John Garretson's national patent litigation and counseling practice focuses on pharmaceuticals, biotech, medical devices and information technology. He has successfully handled cases in federal courts across the country, including more than a dozen trials and appeals to the Federal Circuit, and has first-chaired cases for both domestic and international clients. He is a co-author of "U.S. Patent Litigation — 150 Questions and Answers," published in Japan, and is a contributing author to Patent Resources Group's "Pharma and Biotech Strategies — Hatch-Waxman and Litigation" (2011). He is frequently quoted in industry publications such as Ingram's, Inside Counsel, Genetic Engineering and Biotechnology News and Law360 with respect to biotech, Food and Drug Administration and pharmaceutical patent issues.

Before his legal career, Mr. Garretson was a sailing, celestial navigation and coastal charting instructor at Culver Summer Naval School in Culver, Indiana. He also served as technical director and as a board member of the Georgetown Gilbert & Sullivan Society, a community musical theater group in Washington, D.C. A former trombonist, orchestra member and occasional jazz group musician, Mr. Garretson sang baritone in the University Glee Club of New York City, a men's choral group that gives concerts in the United States and internationally. In addition, he is a member of the Samaritan’s Circle for the New York City Rescue Mission, a ministry and shelter that reaches out to New York City’s homeless population.

Representative Matters

Pharmaceuticals, Chemistry and Cosmetics

Pactiv v. Mitsubishi Gas Chemical America et al. – (activated oxygen scavengers) Lead counsel for MGCA in defense of five-patent infringement suit involving meat packaging systems incorporating gas exchange technology; case successfully resolved without payment or other obligation to plaintiff.

In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Litigation – (Amrix®) Trial counsel for plaintiffs Cephalon, Eurand, and Anesta AG in eight Hatch-Waxman cases against Mylan, Barr, Impax and Anchen relating to the skeletal muscle relaxant Amrix®.

Japan Tobacco, Inc. v. Kappos – (crystalline oxoquinoline) Lead litigation counsel for Japan Tobacco in patent term adjustment litigation relating to proper B delay calculation under 35 U.S.C. § 154(b)(1)(B).

Tyco Healthcare Group L.P. and Mallinckrodt Inc. v. Mutual and URL – (temazepam) Counsel for plaintiffs/counterclaim defendants in antitrust case based on prior Hatch-Waxman litigation relating to 7.5 mg Restoril®; obtained summary judgment on antitrust claims (ongoing).

Sciele Pharma et al. v. Mylan Labs, et al. – (Sular®) Counsel for plaintiffs in Hatch-Waxman action over Sciele’s blood pressure drug Sular®; case successfully resolved upon patent expiration.

Hoffmann-La Roche v. Mylan, v. Teva, and v. Roxane – (Xeloda®) Counsel for Roche in three Hatch-Waxman cases involving the anti-cancer drug Xeloda®.

Warner-Lambert v. Teva Pharmaceuticals – (quinapril, Univasc®) Represented intervenor and patent licensee Schwarz Pharma in litigation related to Teva’s filing of a Paragraph IV ANDA on quinapril hydrochloride.

Housey Pharmaceuticals v. Boehringer Ingelheim Corp. et al. – (Mobic®) Defended Boehringer and international sister companies against drug discovery infringement allegations related to cell-based screening assays. Won summary dismissal of case by demonstrating lack of an actionable claim under 35 U.S.C. § 271(g).

Purdue Pharma v. Faulding Inc. et al. – (Kadian®) Represented Purdue Pharma in asserting infringement of patent claims related to sustained-release opioid formulations.

International Nutrition Company v. Indena U.S.A. et al. (proanthocyanidins) Defended Indena against infringement allegations related to the administration of free radical-scavenging plant extracts.

Various counseling matters related to skin applications, including tretinoin, alpha-hydroxy acid, hydrating/emollient, liposomal and transdermal patch formulations.

Biotechnology

Boehringer Ingelheim Vetmedica v. Schering-Plough – (ResPRRS® viral vaccine) Represented Boehringer in two jury trials and intervening appeal related to Boehringer’s patented method for making modified live PRRS vaccines, resulting in a permanent injunction and multimillion dollar damages award.

Invitrogen v. Clontech – (RNase H-minus reverse transcriptase) Trial counsel for Clontech in takeover case involving replication enzymes; case settled on favorable business terms after first phase of trial.

