- Overview
- Experience
- Insights
- Recognition
About Brian
Mr. Coggio is of counsel to the New York office of Fish & Richardson P.C. He has extensive law firm experience as a senior trial attorney and counselor and has litigated disputes across a wide range of technologies with a particular focus in chemical, pharmaceutical, medical device, and biotechnology. He has also been involved in cases before the U.S. International Trade Commission and in various foreign countries including Germany, Great Britain, Switzerland, Italy, and the Netherlands. In addition, Mr. Coggio has also represented clients in numerous cases under the Hatch-Waxman Act and has written and lectured extensively on this and related topics in this country, Europe, Canada and Japan. He is presently an adjunct professor at Fordham Law School and, before that, at New York Law school, where he teaches a course in patent litigation.
Teaching Positions
- Adjunct Professor, Fordham Law School (1999-present)
- Adjunct Professor, New York School of Law (1995-1998)
Publications
- “Regenxbio v. Sarepta: Make Sure You’re Safely Within the Safe Harbor Before Using a ‘Research Tool,'” IP Litigator (March/April 2022)
- “Eli Lilly vs Fresenius Kabi: A Continued Balancing Act for Doctrine of Equivalence?” European Summit on Pharma and Biotech Patent Litigation (March 16, 2022)
- “REGENXBIO v. Sarepta: Make Sure You’re Safely Within the Safe Harbor Before Using a ‘Research Tool,” Fish Litigation Blog (January 19, 2022)
- “Users of Research Tools Take Note,” Fish Litigation Blog (June 4, 2021)
- “First Circuit Finds Device Patent Improperly Listed in the Orange Book,” IP Litigator (September 2020)
- “Attorneys for Branded Companies Should Carefully Review ANDAs for Admissions Regarding Generic Infringement,” Fish Litigation Blog (August 2020)
- “First Circuit Finds Device Patent Improperly Listed in the Orange Book,” Fish Litigation Blog (June 2020)
- “Generic Drug Labeling and Induced Patent Infringement,” Fish Litigation Blog (June 2020)
- “Overview of Approaches to Compulsory Licensing,” Fish IP Law Essentials Blog (May 2020)
- Also published in Vol 40 (7) The Licensing Journal page 1 (Aug. 2020)
- “Prodrugs – Federal Circuit Holds That A PTE Does Not Cover Their Metabolites,” Fish IP Law Essentials (May 2020)
- “Potential Ways for Avoiding the Presumption of Prosecution History Estoppel of an Allowable Dependent Claim Depending from a Rejected Independent Claim,” Fish Patent Blog (April 2020)
- “Biosimilars: Comparison between Canada, US and Europe,” Smart & Biggar’s “Rx IP Update” (November 2019)
- “Ensnarement Defense To Doctrine of Equivalents Succeeds On Summary Judgment,” Fish Litigation Blog (November 2019)
- “The Doctrine of Equivalents and Its Limitations, Including ‘Ensnarement,’ a Particularly Potent Defense,” IP Litigator (September/October 2019)
- “California Court Confirms that Venue Does Not Require a Nexus Between an ‘Act of Infringement’ and a ‘Regular and Established Place of Business,’” Fish Litigation Blog (September 2019)
- “A District Court Split on Hatch-Waxman Venue Determinations,” Law360 (August 2019)
- “Venue in Hatch-Waxman Actions is Governed by 28 U.S.C. § 1400(b) Not § 1391(b),” Fish Litigation Blog (May 2019)
- “Court Confirms ‘Unique’ Pleading Requirements in Hatch-Waxman Actions,” Fish Litigation Blog (April 2019)
- “Who can be a Defendant in Biosimilar Patent Litigation?” Law360 (April 2019)
- “Comparison of the Hatch-Waxman Act and the BPCIA,” Fish Life Sciences (March 2019)
- “Litigation-Related Issues Under the Biologics Price Competition and Innovation Act,” Biosimilars. AAPS Advances in the Pharmaceutical Sciences Series, Vol 34. Springer (January 2019)
- “Canada’s New Linkage Litigation Scheme: A Comparison to Hatch-Waxman,” Smart & Biggar (January 2019)
- “Should Stockpiling Be Protected by the Hatch-Waxman Safe Harbor?” Fish Litigation Blog (September 2018)
