Vincent L. Capuano, Ph.D.
Partner
Duane Morris LLP
100 High Street, Suite 2400
Boston, MA 02110-1724
USA
Phone: +1 857 488 4250
Fax: +1 857 401 3002
Email: vcapuano@duanemorris.com

Vincent L. Capuano, Ph.D. is the national chair of Duane Morris' Hatch-Waxman IP practice group. He practices in the area of intellectual property law, with a focus on patent law in the chemical and pharmaceutical industries and an emphasis on representing generic pharmaceutical companies filing Abbreviated New Drug Applications (ANDA) with the U.S. Food and Drug Administration. Dr. Capuano has extensive experience representing pharmaceutical companies in prelitigation strategic planning and patent litigation. Dr. Capuano also counsels clients in all areas of patent procurement, exploitation and enforcement, including domestic and foreign patent preparation and procurement, patent validity and infringement analysis, patent licensing and due diligences.

Prior to entering the practice of law, Dr. Capuano was an Innoue Foundation for Science postdoctoral fellow at Hiroshima University School of Medicine in Hiroshima, Japan, and an NIH/CNRS postdoctoral fellow at the Université Louis Pasteur in Strasbourg, France.

Dr. Capuano is a 1999 graduate of the University of Akron School of Law and a graduate of the University of Texas at Austin (Ph.D., Organic Chemistry, 1991) and Ohio State University (B.S., Chemistry, 1987).

Areas of Practice

• Intellectual Property
• Patents
• Abbreviated New Drug Application (ANDA)

Representative Matters

• Apotex Inc. et al. v. Otsuka Pharmaceutical Co., Ltd., No. 12-571 (U.S. Supreme Court). Represented Mylan Inc. as amicus curiae in support of petition of Apotex Inc. for writ of certiorari regarding appeal from a decision of the Federal Circuit upholding the validity of the patent covering the product Abilify®, the active ingredient of which is aripiprazole.
• In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation, No. 12-514 (U.S. Supreme Court). Represented Generic Pharmaceutical Association (GPhA) as amicus curiae in support of petition of Mylan Pharmaceuticals, Inc. for writ of certiorari regarding appeal from a decision of the Federal Circuit upholding the validity of the patent covering the product Amrix®, the active ingredient of which is cyclobenzaprine hydrochloride.
• Pfizer Inc., et al. v. Wockhardt, Ltd., et al., 12-CV-817 (SLR) (Consolidated) (D. Del.) 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.
• Warner-Chilcott Co. LLC, et al. v. Ranbaxy, Inc., et al., 12-CV-2474 (FSH) (Consolidated) (D. NJ) Patent infringement action regarding Ranbaxy’s ANDA to make a generic version of Warner-Chilcott's osteoporosis product Atelvia®, the active ingredient of which is risedronate sodium.
• Avanir Phamaceuticals, Inc., et al. v. Wockhardt, Ltd., et al., 11-CV-704 (Consolidated) (LPS) (D. Del.) Patent infringement action regarding Wockhardt's ANDA to make a generic version of Avanir's PBA product Nuedexta®, the active ingredients of which are dextromethorphan hydrobromide and quinidine hydrobromide.
• Shire LLC, et al. v. Sandoz Inc., No. 11-CV-01110 (RBJ)(KMT) (D. Col.) 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.
• Genentech, Inc.. v. Sandoz Inc., No. 11-CV-1925 (JSW) (N.D.Cal.) Patent infringement action regarding Sandoz's ANDA to make a generic version of Genentech's antiviral product Valcyte®, the active ingredient of which is valganciclovir hydrochloride.
• King Pharmaceuticals, Inc., et al. v. Actavis Inc., et al., No. 07-CV-05041 (GEB) (MCA) (D. N.J.). Patent infringement action regarding Actavis' ANDA to make a generic version of King's pain product Avinza®, the active ingredient of which is morphine sulfate.
• Pfizer Inc., et al. v. Mylan Pharmaceuticals, Inc., Case No. 10-CV-00085 (JJF)(D. Del.). Patent infringement action regarding Mylan's ANDA to make a generic version of Pfizer's cardiovascular product Caduet®, the active ingredients of which are atorvastatin calcium and amlodipine besylate.
• Pfizer Inc., et al. v. Apotex, Inc., Case No. 10-CV-5257 (S.D.N.Y.) (LAK). Patent infringement action regarding Apotex's ANDA to make a generic version of Pfizer's migraine product Relpax®, the active ingredient of which is eletriptan hydrobromide.
• Boehringer Ingelheim Pharmaceuticals, Inc., et al., v. Barr Laboratories, Inc., et al., Appeal No. 2009-1032 (Federal Circuit). Represented Apotex Inc. and Apotex Corp. as amici curiae in support of petition for rehearing and rehearing en banc regarding appeal from a decision stemming from patent litigation over a generic version of Boehringer’s Parkinson’s Disease product Mirapex®, the active ingredient of which is pramipexole.
• Sepracor Inc. v. Teva Pharmaceuticals USA, Inc., et al., Case No. 09-CV-1302 (DMC)(D NJ). Patent infringement action regarding Wockhardt USA LLC's ANDA to make a generic version of Sepracor's insomnia product Lunesta®, the active ingredient of which is eszopiclone.
• Merck & Co., Inc. v. Sandoz, Inc., D. NJ. Case No. 3:09-cv-00890-MLC-LHG. Patent infringement action regarding Sandoz's ANDA to make a generic version of Merck's antinausea product Emend®, the active ingredient of which is aprepitant.
• Alcon Research, Ltd. et al. v. Sandoz, Inc., Case No. 09-CV-0103 (LJM)(SD IN). Patent infringement action regarding Sandoz's ANDA to make a generic version of Alcon's ophthalmic product Patanol®, the active ingredient of which is olopatadine hydrochloride.
• Aventis Pharma S.A. and Sanofi-Aventis U.S. LLC v. Apotex Inc. and Apotex Corp., Case No. 08-496 (GMS) (D. Del. 2010). Patent infringement action regarding Apotex's ANDA to make a generic version of Sanofi-Aventis' anti-cancer product TAXOTERE®, the active ingredient of which is docetaxel. Following a two-week trial, obtained an order for Apotex striking down the patents-in-issue as invalid and unenforceable due to Sanofi-Adventis' inequitable conduct in procuring the patents.
• Medicis Pharmaceutical Corp. v. Sandoz, Inc. et al., Case No. 09-033 (JJF) (D Del.). Patent infringement action regarding Sandoz's ANDA to make a generic version of Medicis's acne product Solodyn®, the active ingredient of which is minocycline hydrochloride.
• Endo Pharmaceuticals Inc. et al. v. Sandoz, Inc., Case Nos. 08-534 and 08-970 (KSH) (D Del.). Patent infringement action regarding Sandoz's ANDA to make a generic version of Endo's pain product Opana® ER, the active ingredient of which is oxymorphone hydrochloride.
• Aventis Pharmaceuticals, Inc. et al. v. Barr Laboratories, Inc. et al., Case No. 01-3627-JAG (D NJ). Patent infringement action regarding Barr Laboratories' ANDA to make a generic version of Aventis's allergy products Allegra® and Allegra-D®, the active ingredient of which is fexofenadine hydrochloride.
• Eli Lilly & Co. v. Barr Laboratories, Inc., Case No. 02-1844-SEB (SD IN). Patent infringement action regarding Barr Laboratories' ANDA to make a generic version of Lilly's osteoporosis product Evista®, the active ingredient of which is raloxifene hydrochloride.
• Ferring B.V. et al. v. Barr Laboratories, Inc., Case No. 02-9851 (SD NY). Patent infringement action regarding Barr Laboratories' ANDA to make a generic version of Ferring's urinary incontinence product DDAVP®, the active ingredient of which is desmopressin acetate.
• Bayer Schering AG, et al. v. Barr Laboratories, Inc., Case No. 05-2308-JPS-ES(D.N.J.) Patent infringement action regarding Barr Laboratories' ANDA to make a generic version of Bayer Schering's oral contraceptive Yasmin®, the active ingredient of which is drospirenone.

