Federal Circuit Overturns $39 Million Jury Verdict, Invalidates Allergan Hair Loss Patent for Inadequate Written Description

The U.S. Court of Appeals for the Federal Circuit delivered a significant blow to Allergan Sales, LLC查看公司主页 and Duke University (搜索)搜索该词条 on Tuesday, overturning a $39 million jury verdict and invalidating their hair loss (搜索)搜索该疾病 patent for failing to meet written description requirements. The precedential decision in Duke University v. Sandoz Inc.查看公司主页 reverses a lower court judgment and finds claim 30 of U.S. Patent No. 9,579,270 invalid, affecting the intellectual property protection for LATISSE查看药品详情, Allergan's eyelash growth drug.

Patent Specification Failed to Support Claimed Invention

The Federal Circuit, in an opinion authored by Circuit Judge Stark and joined by Judges Dyk and Stoll, determined that the patent specification was fatally deficient in describing the claimed invention. The court found that "a person of ordinary skill in the art, reviewing the specification of the [asserted] patent, would be unable to visualize or recognize the members of the [claimed genus] based upon the specification's disclosures."

The disputed patent, which issued in 2017, relates to methods for growing hair by topically applying compositions containing prostaglandin F (搜索)搜索该靶点 (PGF) analogs. While the specification described a "universe of billions of possible compounds," claim 30 covered only a narrow subgenus of either 1,620 or 4,230 compounds, creating what the court characterized as a vast discrepancy between disclosure and claim scope.

Court Identifies "Maze-Like Path" in Patent Specification

The Federal Circuit agreed with Sandoz's argument that the patent failed to provide adequate guidance to skilled artisans. The court explained that to satisfy written description requirements, "the specification must provide sufficient indication as to how a skilled artisan would narrow the disclosed universe of billions of compounds described in the specification to the subset of just 1,620-4,230 compounds actually claimed."

The court found the patent's guidance particularly problematic at key chemical positions. For the C1 position, the patent identified five "preferred" options, none of which was the amide required by the claim. As the court noted, "the 'preferred' and 'more preferred' blaze marks direct a skilled artisan away from, rather than toward, the claimed subgenus."

Similarly, for the Z position, while the patent identified phenyl as the most preferred aromatic group, a skilled artisan would first need to select from eight initial options without clear direction from the specification.

Synthesis Schemes Insufficient to Cure Deficiency

Allergan argued that the specification's four different synthesis schemes describing how to synthesize amides provided adequate guidance to the invention. The Federal Circuit rejected this argument, stating that the synthesis schemes still presented multiple choices and failed to single out the claimed compounds. The court noted that two specific examples in the synthesis schemes used sulphonamides or hydroxamic acid, which Allergan's own expert admitted were not within the scope of the patent's claims.

"Following [such a] maze-like path, each step providing multiple alternative paths, is not a written description," the court stated, citing precedent from Regents of the University of Minnesota v. Gilead Sciences, Inc.

Structural Features Deemed Inadequate

The court also found insufficient the three common structural features that Allergan claimed the patent disclosed. The shared "hairpin structure" was dismissed as a generic feature of all prostaglandins that did not distinguish the claimed compounds. The specification failed to expressly disclose even a single embodiment of a compound falling within claim 30's scope.

The Federal Circuit emphasized that the specification presented a "'laundry list' disclosure of every possible moiety for every possible position," with numerous branching options and stated preferences that pointed away from the claimed invention.

High Burden for Overturning Jury Verdict Met

The Federal Circuit concluded that Sandoz had overcome the "doubly high burden" of overturning a jury verdict, finding that no reasonable juror could have concluded anything other than clear and convincing evidence that claim 30 was invalid.

"The specification fails to provide the relevant artisan with sufficient blaze marks or structural commonalities among the claimed compounds to lead her to conclude that the inventor actually possessed the claimed invention," the court concluded. The multiple branching paths were "clear on the face of the patent" and were explained in detail by Sandoz's expert, Dr. Clayton Heathcock, with their existence undisputed by Allergan's expert, Dr. Allen Reitz.

Broader Implications for Chemical Patents

The decision establishes important precedent for written description requirements in pharmaceutical patents, particularly those claiming chemical genus inventions. The court reinforced that patent applicants cannot "disclose a forest in the original application, and then later pick a tree out of the forest and say 'here is my invention.'" Instead, specifications must provide "blaze marks directing the skilled artisan to that tree."

The Federal Circuit declined to address Sandoz's other invalidity arguments concerning obviousness and lack of enablement, finding the inadequate written description alone sufficient to reverse the judgment. The case originated from Allergan's 2018 patent infringement lawsuit against Sandoz, where Sandoz stipulated to infringement but challenged the patent's validity.