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The PTAB Places Emphasis on Reasonable Expectation of Success

In Coalition for Affordable Drugs VIII, LLC, v. The Trustees of the University of Pennsylvania, No. IPR2015-01835, Paper No. 56 (P.T.A.B. March 6, 2017), the PTAB concluded that despite evidence that the combinations of prior art references may have disclosed the claimed invention, an ordinary artisan would not have had a reasonable expectation of success in combining the references. The PTAB also considered whether a slideshow prior art reference qualified as a printed publication.  The Board ultimately held that the Petitioner failed demonstrate that claims 1-10 of U.S. Patent No. 8,618,135 were unpatentable as obvious.

The patent at issue teaches “methods for treating a subject suffering from a disorder associated with hyperlipidemia and/or hypercholesterolemia.” Specifically, the challenged claims recite the administration of a microsomal triglyceride transport protein (“MTP”) inhibitor, lomitapide, in three separate doses. The claims disclose “first dose level is from about 2 to about 13 mg/day, a second dose level is from about 5 to about 30 mg/day, and a third dose level is from about 10 to about 50 mg/day.” Slip op. at 7.

Petitioner argued that the claims were unpatentable as obvious based on combinations of the prior art references. Petitioner asserted that the claims were obvious in in view of Stein (a slide presentation teaching the use of MTP inhibitors specifically implitapide in the treatment of hypercholesterolemia) and Chang (discusses animal studies of implitapide and lomitapide and the clinical efficacy of the inhibitors). Petitioner also argued that the claims were obvious in view of Chang and Pink Sheet (discusses how PPD was conducting proof-of-concept studies on the use of implitapide in statin therapy with the hope of establishing its safety and efficacy for use in the treatment of hypercholesterolemia).

With respect to the issue of a “printed publication”, Petitioner asserted that Stein was presented and that a hyperlink for the presentation was disseminated to interested parties. Using the specific factors provided set forth in In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004), the Board held that there was no evidence that ordinary artisans would have located the hyperlink because the hyperlink was not targeted at skilled artisans interested in MTP inhibitors. The Board further concluded that Petitioner’s use of a Wayback Machine screenshot of the hyperlink was not sufficient to establish that the hyperlink worked or that the slides could be obtained through the link by ordinary artisans.  The PTAB held that Stein failed to qualify as a printed publication and then focused its analysis of the issue of “reasonable expectation of success.”

Patent Owner argued that a person of ordinary skill in the art would not have had a reasonable expectation of success in substituting lomitapide for implitapide in the process taught by the prior art.  A person of ordinary skill in the art would not have looked to lomitapide because of its known liver toxicities.  Relying on expert testimony, Patent Owner argued that the prior art only discloses a proof-of-concept study, lacking any reported results which would have been necessary in order to successfully develop a dosing regimen.

Petitioner, quoting the Board’s Institution Decision asserted that “as explained by the Board, Petitioner has made this showing: ‘Given Chang’s teaching that CP-346086, implitapide (BAY-13-9952), and lomitapide (BMS-201038) have similar efficacies, we determine that Petitioner has sufficiently demonstrated a reasonable expectation of success of substituting lomitapide for implitapide and achieve a dosage level that would fall within the claimed ranges.’” Slip op. at 36.

In its analysis, the PTAB held that while it is a “close call”, a person of ordinary skill in the art would not have had a reasonable expectation of success in combining the prior art references to arrive at the present invention. The PTAB rejected Petitioner’s reliance on its Institution Decision, stating that that decision was based on evidence of record at the time and that the evidence put forth by the Patent Owner weighed in favor of reaching a different conclusion from its previous decision.

The PTAB emphasized that the ‘135 patent noted that previous clinical development of lomitapide for the use in the treatment of hypercholesterolemia had been discontinued due to serious hepatotoxicities. The PTAB held that Petitioner failed to provide any evidence of what doses of lomitapide exhibited hepatotoxicities. The PTAB relied on Patent Owner’s expert who explained that although the prior art disclosed that lomitapide has been tested in human trials, the methods, dosages and results were never disclosed and thus were unknown to a person of ordinary skill in the art.

The Board further stated that with respect to the reasonable expectation of success, absolute predictability is not required. Specifically, the Board found persuasive Patent Owner’s evidence that not all MTP inhibitors act the same and as such an ordinary artisan would not anticipate that dosages used for implitapide would have the same effect when substituted with lomitapide. The Board thereby concluded that a person of ordinary skill in the art would not have had a reasonable expectation of success that using the dosages taught by the prior art for implitapide would provide a therapeutically effective lomitapide with reduced hepatotoxicities.

The Board also found the evidence of secondary considerations to be substantial, specifically commercial success. Patent Owner asserted that in 2013 its licensee, Aegerion received FDA approval for JUXTAPID, a lomitapide treatment using the claimed method and began to market the drug. Petitioner argued that Patent Owner failed to establish the proper nexus between the commercial success and the claims. Citing PPC Broadband, Inc. v. Corning Optical Comm. RF LLC, 815 F.3d 734, 747 (Fed. Cir. 2016)), the Board noted however, that the nexus is presumed as petitioner has the ability to rebut a patent owner’s evidence. The Board further noted that the Petitioner did not contest that the marketed drug is a commercial success and as such the Patent Owner’s evidence thus established that the marketed drug is a commercial success. Therefore, the Patent Owner prevailed with respect to both challenges.

This case offers a variety of insight into the Board’s analysis of printed publications. The Board has demonstrated that a screenshot from the Wayback Machine is not sufficient to establish proof of a printed publication. A petitioner relying on the Wayback Machine must be sure that the reference was actually available to ordinary artisans as prior art. This case also highlights the importance of the “reasonable expectation of success” factor and the role it may play in the minds of the panel. Such evidence has previously not been widely effective at PTAB, but may now provide patent owners with successful path to rebutting challenges to patentability.