Israel Bio-Engineering Project v. Amgen, Wyeth, Yeda and Serono – (Enbrel® (etanercept)) Represented Yeda Research & Development Company in patent litigation relating to a recombinant tumor necrosis factor binding protein; case resolved successfully on summary judgment, affirmed on appeal.

Genetic Technologies Ltd. v. Applera – (non-coding DNA; single nucleotide polymorphisms) Defended Applera Corporation (Applied Biosystems, Celera Diagnostics and Celera Genomics) against infringement allegations relating to commercial SNP assays, disease-related genetic research, and the Celera Discovery System; case successfully resolved after filing of amended answer asserting supplemental defense developed during discovery.

Roche Molecular Systems v. Promega – (PCR technology) Represented Roche in asserting infringement of patent claims related to the polymerase chain reaction, a Nobel Prize-winning technology.

Genzyme v. Transkaryotic Therapies – (Fabrazyme®) Represented Genzyme in asserting infringement of patent claims related to recombinant enzymes for treating Fabry disease. This case involved Biologics License Applications filed by both parties as well as issues arising under the Orphan Drug Act.

Ares-Serono v. Organon Int’nat’l B.V. – (Puregon® recombinant fertility hormone) Defended Organon against infringement allegations with respect to Puregon®.

Monsanto v. Pioneer Hi-Bred Int’l – (laser chippers; seed handling and sorting systems) Represented DuPont Pioneer in sixteen-patent case involving cross-claims of infringement; case successfully resolved.

Medical Devices

Palomar v. Cutera – (laser hair removal) Defended Cutera against infringement allegations relating to FDA-approved laser hair removal devices; case successfully resolved pre-trial.

Pall v. Hemasure – (blood filtration packs) Represented Hemasure in Federal Circuit appeal relating to commercial leukocyte filtration units, resulting in entry of judgment of non-infringement in Hemasure’s favor.

Bionx v. Linvatec – (meniscal implants) Defended Linvatec against infringement allegations relating to implants and implant delivery systems for repairing damaged knee cartilage; obtained summary judgment of non-infringement.

Terumo Cardiovascular Systems Corp. v. Maquet – (endoscopic vein harvesting tools) Counsel for Terumo in patent infringement action relating to Vasoview® vessel harvesting systems; case settled on favorable business terms.

RTP Pharma v. Boehringer Ingelheim GmbH – (drug formulation systems) Defended Boehringer against infringement allegations related to methods and devices for preparing fine particulate suspensions of insoluble drugs in liquids; case successfully resolved.

Schneider v. Cordis Corp. – (cardiac catheters) Represented Schneider (a division of Pfizer) in asserting patent claims related to balloon angioplasty catheters; case settled on favorable business terms.

Hardware and Software

Storage Technologies Corp. v. Cisco Systems – (flow caching software) Trial counsel for Cisco in successful defense of $3 billion infringement claim relating to Cisco’s Netflow Feature Acceleration source code; jury verdict of invalidity and no infringement.

Samsung Electronics Co. v. Renesas – (semiconductor chip lithography) ITC trial counsel for Samsung on patents relating to chip fabrication methods; case settled post-trial on very favorable terms before Commission decision.

Honeywell v. Victor Company of Japan (JVC) – (camcorder chip architecture) In takeover case, defended JVC against bifurcated allegations of willful infringement, resulting in summary judgment of no willfulness.

August Technology Corp. v. Camtek Ltd. – (semiconductor wafer inspection systems) Trial counsel for Camtek in defense of infringement allegations relating to Falcon® optical inspection tools.

StrikeForce Technologies v. PhoneFactor Corp. – (multi-factor authentication) Lead counsel for PhoneFactor in defense of infringement claims relating to secure computer access (ongoing).

Oracle Corp. v. Rimini Street – (ERP software) Representing Rimini Street in defense of copyright infringement claims relating to enterprise resource planning software (ongoing).

Sprint v. Comcast – (SONET) Trial counsel for Sprint on patents relating to synchronous optical networking; obtained multimillion dollar jury verdict (ongoing).

Sprint v. Comcast, Cox and TimeWarner Cable – (voice over packet, SONET and cable technology) Representing Sprint in series of cases in multiple jurisdictions relating to architectures for providing telecommunication and data services (ongoing).

McRo, Inc. v. Sony Computer Entertainment America LLC et al. - (facial animation software) Representing SCEA in defense of infringement claims relating to game character speech animation.

