Merely Articulating A Goal Does Not Provide Reasonable Expectation Of Success
Thursday, June 27, 2019

The US Court of Appeals for the Federal Circuit affirmed a district court non-obviousness decision, finding that a prior art reference that articulates a goal without explaining how that goal is achieved does not provide a reasonable expectation of success. Endo Pharmaceuticals Inc. v. Actavis LLC, Case No. 18-1054 (Fed. Cir. May 3, 2019) (Wallach, J) (Stoll, J, dissenting).

Mallinckrodt Pharmaceuticals owns a patent, licensed by Endo Pharmaceuticals, directed to compounds known as morphinan alkaloids, such as oxymorphone, that are useful analgesics, and to “processes for preparing [a] highly pure morphinan-6-one” drug having low amounts of α,β unsaturated ketone (ABUK) impurities. The asserted claims of the patent are directed to “hydrochloride salt of oxymorphone comprising less than 0.001% of 14-hydroxymorphinone.” Endo sued several drug manufacturers (collectively, Actavis) that had filed abbreviated new drug applications to market generic versions of the drug.

Actavis argued that the patent claims were invalid as being anticipated by, or obvious over, several prior art references. Based on the specification and the testimony from Actavis’s expert, the district court construed the claim term “14-hydroxymorphinone” to mean “14- hydroxymorphinone hydrochloride” and “not as a separate non-salt, non-hydrochloride component.” The district court further found that a person of ordinary skill in the art would not have a reasonable expectation of success in combining the prior art to arrive at the claimed composition despite a US Food and Drug Administration (FDA) mandate requiring opioid manufacturers to reduce ABUK impurities in oxymorphone to below 0.001%. The district court found that the FDA communications were not prior art because they were not publicly available, and concluded that the asserted claims were not invalid due to obviousness. Actavis appealed.

The issues before the Federal Circuit were whether the district court had erred in its claim construction and whether the district court’s finding of non-obviousness was erroneous. On the first issue, the Court found that the intrinsic and extrinsic evidence supported the district court’s claim construction, which also nullified Actavis’ contention of anticipation. On the second issue, the Court found that the cited “purification” references did not provide a reasonable expectation of success because the two methods suggested in the prior art had not reasonably demonstrated that the claimed level of purity was attainable.

The Federal Circuit further found that although the FDA mandate was not widely circulated, it was still pre-America Invents Act 35 USC § 102(f) prior art. Nonetheless, the majority found that the FDA mandate did not rectify the limitations of the primary “purification” references but instead simply outlined a goal. The Court pointed to the technical difficulties associated with producing a highly pure oxymorphone composition and the extensive experimentation required to attain the mandated purity level as factors supporting its finding. The Court explained that since the mandate recognized the challenges associated with attaining the required standard of purity, it actually supported a finding of non-obviousness. The Federal Circuit therefore affirmed the district court’s findings of non-obviousness and infringement.

Judge Stoll dissented, arguing that the FDA mandate provided a motivation to reformulate the prior art to arrive at the claimed composition, which was sufficient for the inquiry. According to Judge Stoll, the patentee “took advantage by claiming the directive itself [and secured] exclusive rights to a drug first approved in 1959,” which was contrary to the goals of the patent system.

 

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