Patricia A. Carson, Ph.D.
Overview
Pat Carson is a partner in Kirkland's New York Office. She has established a reputation as a top litigator in the life sciences field. While she focuses her practice on patent litigation including jury and bench trials, Pat also has extensive experience counseling clients on patenting strategy, patenting evaluation and IP due diligence relating to transactions, including licensing, joint ventures and acquisitions. She has represented clients in the pharmaceutical, biotechnology, chemical, medical device, consumer health care, consumer electronics and semiconductor fields. Pat was recognized as a “Northeast Trailblazer” by The American Lawyer in 2021. In fall 2018, Pat was recognized as “Litigator of the Week” by The American Lawyer in an article entitled “It’s No Secret That Kirkland Trio Crushed This Case.” Pat has been recognized in The National Law Journal's "Defense Hot List" feature and by Intellectual Asset Management (IAM) Life Sciences 250 — The World's Leading Life Sciences Lawyers. In 2013–2014, Pat was honored in Managing Intellectual Property’s IP Stars - Top 250 Women in IP, she was also selected as a "Life Science Star" by LMG Life Sciences. She has also been consistently named among the "World's Leading Patent Practitioners" by IAM Magazine and was listed as "Recognized Practitioner" in the 2015–2017 editions of Chambers USA. Pat was also recognized for her patent work in the 2021–2024 editions of Chambers USA, noting she is “trusted IP counsel for a number of market-leading life sciences clients.”
Pat recently led the trial team in Regeneron v. Merus, prevailing on behalf of her client Merus on all counterclaims including non-infringement, invalidity and inequitable conduct. In a landmark victory benefiting not only her client Wyeth, but hundreds of similarly situated patent-holders, Pat successfully challenged the U.S. Patent and Trademark Office's interpretation of a statute designed to compensate patent holders for loss of patent term due to delays in processing applications. The victory resulted in significant patent term being added to the patents at issue in that case and to patents assigned to countless other companies as well. Pat recently acted as lead counsel for Pfizer in Pfizer v. Watson, and successfully defended the company against Watson's attempt to launch a generic version of Rapamune®, a drug used to prevent organ rejection in transplant patients.
Pat has a scientific background and experience as a patent examiner. She holds a Ph.D. in microbiology and immunology from Temple University School of Medicine. She devoted several years to postdoctoral studies at the Medical College of Virginia and the National Institutes of Health. She also spent several years in the U.S. Patent and Trademark Office as a patent examiner in the biotechnology group.
Experience
Representative Matters
Butamax v. Gevo — Defended Butamax Advanced Biofuels LLC against plaintiff Gevo, Inc.'s claims that Butamax's process for producing isobutanol infringed two of Gevo's patents. The judge granted summary judgment in favor of Butamax, holding that Butamax did not infringe Gevo's patents. The judge also invalidated one of the asserted patents on summary judgment for failing to comply with the written description and enablement requirements. Butamax's decisive victories on summary judgment obviated the need for trial.
ARIAD v. Eli Lilly — Represented ARIAD Pharmaceuticals, Inc., Massachusetts Institute of Technology, The Whitehead Institute for Biomedical Research, and The President and Fellows of Harvard College, in their lawsuit against Eli Lilly and Company ("Lilly"), claiming infringement of their pioneering U.S. patent covering methods of treating human disease by regulating NF-kB cell-signaling activity. The jury in the U.S. District Court for Massachusetts ruled unanimously in favor ARIAD et. al., finding the patent was valid and infringed by Lilly's osteoporosis drug, Evista®, and septic shock drug, Xigris® and awarded damages of approximately $65.2 million plus future damages on an ongoing basis through the patent expiration date in 2019.
Wyeth/Elan v. Kappos — Represented Wyeth (Pfizer) and Elan, in a landmark victory successfully challenging at the district court and on appeal to the Federal Circuit, the U.S. Patent and Trademark Office's interpretation of the statute designed to compensate patent holders for loss of patent term due to delays in processing applications. At the time of the Federal Circuit's decision affirming the district court's ruling in favor of Wyeth and Elan, more than 100 cases were pending in the U.S. District Court and waiting on the decision on appeal.
Pfizer/Wyeth v. Watson — Represented Pfizer/Wyeth against Watson Pharmaceuticals, Inc. over Watson's efforts to gain FDA approval to market generic sirolimus tablets, which Pfizer markets under the brand name Rapamune®. Rapamune is approved to prevent organ rejection in kidney transplant patients. The district court rejected all of Watson's invalidity theories and issued an order barring the FDA from approving Watson's generic product prior to the expiration of Pfizer's patent.