Publications

Herman H. Yue & John D. Garretson, Skinny Labeling after Hospira v. Burwell: An End-Run around Pharmaceutical Method of Use Patents?, Food and Drug Law Institute's Update, July/August 2015.

Litigating Patent Cases: Industry-Specific Developments, Issues and Strategies, (book chapter), Recent Trends in Patent Infringement Lawsuits, Aspatore’s Inside the Minds™ series (2013 ed.).

John D. Garretson and Elena K. McFarland, It’s (Not) Only Natural, Corporate Counsel (June 2012). 

John Garretson and Ben Tabor, "America Invents Act": The Impact of Patent Reform, 5:35 Bloomberg Law Reports: Intellectual Property (August 2011). 

150 Questions and Answers about U.S. Patent Litigation (co-author), with Abe, Ikubo and Katayama in Japan (2011).

Biotechnology: Patent Prosecution, Licensing, Litigation and Hatch-Waxman (co-author, two-volume set), Patent Resources Group (2011).

J.D. Garretson and L.M. Pringle, Patenting More than a Mere Idea: Testing the Bounds of Enablement, Journal of Industrial Biotechnology 5(4): 227-229 (2009).

J.D. Garretson, Major Changes Ahead – U.S. Patent Reform and Follow-On Biologics, BIOforum Europe 6-7: 16-17 (2009).

T.E. DeMasi and J.D. Garretson, Willful Patent Infringement Law Needs Reform, New York Law Journal (July 28, 2003).

J.D. Garretson and P.E. Neumann, Further Evidence that a Mouse Chromosome 4 Locus Influences Cerebellar Folial Pattern, Brain Res. 630: 221-25 (1993).

P.E. Neumann, J.D. Garretson, G.P. Skabardonis, and G.G. Mueller, Genetic Analysis of Cerebellar Folial Pattern in Crosses of C57BL/6J and DBA/2J Inbred Mice, Brain Res. 619(1-2): 81-88 (1993).

Presentations

Incorporating IPR Into Biosimilar Litigation Strategies, American Conference Institute's 6th Annual Summit on Biosimilars, New York, NY; panel presentation (June 2015).

Inter Partes Review and Pharma/Bio Patent Litigation, New York, NY (February 2015).

Going Beyond the Hatch-Waxman Comparisons: Delving into Pre-Suit Due Diligence and Pre-Litigation Tactics for Evaluating Patent Strength and Assertion Strategies, American Conference Institute's 5th Annual Summit on Biosimilars, New York, NY; panel presentation (June 2014).

Non-Practicing Entities, Rochester Intellectual Property Law Association IP CLE, Rochester, New York (October 2013); with Phil S. Goldberg.

Estimating Patent Damages: Which Model to Choose?, DuPont Widener IP CLE, Wilmington, Delaware (October 2013).

Preparing for the Impending Reality of Biosimilars Patent Litigation: Immediate Action Plans for the First Wave, American Conference Institute’s 4th Advanced Forum on Biosimilars; New York, NY; panel presentation (June 2013).

Protecting Your Company’s Intellectual Property, FDCC Corporate Counsel Symposium; Philadelphia, Pennsylvania; panel presentation (September 2012).

New Procedures for 3rd Party Submission of Prior Art, Supplemental Review and Post-Grant Validity Challenges and Changes in Litigation Issues, Lawyers Association of Kansas City's 4th Annual IP CLE; Kansas City, Missouri (December 2011).

Hatch-Waxman: Strategic Planning in View of Supreme Court, FOA, FTC and Legislative Developments, American Association of Corporate Counsel Seminar; Orange County, California (September 2011).

Biotech and Pharmaceutical Patents at the Federal Circuit: 2010 Year in Review, Boston, Massachusetts (January 2011).

Biotech, Pharma and General Patent Seminars co-sponsored with the Oh-Ebashi law firm; Osaka, Japan (November 2010; November 2009).

Special Discovery Issues in Pharmaceutical and Biotech Litigation: Reducing Costs While Maintaining Control Over the Process, AIPPI Seminar; Tokyo, Japan (May 2009).

U.S. IP Law – Recent Major Developments, Field Fisher Waterhouse IP Crammer; London, United Kingdom (October 2008).

Worthwhile Patents (What Makes the Lawyers Say “Yes”?), Pharma and Biotech Licensing Summit; Philadelphia, Pennsylvania (May 2008).

When is an Invention Obvious? Practical Implications for Dealing with Shifting Legal Standards, Munich, Germany (January 2008).