Court Opinion

ID: 9820703
Source: CourtListenerOpinion
Date Created: 2023-09-01 07:30:34.66156+00
Date Added: 2024-06-11T07:38:43.549401
License: Public Domain

NEWMAN, Circuit Judge,
dissenting.
This appeal is a companion to Merck & Cie v. Gnosis S.p.A., No. 14-1777 (Gnosis I), decided concurrently, and consolidates the appeals of three related Inter Partes Review decisions of the Patent Trial and Appeal Board (PTAB). The claims of the three appeals are directed to compositions containing L-5-methyltetrahydrofolic acid (L-5-MTFA) and various uses thereof. In each IPR proceeding the- PTAB held the claims invalid as obvious based on the combination of the Serfontein reference (European Patent No. 0595005 (“EP '005”)) and the Marazza reference (United States Patent No. 5,194,611 (the “'611 Patent”)). One IPR decision, IPR2013-00119, included in the combination a third reference, Ueland and Redsum, Plasma homo-cysteine, a risk factor for vascular disease: Plasma levels in health, disease, and drug therapy, J. Lab. Clin. Med., Vol. 114, pp. 473-501 (1989).
For the reasons I discussed in Gnosis I, these references do not fill the gap between the folate compounds described by Marazza and the uses described by Ser-fontein, such that a person of ordinary skill in this field would have been motivated to combine these references to treat elevated homocysteine with a reasonable expectation of success. Ueland provides a description of folate and homocysteine biochemistry, and shows the biochemical relationship between homocysteine and L-5MTHF. Ueland adds to the scientific investigations that have been conducted, but Ueland does not suggest that L-5-MTHF would successfully treat the specified diseases and overcome the known uncertainties of stability, metabolism, and bioavaila-bility. Ueland does not suggest that there would be a likelihood of success in using L-5-MTHF compositions for the specific purposes discovered and developed by the South Alabama scientists. The scientific acclaim and licensing and copying that followed their work add to the evidence of unobviousness. The PTAB erred in evaluating and weighing this evidence.
For the reasons discussed in my dissenting opinion in Gnosis I, obviousness was not established by a preponderance of the *829evidence. From my colleagues’ contrary ruling, I respectfully dissent.