In Nalpropion Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc., [2018-1221] (August 15, 2019), the Federal Circuit held that the district court did not err in finding claim 11 of the U.S. Patent 8,916,195 patent not invalid for lack of written description, but did err in finding that claim 1 of the ’111 patent and claims 26 and 31 of the U.S. Patent 7,462,626 patent would not have been obvious in view of the prior art.

The ’195 patent is also directed to methods of treating overweight or obesity, but the claims are drawn to specific dosages of sustained-release naltrexone and bupropion that achieve a specific dissolution profile. The Federal Circuit conclude that the district court did not clearly err in finding that the inventors had possession of the invention consisting of treating overweight and obesity with the stated amounts of bupropion. The district court found that irrespective of the method of measurement used, the specification shows that the inventors possessed the invention of treating overweight or obesity with naltrexone and bupropion in particular amounts and adequately described it. The Federal Circuit concluded that this finding did not present clear error.irrespective of the method of measurement used, the specification shows that the inventors possessed the invention of treating overweight or obesity with naltrexone and bupropion in particular amounts and adequately described it.

The test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. It is not necessary that the exact terms of a claim be used in haec verba in the specification, and equivalent language may be sufficient. The Federal Circuit noted that while as a general matter written description may not be satisfied by so-called equivalent disclosure, in the present case, buttressed by the district court’s fact-finding, and where the so-called equivalence relates only to resultant dissolution parameters rather than operative claim steps, the Federal Circuit affirmed the district court’s conclusion, noting “rigidity should yield to flexible, sensible interpretation.

The ’111 patent is directed to a composition of sustained-release bupropion and naltrexone for affecting weight loss, and the ’626 patent is drawn to a method for treating over-weight or obesity comprising. Although the district court found the claims non-obvious, in the Federal Circuit’s view, the prior art disclosed the claimed components of the composition claims and the steps of the method claims including the use claimed by the method.

Nalpropion argued that bupropion does not possess sufficient weight loss efficacy to obtain FDA approval by itself, but the Federal Circuit said that motivation to combine may be found in many different places and forms; it cannot be limited to those reasons the FDA sees fit to consider in approving drug applications. Instead, the court should consider a range of real-world facts to determine whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.

The Federal Circuit said that the inescapable, real-world fact here is that people of skill in the art did combine bupropion and naltrexone for reductions in weight gain and reduced cravings—goals closely relevant to weight loss. Contrary to Nalpropion’s view, persons of skill did combine the two drugs even without understanding bupropion’s mechanism of action but with an understanding that bupropion was well-tolerated and safe as an antidepressant. Thus, the Federal Circuit concluded that skilled artisans would have been motivated to combine the two drugs for weight loss with a reasonable expectation of success. The Federal Circuit examined the claims, and concluded that every limitation in the claims at issue was met by the prior art.

The Federal Circuit then examined objective indicia of nonobviousness. Nalpropion argues that many others tried and failed to find a combination effective for weight loss and that the claimed combination exhibited un-expected results, but the Federal Circuit found that a combination drug that affected weight loss—could not have been unexpected. The Federal Circuit said that the failure of others alone cannot overcome the clear record that the combination of the two drugs was known and that both drugs would have been understood to be useful for claimed purpose.

The Federal Circuit affirmed the district court’s decision on written description, but reversed the district court’s decision that the claims were not obvious.