Patrick C. Gallagher

Patrick 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.

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.
• AGA Medical Holdings v. W. L. Gore, Case No. 10-cv-03734 (D.Minn.): Patent litigation relating to septal occluder medical devices.
• 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.
• Grunenthal v. Actavis, Case No. 13-cv-04507 (D.N.J.): Patent litigation regarding patents related to tapentadol oral tablets.
• 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.
• Roxane Labs. v. Novel Labs., Case No. 15-cv-05618 (D.N.J.): Obtained settlement for ANDA filer.
• 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.

Education:

• DePaul University College of Law, J.D., cum laude, 2007
• University of Kentucky, Ph.D., Molecular Genetics, 2001
• University of Wisconsin, B.S., Genetics, 1997

Admissions:

• Florida
• 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

Professional Activities:

• Food and Drug Law Institute, – Global Committee
• American Bar Association, – Young Lawyer’s Division
• Illinois State Bar Association