Patrick C. Gallagher, Ph.D.

Representative Matters

• PeriphaGen, Inc. v. Krystal Biotech, Inc., et al. (Western District of Pennsylvania, 2020-22) (HSV-1 gene therapy): Co-lead counsel for plaintiff PeriphaGen in complex trade secret litigation. Case settled during discovery with the defendant making an upfront payment of $25 million, plus potential future payments totaling an additional $50 million. Law 360 Report on the Settlement

• Represented Somerset Therapeutics LLC in settling Hatch-Waxman litigation related to 0.7% olopatadine ophthalmic solution in the United States, a generic version of PATADAY® Once-Daily, permitting entry into the market prior to patent expiry.

• 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
• 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

• Co-author, "FDA and USPTO Announce Public Listening Session to Promote Greater Access to Medicines," Duane Morris Alert, December 27, 2022
• Co-author, "FDA Issues Guidance on the Background and Evaluation of Therapeutic Equivalence Codes," Duane Morris Alert, August 4, 2022
• Co-author, "FTC Publishes Proposed Changes to Guides Concerning the Use of Endorsements and Testimonials in Advertising," Duane Morris Alert, June 28, 2022
• Co-author, "FDA Issues Guidance on Compounding Animal Drugs from Bulk Drug Substances," Duane Morris Alert, April 20, 2022
• Co-author, "FDA Issues Final Guidance on Initiation of Voluntary Recalls," Duane Morris Alert, March 16, 2022
• Co-author, "District Court of Delaware Rules for Generic Pharma's Use of Skinny Label, but Permits Induced Infringement Suit to Proceed Against Insurer," Duane Morris Alert, February 10, 2022
• Co-author, "FDA Issues Draft Guidance on Content of Premarket Submissions for Device Software Functions," Duane Morris Alert, December 6, 2021
• 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