Blake, Chair of Hatch, Waxman, & Biologics Litigation for Cozen O’Connor, focuses his practice on patent litigation and counseling for clients in the biotechnology and pharmaceutical industries.
A registered patent attorney, Blake has deep subject-matter knowledge in the areas of biochemistry, molecular and cellular biology, gene synthesis, recombinant DNA technology, immunology, pharmaceuticals, therapeutic methods, diagnostic assays, and vaccines.
He counsels pharmaceutical companies in the areas of Paragraph IV design strategies, Hatch-Waxman litigation, and biosimilar market opportunities. Blake’s broader experience includes preparing patentability, infringement, and invalidity opinions; prosecuting U.S. and foreign patent applications; developing patent portfolios; advising on complex IP licensing and transactional due diligence; and counselling on trade secret protection, litigation avoidance, and risk management. Blake represents patent owners and challengers in inter partes reviews before the Patent Trial and Appeal Board.
Blake is not just a litigator; he’s a trial lawyer. His ability to bring clarity to complex issues through effective depositions and examinations of witnesses have led to significant victories for his clients. Blake’s notable trial wins in the pharmaceutical sector include a favorable decision of non-infringement in the first ever case to go to trial under the Biologics Price Competition and Innovation Act and the only successful defense to date of patents on a transdermal testosterone product.
In addition to his patent practice, Blake represents clients in trademark and trade secret litigation. He has represented a major river cruise company in trademark and breach of contract litigation and a group of major league baseball teams in trade secret litigation over methods for pitching a baseball.
Blake graduated from DePaul University College of Law. He earned a master’s degree in molecular cell biology from Washington University in St. Louis and his bachelor’s degree in biology, cum laude, from Birmingham-Southern College.
Outside of his legal practice, Blake enjoys volunteering as a baseball coach. He takes great pride in mentoring kids and teaching them the right way to play sports, and has taken several of his baseball teams to play in tournaments up and down the East Coast.
Earlier this year, we discussed Amgen’s petition for Supreme Court review of the Federal Circuit’s affirmance invalidating several antibody patent claims based on a lack of enablement for genus claims. At that time, we believed Amgen had a slim chance of its petition being granted—mainly because the Supreme Court denied a similar petition from Idenix in 2021 (No. 20-380, January 19, 2021).
However, on April 18, the Supreme Court invited the Solicitor General to file a brief expressing the views of the U.S. government on the questions presented. The Supreme Court’s likelihood of granting cert. in any particular case increases by about 10-fold when a Solicitor General’s brief is requested, but more importantly, the Supreme Court follows the Solicitor General’s recommendation about 75% of the time.
As we enter the second month of 2022, the old saying, “If at first you don’t succeed, try, try again” and the famous line, “I’m not dead,” from Monty Python and the Holy Grail, come to mind to describe two issues we’ll be watching closely this year relating to litigation involving small and large molecule therapies. In the first instance, Amgen recently petitioned the Supreme Court to review the Federal Circuit’s affirmance invalidating several patent claims based on the lack of enablement for genus claims. This case comes on the heels of the Supreme Court’s denial of cert. in Idenix Pharms. LLC v. Gilead Sci. Inc., 941 F.3d 1149 (Fed. Cir. 2019) on similar issues. Amgen now hopes for a better result.
As we turn the page to 2021, we expect at least two major cases to be resolved that could have long-lasting effects on where and how Hatch-Waxman and Biologics Price Competition and Innovation Act (BPCIA) cases are litigated. Specifically, the future of skinny labels is in doubt, and available venues for Plaintiffs could be significantly narrowed. The number of new drugs eligible for generic competition will also rebound in 2021, but only time will tell if the global pandemic affects the overall number of generic filings. While there are many more Hatch-Waxman and BPCIA developments to watch this year, these are a few that we will be following closely.
On September 16, 2020, the Patent Trial and Appeal Board (PTAB) denied institution of Mylan Labs Ltd.’s petition for IPR of U.S. Patent No. 9,439,906 (“the ’906 patent”) in IPR2020-00440. In doing so, the PTAB exercised discretion to deny institution based on the six factors set forth in its precedential order in Apple Inc. v Fintiv Inc. For Hatch-Waxman Defendants interested in challenging the validity of Orange Book-listed patents at the PTAB, IPR petitions should be filed as early as possible in order to avoid this same result.