Publications & Presentations
February 2018
Polsinelli is proud to announce that Principal Timothy A. Worrall, Ph.D. and Shareholder David W. Clough, Ph.D. are featured presenters for the Biosimilars track of the Life Sciences Market Access and Commercialization Summit in Philadelphia, Pennsylvania. The conference draws market access and commercialization professionals and key external stakeholders to collaborate on common challenges, discuss evolving opportunities for innovative product launches, and establish best practices for payer engagement. The summit features four co-located focus tracks: Biosimilars, Oncology, Rare Diseases, and Cell and Gene Therapies.

Preparing the Field: Patent Strategy in Patent Dance-Optional World, February 7, 2018, 9:45 AM

Presented by: Timothy A. Worrall, Ph.D. and David W. Clough, Ph.D.

In the 2017 Sandoz v. Amgen decision, the Supreme Court held that several provisions of the Biologics Price Competition and Innovation Act (BPCIA) cannot be enforced by federal injunction. The Federal Circuit Court of Appeals held that the BPCIA pre-empts state law remedies for failure to comply with provisions of the BPCIA. Biosimilar makers now will have to give serious consideration to the extent to which they wish to engage in the “patent dance,” in which biosimilars and innovators exchange information on a prescribed timeline. Post-grant proceedings such as Inter Partes Review provide alternative avenues to challenge patent validity as part of a larger strategy. As several early biologics fall off a patent cliff, biosimilar makers and biologics innovators should consider eventual patent litigation strategies in developing patent portfolios.

The session features:
  • A discussion of strategic considerations for engaging in the patent dance from an innovator and biosimilar perspective
  • Strategies for developing biologics patent portfolios in the era of patent dance and litigation alternatives
  • The biologics patent cliff and consequences for the biosimilar industry