K. Nicole Clouse, PhD, focuses her practice on patent infringement litigation on behalf of pharmaceutical, biotech and medical device clients. Her cases have involved monoclonal antibody biologics, small molecule drugs, vaccines, therapeutic regimens and biologics manufacturing.
Nicole also has extensive transactional IP experience on behalf of life sciences clients, including the preparation, prosecution and strategic management of complex international patent portfolios; patent-related opinion work, such as freedom to operate, patentability, invalidity, non-infringement and litigation avoidance analyses; interpretation and enforcement of licensing and research collaboration agreements; and development and implementation of IP strategy in the context of large corporate divestitures.
While in law school, Nicole was a member of the BU Law Intellectual Property Law Society. She is also a published author in peer-reviewed scientific journals. Nicole earned her doctoral and master’s degrees in molecular biology and her bachelor’s degree in biological chemistry. Combined with her legal knowledge, Nicole’s deep technical knowledge allows her to simultaneously consider both legal and scientific issues when evaluating problems and formulating strategy, and to make highly complex scientific concepts accessible and clear to the layperson.
Represents Amgen in a patent litigation against Sanofi and Regeneron concerning therapeutic monoclonal antibodies against the IL-4 receptor for treatment of inflammatory conditions (D. Mass. and C.D. Cal.)
Represents Amgen in a patent litigation against Sanofi and Regeneron concerning therapeutic monoclonal anti-PCSK9 antibodies for the treatment of high cholesterol (D. Del. And Federal Circuit)
Represented Novartis Vaccines & Diagnostics in a patent litigation against Microbix involving improved methods for manufacturing egg-based influenza vaccines (E.D. Tex., with companion cases in Italian and German courts)
Represented Seikagaku and Zimmer in a patent litigation against Genzyme involving a hyaluronic acid–based medical device for treatment of osteoarthritis (D. Mass.); this case was named 2013 Regional Impact Case in the Benchmark Litigation Annual Awards and a finalist for 2013 Client Advisor Awards/Large Professional Services Firm
Represented Sandoz in three different Hatch-Waxman patent disputes (D.N.J. and D. Del.)
Represented Novartis Pharma in a patent litigation against Biogen, MedImmune, and Alexion involving systems and vectors for protein expression (D. Del.)
Served as IP counsel to Novartis Vaccines and Diagnostics with respect to the $7B sale of its vaccines business to GSK and the sale of its influenza vaccines business to CSL
Represented a small pharmaceutical company in pursuing allegations of patent infringement against a larger competitor in the United States, the UK and China; coordinated a “trap purchase” and analytical testing of the infringing product in all three jurisdictions, and sent cease and desist letters that led to cessation of infringement
Advised a large pharmaceutical company with respect to the license of a patent to a competitor; the parties disputed whether the licensee’s blockbuster drug fell within the scope of the license, and the parties reached a settlement with very favorable financial terms for our client
Advised a large pharmaceutical company in defending allegations, made by its research collaborator, of trade secret misappropriation, breach of confidentiality and improper patent ownership; participated in negotiations that resulted in a settlement that was not only favorable to our client, but also helped salvage the ongoing business relationship between the parties
Courts / Agencies
Cour d’appel des États-Unis pour le circuit fédéral
US Court of Appeals for the First Circuit
US District Court for the District of Massachusetts
US District Court for the Eastern District of Texas
US Patent and Trademark Office
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