A weekly summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit and the opinions designated precedential or informative by the Patent Trial and Appeal Board.

University of Strathclyde v. Clear-Vu Lighting, LLC, No. 2020-2243 (Fed. Cir. (PTAB) Nov. 4, 2021). Opinion by Stoll, joined by Reyna and Clevenger.

The Federal Circuit reversed a Patent Trial and Appeal Board’s obviousness determination because “neither the Board’s finding that the prior art disclosed all claim limitations nor its finding of a reasonable expectation of success is supported by substantial evidence.” 

The patented invention relates to methods for photoinactivating certain antibiotic-resistant bacteria without using a photosensitizing agent. The Board found that claims 1 and 3 would have been obvious over the combination of “Ashkenazi” and “Nitzan” and that claims 2 and 4 would have been obvious in further view of a third reference. 

In Ashkenazi, each of the disclosed methods involved growing bacteria in the presence of a photosensitizer. And in Nitzan, the disclosed experiments involved four different categories of cultures prepared for certain bacteria, two of which were exposed to a photosensitizer, and two of which were not. For the cultures not exposed to a photosensitizer, Nitzan reported a survival fraction of 1.0, meaning the bacteria were not inactivated. The Board nonetheless found the patent claims obvious in view of the combination of Ashkenazi and Nitzan on the basis that “a skilled artisan would have reasonably expected ‘some’ amount of inactivation” without using a photosensitizer.

On appeal, the Federal Circuit reversed. First, the court saw “nothing in Ashkenazi that discloses or suggests inactivating [any] bacteria without using a photosensitizer.” Second, while Nitzan provided examples where the bacteria was not exposed to a photosensitizer, there was “no evidence that Nitzan successfully achieved inactivation under this condition.” Thus, the Federal Circuit failed to see “why a skilled artisan would opt to entirely omit a photosensitizer when combining these references.” The combination thus did not disclose the claim requirement of inactivating the bacteria without using a photosensitizer.

Additionally, the Board’s finding of a reasonable expectation of success was unsupported. As the Federal Circuit explained, “the only support for such a finding is pure conjecture coupled with hindsight reliance on the teachings in” the patent being challenged. Moreover, the record included evidence that others had failed to inactivate the bacteria without using a photosensitizer, and “such failures undermine a finding of a reasonable expectation of success.” The court reaffirmed “that absolute predictability of success is not required, only a reasonable expectation.” But here, “the prior art evidences only failures to achieve that at which the inventors succeeded,” and “no reasonable fact finder could find an expectation of success based on the teachings of that same prior art.” 

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Celgene Corp. v. Mylan Pharmaceuticals Inc., et al., No. 2021-1154 (Fed. Cir. (D.N.J.) Nov. 5, 2021). Opinion by Prost, joined by Chen and Hughes. 

The Federal Circuit affirmed a district court’s dismissal of a Hatch-Waxman lawsuit based on improper venue and failure to state a claim. 

Celgene markets pomalidomide and has patents related to that drug. Mylan and others sought to bring generic pomalidomide to market and thus submitted an abbreviated new drug application (ANDA), prompting Celgene to sue for infringement.

Celgene filed the lawsuit in New Jersey, where Celgene is headquartered.  None of the defendants are headquartered there, and so the question of proper venue turned on whether the defendants committed acts of infringement in the district and have a regular and established place of business there. The district court found that Celgene proved neither aspect. The district court also determined that, as to a foreign defendant, Celgene failed to state a claim upon which relief could be granted.

The Federal Circuit affirmed. In a litigation filed under the Hatch-Waxman Act, “the alleged infringing act is the submission of the ANDA,” and “this means venue is proper ‘where an ANDA-filer submits its ANDA to the FDA,’ not ‘wherever future distribution of the generic is contemplated.’” The Federal Circuit disagreed with Celgene’s position that infringement for venue purposes includes “all acts that are sufficiently related to the ANDA submission,” such as sending a Paragraph IV notice letter. The Federal Circuit thus concluded that Celgene failed to establish that the defendants committed an act of infringement in New Jersey.

Celgene also failed to establish that the defendants had a regular and established place of business in New Jersey. The handful of Mylan employees located in New Jersey, out of the tens of thousands employed by Mylan, did not satisfy the venue requirements. Those employees’ home-based workspaces and storage lockers were not controlled by Mylan; rather, Mylan simply allowed its employees to work remotely. Additionally, a now-defunct entity’s prior presence in the district could not be imputed to the parent defendant. 

As to the foreign defendant, the Federal Circuit affirmed the district court’s dismissal for failure to state a claim. Celgene did not sufficiently plead that the foreign entity was either actively involved in or directly benefited from the ANDA, nor did Celgene prove that the foreign defendant was an “alter ego” of the ANDA filer.

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