The PTAB instituted an IPR on claims of Mayne Pharma International Pty Ltd.’s (“Mayne”) U.S. Patent No. 6,881,745 B2 covering formulations of azole antifungals in IPR2016-01186. In response to Merck Sharp & Dohme Corp.’s (“Merck”) Petition, the PTAB instituted review of some claims on anticipation grounds, and of all challenged claims on the grounds of obviousness.

Claim 1 of the ‘745 patent recites:

A pharmaceutical composition consisting essentially of about 100 mg of an azole antifungal drug and optionally at least one polymer having acidic functional groups wherein in vivo the composition provides a mean CMAX of at least 100 ng/ml, after administration in the fasted state.

Claim 5 recites the same composition as claim 1, but with an AUC limitation instead of the CMAX limitation.

The Board held that Merck demonstrated a reasonable likelihood of prevailing in its anticipation challenge to claims 1-3, 5-7, 9, 11, 12, and 14 over Kai, a prior art reference that disclosed administration of 100 mg of an azole antifungal drug to dogs in a solid dispersion powder containing a polymer having acidic functional groups. The PTAB accepted Merck’s argument that the treatment of dogs in a fasted state provided CMAX and AUC values that satisfied the claims.

Claims 1 and 5 each contain a “wherein” clause specifying CMAX and AUC pharmacokinetic parameters. The Board awarded patentable weight to the CMAX and AUC parameters after determining that the parameters were a necessary property of the claimed composition. The Board applied the broadest reasonable interpretation to the parameters and did not limit the CMAX and AUC levels to those found in humans, even though the specification only described in vivo data in humans, since the patentee did not provide an intent to read the claims so restrictively.

The Board also applied the broadest reasonable interpretation to the terms “drugs” and “pharmaceutical compositions.” It was not persuaded by Mayne’s assertion that Kai’s antifungal agent was not a “drug” that can be used in a “pharmaceutical composition” since the agent was associated with toxicity. At this time, it determined that the terms “pharmaceutical compositions” and “drugs” did not exclude agents with both adverse and beneficial effects.

The Board found that Merck established a reasonable likelihood of showing that all of the challenged claims were obvious over Kai in combination with one or more secondary references. The Board agreed with Merck that, while Kai did not place its powder in a capsule, a skilled pharmaceutical chemist would have known to place the composition of Kai in a capsule.

The Board held that Merck demonstrated a reasonable likelihood of prevailing in its challenge to claims 1, 3, 5, and 7 as anticipated by a second prior art reference, Thorpe. Mayne contested that Thorpe (among other references) was not a “printed publication,” alleging that the publication date on Thorpe, a reprint of a 1990 journal article, is impermissible hearsay. The PTAB rejected Mayne’s argument, stating that these journal articles fall under at least one exception to hearsay, and declined to exclude Thorpe and other references as printed publications at this time.

While the Board declined to deny the Petition based on Mayne’s assertion that the Petition failed to identify the parent company MCI (Merck & Co., Inc.) as a real party-in-interest, the Board noted that the parties should be prepared to address this issue at the next stage of the proceeding.