Following all of the latest IP developments in life sciences.

(Co-authored by Dan Rudoy)

Today, companies are developing artificial intelligence (AI) systems to meaningfully analyze the deluge of biomedical data. A substantial investment in building and deploying machine learning (ML) technology—the most active area of AI technology being developed today—warrants carefully considering how to protect the resulting intellectual property (IP), but there are challenges to doing so. In this post, we explore strategies of protecting IP for ML technology, including what aspects to consider patenting given current and ongoing changes to US patent law, and when to consider trade secret protection.

Q: Why did you decide to become an attorney? 

Andrew: When I was an undergraduate at the University of Iowa majoring in Biochemistry, I got involved in student politics in my free time. When I started applying to graduate programs, I was a little jealous of my friends that were taking the LSAT (I know, right?). But for some reason, I always knew that I would end up going to law school at some point. I just didn’t realize at the time that it would be after my PhD and a stint as a post-doc.

Gabe: I was inspired to pursue becoming a patent attorney in the life sciences towards the end of my PhD studies when I filed a patent application on my own research. In addition, I had a few mentors at the time who had already moved from science into patent law, and each of them helped guide me down my new path. Combining my training in science and law is enormously satisfying and rewarding.

Overview

On January 29, 2020, the Federal Circuit reversed and remanded an August 21, 2019 decision (Galderma v. Teva, 390 F.Supp.3d 582 (2019)) handed down by the United States District Court for the District of Delaware in the patent infringement dispute between Galderma Laboratories and generic manufacturer, Teva Pharmaceuticals, relating to Teva’s Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of Galderma’s Soolantra® (1% ivermectin cream for topical use) for treating inflammatory lesions of rosacea. Galderma Laboratories, L.P. et al. v. Teva Pharmaceuticals USA, Inc., Nos. 2019-2396, 2020-1213 (Jan 29, 2020). Each of the asserted claims recite administering a 1% ivermectin formulation together with the appearance of one or more functional efficacy metrics. In siding with Galderma, the Federal Circuit reversed the district court’s finding that Galderma’s asserted claims were anticipated based on two references (McDaniel-U.S. Patent No. 5,952,372 and Manetta-US Patent No. 7,550,440), contrary to the axiom that “a patent claim can only be invalid for anticipation if a single reference discloses each and every limitation of the claimed invention.” According to the Federal Circuit, the district court erred in two ways.

When can a prior art reference that discloses a protein purification step at room temperature render invalid a patent claim with a temperature range from about 10°C to about 18°C? Answer: When that prior art reference defines room temperature to include 18°C (which is about 64.4°F). The Federal Circuit reiterated, in Genentech, Inc. v. Hospira, Inc., that even a small overlap at the extremes of a range can invalidate claims that incorporate that range, absent a showing that the particular range is critical or that the parameter is not a result-effective variable.

WOLF TRACKS

The WOLF TRACKS LIFE SCIENCES IP BLOG covers important life sciences news through an intellectual property lens. We discuss legal cases and opinions, breakthrough innovations, and other timely topics impacting the life sciences industry. Our goal is to provide helpful summaries, insightful thoughts and key takeaways on news legal practitioners need to know.