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13 May 2024
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This case is an appellate review of the district court's findings regarding patent obviousness and priority date.
United States Intellectual Property
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This case is an appellate review of the district court'sfindings regarding patent obviousness and priority date.
Background
Amgen produces and markets apremilast, a medication for thetreatment of certain types of psoriasis and psoriatic arthritis,under the brand name Otezla. Amgen also owns three patents —the '638, '101, and '541 patents — coveringOtezla. Sandoz submitted an Abbreviated New Drug Application (ANDA)seeking approval to market a generic version of apremilast.Celgene, the prior owner of the asserted patents, then sued Sandozfor infringing them, and Amgen was substituted as plaintiff whenCelgene transferred Amgen these three patents. The district court(District of New Jersey) held that the asserted claims of the'638 and '101 patents were not invalid as obvious and thatthe asserted claims of the '541 patent were invalid asobvious.
Both Amgen and Sandoz appealed. Regarding the '638 patent,Sandoz argued that the district court erred in failing to find amotivation to isolate apremilast from a known racemic mixture andalso for failing to find a reasonable expectation of success inseparating the mixture. Regarding the '101 patent, Sandozargued that the district court erred in holding that the '515provisional application inherently disclosed the crystalline Form Bof apremilast and thus that it did not provide the necessarywritten description support to entitle the patent to a March 2002priority date. Regarding the '541 patent, Amgen argued that thedistrict court erred in holding that the claimed dose-titrationschedule would have been obvious.
Issues
- Is the '638 patent invalid as obvious given objectiveindicia of non-obviousness?
- Did the '515 provisional application provide necessarywritten description support to entitle the '101 patent to aMarch 2002 priority date?
- Would the claimed dose-titration schedule in the '541patent have been obvious?
Holding(s)
- The '638 patent is not invalid as obvious given objectiveindicia of non-obviousness.
- The '515 provisional application provides the necessarywritten description support to entitle the '101 patent to aMarch 2002 priority date.
- The claimed dose-titration schedule in the '541 patentwould have been obvious.
Reasoning
(1) The Federal Circuit found no clear error in the districtcourt's holding that Sandoz did not meet its burden ofestablishing that the prior art gave a skilled artisan reason ormotivation to isolate apremilast from a known racemic mixture,i.e., to resolve the racemic mixture into its enantiomers. TheFederal Circuit held that the district court properly credited bothparties' experts and found Amgen's expert to be morepersuasive. Amgen's expert had provided informationestablishing that resolving a racemic mixture is a difficultprocess based on trial-and-error experimentation with many possibleoptions for the solvent system at the time.
As for the objective indicia, the Federal Circuit affirmed thatthe trial record established the presence of unexpected results,including testimony from a researcher listed as an inventor on the'638 patent, stating that they did not expect a 20-folddifference in potency between apremilast alone and the apremilastcontaining racemic mixture. The Federal Circuit also credited otherobjective indicia, each supported by expert testimony, such aslong-felt need, failure of others in the field, and industry andregulatory skepticism.
(2) The Federal Circuit found that crystalline Form B ofapremilast is actually disclosed in the '515 provisionalapplication, which provided support for relevant claims in the'101 patent to be entitled to a March 2002 priority date. TheCourt noted that Amgen provided over a dozen of experiment resultsto show the procedure in Example 2 of the '515 provisionalapplication resulted in crystalline Form B of apremilast and thatSandoz provided no evidence to show that the procedure "mayhave been capable of producing a crystalline Form other than FormB." The Court further held that it did not need to reach theissue of inherent disclosure because inherency is not requiredgiven the experiment results and expert testimony.
(3) The Federal Circuit affirmed the district court ruling thatcredited Sandoz's expert testimony that titrating doses totreat a patient with psoriasis is well within a skilledartisan's ability. The Court agreed that modifying the dosingschedule (dose titration) taught in a prior art reference wouldhave been obvious to a skilled artisan. The Court found that whenprescribing drugs with known dose-dependent adverse events in theearly weeks of treatment, a skilled artisan would have beenmotivated to use the prior art schedule "as a starting pointand extend it to titrate the dosing up in smaller amounts."Thus, citing Genentech, Inc. v. Sandoz Inc., 55 F.4th1368, 1376–77 (Fed. Cir. 2022), the Federal Circuit held thatvarying a dose in response to the occurrence of side effects iswell-known and obvious to the skilled artisan.
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