Laura Vogel advises clients in the pharmaceutical and biotechnology industries on intellectual property matters, including litigation, particularly Hatch-Waxman litigation; patent prosecution and portfolio development; due diligence investigations; as well as freedom-to-operate, patentability, infringement, validity, and inequitable conduct opinions. She has more than a decade of experience in pharmaceutical practice and has been involved in more than 20 abbreviated new drug application (ANDA) litigations as litigation counsel or co-counsel relating to all types of dosage forms, including oral (tablets, capsules, ODTs, solutions), intravenous, intramuscular, ophthalmic formulations, transdermal patches, and abuse-resistant dosage forms. Her practice regularly involves citizens petitions and the analysis of regulatory issues, such as patent-based and FDA-granted exclusivities.
Laura has represented clients in interferences before the U. S. Board of Patent Appeals and Interferences, now the U.S. Patent Trial and Appeal Board (PTAB), where she has served as lead counsel in multiple inter partes reviews (IPRs). She has prepared and prosecuted U.S. and foreign patent applications in the areas of biotechnology, pharmaceuticals, food sciences, molecular and cellular biology, recombinant DNA technology, therapeutic proteins, diagnostic assays, gene therapy, vaccines, and tissue sealant technology.
Prior to joining Barclay Damon, Laura represented pharmaceutical and biotech companies in opinion, litigation, and prosecution matters and played a vital role in establishing a Hatch-Waxman (ANDA) litigation practice at a previous firm.
- Reckitt Benckiser LLC v. Aurobindo Pharma Limited et al, Case No. 1:14-cv-01203-LPS: Represented the maker of the popular extended-release drug product Mucinex against a generic manufacturer’s ANDA challenge.
- Janssen Pharmaceuticals, Inc. and Grünenthal GMBH v. Actavis Laboratories UT, Inc. f/k/a Watson Laboratories, Inc. (CA No. 2:14-cv-04617) (D.N.J.): Patent infringement action regarding Actavis’s ANDA to make generic versions of Janssen’s pain management products Nucynta® and Nucynta® ER, the active ingredient of which is tapentadol HCl.
- Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited v. Wockhardt BIO AG, Wockhardt Ltd. and Wockhardt USA LLC (CA 15-cv-5619) (D.N.J.): Patent infringement action regarding Wockhardt’s ANDA to make a generic version of Jazz’s narcolepsy product Xyrem® Oral Solution, the active ingredient of which is sodium oxybate.
- Cepahon, Inc. v. Actavis LLC, Case No. 1:14-CV-00122 (GMS) (D. Delaware): Patent infringement action regarding Actavis's ANDA to make a generic version of Cephalon's anti-cancer product Treanda®, the active ingredient of which is bendamustine hydrochloride.
- Intelgenx Corp. v. Wockhardt Bio, AG, Case No. 13-5074-JBS-JS (D.N.J.): Patent infringement action regarding Wockhardt’s ANDA to make a generic version of Edgemont Pharma’s antidepressant product Forfivo®, the active ingredient of which is bupropion hydrochloride.
- Pfizer Inc. v. Wockhardt, Ltd., 12-CV-817 (SLR) (Consolidated) (D. Delaware): Patent infringement action regarding Wockhardt’s ANDA to make a generic version of Pfizer’s antidepressant product Pristiq®, the active ingredient of which is desvenlafaxine succinate.
- Pfizer Inc. v. Mylan Pharmaceuticals, Inc., Case No. 10-00085 (D. Delaware – J. Farnan): Represented Mylan in ANDA litigation involving Pfizer’s cardiovascular product CADUET®, the active ingredients of which are atorvastatin calcium and amlodipine besylate. Settled prior to trial.
- Shire LLC v. Sandoz Inc., No. 11-CV-01110 (RBJ)(KMT) (D.D.C.): Patent infringement action regarding Sandoz’s ANDA to make a generic version of Shire’s ADHD product Intuniv®, the active ingredient of which is guanfacine hydrochloride.
- University of New Hampshire, B.S., cum laude, 1997
- Tulane University Law School, J.D., 2002
- Massachusetts, 2002
- New York, 2003
- District of Columbia, 2004
- U.S. Patent and Trademark Office, 2003
- U.S. District Court, District of Massachusetts
- U.S. Court of Appeals, Federal Circuit
- Women in BIO
- New York State Bar Association
- Massachusetts Bar Association
- Boston Patent Law Association
- Co-author of “Proactive Brand Protection Strategies For Pharma Innovators,” Law360, December 4, 2017
- “Ethical Considerations in Paragraph IV Practice: A Roadmap for 2016,” American Conference Institute 10th Annual Paragraph IV Disputes Conference, New York City, April 26, 2016
- Panel, “Hatch-Waxman and BPCIA 101 – A Primer on IP Basics and Regulatory Fundamentals,” American Conference Institute Paragraph IV Disputes Conference, New York City, April 23, 2012
- "Hatch-Waxman Litigation: The Evolving Legal and Regulatory Framework," Webinar, The Knowledge Group, September 26, 2017
- "Devising Strategies for IPR Best Practices and Navigating Dual Forums in Hatch–Waxman Litigation," 11th Annual Paragraph IV Disputes, ACI Conference, April 24-26, 2017, New York, New York
- Wolf, Greenfield & Sacks P.C., Counsel
- Duane Morris LLP, Partner
- Sterne, Kessler, Goldstein & Fox PLLC, Associate