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.
Experience
Finnegan is lead and preferred IP transactions counsel for one of the largest pharmaceutical companies in the world, handling more than 50 diligence projects each year, including all IP and related transactional aspects of the matters. The transactions span the full gamut of technologies from small molecule through biologics such as antibodies, oligonucleotides, and gene therapies. Finnegan also provides extensive assistance with post-deal integration procedures and subsequent global prosecution and portfolio strategy, ensuring a seamless transition of IP assets to the company and maximum value from acquired IP.
Finnegan is lead and preferred IP strategy counsel for one of the largest pharmaceutical companies in the world, handling all aspects of prosecution and portfolio management for multiple top-tier products for the client. The work spans the gamut from drafting and prosecution through larger strategic planning, patent term extension, and pre-litigation preparation on blockbuster small molecule and biologic products in the oncology, rheumatology, immunology, neuromuscular, and cell and gene therapy spaces.
Represented Rocket Pharmaceuticals, Inc. in district court litigation involving claims of trade secret misappropriation and breach of contract against corporate and individual defendants relating to complex treatments for genetic disorders. Obtained successful outcome including permanent injunction and other remedies against all defendants.
3:24-cv-02170, D. Or., Judge Simon
Representing Sarepta in defensive patent litigation involving Elevidys®, a one-time gene therapy for the treatment of a neuromuscular disease known as Duchenne muscular dystrophy (DMD) and in parallel offensive inter partes reviews (IPRs).
1:24-cv-00882, D. Del., Judge Andrews
Successfully represented Incyte in patent litigation, including preliminary injunction proceedings related to Sun Pharmaceuticals’ deuterated Janus kinase (JAK) inhibitor, LEQSELVI™. Case settled favorably for our client.
2:24-cv-06944, D.N.J., Judge Padin
Represented Rocket Pharmaceuticals, Inc. in district court litigation involving claims of trade secret misappropriation and breach of contract against individual and corporate defendants and relating to complex treatments for genetic disorders. Successfully opposed motion to dismiss key claims and obtained settlement with all defendants following completion of fact discovery.
1:23-cv-09000, S.D.N.Y., Judges Castel, Aaron
