Patrick C. Gallagher, Ph.D., chairs the Pharmaceuticals and Biopharmaceuticals Litigation and Regulatory group of Duane Morris' global Intellectual Property practice and serves as a team lead for the Life Sciences and Medical Technologies industry group. 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).
Represented Patrin Pharma in Hatch-Waxman litigation related to Assertio’s migraine medication, Cambia (Assertio Therapeutics, Inc. et al. v. Patrin Pharma, Inc., Civil Action No. 20-cv-05055 (N.D. Ill.). Achieved a settlement and license agreement related to all asserted patents.
- 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.
- Represented TheraCour Pharma, Inc., a research and development pharmaceutical company, in a license agreement with NanoViricides, Inc. (NYSE Amer.: NNVC), a global leader in nanomedicines against viruses. Under the license agreement, TheraCour licensed technology to NanoViricides for VZV, the virus that causes chickenpox in children and shingles in adults.
- Represented Immunome, Inc., a biotechnology company focused on developing first-in-class cancer therapies by harnessing the human immune response, in a collaboration and licensing agreement with pH Pharma, a clinical-stage biopharmaceutical company focused on developing innovative healthcare products for unmet clinical and patient needs.
- 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. Affirmed on appeal 2017-1575, -1594, -1595, and -1596 (Fed. Cir.).
- 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
- 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
- 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
- Duane Morris LLP
- Partner, 2016-present
- Associate, 2013-2015
- Locke Lord LLP
- Associate, 2006-2013
- PCG Equine Research, Inc.
- President, 2003-2004
- 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
- Co-author, "FDA Issues Final Rule on 'Intended Use'," Duane Morris Alert, September 27, 2021
- Co-author, "FDA Issues Final Guidance on Form and Content of Unique Device Identifier Labeling System," Duane Morris Alert, July 26, 2021
- Featured, "What Kind of Consistency Can Industry Expect from the FDA Post Pandemic?," The BioPharma-Reporter Podcast, July 22, 2021
- Co-author, "FDA Issues Final Guidance on Post-Approval Chemistry, Manufacturing and Controls Changes to Biologics," Duane Morris Alert, June 28, 2021
- Co-author, "D.C. Circuit Rules That FDA Lacks Authority to Regulate a Product as a Drug When It Also Satisfies Statutory Definition of a Device," Duane Morris Alert, April 26, 2021
- Co-author, "New FDA Guidance Embraces "Remote Interactive Evaluations" but Stops Short of Permitting Virtual 704(a) Inspections," Duane Morris Alert, April 19, 2021
- Quoted, "Why Is President-Elect Joe Biden a Good Pick for the Pharma Industry?," Pharmaceutical Technology, December 14, 2020
- Co-author, "FDA's Additional Draft Guidance on Biosimilarity and Interchangeability to Seek Comments and Suggestions by January 19, 2021," Duane Morris Alert, December 11, 2020
- Co-author, "Guidance for Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA II," Duane Morris Alert, December 3, 2020
- Co-author, "Federal Circuit Holds That, for Venue Purposes, Patent Infringement Occurs Only in Districts Where Actions Related to ANDA Submissions Occur," Duane Morris Alert, November 18, 2020
- Co-author, "Federal Circuit Finds Induced Infringement of Drug Patent, Even When Skinny Label Was Used," Duane Morris Alert, October 30, 2020
- Co-author, "New MAPP Explains Process for Changing Ownership of Generic Drug Applications," Duane Morris Alert, September 8, 2020
- Co-author, "FDA Clarifies Policy on Scope of Review of Multiple-Function Device Products," Duane Morris Alert, August 6, 2020
- Co-author, "FDA Issues Guidance on Procedures for Device Establishment Inspections," Duane Morris Alert, July 8, 2020
- Co-author, "New FDA Compliance Program Details FDA Expectations for Inspections of CDER- or CDRH-Led Combination Product Manufacturers," Duane Morris Alert, June 12, 2020
