Vincent L. Capuano, Ph.D.

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Vincent L. Capuano, Ph.D. is chair of Duane Morris' Intellectual Property: Generic Pharmaceuticals and Biosimilars 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. He 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. Dr. Capuano is a recognized thought leader and frequent speaker on strategies affecting generic and biosimilar pharmaceutical companies.

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 (advisor Eiichi Kimura), and an NIH/CNRS postdoctoral fellow at the Université Louis Pasteur in Strasbourg, France (advisor Jean-Pierre Sauvage – Nobel Prize in Chemistry 2016).

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, advisor Jonathan Sessler) and Ohio State University (B.S., Chemistry, 1987).

Areas of Practice

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

Representative Matters

  • Bristol-Myers Squibb Co. et al. v. Prinston Pharmaceuticals Inc., et al., 17-CV-00426 (LPS) (D.Del.) Patent infringement action regarding Prinston's ANDA to make a generic version of BMS’s anticoagulant product Eliquis®, the active ingredient of which is apixaban.
  • Alnylam Pharmaceuticals, Inc. v. Dicerna Pharmaceuticals, Inc., 15-CV-04126-H (EPL) (Mass. Sup. Ct.) Trade secret action regarding RNA interference technology.
  • Astellas Pharma Inc. et al., v. Prinston Pharmaceuticals Inc., et al., 16-CV-00943 (SLR) (D.Del.) Patent infringement action regarding Prinston's ANDA to make a generic version of Astellas's overactive bladder product Myrbetriq®, the active ingredient of which is mirabegron.
  • Helsinn Healthcare S.A., et al. v. Actavis LLC, 16-CV-00902 (SLR) (D. NJ) Patent infringement action regarding Actavis's 505(b)(2) NDA to make a generic version of Eisai's anti-nausea product Aloxi®, the active ingredient of which is palonosetron hydrochloride.
  • Bayer Pharma AG et al., v. Prinston Pharmaceuticals Inc., et al., 15-CV-00902 (SLR) (D.Del.) Patent infringement action regarding Prinston's ANDA to make a generic version of Janssen's cardiovascular product Xarelto®, the active ingredient of which is rivaroxaban.
  • Inter Partes Review Nos. 2015-01976, -01980 and -01981. Representing Petitioner Amneal Pharmaceuticals LLC in IPR of U.S. Patent Nos. 8,232,250, 8,399,413 and 8,969,302, owned by Yeda Research and Development Co., Ltd., and listed in the FDA Orange Book for Teva's MS product Copaxone®, the active ingredient of which is glatiramer acetate 40 mg.
  • In re Copaxone 40 mg Consolidated Cases, 14-CV-01171 (GMS) (D.Del.) Patent infringement action regarding Amneal's ANDA to make a generic version of Teva's MS product Copaxone®, the active ingredient of which is glatiramer acetate 40 mg.
  • Eli Lilly & Co. et al. v. Amneal Pharmaceuticals LLC, 14-CV-02025 (SEB)(DML) (SD IN) Patent infringement action regarding Amneal's ANDA to make a generic version of Lilly's testosterone replacement product Axiron®, the active ingredient of which is testosterone.
  • Inter Partes Review Nos. 2014-01041 and -01043. Representing Petitioner Metrics, Inc. in IPR of U.S. Patent Nos. 8,129,431 and 8,669,290, owned by Senju Pharmaceutical Co., Ltd., and listed in the FDA Orange Book for Senju's ophthalmic product Prolensa®, the active ingredient of which is bromfenac sodium.
  • Senju Pharmaceutical Co., Ltd., et al. v. Metrics, Inc. et al., 14-CV-3962 (JBS)(KMW) (D. NJ) Patent infringement action regarding Metrics ANDA to make a generic version of Senju's ophthalmic product Prolensa®, the active ingredient of which is bromfenac sodium.
  • Astrazeneca, AB v. Wockhardt Bio AG, et al., 14-CV-667 (GMS) (Consolidated) (D. Del.) Patent infringement action regarding Wockhardt's ANDA to make a generic version of Astrazeneca’s diabetes product Onglyza®, the active ingredient of which is saxagliptin.
  • Cepalhon, Inc. et al. v. Actavis LLC, 1:14-CV-00122 (GMS) (D DE) 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, No. 13-5074-JBS-JS (D. NJ) Patent infringement action regarding Wockhardt’s ANDA to make a generic version of Edgemont Pharma’s antidepressant products Forfivo®, the active ingredient of which is bupropion hydrochloride.
  • Depomed, Inc. et al. v. Actavis Elizabeth et al., 2:13-CV-04507 (CCC) (D. NJ) Patent infringement action regarding Actavis's ANDAs to make a generic version of Janssen's pain products Nucynta® and Nucynta® ER, the active ingredient of which is tapentadol hydrochloride.
  • 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 Pharmaceuticals, 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.

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

Professional Activities

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

Honors and Awards

  • Listed in Massachusetts Super Lawyers in the field of intellectual property, 2016-2017
  • Listed as an "IP Star" in Managing Intellectual Property's IP Stars, 2013-2017
  • Named to Euromoney's LMG Life Sciences Stars, 2012, 2013 and 2016

Selected Publications

Selected Speaking Engagements

  • "Pharmaceutical Patent Invalidity Challenge Score Card: District Courts v. The PTAB," American Conference Institute's Paragraph IV Disputes Conference, New York, April 2016
  • ""Legal & Regulatory Implications of 'Similarity' and 'Interchangeability,'" Biosimilars Clinical Studies & Analytical Similarity Summit, Boston, March 2016
  • "Update from the U.S.: Regulatory Exclusivities, Biosimilars Progress and New Court Decisions," World Generic Medicines Congress, Barcelona, Spain, April 3, 2014
  • "Latest Developments in Pharma/Life Sciences Patent Litigation," Fordham University School of Law IP Summit, New York, November 2013
  • "Understanding the Nuts and Bolts of Biosimilar Regulatory Requirements," 14th Annual Business of Biosimilars Conference, Boston, October 15, 2013
  • "Litigation Management Strategy Discussion: Special Litigation Considerations for Paragraph IV Disputes Involving Multiple ANDA Filers," Momentum's International Congress on Paragraph IV Litigation, New York, September 2013
  • 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