Aaron Lukas co-chairs Cozen O’Connor’s Hatch-Waxman and Biologics Practice and is a member in the Washington, DC office, where he litigates and arbitrates disputes in the pharmaceutical, biotech, and semiconductor fields.
Aaron has handled all aspects of cases including pre-suit investigations, fact and expert discovery, dispositive motions, and trial. He also has experience in IPR matters at the PTAB on behalf of both patent owners and challengers. In addition to patent litigation, his practice includes representing clients seeking patentability, infringement, and invalidity analyses, as well as developing strategic plans for clients seeking to protect their intellectual property around the world. Aaron has worked with clients in a wide range of high technology fields, including nanotechnology, semiconductor devices, display technologies, gene synthesis, recombinant DNA technology, diagnostic assays, and pharmaceuticals.
Prior to entering the legal field, Aaron was a senior research scientist at Air Products and Chemicals, Inc. where he developed thin film precursors and deposition methods for use in flat panel displays, interconnects, and other high tech applications (2001-2005), which resulted in 18 issued patents. While earning his doctorate in chemistry at Northwestern University International Center for Nanotechnology and Department of Chemistry, he synthesized and studied light-absorbing organic molecules for use as molecular switching devices (1996-2001). He is a graduate of Georgetown Law, and earned bachelor’s degrees in chemistry and humanities, cum laude, from Seattle University.
A large portion of the technology that we rely on daily—cell phones, computers, and the sensors and infrastructure that connect them, as well as an increasing percentage of drugs—is manufactured outside the United States, and in particular China. Indeed, over the past 25+ years the value of goods imported from China has increased ten-fold. Most companies are aware of the potential patent infringement liability for sales made in the United States but may not know that liability for infringing a U.S. patent can also extend to the processes used to make their product—even when manufacturing is done entirely outside the United States by a contract manufacturer.
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.