- “Ensnarement — A 2nd Bite At The Noninfringement Apple,” Law360 (August 2018)
- “Searching For ‘Act Of Infringement’ Under Hatch-Waxman,” Law360 (March 2018)
- “Canada’s New Linkage Litigation Scheme: A Comparison to Hatch-Waxman,” Lexology (December 2017)
- “U.S. Supreme Court Provides Limited Guidance Regarding Biosimilar Patent Litigation,” 16 BioScience Law Review 153 (2017)
- “The Unclear Scope Of ‘All Patent Rights’ In Patent Exhaustion,” Law360 (September 2017)
- “A Review Of Willfulness Findings In Hatch-Waxman Actions,” Law360 (September 2017)
- “Has Amgen Already Won Its BPCIA Dispute With Sandoz?” Law360 (August 2017)
- “Reviving ‘Regular And Established Place Of Biz’ Case Law,” Law360, (June 2017)
- “Safe Harbor in the United States and Europe,” Pharmaceutical Law & Industry Report, 14 PLIR 47 (December 2016)
- “Can Reference Product Sponsor Forfeit Right To Sue Under BPCIA?” Law360 (July 2016)
- “What the Court Got Wrong About Hatch-Waxman in Alcon,” Law360 (February 2016)
- “Fed. Cir. Limits Safe Harbor for Post-Approval Conduct,” Law360 (November 2015)
- “Safe Harbor Protects Supplier of Active Ingredient for ANDA,” Law360 (September 2015)
- “Process Patents Are Vital In Biotech — Why Not Extend Them?” Law360 (August 2015)
- “Hatch-Waxman Action: Who Do You (Can You) Sue?,” Pharmaceutical Compliance Monitor (June 2015)
- “Commil v. Cisco – Who Really Won?” IP Law360 (June 2015)
- “Personal Jurisdiction in Hatch-Waxman Actions in view of Daimler,” Pharmaceutical Compliance Monitor (June 2015)
- “Post-Approval Conduct and the Hatch-Waxman Safe Harbor,” Pharmaceutical Compliance Monitor (April 2015)
- “The Trouble with Commil is DSU,” Law360 (January 2015)
- “Inter Partes Review by Hatch-Waxman Competitors Will Likely Increase Because of the Effect of IPR Decisions on the 30-Month Stay,” BioTechnology Rept. Vol 33, No. 6:249-51 (December 2014)
- “Is Stockpiling Protected By Hatch-Waxman Safe Harbor?,” Law360 (November 2014)
- “Drug Labels Can Provide Specific Intent for Inducement,” IP Law 360 (October 3, 2014)
- Cited in the Brief for the United States as Amicus Curiae supporting the Petition for Certiorari, in Commil USA, LLC v. Cisco Systems, Inc., Nos. 13-896 and 13-1044.
- “IPR’s and the Hatch-Waxman 30-Month Stay of FDA Approval,” Fish Litigation Blog (August 2014)
- “A Common Sense Discussion of Patenting Medical Diagnostics,” Genetic Engineering & Biotechnology News (April 2014)
- “In Vivo Conversion as Inducement to Infringe,” Pharmaceutical Compliance Monitor (February 2014)
- “Hatch-Waxman Safe Harbor Expansion continues,” Fish Litigation Blog (February 2014)
- “Research Tools and the Hatch-Waxman Safe Harbor,” 22 Biotechnology Law Report 1 (November 2014)
- “License to Infringe on Research Tool Patents,” 33 Genetic Engineering & Biotechnology News 10 (October 2013)
- “The Patentability of Drug Enantiomers,” 190 N.J.L.J. 51 (October 2007)
- “Scope of the Safe Harbor Exemption of the Hatch-Waxman Act After Merck v. Integra Lifesciences,” 15 Fordham Intellectual Prop. L.J. (2005)
- “Overview of Patent Litigation,” 11(1) IP Litigator 1 (2005)
- “‘CREATE’ Act of 2004 Extends ‘Safe Harbor’ Aspects of Patent Laws,” N.Y.L.J. 4 (February 2005)
- “The Right to a Jury Trial in Actions for Patent Infringement and Suits for Declaratory Judgment,” 13 Fordham Intellectual Prop. L.J. 205 (2002)
- Reprinted as Chapter 21, “Survey of Developments of Intellectual Property and Technology Law,” WebCredenza, Inc. (2004)
- “New Horizons in Patent Litigation: Discovering Electronic Information,” N.Y.L.J. S4 (October 2004)
- “Recent Federal Circuit Decisions of Significance to Biotech/Pharmaceutical Practitioners”, Biotechnology & Pharmaceutical Law, Practising Law Institute (October 2004)
- “Electronic Discovery: Where We Are and Where We are Headed,” 16 Int’l Prop. & Tech. L.J. 16 (March 2004)
