Patrick C. Gallagher, Ph.D., chairs the Pharmaceuticals and Biopharmaceuticals Litigation and Regulatory group at Duane Morris. He practices in the area of intellectual property and regulatory law assisting pharmaceutical companies, compounding pharmacies, and others in the agricultural, chemical, and biotechnology industries with intellectual property and regulatory matters. Dr. Gallagher assists clients with prevention and resolution of disputes and advises on best practices for gaining competitive advantage through development of a coordinated intellectual property and regulatory strategy. Dr. Gallagher regularly advises clients in the pharmaceutical and biotechnology industries on strategies to develop intellectual property that delivers competitive advantage in the marketplace coordinated with strategies that will most efficiently navigate the various regulatory pathways for pharmaceutical, biologic, and biosimilar medications. Dr. Gallagher has been involved in all aspects of patent and trade secrets litigation to execute on those intellectual property strategies.  Dr. Gallagher also counsels both pharmaceutical companies and compounding pharmacies on compliance with applicable Food and Drug Administration (FDA) regulations as well as applicable state laws and regulations enforced by State Boards of Pharmacy. Dr. Gallagher also regularly advises veterinary compounding pharmacies with respect to differences in applicable regulations for compounded medications intended for veterinary use, and development of business practices to comply with applicable regulations understanding the nature of veterinary medical practice served by compounding pharmacies.

Prior to entering the practice of law, Dr. Gallagher was the president of PCG Equine Research, Inc., spearheading a research project to investigate the genetic basis of spinal skeletal deformities in horses.

Dr. Gallagher is a 2007 cum laude graduate of DePaul University College of Law, where he was on the editorial board and business manager of the DePaul Law Review, and a graduate of the University of Kentucky (Ph.D., Molecular Genetics) and the University of Wisconsin (B.S., Genetics).

