Our life sciences, biotechnology and pharmaceuticals practice is unique in its scope and encompasses all facets of practice in these industries. We handle patent prosecutions, product licensing and acquisition, as well as issues related to product development and clinical trials, NDA filings and regulatory compliance, manufacturing, packaging, private labeling, marketing and commercialization, royalty financing and product sales. Attorneys in this practice also represent clients in dispute resolution and litigation.
Our life sciences clients include medical service providers, researchers, biotechnology companies, pharmaceutical manufacturers, medical device manufacturers and investors focused in the area of life science.
CTSW stands out for having its own patent counsel and FDA counsel. We have represented clients in patent prosecution, in design-arounds, in modifications of proposed formulations for ANDAs, and in IND applications. Our attorneys are experienced in preparing patent applications and opinions and have litigated complex commercial cases involving generic and branded drugs, cosmetics, biotechnology and diagnostic medical agents. We also understand the risks of litigation inherent in intellectual property development, and we advise companies on managing litigation so as to prevent it from overwhelming or undermining its business goals. Visit our Intellectual Property and Intellectual Property Litigation pages for more information.
We have a sophisticated licensing practice working with pharmaceutical and life sciences companies. Leveraging our experience with both intellectual property and with corporate transactions, and drawing from the best practices of our licensing work in other industries, we see the broader business context of every licensing deal so we can tailor it to each client’s business goals. We advise on collaboration agreements, development agreements, outsourcing and services agreements, IP strategy exclusive and nonexclusive license agreements, joint ventures, and strategic partnerships.
Despite our depth in life sciences, we are not a life sciences boutique. We understand the broader business needs of life sciences clients as they advance through stages of growth and pursue business opportunities. We represent clients in agreements for joint ventures, manufacturing, supply, distribution, and consulting. When clients seek or require investments to fuel growth, we ensure that these investments take place while protecting the business and preserving alignment with overall business goals.
We assist clients with responding to and complying with the FDA by devising strategies for response and sound arguments to agency representatives when appropriate and necessary. While we understand the complex and technical expertise required to navigate regulation, we are not merely technicians. We work in tandem with clients’ regulatory affairs teams and with scientists, always with the priority of grounding our legal counsel in business goals.