In BTG International Limited v. Amneal Pharmaceuticals LLC, [2019-1147, 2019-1148, 2019-1323, 2019-1324, 2019-1325] (May 14, 2019), in consolidated appeals from the District of New Jersey and the PTAB involving U.S. Patent No. 8,822,438, the Federal Circuit affirmed the PTAB’s Final Written Decision in one of the IPRs, mooting the other appeals.

The ‘438 Patent is directed to methods and compositions for treating cancer. Appellants asserted that the PTAB erred by improperly construing the term “treatment” by not requiring prednisone to have an anti-cancer effect, and then relying on that incorrect construction to find that the asserted claims would have been obvious.

The Federal Circuit agreed with the PTAB’s construction, noting that the claims, specification, and prosecution history teach that treatment includes both anti-cancer effects and palliation or reduction in side effects. The claim required “a therapeutically effective amount,” which was defined in the specification as an amount “effective for treating a disease or disorder . . . such as cancer.” The specification further stated that a “therapeutic agent” may be either “an anti-cancer agent or a steroid.” The Federal Circuit pointed out that the use of “or” in between “anti-cancer agent” and “steroid” suggests that a steroid is not necessarily the same thing as an anti-cancer agent. The Federal Circuit added that if the patentee intended to limit “treating” and “therapeutic agents” to anti-cancer agents, the patentee would not have identified steroids separately as an agent for reducing adverse side effects nor described prednisone repeatedly in the specification as a steroid without mentioning any anti-cancer effect.

The Federal Circuit found that the PTAB correctly concluded that the Asserted Claims cover a therapy in which abiraterone has an anticancer effect, while prednisone either has its own anti-cancer effect or has a palliative/side-effect reduction effect.

Based upon this construction, the Federal Circuit found substantial evidence supported the PTAB’s determination of obviousness.

Takeaway

Because the specification is the single best guide to the meaning of claim terms, it is important that the use of the terms in the specification be consistent with the claim construction the patent owner wants.