- “Recent Developments Regarding The Hatch-Waxman Act,” N.Y.L.J. S2 (January 2004)
- “Can the Seventh Amendment Ever Require That the Defense of Inequitable Conduct be Presented to a Jury?,” 9 (7) IP Litigator 1 (2003)
- “The Period of Liability for Patent Infringement,” 10(7) IP Today 36 (2003)
- “Overview Of Patent Litigation,” What Every Litigator Must Know About Intellectual Property 2003, Practising Law Institute (July 2003)(Updated July 2004)
- “Patent Disputes: Litigation Forms and Analysis,” Battersby & Grimes (2003)
- “Trademark & Copyright Disputes: Litigation Forms and Analysis,” Battersby & Grimes (2003)
- “Disqualification of Opinion Counsel as Trial Counsel When an Advice of Counsel Defense is Asserted,” 9(2) IP Litigator 11 (2003)
- “Integra Life Sciences I Ltd. v. Merck KGaA: Exemptions For Research Tool Patents,” 9(3) IP Strategist 6 (2002)
- “Court is Taking a Dim View of Best-Mode Defense,” 25(12) Nat’l L.J., Sec. C. (November 2002)
- “The Safe Harbor Provision of the Hatch – Waxman Act: Present Scope, New Possibilities, and International Considerations,” 57 Food Drug L.J. 161 (2002)
- “The Right to a Jury Trial Under the Waxman-Hatch Act – The Question Revisited and Resolved,” 57 Food Drug L. J. 1 (2002)
- “The Identification and Selection of Expert Witnesses,” 6(3) IP Litigator 1 (2000)
- “Adequate Notice: The Key to Obtaining Pre-Suit Damages in Patent Infringement Actions,” 6(2) Met. Corp. Counsel 20 (1998)
- “Arbitration of Patent Infringement Disputes,” 6(3) Metropolitan Corp. Counsel 13 (1998)
- “Avoiding Patent Infringement During the Drug Approval Process,” N.Y.L.J. S4 (March 1998)
- “The Application of the Patent Laws to the Drug Approval Process,” 52 Food Drug L.J. 345 (1997)
- “The Right to a Jury Trial in Actions Under the Hatch-Waxman Act,” 52 Food Drug L.J. 259 (1997)
- “Developing Pharmaceutical Products Without Fear of Patent Infringement,” 5(6) Met. Corp. Counsel (1997)
- “Are Clinical Trials Conducted to Obtain FDA Approval Fatal to Patent Validity?” 5(4) Met. Corp. Counsel (1997)
- “The Utilization of U.S. Patents to Prevent the Importation and Sale of Gray Goods,” 83 Trademark Rptr. 481 (1993)
- “The Exercise of Patent Rights Through Multiple Exclusive Field-of-Use Licensing,” 4 Rutgers Comp. & Tech. L.J. 383 (1985)
- “History and Present Status of Gray Goods,” 75 Trademark Rptr. 433 (1985)
- Reprinted in Common Market and International Antitrust: A Comparative Guide (Prentiss Hall 1986)
Speaking Engagements
- “Examine Practical Approaches to Achieve Maximal Exclusivity,” Life Sciences Strategy Summit on IP & Exclusivity, Munich, Germany (October 12, 2022)
- “REGENXBIO v. Sarepta: Make Sure You’re Safely Within the Safe Harbor Before Using a ‘Research Tool,” Fish Litigation Blog (January 19, 2022)
- “The Evolution of Safe Harbours and Patent Exemptions in Europe and the United States: Understanding the Expanding Reformation to Patent Infringement,” C5’s Pharma & Biotech Patent Litigation in Europe Conference (February 23, 2021)
- “Navigating to the Safe Harbor: What to Know in Advance,” Fish Life Sciences Webinar Series (July 2020)
- “Antitrust Implications of Biologic Patent Settlements,” Fish Life Sciences Webinar (July 2020)
- “Biologics & Biosimilars: Innovator Versus Competitor,” C5’s 10th Pharma & Biotech Patent Litigation Conference (February 2018)
- “Litigating Biosimilars,” C5’s Life Sciences IP Summit (October 2017)
- “Understanding the U.S. Safe Harbor, and Regulatory and Research Safe Harbors in the EU/Canada,” Fish Litigation Webinar (January 2017)
Mr. Coggio consults various pharmaceutical companies on aspects of the Hatch-Waxman Act and prepares validity and infringement opinions on life sciences issues. For example, most recently, he was in charge of a worldwide patent analysis of hundreds of medical device patents dealing with drug delivery systems.
