In Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc., No. 14-1391 (Fed. Cir. Dec. 3, 2014), the Federal Circuit vacated the district court's invalidity determination and remanded for further analysis consistent with its precedent on inherency in the obviousness context.
Par Pharmaceutical, Inc. ("Par") owns U.S. Patent No. 7,101,576 ("the '576 patent"), which claims methods of increasing body mass using megestrol nanoparticles in patients suffering from anorexia, cachexia, or loss of body mass. The nanosized megestrol formulation, which Par markets as Megace ES, has a greatly reduced food effect as compared to a micronized megestrol formulation sold as Megace OS. TWi Pharmaceuticals, Inc. ("TWi") filed an ANDA seeking approval to market a generic version of Par's nanosized megestrol and Par filed suit. The district court concluded that the '576 patent was obvious, finding the lack of a food effect in nanosized megestrol was an inherent property. Par appealed.
"A party must . . . meet a high
standard in order to rely on inherency to establish the existence
of a claim limitation in the prior art in an obviousness
analysis—the limitation at issue necessarily must be present,
or the natural result of the combination of elements explicitly
disclosed by the prior art."
Slip op. at 16.
On appeal, the Federal Circuit vacated the district court's judgment that the '576 patent was invalid, holding that the district court applied the incorrect standard for inherency in its obviousness analysis. Harmonizing recent precedent with its early precedent and that of its predecessor court, the Court cautioned that "the concept of inherency must be limited when applied to obviousness." Slip op. at 15. The Court explained that the district court had not required TWi to meet the high standard for inherency in the obviousness context—namely, that "the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art." Id. at 16. Looking to the claim limitations, the Court held that the district court did not conclude that the reduction in particle size naturally resulted in "no substantial difference" in the food effect as claimed. Id. "[P]er the district court, the reduced particle size would, ipso facto, lead to a reduced food effect," a broad diktat not commensurate with the actual limitations. Id. (emphasis added). Because it could not, on the record before it, conclude that TWi failed to demonstrate that the claimed food effect limitations necessarily were present in the prior art combinations, the Court vacated the district court's judgment and remanded.
Although the Court vacated the district court's judgment with respect to inherency, it agreed with the district court's analysis on the motivation to combine the asserted prior art references and the reasonable expectation of success. The Court, like the district court, rejected Par's argument that there was no motivation to combine because a person of ordinary skill at the time of the invention would not have known of a food effect for Megace OS, noting that "[m]otivation to combine may be found in many different places and forms." Id. at 18 (alteration in original) (quoting Allergan, Inc. v. Sandoz, Inc., 726 F.3d 1286, 1292 (Fed. Cir. 2013)). The Court held that the district court did not err in finding a motivation to combine megestrol with nanoparticle technology due to the known viscosity and interpatient variability problems with micronized megestrol. The Court also rejected Par's argument that TWi failed to establish a reasonable expectation of success because, at the time of invention, nanoparticle technology was "new, untested, and unpredictable." Id. at 20 (citation omitted). Instead, the Court found no clear error in the district court's conclusion that a skilled artisan "would have believed making nanoparticles was not extremely difficult" and "could successfully be implemented with a wide variety of drugs," noting that a reasonable expectation of success does not require absolute certainty. Id. (citation omitted).
The Court further concluded that the district court did not err in its analysis of the objective indicia of nonobviousness. The Court reasoned that even though the district court turned to the indicia only after concluding that TWi proved a prima facie case of obviousness, it was clear that the district court considered them before reaching its ultimate obviousness conclusion. The Court agreed with the district court that the evidence of unexpected results, while not categorically excluded, was not entitled to substantial weight when factored into the overall obviousness analysis. The Court also agreed with the district court's conclusion that an equivocal statement that nanosized megestrol "may be preferable" to micronized megestrol was not sufficient to establish long-felt need. Id. at 25 (citation omitted).
Judges: O'Malley (author), Wallach, Hughes
[Appealed from D. Md., Judge Blake]
This article previously appeared in Last Month at the Federal Circuit - January 2015
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