- Quoted, "Faulty Virus Antibody Tests Put Pressure on FDA to Demand Better," Bloomberg Law, June 12, 2020
- Co-author, "FDA Provides Two New Guidances for Investigational New Drug Applications and Clinical Trial Expectations for Drugs and Biological Products Proposed for Use Against COVID-19," Duane Morris Alert, June 1, 2020
- Co-author, "CDC Provides Guidance on COVID-19 Antibody Testing," Duane Morris Alert, May 29, 2020
- Quoted, "After Finding a Virus Vaccine, the Challenge Is Making Enough," Bloomberg Law, May 28, 2020
- Co-author, "Florida Initiates Phase 1 of Reopening, with South Florida Counties Following a Different Track," Duane Morris Alert, May 4, 2020
- Co-author, "FDA Takes Steps to Enhance Availability of Safe and Effective Face Masks," Duane Morris Alert, April 22, 2020
- Co-author, "CARES Act Expands Immunity Protections for Covered Countermeasures and Healthcare Volunteers," Duane Morris Alert, April 13, 2020
- Co-author, "CARES Act Package Ushers in Changes to OTC Drug Review Process," Duane Morris Alert, April 13, 2020
- Co-author, "Florida Governor Clarifies Terms of First Statewide Safer-at-Home Order," Duane Morris Alert, April 6, 2020
- Quoted, "How COVID-19 Could Shake Up Patent Strategies," Law360, April 6, 2020
- Co-author, "Florida Governor Issues Statewide Order Restricting Activities Outside the Home," Duane Morris Alert, April 2, 2020
- Co-author, "FDA Unveils Program to Expedite Coronavirus Treatments," Duane Morris Alert, April 1, 2020
- Co-author, "Florida Governor Issues Stay-at-Home Order—But Only for Southeast Florida," Duane Morris Alert, March 31, 2020
- Co-author, "FDA Guidance Aims to Accelerate Availability of COVID-19 Tests," Duane Morris Alerts, March 18, 2020
- Author, "Declaration Provides Immunity for Certain COVID-19 Pandemic Medical Countermeasure Activities," Duane Morris Alert, March 18, 2020
- Co-author, "USTR Implements New Section 301 Exclusions for Certain Medical Products in Wake of Coronavirus (COVID-19)," Duane Morris Alert, March 13, 2020
- Co-author, "FDA Postpones Foreign Inspections Through April in Response to COVID-19," Duane Morris Alert, March 12, 2020
- Contributor, "The Business Case and Pathway to Purpose-Driven Marketing," PM360, March 7, 2020
- Co-author, "FDA's Bark May Be Worse Than Its Bite: Revised Guidance Permits Certain Compounding of Animal Drugs from Bulk Drug Substances," Duane Morris Alert, November 25, 2019
- Co-author, "In a Regulatory 'One-Two,' FDA Modifies Terms of Oversight Concerning Homeopathic Drugs," Duane Morris Alert, October 31, 2019
- Co-author, "Federal Agencies Issue Draft Guidance for Drug Master Files for First Time in 30 Years," Duane Morris Alert, October 22, 2019
Author, "Transparency and Predictability - FDA Adds Useful Information to the ANDA Paragraph IV Certifications List," Duane Morris Alert, June 26, 2019
Quoted, "Examining the Truvada #BreakThePatent Debate: Gilead Responds," IP Watch Dog, March 3, 2019
Quoted, "Duane Morris Taps Boca Raton Partner to Lead Pharma IP Litigation Group," Daily Business Review, October 25, 2018
Author, "Biosimilar Regulatory Inefficiencies: Would Data Sharing Violate The U.S. Constitution?" Biosimilar Development, October 11, 2018; republished in Bioprocess Online, October 11, 2018
Co-author, "FDA Estimates for Formal Meetings Regarding Development of Biosimilars Show Continued Growth of Biosimilars in the United States," Duane Morris Alert, October 2, 2018
Co-author, "FDA Releases Revised Draft Memorandum of Understanding for Human Drug Compounding," Duane Morris Alert, October 1, 2018
Roundtable discussion, "Trends in Biosimilars," Financier Worldwide, October 2018
Co-author, "FTC Recommends Ways to Increase Competition and Stimulate Growth in Biosimilars and Interchangeable Market," Duane Morris Alert, August 9, 2018
Quoted, "FDA Withdraws Some ‘Best Practices’ for Biosimilar Makers," Bloomberg News, June 21, 2018
Author, "Will EU Patent System Changes Speed Market Entry For Biosimilars?," Biosimilar Development, November 21, 2017
- Quoted, "FDA Guidance Outlines How to Assess Biosimilar Similarity," Bloomberg BNA, September 22, 2017
