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University of Strathclyde v. Clear-Vu Lighting LLC, Appeal No. 2021-2243 (Fed. Cir. Nov. 4, 2021)

In this week’s Case of the Week, the Federal Circuit reversed an inter partes review decision finding claims directed to light-based disinfecting methods to be obvious over the prior art.  This case provides a helpful example of how negative claim limitations can affect an obviousness determination.

The claims at issue were directed to the use of blue light with wavelengths in the range of 400-420 nm to inactivate certain types of bacteria with cell wall characteristics that make them resistant to antibiotics, such as Methicillin-resistant Staphylococcus aureus (“MRSA”).  As relevant to the appeal, the challenged claims each affirmatively required that such bacteria be inactivated without the use of a photosensitizer, or a chemical agent applied to the bacteria to facilitate photoinactivation.

While the prior art disclosed the inactivation of MRSA and other bacteria using blue light within the claimed wavelength range, prior methods relied on the use of photosensitizers to achieve this result.  In finding the claims obvious, the Patent Trial and Appeal Board had relied on two prior art references referred to as Ashkenazi and Nitzan.  Ashkenazi was an article that discussed the inactivation of an acne-causing bacteria using 407-420 nm blue light both with and without δ-aminolevulinic acid (“ALA”), a photosensitizer.  However, it was undisputed that the agar medium used to culture all of Ashkenazi’s bacteria would have contained riboflavin, which is also a photosensitizer.  Ashkenazi reported that ALA had a positive effect on inactivation rates, and that increasing the frequency and intensity of light doses resulted in higher inactivation rates for both ALA-treated and non-ALA-treated samples.  Nitzan studied the effects of ALA on photoinactivation of MRSA with the same wavelengths of blue light, and found no significant inactivation of the non-ALA-treated samples.

In finding the claims obvious, the Patent Trial and Appeal Board found that a skilled artisan would have been motivated to use Nitzan’s MRSA cultures with the increased light doses of Ashkenazi to achieve some amount of inactivation without the use of a photosensitizer, and so Ashkenazi and Nitzan together disclosed the negative limitation.  The Federal Circuit disagreed, finding that due to the presence of photosensitizing riboflavin in Ashkenazi’s control cultures, neither Ashkenazi nor Nitzan disclosed the limitation that inactivation be achieved without a photosensitizer, and so the limitation was not disclosed in the prior art.  The Court also found that the Board’s finding of a reasonable expectation of success was undermined by the failure of Nitzan’s non-ALA cultures to achieve inactivation, and was supported primarily only by hindsight reliance on the challenged patent itself.

Because neither the Board’s finding that the prior art disclosed all limitations nor its finding of a reasonable expectation of success were supported by substantial evidence, the Court reversed the Board’s obviousness determination.

A copy of the opinion can be found here.

By Jason Wrubleski

ALSO THIS WEEK

Celgene Corporation v. Mylan Pharmaceuticals, Inc., Appeal No. 2021-1154 (Fed. Cir. Nov. 5, 2021)

In a case involving an ANDA application to sell generic pharmaceuticals, the Court affirmed a dismissal on grounds of improper venue.  Celgene brought suit against Mylan in New Jersey.  But the Court held that Mylan did not commit any acts of infringement in New Jersey.  Rather, infringement in this case was the submission of the ANDA, which did not take place in New Jersey.  Additionally, in what appears to be a matter of first impression, the Court affirmed that the sending of the paragraph IV notice letter to Celgene in New Jersey was not an act of infringement sufficient to trigger venue in New Jersey.  The Court also found that Mylan did not have a regular and established place of business in New Jersey – only a few employees lived in New Jersey, and none were asked by Mylan to live there, and affiliates residing in New Jersey could not be imputed to the parent company for venue purposes.

The Court also affirmed dismissal as to Mylan N.V. because the pleadings made only conclusory allegations that Mylan N.V. “submitted” the ANDA, even though it was submitted on its face by its U.S.-based subsidiaries.  The Court also affirmed that the district court did not abuse its discretion in denying leave to amend its complaint.

A copy of the opinion can be found here.

By Nika Aldrich

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