In Short
The Situation: In a Hatch-Waxman litigation, the claims recite oxymorphone with less than 0.001% of an impurity called 14-hydroxymorphinone. The prior art includes confidential communications from the FDA to oxymorphone manufacturers, requiring that the level of 14-hydroxymorphinone in oxymorphone be reduced to less than 0.001%.
The Result: On appeal, the Federal Circuit clarified that such confidential communications may qualify as prior art under pre-America Invents Act ("AIA") §102(f). The Federal Circuit affirmed for lack of reasonable expectation of success because the FDA communications said nothing about how to attain the stated goal of reducing the impurity.
Looking Ahead: Post-AIA §102 does not contain a provision corresponding to pre-AIA §102(f). Rather, the AIA created "derivation proceedings" and a cause of action for derivation. It remains to be seen whether (and how) such confidential communications may be used as prior art under post-AIA §102 in district court infringement suits.
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The Federal Circuit recently affirmed a district court's nonobviousness determination in a Hatch-Waxman litigation. The court's reasoning in that case reinforces its previous holding that "knowledge of the goal does not render its achievement obvious," where there was no reasonable expectation of success. Endo Pharm. Inc. v. Actavis LLC, 922 F.3d 1365, 1377 (Fed. Cir. 2019) (quoting Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341, 1352 (Fed. Cir. 2008)).
Mallinckrodt owns a patent claiming a certain pharmaceutical compound (oxymorphone hydrochloride) with less than 0.001% of a particular impurity (14-hydroxymorphinone). Oxymorphone is an opioid approved by the Food and Drug Administration ("FDA") for treating pain, but prior processes for making it yielded products containing 14-hydroxymorphinone, a potentially toxic impurity (also called the "ABUK" impurity). In 2004, through confidential communications with producers of oxymorphone, including Mallinckrodt, the FDA required that the ABUK levels in oxymorphone be reduced to less than 0.001%. After extensive experimentation, Mallinckrodt was able to achieve that impurity level and applied for a patent claiming oxymorphone hydrochloride with less than 0.001% of 14-hydroxymorphinone.
In the Hatch-Waxman litigation, the defendants sought to invalidate Mallinckrodt's patent claims as obvious, citing the FDA communications and certain prior-art processes for making opioids. The district court first concluded that confidential FDA communications were not prior art. Endo, 922 F.3d at 1373 n.9. But in any event, the district court found that the FDA communications did not offer any reasonable expectation of success because they "provided no substantive information about how the companies were to go about producing low-ABUK oxymorphone." Id. at 1374.
On appeal, the...