- Author, "The Rules of Engagement For Biosimilar Legal Battles," Biosimilar Development, May 10, 2017
Author, "Surveying The Current Legal Landscape For Biosimilars," Biosimilar Development, May 3, 2017
- Author, "Amgen Vs. Sandoz: Who Will Win Over The Supreme Court?," Biosimilar Development, April 26, 2017
- Co-author, "Generics," Bringing Your Pharmaceutical Drug to Market, April 2015
- Author, "FDA Issues New Documents Governing Drug Compounding," Duane Morris Alert, April 6, 2015
- Author, "Drug Quality and Security Act Does Not Apply to Veterinary Compounding," Duane Morris Alert, March 6, 2015
- Co-author, The Regulation of Pharmacy Compounding: FDA Authority and the Compounding Quality Act of 2013, Food and Drug Law Institute Primer, 2014
- Co-author, "FDA Requests Comments and Issues Notice of Public Hearing Related to Implementation of GDUFA," Duane Morris Alert, August 20, 2014
- Co-author, "Chapter 18: ANDA Preparation (with an Eye toward Approval and Litigation) and the FDA Review," Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, 2014
- Co-author, "FDA Biosimilar Rules Will Provide Testing Clarity," Law360, May 27, 2014
- Co-author, "Inch-by-Inch: FDA's New Biosimilars Guidance Inches the Industry Closer to Clinical Testing Clarity," Duane Morris Alert, May 15, 2014
- Co-author, "2 Traps For Unwary ANDA Filers," Law 360, January 3, 2014
- Author, "U.S. House Introduces Bill on Federal Oversight of Compounding Pharmacies," Duane Morris Alert, September 19, 2013
- Author, "Further Defenses to Induced Infringement Following Federal Circuit Decision," Duane Morris Alert, June 28, 2013
- Co-author, "How to Make Technical Briefs Understandable for Generalist Judges," Verdict, Spring 2011, at 2
- Co-author, "Genetics of Swayback in American Saddlebred Horses," 41(Supplement 2) Animal Genetics 64 (2010)
- Author, "Challenging the Constitutionality of the Illinois Consecutive Sentencing Statute," 95 Illinois Bar Journal 96 (2007)
- Co-author, "Your Horse's Back, Equus, March 2006, at 44
- Author, "Pedigree Profiles," Thoroughbred Times Today, Recurring 2003-2004
- Author, "Superior Genes, Approaching Limits," Thoroughbred Times, August 3, 2003, at 53
- Author, "Lordosis and Swayback: Definitions and Distinctions," American Saddlebred, July/Aug 2003, at 56
- Author, "The Biology of Swayback, American Saddlebred, March/April 2003, at 86
- Co-author, "Measurement of Back Curvature in American Saddlebred Horses: Structural and Genetic Basis for Early-Onset Lordosis," 23 J. Equine Vet. Sci., 71-76 (2003)
- Co-author, "Two SINE Families Associated with Equine Microsatellite Loci," 10 Mammalian Genome 2, 140-44 (1999)
Selected Speaking Engagements
- Speaker, "Inventions at the 'Litigation' Stage: Inter Partes Review and/or District Court," Inventing and "Reinventing" Under Patent Law Webinar, Notre Dame Law School, September 17, 2020
- Speaker, "How COVID-19 Is Affecting Life Sciences and Medical Technologies," Duane Morris Webinar, April 16, 2020
- Speaker, "Introduction to US Biologics and Biosimilars Law and Regulation," Food and Drug Law Institute, Virtual Event, March 31, 2020
- Speaker, "Strategies for Protection Intellectual Property Involving SaMD and Artificial Intelligence," Life Science Women's Conference, Tampa, FL, February 19, 2020
Speaker, "Introduction to Biologics and Biosimilars Law and Regulation," Food and Drug Law Institute, Virtual Event, October 1, 2019
Speaker, "Predicting How Changes Under a New FDA Commissioner Will Impact the Life Sciences Community," ACI's FDA Boot Camp, Boston, September 18, 2019
Panelist, "Entering the U.S. Market: Considerations for Strategic Transactions and Collaborations," Innovation Across Borders: Strategies for Chinese Life Sciences Companies Doing Business in the U.S., Shanghai, March 7, 2019
Moderator, "Innovation Across Borders: Strategies for U.S. and Chinese Companies in the Health Sciences Industry," Duane Morris LLP and Chinese Biopharmaceutical Association (USA), January 8, 2019
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