Experience

Biologics

About

Biologics is part of our work in Life Sciences.

Protecting complex science in a rapidly growing industry

Introduced nearly ten years ago, the Biologics Price Competition and Innovation Act (BPCIA) opened the door for companies to seek U.S. Food and Drug Administration (FDA) approval to manufacture and sell biosimilar or interchangeable versions of brand name biological products. The BPCIA provides reference product sponsors with 12 years of market exclusivity. It also provides a statutory basis for patent litigation between the reference product sponsor and the biosimilar, as patents can provide additional exclusivity for the branded product. Unlike the Hatch-Waxman Act, the BPCIA does not require reference product sponsors to list patents in an Orange Book equivalent. Instead, it defines specific pre-litigation procedures, sometimes called the “patent dance,” that requires identification of relevant patents and each party’s basis for infringement and validity.

Understanding the law, science, and technology

Finnegan advises clients on virtually every intellectual property issue related to the complex and evolving area of biologics, including patent prosecution, due diligence investigations, portfolio management, and litigation. Our team comprises experienced life science intellectual property attorneys, who have an in-depth understanding of the complex legal, technical, regulatory, and business issues surrounding these complex molecules, and how those issues impact life science companies.

We help with:

Litigating high value products in district and appellate courts with experienced trial and appellate teams
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 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
Providing trademark prosecution and counseling services

Everyone in this industry

Experience

Advised a global investment firm on patent and life sciences regulatory aspects in respect of medicines for rare diseases and specialty care products.

Advised a global life sciences company on (non-)infringement issues relating to a chemistry-related patent covering an anti-cancer drug for treating leukemias.

Advised a pulmonary drug delivery company on (non-)infringement issues relating to inhalers.

Represented a global pharmaceutical company against a generic company on a patent covering an injectable painkilling medicine for short-term pain relief.

Advised a biopharmaceutical company on patents covering a well-known biologic medicine for treating multiple types of cancer.

Advised a global healthcare company on supplementary protection certificate (SPC) protection covering a small molecule medicine for treating leukemia.