Representative Matters

  • Represented a generic pharmaceutical manufacturer in Inter Partes Review litigation related to a prescription drug resulting in an agreement to settle with a license date prior to expiration of patents.
  • Sears Petroleum & Transport v. MLI Associates LLC, Case No. 03-cv-01120 (N.D.N.Y.): Obtained jury verdict of non-infringement in favor of Defendant MLI Associates LLC.
  • Senju v. Apotex, Case No. 07-cv-00779 (D.Del.) (Fed. Cir.): Obtained judgment of invalidity for obviousness following bench trial on patent concerning ophthalmic formulation of antibiotic gatifloxacin.
  • Apotex v. Glaxo Wellcome, Case No. 09-cv-00485 (M.D.N.C.): Patent litigation regarding patents related to valacyclovir.
  • IN RE: METHOD OF PROCESSING ETHANOL BYPRODUCTS AND RELATED SUBSYSTEMS ('858) PATENT LITIGATION (Adkins Energy, LLC), Case No. 10-ml-02181 (S.D.Ind.): Multi-district litigation member of defense team obtained summary judgment of invalidity and non-infringement of patents relating to methods for processing corn to produce corn oil.
  • AGA Medical Holdings v. W. L. Gore, Case No. 10-cv-03734 (D.Minn.): Patent litigation relating to septal occluder medical devices.
  • Genentech v. Apotex, Case No. 11-cv-02410 (N.D.Cal.): Patent litigation regarding patents related to valacyclovir.
  • Shire v. Roxane, Case No. 11-cv-03886 (D.N.J.): Patent litigation relating to patents for lisdexamfetamine.
  • Senju v. Apotex, Case No. 11-cv-01171 (D.Del.): Won dismissal of patent lawsuit related to patent concerning ophthalmic formulation of antibiotic gatifloxacin.
  • Senju v. Apotex, Case No. 12-cv-00159 (D.Del.): Obtained stipulated dismissal of litigation on patents related to gatifloxacin ophthalmic formulation.
  • Apotex v. Allergan, Case No. 12-cv-00196 (D.Del.): Antitrust action concerning marketing of ophthalmic gatifloxacin formulations.
  • W. L. Gore v. AGA Medical, Case No. 12-cv-00827 (D.Minn.): Declaratory judgment action regarding septal occluder medical device.
  • Pfizer v. Wockhardt, Case No. 12-cv-00808 (D.Del.): Obtained settlement for ANDA filer to resolve patent litigation concerning desvenlafaxine.
  • Grunenthal v. Actavis, Case No. 13-cv-04507 (D.N.J.): Patent litigation regarding patents related to tapentadol oral tablets.
  • Forest Laboratories, Inc. et al. v. Glenmark , Case No. 1:13-cv-1602 (D. Del. 2013) Obtained settlement for ANDA filer to resolve patent litigation concerning milnacipran.
  • Eli Lilly v. Glenmark, Case No. 14-cv-00389 (S.D.Ind.): Obtained stay of litigation in favor of successful Inter Partes Review (IPR) petition invalidating patents related to uses of prasugrel.
  • AstraZeneca v. Wockhardt, Case No. 14-cv-00667 (D.Del.): Patent litigation regarding patents concerning saxagliptin.
  • In Re Copaxone 40 MG Consolidated Cases (Amneal), Case No. 14-cv-01171 (D.Del.): Obtained judgment of invalidity for obviousness of four patents related to glatiramer acetate 40 mg/mL.
  • Galderma v. Glenmark, Case No. 15-cv-01416 (N.D.Tex.): Obtained settlement for ANDA filer to resolve patent litigation concerning common acne treatment.
  • Roxane Labs. v. Novel Labs., Case No. 15-cv-05618 (D.N.J.): Obtained settlement for ANDA filer.
  • Jazz Pharmaceuticals v. Wockhardt, Case No. 15-cv-05619 (D.N.J.): Obtained settlement for ANDA filer to resolve patent litigation concerning sodium oxybate.
  • Eaton Veterinary Pharmaceutical v. Wedgewood Pharmacy, Case No. 15-cv-00687 (W.D.Mo. And Fed. Cir.): Obtained writ of mandamus ordering transfer of case from Western District of Missouri to home forum in District of New Jersey.
  • Depomed v. Actavis, Case No. 15-cv-06797 (D.N.J.): Patent litigation regarding patents related to tapentadol oral tablets.
  • Eaton Veterinary Pharmaceutical v. Wedgewood Pharmacy, Case No. 16-cv-02086 (D.N.J.): Obtained settlement for compounding pharmacy in patent litigation related to veterinary uses of tacrolimus.
  • Amneal v. Teva, Case No. 17-cv-00074 (D.Del.): Obtained settlement for ANDA filer of patents related to methods of manufacture for glatiramer acetate 40 mg/mL.
  • Teva v. Amneal, Case No. 17-cv-00416 (E.D.N.Y.): Successfully challenged venue of case in E.D.N.Y. in favor of venue in Delaware.
  • Biogen v. Prinston, Case No. 17-cv-00823 (D. Del.): Patent litigation regarding patents related to dimethyl fumarate treatment for multiple sclerosis.
  • Glenmark v. Daichii Sankyo, Case No. IPR2015-00864 (PTAB): Won unpatentability of all challenged claims for patent related to uses of prasugrel with aspirin.
  • Wockhardt v. Jazz Pharmaceuticals, Case No. IPR2015-00554 (PTAB): Obtained settlement of IPRs and litigation for ANDA filer to resolve patent disputes concerning sodium oxybate.

