Obviousness-Type Double Patenting Does Not Invalidate a Patent Term ExtensionDecember 12, 2018
The Federal Circuit recently addressed the interplay between the statutory patent term extension (PTE) and the non-statutory doctrine of obviousness-type double patenting (ODP). The court determined that a patent is not invalid for ODP where PTE results in the subject patent expiring after another commonly-owned patent claiming an indistinct invention. Novartis AG v. Ezra Ventures LLC, No. 2017-2284, 2018 WL 6423564 (Fed. Cir. Dec. 7, 2018).
Novartis markets a multiple sclerosis drug under the name Gilenya®. The active ingredient is claimed in a Novartis patent that received PTE due to the FDA’s delay in approving the drug. The patent is listed in the FDA’s Orange Book. Ezra Ventures filed an application to market a generic version of the drug containing the same active ingredient. Novartis then sued Ezra for infringement. The PTE extended the patent’s term beyond that of a later-filed patent claiming treatment methods using the active ingredient. Ezra argued, among other things, that ODP curtails the PTE. The court disagreed.
In an earlier case, the court concluded that a terminally disclaimed patent could still have its term extended by PTE. Merck & Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317, 1323 (Fed. Cir. 2007). The Novartis court relied on Merck, concluding that ODP does not invalidate otherwise validly obtained PTE. The court’s decision also addresses a concern that arose from the court’s 2014 decision in Gilead Sciences, Inc. v. Natco Pharma Ltd., which held that a later-issued, earlier-expiring patent could serve as an ODP reference against an asserted patent. 753 F.3d 1208 (Fed. Cir. 2014). Novartis now holds that PTE “is valid so long as the extended patent is otherwise valid without the extension.” Novartis, 2018 WL 6423564, at *6.
Interestingly, the court noted that ODP is “‘a ‘judge-made doctrine’ that is intended to prevent extension of a patent beyond a ‘statutory time limit,’” and invalidating PTE on this basis would cut off a statutorily-authorized extension. Id. (quoting In re Berg, 140 F.3d 1428, 1431–32 (Fed. Cir. 1998)). Arguably, the court’s reasoning could extend to patent term adjustment, which is also statutorily-authorized; however, the court has not yet addressed this more prevalent issue.
If you have questions or concerns relating to the ramifications of Novartis v. Ezra Ventures on your portfolio, please contact Douglas G. Bolesch, Ph.D. or another attorney in the Biotechnology & Life Sciences practice group at Marshall Gerstein.
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