Pfizer v. Teva — Represented Pfizer against Teva Pharmaceuticals over Teva's efforts to gain FDA approval to market generic linezolid, which Pfizer markets under the brand name Zyvox®. Zyvox is a first-in-class antibiotic to treat vancomycin resistant bacterial infections. The case was resolved by settlement on favorable terms for Pfizer.
Genzyme v. TKT — Represented TKT in a patent infringement action brought by Genzyme asserting that TKT's production of its protein drug to treat Fabry disease, infringed Genzyme's patent directed to processes for making human alpha-galactosidase A. The district court ruled on summary judgment in favor of TKT (affirmed on appeal) that TKT's revolutionary gene activation technology did not infringe Genzyme's patent.
Genentech v. Amgen — Represented Genentech in a seven-year dispute regarding Genentech's pioneering patents for producing proteins recombinantly. The lawsuit, filed in the Northern District of California by Genentech, asserted infringement by Amgen's process for producing its top selling drug, Neupogen®, used to fight infections in cancer patients undergoing chemotherapy. The case ultimately settled and under terms of the settlement, Amgen agreed to make a one-time payment to Genentech.
Amgen v. Hoffmann-La Roche — Represented Hoffman La Roche in a patent infringement action brought by Amgen and tried before a jury in the U.S. District Court for the District of Massachusetts relating to Roche's new synthetic drug for treating anemia. On September 15, 2009, the Federal Circuit affirmed in part and reversed and remanded in part the district court's ruling in favor of Amgen and the two companies subsequently entered into a settlement agreement. The agreement allows Roche to market its drug prior to the last expiration date of Amgen's asserted patents.
Prior Experience
Kaye Scholer LLP (Partner)
Clifford Chance U.S. (Partner)
More
Thought Leadership
Publications
Pat's recent publications include the following:
"Implications of inter partes review proceedings on biotech/pharma litigation," Pharmaceutical Patent Analyst, Vol. 8, No. 3, pp. 65-70, June 2019
“CRISPR patents: guidance from US courts,” co-authored with Mira Atanassova Mulvaney, published by Life Sciences IP Review, 2018
Chapter 19: “Witnesses” in Evidence in Patent Cases, co-authored with Thomas Fleming, published by Bloomberg Law Book Division, 2018
"The road ahead: potential challenges facing CRISPR/Cas patents," co-authored with Ashley Ross, published by Life Sciences IP Review, November 2017
"Biomedical Patents: The Quest for Balance," co-authored with Mira Atanassova Mulvaney, published by Life Sciences IP Review, August 2016
"Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio," co-authored Chapter 7: Investigational New Drug (IND) and New Drug Applications (NDA) with Dan Forchheimer and Howard S. Suh, published by ABA Book Publishing, 2014
"Post-Therasense inequitable conduct: a pharmaceutical perspective." Pharmaceutical Patent Analyst, Vol. 2, No. 4, pp. 467-79, July 2013
"Trial Strategies in the Era of the Troll," Corporate Counsel, September 7, 2010
Written Description, Chapter in Pharmaceutical and Biotech Patent Law, published by the Practising Law Institute, 2008
Seminars
Pat also speaks frequently on topics of interest to the life sciences industry. Her most recent seminars include the following:
“Mitigating M&A Risk Through Improved Due Diligence: A Case Study from both the Target and Acquirer Perspectives,” American Conference Institute (ACI) 3rd Annual Life Sciences IP Due Diligence, November 2019, New York
"Assessing the Impact of New PTO Procedures Under the AIA on Paragraph IV Litigation," American Conference Institute (ACI) Paragraph IV Disputes, May 2013
"IP Overview for Drugs and Biologics: Hatch-Waxman, BPCIA," FDA Boot Camp, ACI March 2013
Panelist: "The U.S. District Court and ITC Judicial Perspectives," USPTO Post-Grant Patent Trials Practicing Law Institute (PLI) March 2013
Speaker: annual American Conference Institute's conference on "Maximizing Pharmaceutical Patent Life Cycles;" most recently a speaker in October 2012 on "Inequitable Conduct Post-Therasenseand How it Impacts Life Cycle Planning"
Credentials
Admissions & Qualifications
- New York
- New Jersey
Education
- Fordham University School of LawJ.D.
- Temple University School of MedicinePh.D.NIH Fellow
- Rutgers UniversityB.S.