In Teva Pharmaceuticals USA, Inc., v. Sandoz Inc., [2017-1575] (October 12, 2018), the Federal Circuit affirmed the district court decision invalidating for obviousness all asserted claims of patents directed to COPAXONE® 40mg/mL, a product marketed for treatment of patients with relapsing forms of multiple sclerosis.
On appeal, Teva argued the district court improperly discounted the “sufficiency” terms in its claims, construing these terms to be nonlimiting statements of intended effect. The Federal Circuit said that “the regimen being sufficient to reduce the frequency of relapses in the patient” does not change the express dosing amount or method already disclosed in the claims, or otherwise result in a manipulative difference in the steps of the claims.” The Federal Circuit further found that Teva’s argument that the sufficiency terms were added during prosecution to overcome rejections overstated the intrinsic record. Accordingly, the Federal Circuit found no error in the district court’s construction.
As to obviousness, Teva argued for the patentability of its claimed dosing regimen, the improved tolerability, reduced frequency of adverse effects, and the reduced severity of injection site reactions.
The Federal Circuit rejected Teva’s argument that the district court engaged in an improper obvious to try analysis. An “obvious to try” analysis is improper if it suggests varying all parameters or trying every available option until one succeeds, where the prior art gave no indication of critical parameters and no direction as to which of many possibilities is likely to be successful. An “obvious to try” analysis involves a new technology or general approach in a seemingly promising field of experimentation, but the prior art gives only general guidance as to the particular form or method of achieving the claimed invention.
The Federal Circuit said that neither of these was what the district court did. The prior art focused on two critical variables — dose size and injection frequency — and provided clear direction as to choices likely to be successful in reducing adverse side effects and increasing patient adherence.
Teva contends that the unpredictable nature of the compound categorically precludes the obvious to try analysis employed by the district court. The Federal Circuit disagreed again, noting obviousness was proven through human clinical studies establishing the safety, efficacy, and tolerability at doses and dose frequencies similar to the claimed regimen.
Regarding improved tolerability and reduced frequency, Teva argued that the prior art did not lead persons of ordinary skill in the art to expect improved tolerability and reduced frequency of injection reactions from the claimed regimen compared to the prior art, but the Federal Circuit disagreed. Teva found fault with the district court’s reference to “common sense” in its reliance on expert testimony, and argued that the expert testimony was conclusory and unsupported by the prior art. The Federal Circuit found no error in what is essentially a credibility determination.
On reduced severity, the Federal Circuit again agreed with the district court that the evidence provided a reasonable expectation to those skilled in the art that reducing the number of injections per week may also reduce the severity of injection site reactions.