Areas of Practice

  • Intellectual Property Law
  • Pharmaceuticals

Admissions

  • Florida
  • Illinois
  • U.S. Patent and Trademark Office
  • U.S. District Court for the Northern District of Illinois
  • U.S. Court of Appeals for the Federal Circuit

Education

  • DePaul University College of Law, J.D., cum laude, 2007
    - Executive Editorial Board — Business Manager, DePaul Law Review
  • University of Kentucky, Ph.D., Molecular Genetics, 2001
  • University of Wisconsin, B.S., Genetics, 1997

Experience

  • Duane Morris LLP
    - Partner, 2016-present
    - Associate, 2013-2015
  • Locke Lord LLP
    - Associate, 2006-2013
  • PCG Equine Research, Inc.
    - President, 2003-2004

Professional Activities

  • Food and Drug Law Institute
    - Global Committee
  • American Bar Association
    - Young Lawyer's Division
    -- Vice-chair, Intellectual Property Committee, 2011-2012
  • Illinois State Bar Association

Honors and Awards

  • Listed in Illinois Super Lawyers Rising Stars, 2016 and 2017
  • Selected as an Emerging Lawyer, Emerging Lawyers, 2015
  • Received Chicago Volunteer Legal Services Distinguished Service Award, 2010

Civic and Charitable Activities

  • Giveback for Special Equestrians

    - Board Member, November 2018-present

  • Health and Disability Advocates
    - Board Member, 2012-2016

  • Public Interest Law Initiative
    - Board Member, 2007-2010
  • Old St. Patrick's Church
    - Social Justice Committee, 2006-2009
  • First Light Tutoring Program
    - Tutor, 2004-2007

Selected Publications

Selected Speaking Engagements

  • Speaker, "Introduction to Biologics and Biosimilars Law and Regulation," Food and Drug Law Institute, Washington, D.C., October 3, 2018

  • "Origins and Organizational Structure of FDA and Overview of the Regulation of Biological Products" & "FDA's Regulatory Processes" FDLI's Introduction to Biologics Program, March 20, 2018

  • Speaker, "BPCIA Litigation: Latest Developments for 2015 and Beyond Webcast," The Knowledge Group, September 1, 2015
  • "Position Your Biosimilar in Global Markets," CBI's 10th Annual Summit on Biosimilars, January 29, 2015
  • "FDA's New Clinical Biosimilars Guidance: Best Practices to Preparing a Successful 351(k) Application," FDAnews, Webinar, June 27, 2014
  • Co-presenter, TexasBar CLE: Advanced Appellate Course, September 2011
  • Co-presenter, TexasBar CLE: Advanced Patent Litigation Course, July 2011
  • "On simplifying technical subject matter," 2011 Global Legal Skills Conference, The John Marshall Law School, May 2011
  • Co-presenter, "How to Make Technical Briefs I=Understandable, and Maybe even Enjoyable, for Generalist Judges," 26th Annual Intellectual Property Law Conference, American Bar Association, Section of Intellectual Property Law, April 2011
  • "Patentability of Isolated and Purified DNA Molecules: Implications of Recent Court Decisions for Agricultural Genomics Researchers," Seminar at Plant and Animal Genome Conference: Cattle/Swine/Sheep Workshop, January 2011
  • "Owning a piece of Secretariat?: Patenting DNA Molecules for Equine Genomics Research and Improvement of Horse Health and Performance," Plant and Animal Genome Conference: Horse Workshop, January 2011
  • "How to Make IP Technical Briefs Understandable," BNA Webinar, December 2010
  • "Simplifying Complicated Briefs," Annual Meeting of Illinois Creditors' Bar Association, November 2010
  • "Lordosis Research Update," American Saddlebred Horse Association Convention, February 2005
  • "Lordosis in the American Saddlebred," American Saddlebred Horse Association Convention, February 2003
  • "Lordosis in Horses," University of Kentucky, January 2001
  • Guest Lecturer, Animal Science 410G: Horse Science, University of Kentucky, April 2001 and April 2000
  • "Horse Genetics," Boyd County, Kentucky Agricultural Extension Meeting, March 2001
  • Guest Lecturer, Veterinary Science 351: Animal Hygiene and Disease Control, University of Kentucky, March 2000
  • Guest Lecturer, Graduate Animal Genetics Course, The Ohio State University, March 1998
  • "SINEs in the Horse Genome," University of Kentucky, February 1998