Headaches associated with claiming antibody-based inventions in the broad sense – Intellectual Property

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Recent Federal Circuit decisions call into question the value of patents broadly claiming inventions on antibodies and their function in the treatment of debilitating diseases. The decisions in these cases were handed down by district courts and arguably swept aside the merits of scientific breakthroughs because the claimed inventions were not authorized or were not sufficiently described to warrant their broad scope.* 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 largely claiming antibodies. as obvious. More precisely, in Suits you, the court upheld the council’s rulings overturning requests for antibodies targeting a central nervous system neurotransmitter known as “CGRP” and known to cause migraines.

Teva’s disputed patents claim humanized antibodies that oppose CGRP and, thus, interfere with its ability to cause headaches. An exemplary claim in one of these patents simply cites an “antagonistic humanized monoclonal anti-CGRP antibody which binds preferentially to human α-CGRP over amylin”. The broad scope of the claim could likely be challenged, consistent with developing precedents *, due to potential weaknesses in its written description and empowerment. But these types of challenges are not allowed before the Commission in the context of inter partes reviews. Instead, before the Commission, Eli Lilly successfully argued that the large scale made the claims obvious when compared to the combination of three previous publications. Two are journal publications dating from the mid-1990s (and predating Teva’s patent filings, circa 2005). Collectively, they explain the biological and therapeutic potentials during antagonism of CGRP and report laboratory studies demonstrating that an exemplary antibody could inhibit CGRP activity 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, all aspects of what Teva broadly claims. In addition, Teva’s patents admit that anti-CGRP antagonist antibodies were known and commercially available before it filed the contested patent applications. So it’s not hard to imagine How? ‘Or’ What these three publications might make the general assertion obvious. But to make a claim obvious, a person ordinarily skilled in this science as of 2005 needed motivation to combine these teachings and have a reasonable expectation of success. Teva argued that neither existed. But based on the deferential standard of review, the court found that substantial evidence in the record contradicted Teva’s arguments.

A few points deserve to be underlined. First of all, Teva complained that the Commission satisfied itself that the suggestion of the prior art study or use humanized antibodies was sufficient motivation, while Eli Lilly argued that the prior art suggestion of therapeutic use such antibodies in humans was the relevant motivation. The court saw no significant distinction, noting that “[c]Common sense and scientific reality dictate that scientists do not study or use humanized antibodies for the ultimate goal of treating disease in test tubes or in rats. »Slip Op. At 12. Second, Teva also complained that one skilled in the art would have expected the treatment to be unsafe or ineffective. But the court was not persuaded because the Commission concluded, based on the evidence on the record, that the potential safety and efficacy issues would not deter those skilled in the art. Username. at 12-14. Third, the tribunal also rejected Teva’s alternative argument based on its complaint that the Commission had misread the prior art publications to conclude that a motivation to manufacture the antibodies was present when, according to the interpretation of Teva, she wasn’t. According to the tribunal, the evidence on the record supported the Commission’s interpretation and, in any event, the “Commission’s decision to favor one conclusion over another is the quintessence of a decision which must be confirmed afterwards. examination of substantial evidence ”. Username. at 15 (internal citations and citations omitted).

Teva also argued that the commercial success of two antibody products – its own AJOVY® product and Eli Lilly’s product Emgality® – makes its claims unclear. By law, the Commission and the tribunal must give substantial weight to such commercial success where there is a sufficient legal and factual connection (“nexus”) between the proof of such success and the claimed invention. The link is presumed when the commercially successful product corresponds to the claimed invention. The court clarified that the link can be presumed even when an unclaimed feature could materially affect the functionality of the allegedly coextensive product. The Commission concluded and the tribunal recognized that such characteristics (i.e., sequence specific affinity, picomolar binding affinity, full-length antibodies against IgG antibody fragments or classes) exist in every product.

A claim of “whatever works” has little to do with a particular product.

The court explained that “it is not difficult to imagine a presumption of connection between a kind of structurally claimed chemical compound and a commercial product which meets each claimed limitation”. Username. at 20 (citing
Immunex Corp. vs. Sandoz Inc., 964 F.3d 1049, 1067–68 (Fed. Cir. 2020), which presumed a link because “the patent claims mentioned the molecular weight and amino acid sequence of the ‘protein’ for which they were intended. “). Here, however, the antibodies were not, according to the court, claimed by reference to their structure, but rather by reference to their functional ability to bind to CGRP :. ” Username. at 21. Due to the breadth of the claims and the relevance of the unclaimed features contributing to the success of the products, the tribunal concluded that no link could be assumed and no link exists. And Teva has apparently presented no further evidence that commercial success warrants a finding of non-obviousness.

The board and court also rejected Teva’s argument that its license of the disputed patents, among a license of 188 patents, to a third party is objective evidence of non-obviousness. Usually, the existence of a license is important because a licensee has apparently chosen to avoid patent litigation. But “given that 188 patents have been licensed,” the court said, “the link between the license and the validity of a specific claim is tenuous to say the least.” Username. at 23. In rejecting Teva’s licensing argument, the court also noted “the true purpose of the link requirement [] is to examine whether the investigator can infer that the license arose out of the recognition and acceptance of the subject matter claimed in the patent. ” Username. at 24 (internal citations and citation omitted). In this case, this inference was not possible from the evidence on the record.

Courts Suits you This decision adds to the headaches associated with the general claim of antibodies based on their functional abilities to preferentially bind. classes “- all functionality which is apparently essential to the ability of the Teva and Eli Lilly commercial products to function. Username. at 21–22. Perhaps reciting one or more of these characteristics could have supported a different conclusion as to whether there was a link with business success. But any potential certainty accompanying such recitations may well be fleeting when, in court, the clearance and written description requirements create further headaches for patentees largely claiming antibody-based inventions.

* See, for example.,
Juno Therapeutics, Inc. v. Kite Pharma, Inc., Appel 2020-1758, Leaflet op. to 9 (Fed. Cir. August 26, 2021) (regarding claims for a chimeric antigen receptor (for a T cell) which comprises any single chain antibody fragment capable of binding to any target) ;
Amgen Inc. v. Sanofi, Aventisub LLC, 987 F.3d 1080 (Fed. Cir. 2021) (regarding claims of antibodies which bind to the PCSK9 protein); see also,
Idenix Pharma. LLC v Gilead Sciences Inc., 941 F.3d 1149 (Fed. Cir. 2019) (relating to a method of treating hepatitis C virus which comprises administering any of a kind of certain nucleoside compounds).

The content of this article is intended to provide a general guide on the subject. Specialist advice should be sought regarding your particular situation.

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