Outstretched ArmsTwo recent PTAB final written decisions highlight the benefits that the “broadest reasonable interpretation” standard for claim construction provides to Petitioners, as well as the difficulty Petitioners face in proving inherent anticipation.  The PTAB instituted two IPRs on the same patent: one on an anticipation ground, and another on an obviousness ground.  The Petitioner failed to prove anticipation, but prevailed on obviousness of all claims of the patent. Eli Lilly & Co. v. Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (Final Written Decisions, IPR2014-00693, and IPR2014-00752.  In several instances the PTAB noted that it rejected the Patent Owner’s arguments because the Board “declined to construe the claims as requiring” certain features.

U.S. Patent No. 8,133,903 is directed to methods of administering a PDE5 inhibitor to patients with specific types of fibrosis.  These types of fibrosis lead to symptoms such as erectile dysfunction (ED). Claim 1 recites administering the PDE5 inhibitor “according to a continuous long-term regimen,” and “at a dosage up to 1.5 mg/kg/day for not less than 45 days,” and “arresting or regressing” the fibrosis. The Patent Owner had previously sued the Petitioner (Eli Lilly & Co.) in California federal court, asserting the Petitioner induced infringement of the patent.  Petitioner filed two IPR petitions several months later, and the litigation was stayed pending outcome of the IPRs. Although the petitions collectively alleged seven grounds, the institution decisions only granted IPR on one ground each, a typical exercise of the PTAB’s discretion to decline multiple grounds.

In IPR2014-00693, the PTAB was not persuaded by Petitioner’s anticipation argument that “relies on the title of [the] Whitaker [reference], which explicitly recites ‘daily dosing,’ along with the argument that Whitaker teaches that the treatment should continue as long as the patient suffers from erectile dysfunction, which would be months, if not longer.”  The PTAB characterized that argument as an obviousness argument, rather than an anticipation argument, that was not sufficient to demonstrate “continuous administration for at least 45 days as required by claim 1.”  In reaching this decision, the PTAB referenced “Whitaker’s teaching that a therapeutically effective extended period may be as short as three days” and its example showing that “at most, the study drug is taken daily approximately 70% of the time during the study.”  Because inherent anticipation requires that the cited reference “necessarily” encompasses every element of the claimed invention, this standard has been difficult for petitioners to meet.  See, e.g.,  PTAB Denies Institution in Cepheid v. Roche: PCR Primers Found not Inherently Anticipated.

In IPR2014-00752, the PTAB’s construction of certain claim phrases was important to the decision. First, the PTAB rejected the Patent Owner’s construction of “continuous long-term regimen” as requiring a “duration and frequency to establish and maintain a constant level.”  The PTAB held that the claim itself required steps (“at a dosage up to 1.5 mg/kg/day for not less than 45 days”) that must meet the limitation of a continuous, long-term regimen.  Second, the PTAB held that a patient with the specified types of fibrosis did not require that the patient be “specifically diagnosed” with those types of fibrosis. Finally, the PTAB held that “arresting or regressing” fibrosis was “the intended result of administering a PDE5 inhibitor at a dosage up to 1.5 mg/kg/day for at least 45 days.”

this decision highlights the advantage that the “broadest reasonable interpretation” standard in IPR gives the petitioner in its quest to invalidate patents.

The PTAB held all claims unpatentable for obviousness, because the cited art “suggests daily dosing for at least 45 days, and provides a reasonable expectation of success of treating ED.”  Each reference “teaches a dosage of a PDE5 inhibitor of no more than 1.5 mg/kg/day.” One reference taught that “fibrosis is associated with ED in those patient populations” treated in the prior art.  The other two references, including the Whitaker reference considered for anticipation in IPR2014-00693, taught daily dosing and treatment for extended time periods, e.g. three, eight, and twelve weeks.  Although none of the patients in the cited art had been diagnosed with fibrosis, the PTAB noted that “that limitation does not require that the patient be specifically diagnosed” with fibrosis.  Similarly, regarding the Patent Owner’s argument that the prior art administration “would not maintain a steady state of the drug in plasma,” the PTAB noted it had “declined to construe the claims as requiring a steady state.”  Given the PTAB’s reasoning, one wonders if the outcome might have been different if the claims had been construed as the Patent Owner wanted.  This decision highlights the advantage that the “broadest reasonable interpretation” standard in IPR gives the petitioner in its quest to invalidate patents.  See BRI is Here to Stay: Federal Circuit Confirms Broadest Reasonable Interpretation Standard of Claim Construction for IPRs.