crafted the successful cross-examination of the opposing chemistry expert in a case involving Plax^® oral rinse). 

Representative Publications & Presentations

• "Induced Infringement after Glaxo v. Teva in US Patent Litigation," 13th Annual Pharma IPR Conference, Mumbai, India, March 5-7, 2024.
• “Skinny-Labeling in Hatch-Waxman Litigations: The Law in Flux?”, Webinar, The Knowledge Group, March 2023.
• “The Rise of the Section 112 Defense and ‘Sudden-Death’ Dispositive Motions in U.S. Pharmaceutical Patent Cases,” Webinar, The Knowledge Group, September 2022.
• “Section 101 Patent Eligibility of Pharma-Biotech Patents,” Webinar, The Knowledge Group, March 2022.
• “Schrödinger’s Patents: Can a Patent Be Valid and Invalid at the Same Time?”, Bloomberg Law, May 7, 2021.
• “New Wrinkle in Patent Licenses with State Universities,” Daily Journal, August 4, 2020 (discussing the Gensetix, Inc. v. Baylor College of Medicine case from the Federal Circuit as regards Eleventh Amendment immunity and patent licenses with state universities).
• “FDA Opens Useful Dialogue on Orange Book Patent Listings,” co-author, Law360, June 18, 2020.
• “Inequitable Conduct Accusations Still Powerful Pharma Patent Tool Post-Therasense,” Jason Lief, Bloomberg Law: INSIGHT, July 17, 2019.
• “Venue Menu: Should Litigants be Concerned about the Venue in a Hatch-Waxman Case,” Jason Lief, Intellectual Property Magazine, July/August 2018 at 43-44.
• “Panel: Hatch-Waxman Cases and Inter Partes Reviews,” Jason Lief, Panel Chair, 2018 BIO International Conference in Boston (quoted in the June 6, 2018 Life Sciences Intellectual Property Review article “Former Judge Weighs in on Differing Patent Standards”).
• “The Fate of Pharma Patents in U.S. Inter Partes Review Proceedings,” Jason Lief et al., LawyerIssue, November 8, 2016.
• “The PTO Versus the Courts: Who Rules and What are the Rules in Parallel Patent Proceedings,” Jason Lief, Chapter in Practicing Law Institute’s 2010 “Reissue and Reexamination Strategies and Tactics with Concurrent Litigation”.
• “Pharmaceutical Patents After KSR: What is Not Obvious?,” Jason Lief and Peter Schuyler, Journal of Commercial Biotechnology, January 2009, Volume 15, Issue 1, pp 44–58.
• “MedImmune’s Effect on Declaratory Judgment Jurisdiction in Pharmaceutical and Hatch-Waxman Litigations,” Jason Lief, 147 Intellectual Property Counselor Article II, March 2009.
• “Revising the Patent System,” Letter to Editor, Jason Lief, Chemical & Eng’g News, Vol. 85, Issue 46, p. 5 (Nov. 12, 2007).
• “Constitution Provides No Right To Be Killed,” Jason Lief, Nat’l L.J., Aug. 26, 1996, at A20.
• “Insuring Domestic Tranquility Through Quieter Products: A Proposed Product-Nuisance Tort,” Jason Lief, 16 Cardozo L. Rev. 595 (Dec. 1994).

Recognition

Jason has been recognized as a New York Super Lawyer^® for Intellectual Property Litigation (2013-2019, 2022-2023). 

Client Testimonials

• “Jason Lief is one of the most talented litigators I have ever had the privilege to work with in my 30 year career.” Jim Harrington, Radius Health, Inc.
• “Jason’s command of trial strategy and tactics is remarkable. … In the courtroom, Jason is masterful and is responsible for the most effective cross examination I have ever observed.” David Banchik, Takeda Pharmaceuticals