The Headaches In Claiming Antibody-based Inventions Broadly

• Published date: 20 October 2021
• Subject Matter: Intellectual Property, Litigation, Mediation & Arbitration, Food, Drugs, Healthcare, Life Sciences, Patent, Trials & Appeals & Compensation, Biotechnology & Nanotechnology
• Law Firm: Marshall, Gerstein & Borun LLP
• Author: Mr Sandip H. Patel

Recent Federal Circuit decisions call into question the value of patents broadly claiming inventions on antibodies and their function in treating debilitating diseases. The decisions in these cases originated in district courts and arguably swept aside the merits of scientific breakthroughs because the inventions claimed were not enabled or were otherwise insufficiently described to justify their broad breadth.* In Teva Pharmaceuticals Int'l GmbH v. Eli Lilly and Company, Appeals 2020-1747, -1748, and -1750 (Fed. Cir. Aug. 16, 2021), the Federal Circuit again dealt with patents broadly claiming antibodies.But here the court confronted Patent Trial and Appeal Board decisions that canceled patent claims as obvious. Specifically, in Teva, the court affirmed Board decisions canceling claims to antibodies that target a central nervous system neurotransmitter, known as "CGRP" and known to cause migraine headaches.

Teva's challenged patents claim humanized antibodies that antagonize CGRP and, thus, interfere with its ability to cause headaches. An exemplary claim in one of these patents simply recites a "humanized monoclonal anti-CGRP antagonist antibody that preferentially binds to human α-CGRP as compared to amylin." The claim's broad breadth likely could be challenged, consistent with the developing precedents,* based on potential frailties in its written description and enablement. But those types of challenges are not permitted before the Board in inter partes reviews. Instead, before the Board, Eli Lilly successfully argued that the broad breadth rendered the claims obvious over the combination of three earlier publications. Two are journal publications from the mid-1990s (and predating Teva's patent filings, circa 2005). Collectively, they explain the biology and therapeutic potentials when antagonizing CGRP, and report lab studies demonstrating an exemplary antibody could inhibit the activity of CGRP in rats. The third publication is a patent filed in 1990, teaching scientists how to make partially-non-human (humanized) antibodies.

These publications teach, at least in isolation, every aspect of what Teva is broadly claiming. Further, Teva's patents concede that anti-CGRP antagonist antibodies were known and commercially available before it filed the applications for the challenged patents. It's not difficult therefore to imagine how these three publications might render obvious the broad claim. But to render a claim obvious, a person ordinarily skilled...