Professional Activities

• American Intellectual Property Law Association
• American Inns of Court
• Biotechnology Industry Organization

Admissions

• Massachusetts
• District of Columbia
• U.S. Patent and Trademark Office
• U.S. Court of Appeals for the Federal Circuit

Education

• University of Akron School of Law, J.D., 1999
• University of Texas at Austin, Ph.D., Organic Chemistry, 1991
• The Ohio State University, B.S., Chemistry, 1987

Experience

• Duane Morris LLP
  - Partner, 2008-present
• Sterne, Kessler, Goldstein & Fox PLLC
  - Associate/Director, 1998-2008
• Oldham & Oldham Co., LLP
  - Patent Agent/Law Clerk, 1996-1998

Honors and Awards

• Listed as an "IP Star" in Managing Intellectual Property's IP Stars, 2013
• Named to Euromoney's LMG Life Sciences Stars list, 2012

Selected Publications

• Co-author, "Biosimilars Now Just About Ready to Roll," Genetic Engineering & Biotechnology News, September 1, 2012
• Co-author, "Claim Construction Strategies for Trial and Appeal in Pharma Litigation," Corporate Counsel Magazine, August 15, 2012
• Quoted, "New Laws of Nature Law: Ruling Questions Scientific Patents," ABA Journal, July 1, 2012
• Co-author, "Addressing Breach of Method-of-Use Patents by Generics," Law360, May 2, 2012
• Co-author, "Federal Circuit Addresses Infringement of Method-of-Use Patents by Generics in Yasmin® Case," Duane Morris Alert, April 18, 2012
• Co-author, "A Proposal to Curb Misuse of 'Exceptional Case' Allegations Against ANDA Applicants," GenericsWeb INNsight, June 2010
• "Takeda V. Mylan — Keeping Your Ducks In A Row," Law 360, January 13, 2009
• "Obviousness of Chemical Compounds: The Lead Compound Concept," Intellectual Property Today, July 2007

Selected Speaking Engagements

• Speaker, "Third Party IP: Preserving Freedom to Operate," The Food and Drug Law Institute's conference on IP Throughout the Drug Development Lifecycle, Washington D.C., July 2012
• "New Standards in Inequitable Conduct Post-Therasense: Ethical Considerations for Paragraph IV Cases," ACI Conference on Paragraph IV Disputes, New York, April 2012
• "Successfully Navigating Claim Construction in Life Sciences Litigation," Intellectual Property Owners Association Chat Channel webinar on current topics in IP, January 2012
• "New Standards and Controversies in Double Patenting Type Obviousness: Repercussions for Paragraph IV Challenges," ACI Conference on Paragraph IV Disputes, May 2011
• "Double Patenting: A Newly Vigorous Defense in Patent Litigation," Intellectual Property Owners Association Chat Channel webinar on current topics in IP, February 2011
• "Litigating with Multiple ANDA Filers: Brand Name and Generic Perspectives," ACI Conference on Paragraph IV Disputes, San Francisco, December 2010
• "Pre-Litigation Strategy, Analysis and Preparation for PIV Disputes," CBI's 3rd Annual Life Sciences Congress on Paragraph IV Disputes, Alexandria, Virginia, October 2010
• "Biosimilars and Follow-On Biologics," Licensing Executives Society, Chicago, May 2008