Hoffman-La Roche. He is lead counsel for Roche in four Hatch-Waxman actions involving the drug XELODA® against Mylan, Teva, Roxanne, and Accord respectively. The cases are pending in the District Court of New Jersey.
Boehringer Ingelheim. In Novartis v. Ben Venue, a Hatch-Waxman action he was lead counsel representing Ben Venue, a subsidiary of Boehringer Ingelheim. He secured a summary judgment of non-infringement, later affirmed by the Federal Circuit.
Bristol-Myers Squibb. He was lead counsel representing Bristol-Myers in Zenith v. Bristol-Myers Squibb, a declaratory action judgment involving the pharmaceutical cefadroxil and related to the Hatch-Waxman Act. The case established the principle of infringement by in vivo conversion of a non-patented product into patented pharmaceutical after ingestion.
Alcon Laboratories. He was part of a team representing Alcon in two Hatch-Waxman actions involving drugs for intraocular administration. Both litigations were successfully resolved on summary judgment in Alcon’s favor.
Marion Merrill Dow. In Marion Merrill Dow v. Geneva and Marion Merrill Dow v. Par Pharmaceuticals, both Hatch-Waxman actions, he was lead counsel asserting infringement of the client’s patent covering a metabolite of the antihistamine terfenadine (Seldane®). In the course of both litigations, various motions for summary judgment of invalidity and/or non-infringement were overcome. He was also involved in related litigations in the Supreme Court of Germany and in the House of Lords.
Bruker Daltonics. In Extrel v. Bruker, he was retained to prosecute the appeal from a decision in which Bruker had been found liable for infringement. Sales of the alleged infringing product, FTICR mass spectrometers, were enjoined, and awards of increased damages and attorney fees had been entered. On appeal, the Federal Circuit reversed the finding of infringement and vacated the injunction and all monetary awards against the client.
Hoechst Marion Roussel. In actions before the International Trade Commission and various district courts, he was lead counsel and led a large team that asserted that methods of producing diltiazen (Cardizem© CD) used by various defendants infringed a patent licensed to Hoechst by Tanaka Seiaku. The lengthy trial before ITC involved examination and cross-examination of witnesses who spoke Japanese, Finnish, Italian, German, or Hebrew.
Hoffmann-La Roche. He was lead counsel for Roche in a patent infringement action instituted by Chiron involving the latter’s patents covering various aspects of the gene encoding the hepatitis C virus. In addition, he coordinated related litigations in the Netherlands, France, Germany, Switzerland, Italy and Japan. He and his team were instrumental in obtaining a favorable worldwide settlement of all the litigations.
Hewlett-Packard. In two district court trials and related appeals to the Federal Circuit in disputes between Hewlett-Packard and Bausch & Lomb involving X-Y plotters, he was part of a team that successfully represented Hewlett-Packard against accusations of patent infringement. Moreover, the team established willful infringement by Bausch & Lomb of Hewlett-Packard’s own patent. As a result, Hewlett-Packard recouped all attorney fees from its adversary.
