Ms. Carson’s practice focuses on patent litigation and patent counseling matters, including IP due diligence and licensing. She has a broad range of experience in the patent law area, having prosecuted and licensed patents and counseled patent holders in a variety of fields.
Ms. Carson has represented clients in the pharmaceutical, biotechnology, chemical, medical device, consumer healthcare, consumer electronics and semiconductor fields. In a landmark victory in Wyeth v. Kappos, she prevailed on behalf of Wyeth and Elan, at the district court, and in the government’s appeal to the Federal Circuit. The case successfully challenged 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. The victory resulted in significant patent term being added to the patents at issue in that case and ultimately, to patents assigned to countless other companies as well.
Drawing on her strong scientific background and experience as a patent examiner, as well as her extensive background in patent litigation, Ms. Carson brings a broad prospective to counseling clients on patenting strategy, patenting evaluation and IP due diligence relating to transactions, including licensing, joint ventures and acquisitions. As a patent litigator with extensive trial experience, she provides patent infringement, validity and freedom to operate opinions based on practical, real-world analysis. Ms. Carson was named to The National Law Journal’s “Defense Hot List” in recognition of the jury trial verdict on behalf of Ariad Pharmaceuticals against Eli Lilly. This year, Intellectual Asset Management (IAM)Magazine identified her as one of the “World’s Leading Life Sciences Patent Litigators.”
Ms. Carson 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.
Representative Matters
- Wyeth 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.
- 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.
- 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.