Summary
The United States Court of Appeals for the Federal Circuit affirmed a District of New Jersey decision concerning the validity of patents covering apremilast, marketed as Otezla. The court held that claims concerning stereomerically pure apremilast and crystalline Form B were not shown to be obvious, while claims concerning a dose-titration schedule were invalid as obvious. The appeals involved consolidated Federal Circuit case numbers 2022-1147, 2022-1149, 2022-1150, and 2022-1151.
Topics
Practice areas
Questions Presented
- Whether claims 3 and 6 of the '638 patent would have been obvious over the '358 patent and the '606 application, including whether a skilled artisan would have had motivation and a reasonable expectation of success in separating apremilast from the disclosed racemic mixture.
- Whether claims 1 and 15 of the '101 patent were entitled to the March 20, 2002 priority date based on written-description support in the '515 provisional application for crystalline Form B of apremilast.
- Whether claims 2, 19, and 21 of the '541 patent, directed to a dose-titration regimen for apremilast, would have been obvious over Papp, Schett, and Pathan.
Holdings
- Sandoz failed to prove by clear and convincing evidence that claims 3 and 6 would have been obvious over the '358 patent and the '606 application.
- Claims 1 and 15 of the '101 patent were entitled to the March 20, 2002 priority date because the '515 provisional application adequately disclosed crystalline Form B of apremilast.
- Claims 2, 19, and 21 of the '541 patent would have been obvious over Papp, Schett, and Pathan.
Key quotations
“There is no specific fold-difference that defines what may, or may not, support a finding of nonobviousness. Nor do we draw a line between a difference in degree insufficient to rebut a showing of obviousness and a difference in kind that may be sufficient to do so; each inquiry need be fact-specific.” (20)
“Demonstrating inherent disclosure requires meeting a stringent standard.” (24)
“We note here, as in Genentech, that varying a dose in response to the occurrence of side effects is well-known and obvious to the skilled artisan.” (28)
Factual background
Amgen markets stereomerically pure apremilast, a PDE4 inhibitor, under the brand name Otezla for psoriasis and related conditions. Sandoz filed an ANDA for a generic version, prompting infringement claims concerning patents covering apremilast compositions, crystalline Form B, and a dose-titration treatment schedule. The asserted prior art included patents and clinical-trial publications concerning racemic apremilast, enantiomer separation, apremilast dosing, and dose escalation.
Procedural history
Celgene initially brought a Hatch-Waxman action after Sandoz filed an ANDA seeking approval to market generic apremilast; Amgen was substituted as plaintiff in February 2020. The district court held that claims 3 and 6 of the '638 patent and claims 1 and 15 of the '101 patent had not been shown invalid as obvious, but held claims 2, 19, and 21 of the '541 patent invalid as obvious. Sandoz appealed the first two determinations, and Amgen cross-appealed the determination concerning the '541 patent. The Federal Circuit affirmed in all respects.