Biologics and Biosimilars
Protecting complex science in an emerging industry
The Biologics Price Competition and Innovation Act (BPCIA) opened the door for companies to seek FDA approval to manufacture and sell biosimilar or interchangeable versions of brand name biological products. Due to the size and complexity of biological products, as compared to small molecule drugs, a biosimilar must be “highly similar” to the reference product with “no clinically meaningful differences” between the two. The BPCIA also provides reference product sponsors with 12 years of market exclusivity, but unlike the Hatch-Waxman Act, it does not require reference product sponsors to list patents in an Orange Book equivalent and does not include an automatic 30-month stay of FDA approval upon the timely filing of a lawsuit. The BPCIA, however, does provide pre-litigation procedures for the parties to follow, including identification of relevant patents and each party’s basis for infringement and invalidity.
Finnegan advises clients on virtually every intellectual property issue related to the complex and evolving area of branded biologics and biosimilars, including patent prosecution, due diligence investigations, portfolio management, and litigation. Our team comprises some of the most experienced life science intellectual property attorneys in the industry with an in-depth understanding of the complex legal, technical, regulatory, and business issues surrounding biologics and biosimilars, and how those issues impact our clients. Our life science practice includes more than 100 attorneys and professionals dedicated to serving our clients’ intellectual property needs. Many of our professionals hold advanced degrees in relevant scientific disciplines such as biology, chemistry, biochemistry, medicine, pharmacology, or biomedical engineering. A significant number have substantial research and/or industry experience, and many joined Finnegan after holding positions in industry, at universities, or as examiners with the U.S. Patent and Trademark Office.
Comprehensive legal, technical, and strategic experience protecting innovations
Our attorneys are well-equipped to work with clients to address every strategic and intellectual property issue related to branded biologics and biosimilars, including:
- Developing and executing patent prosecution strategies to maximize protection of biologic products, including for example, protection for structural and functional characteristics, methods of use, culture conditions and processes, expression systems, and corresponding diagnostic tests;
- Analyzing third party patent portfolios to develop design-around opportunities and identify potential weaknesses;
- Advising on biologic and biosimilar regulatory strategies that intersect with intellectual property considerations;
- Developing and implementing in-licensing and out-licensing programs;
- Conducting due diligence investigations relating to the acquisition of products, patent portfolios, and companies in the life science space;
- Instituting and defending post-grant review proceedings, including inter partes review and post-grant review; and
- Advising and litigating patent infringement and validity suits before district and appellate courts.