Jake Holdreith, Robins Kaplan Receive 2022 LMG Life Sciences Awards

Robins Kaplan LLP is pleased to announce that LMG Life Sciences has named Jake Holdreith Hatch-Waxman Litigator of the Year – Generic, and awarded the firm Impact Case of the Year for its work in Collegium v. Purdue (PTAB 2021). The firm was also shortlisted for Hatch-Waxman Litigation Firm of the Year – Generic, as well as for Inter-Partes Review Firm of the Year.

Holdreith is a member of the firm’s executive board and leader of the firm’s Health and Life Sciences Group. He has tried jury cases to multi-million-dollar verdicts and resolved complex cases at all stages of litigation. He is a skilled and creative strategist and business counselor who can cut to the heart of a matter in the boardroom and the courtroom.

A significant portion of Holdreith’s practice is dedicated to helping pharmaceutical companies get their biosimilar, 505(b)(2), and ANDA products to market fast and defend their exclusivities. His numerous litigation victories have allowed clients to commercialize products or have resulted in licenses permitting clients to enter the market. In addition to providing strategic counseling during due diligence and formulation development, he is known for providing exemplary representation in Hatch-Waxman, biosimilar, and brand-on-brand pharmaceutical litigation.

With Holdreith at the helm, the firm’s eight-year representation of Collegium has included Hatch-Waxman litigation that supported the launch of Xtampza® ER prior to expiration of Orange Book listed patents asserted by Purdue, the successful defense of Xtampza’s exclusivity against a generic challenge from Teva, and ongoing litigation related to Collegium’s Belbuca and Nucynta products.

In a related case at the U.S. Patent Trial and Appeal Board (PTAB), for which LMG Life Sciences has recognized the firm, the PTAB instituted trial for a transitional patent—not otherwise eligible for PGR—based on a showing that it was not entitled to its effective filing date because it lacked written description and enablement support. In November 2021, after more than 18 months of trial, Robins Kaplan secured a first-of-its-kind decision at the PTAB in favor of Collegium: the PTAB rejected Purdue’s novel argument that its own bankruptcy divested the PTAB of its ability to issue a final written decision and found that the patent was invalid for lack of written description and anticipation. The Robins Kaplan PGR team includes Chris Pinahs, Cyrus Morton, Oren Langer, Emily Tremblay, and Brenda Joly.  

“We are grateful for our partnership with Collegium and its outstanding team,” Holdreith said.

The full list of 2022 LMG Life Sciences Awards winners is available here.