Written by Mark E. Davis and Kerry S. Taylor, Ph.D.

The PTAB issued two final written decisions upholding The University of Pennsylvania’s claims to methods of treating high cholesterol based, in part, on commercial success and the meaning of a “printed publication” in Coalition for Affordable Drugs VIII LLC v. The Trustees of The University of Pennsylvania, IPR2015-01835, Paper 56 (P.T.A.B., March 6, 2017) and IPR2015-01836, Paper 58 (P.T.A.B., March 6, 2017).

Kyle Bass’s patent challenging entity, Coalition for Affordable Drugs, filed two inter partes review petitions challenging all claims of two Orange Book-listed Juxtapid® patents owned by The Trustees of The University of Pennsylvania. The patent claims are directed to a method of treating a subject suffering from hyperlipidemia or hypercholesterolemia. Coalition asserted the claims were obvious based on two separate grounds, and the Board instituted the two IPR proceedings as to both grounds.

Coalition’s first ground relied on a slide deck that was presented to investors and subsequently posted online, which Coalition asserted constituted prior art as a printed publication. The University argued that the slide deck was not a printed publication because it was not presented to an audience skilled in the relevant art and because there was insufficient evidence of the public availability of the slide deck. On reply, Coalition argued that the slide deck was available for public download “shortly after” its presentation, qualifying it as a printed publication.

In its second ground, Coalition asserted that a combination of references rendered the claims obvious. The University argued there was no motivation to combine the references and there would not have been an expectation of successfully combining the references. The University also submitted objective evidence of commercial success that a commercial embodiment of the patented claims, Juxtapid®, had generated $420 million in revenue. Coalition argued that there was no nexus between the University’s evidence of commercial success and the challenged claims, and the evidence was not commensurate in scope with the claims.

In its final written decisions, the Board agreed with the university on both grounds. In determining that the slide deck was not a printed publication, the Board applied the Federal Circuit’s factors set forth in In re Klopfenstein, 380 f . 3d 1345 (Fed. Cir. 2004). The Board held that Coalition had not provided sufficient evidence to establish that the target audience of the slide deck would have included ordinary artisans in the relevant field. The Board also found that Coalition’s proffered screenshots from the Wayback Machine failed to establish that the webpage link to the slide deck was functional before the critical date.

On the second ground, the Board concluded that, while a “close call,” Coalition had not met its burden of demonstrating a reasonable expectation of success in combining the two references. Regarding commercial success, the Board held that the University had established a nexus between Juxtapid®’s dosage schedule and the claims, and the dosage schedule was commensurate in scope with the claims.

These cases provide an example of challenging the printed publication status of a slide deck based on evidence from the Wayback Machine. These cases also exemplify how evidence of commercial success can support a finding of non-obviousness.