Following all of the latest IP developments in life sciences.

Overview

On March 17, 2020, the Federal Circuit reversed the district court’s finding that two patents relating to diagnostic methods involving cell-free fetal DNA were invalid for lacking subject matter eligibility under 35 U.S.C. § 101. The court reached its decision entirely on analyzing step one of the two-part Alice/Mayo test, finding that “the claims are not directed to a patent-ineligible concept” and consequently did not need to reach the second step of the test. This decision adds clarity to the metes and bounds of patent eligibility jurisprudence because it suggests that a claimed method relating to a natural phenomenon may be patent eligible so long as concrete processing steps that go beyond merely observing the natural phenomenon are recited in the claim. Also, while the decision does not go as far as requiring a physical transformation or the production of non-naturally occurring material as a result of such processing steps, it may be instructive to consider whether a material not existing in nature results from performing the steps of the claim.

The Federal Circuit’s recent decision in Hospira v. Fresenius Kabi USA is the latest to show how the court handles allegations of inherency in life sciences patent litigation. Jonathan Roses dissects the case, addresses whether the court created a new burden-shifting framework for such challenges and summarizes lessons that parties on both sides on an inherency argument can take away from the decision. To read the full article, which was published in Westlaw Journal, click here.

Overview

On January 15, 2020, Hospira, Inc. filed a petition for rehearing en banc of the Federal Circuit’s December 16, 2019 panel decision in Amgen, Inc. v. Hospira, Inc., Nos. 2019-1067, 2019-1102 (Fed.Cir. 2019) in which Hospira lost on the issue of whether its EPO biosimilar manufacturing activities are entitled to Safe Harbor protections. The petition requested review on the question of “[w]hether 35 U.S.C. § 271(e)(1) provides a safe harbor against infringement of patents claiming a method of manufacture, when the product manufactured is used to generate information for submission to the Food and Drug Administration (‘FDA’) in order to seek approval of a biosimilar drug.” Petition, page 1.  Hospira also alleges that the panel decision is contrary to the Safe Harbor precedent of the US Supreme Court and the Federal Circuit, as well as erring in its claim construction by improperly “reading out a claim limitation” relating to the meaning of “mixture…of isoforms.” The Federal Circuit has yet to decide on the petition.

Earlier this week, the FDA announced that it has made enhancements to the Purple Book. These changes improve how information related to biological and biosimilar products is accessed through the use of a simple internet search. For readers unfamiliar with the Purple Book, it is a database of FDA-licensed biological products. However, until these recent updates, the Purple Book only existed as two lists, one from the Center for Biologic Evaluation and Research and one from the Center of Drug Evaluation and Research. Both of these lists contained current licensed biological products with reference to product exclusivity and any biosimilarity or interchangeability evaluations that have occurred. But unlike the Orange Book for FDA-approved small molecule drugs, the Purple Book does not contain a list of patents covering the drug or its use. Instead, the Purple Book includes significant dates for information relevant to the procedures outlined in the Biologics Price Competition and Innovation Act (BPCIA) for the approval and patent-resolution processes for biosimilar versions of approved biologic drugs. These dates and information include the date the product was licensed, and whether the FDA has evaluated it for reference product exclusivity.

(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.