Hoffmann-La Roche. Throughout his career, he has been counsel to Roche and its foreign subsidiaries, including Nippon Roche and Roche GmbH, in various patent infringement litigations in which Roche has asserted patents covering alpha interferon. Recently, he was involved in related worldwide litigation involving a modified form of interferon (pegylated interferon) marked by Roche as Pegysys®. Most recently, in ICN Pharmaceuticals v. Hoffmann-La Roche, he was lead counsel representing Roche in a Hatch-Waxman action involving the pharmaceutical product ribavirin. That litigation was eventually settled. He was also lead counsel to Roche in a multi-defendant litigation instituted by Housey Pharmaceuticals against numerous pharmaceutical companies involving so-called research tool patents. After a successful result at a Markman hearing, the patentee conceded both invalidity and non-infringement. The ruling was affirmed by the Federal Circuit.
U.S. Biochemical. In Harvard Medical School and U.S. Biochemical v. Pharmacia, he was lead counsel representing plaintiffs in a patent infringement action asserting infringement of a patent covering T7 DNA polymerase used in DNA sequencing. The successful result included the entry of a worldwide license agreement.
Bruker Daltonics. He was lead counsel representing Bruker and Agilent in Finnigan v. Bruker before the International Trade Commission. After a three-week trial, the Administrative Trial Judge held for Bruker. This decision was affirmed by the full commission and by the Federal Circuit. He also coordinated related litigations in U.S. district court and in Germany and Switzerland.
American Cyanamid. In Ethicon v. American Cyanamid, he was part of a team that represented the defendant-patentee who sued Ethicon (a division of Johnson & Johnson) for infringement of a patent covering synthetic absorbable sutures. After 72 days of trial, the case was settled in favor of Cyanamid. He also coordinated related litigations in England, France, and Germany, all of which were successfully resolved.
National Starch. In a patent/trade secret litigation instituted by Air Products, he was lead counsel for National Starch in the trade secret action and defeated claims that the client had misappropriate 13 separate trade secrets.
- “2013 Top Rated – AV® PreeminentTM,” Lawyers in Intellectual Property Law
- Mr. Coggio presented on life sciences issues and the world, including the U.S., Japan, Great Britain, Germany, the Netherlands, France, Japan, and Switzerland
Services
Industries
LL.M., Trade Regulations, New York University School of Law (1980)
J.D. cum laude, Fordham University School of Law (1974) Editor, Fordham Law Review
B.S., Chemical Engineering, Manhattan College (1971)
- U.S. Patent and Trademark Office 1975
- New York 1975
- U.S. Court of Appeals for the Federal Circuit
- U.S. District Court for the Eastern District of New York
- U.S. District Court for the Southern District of New York
What's trending with Brian
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Event
October 11th, 2022 | 4:00 pm CET
Life Sciences Strategy Summit on IP & Exclusivity
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News
March 31, 2022
Fish Attorneys Author IP Litigator Article, "Regenxbio v. Sarepta: Make Sure You’re Safely Within the Safe Harbor Before Using a 'Research Tool'"
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Event
March 15th, 2022 | 8:00 am CET
European Summit on Pharma and Biotech Patent Litigation
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Blog
January 19, 2022
REGENXBIO v. SAREPTA: Make Sure You’re Safely Within the Safe Harbor Before Using a “Research Tool”
Authors: Kelly Allenspach Del Dotto, Brian D. Coggio
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Blog
June 4, 2021
Users of Research Tools Take Note
Author: Brian D. Coggio
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Event
February 23rd, 2021 | 8:00 am CET
C5 13th Annual Pharma & Biotech Patent Litigation in Europe
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Blog
August 5, 2020
Attorneys for Branded Companies Should Carefully Review ANDAs for Admissions Regarding Generic Infringement
Authors: Brian D. Coggio, Katie Ning
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Blog
June 26, 2020
First Circuit Finds Device Patent Improperly Listed in the Orange Book
Authors: Kayleigh E. McGlynn, Brian D. Coggio
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Event
July 21st, 2020 | 1:30 pm EDT
Webinar | Navigating to the Safe Harbor: What to Know in Advance
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Event
July 7th, 2020 | 1:30 pm EDT
Webinar | Antitrust Implications of Biologic Patent Settlements
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Blog
June 4, 2020
Generic Drug Labeling and Induced Patent Infringement
Authors: Karrie Wheatley, Ph.D., Brian D. Coggio, Geoffrey D. Biegler
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Blog
May 21, 2020
Overview of Approaches to Compulsory Licensing
Authors: Cheryl Wang, Brian D. Coggio, Sushil Iyer, Ph.D.