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Federal Circuit Restores Induced Infringement Verdict Against Teva

Addressing the issue of whether a generic pharmaceutical company can be found to induce infringement even when all patented uses have been “carved out” of the label (resulting in a so-called “skinny label”), the US Court of Appeals for the Federal Circuit held that circumstantial evidence of inducement was sufficient. The Court relied on evidence that defendant stated its drug was a “complete replacement” for plaintiff’s drug covered by the asserted patent. GlaxoSmithKline LLC et al. v. Teva Pharmaceuticals USA Inc., Case Nos. 18-1976, -2023 (Fed. Cir. Oct. 2, 2020) (Newman, J.) (Prost, C.J., dissenting). The Court reinstated a jury verdict against Teva Pharmaceuticals, ordering it to pay GlaxoSmithKline (GSK) $235 million. GSK brought suit against Teva in 2014 in response to Teva’s attempt to market a generic form of carvedilol, developed and marketed by GSK under the brand name Coreg®. Coreg® was US Food and Drug Administration (FDA) approved for three...

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Article III Standing Required to Appeal Final Decisions by the PTAB

Addressing the issue of Article III standing in an appeal of an inter partes review (IPR) decision, the US Court of Appeals for the Federal Circuit dismissed the appeal because the party appealing failed to establish an injury sufficient to confer standing. Argentum Pharms. LLC v. Novartis Pharms. Corp., Case No. 18-2273 (Fed. Cir. Apr. 23, 2020) (Moore, J.). Apotex filed an IPR petition of a patent owned by Novartis. The Patent Trial and Appeal Board (PTAB) instituted proceedings and granted Sun (and related entities), Teva, Actavis and Argentum’s (collectively, Petitioners) requests for joinder under 35 U.S.C. § 315(c). After PTAB concluded that Petitioners did not demonstrate unpatentability of the patent claims, Petitioners appealed. Before opening briefs were filed, Novartis filed a motion to dismiss Argentum’s appeal for lack of standing. Argentum opposed and included declarations from the CEOs of Argentum and KVK, Argentum’s manufacturing and marketing...

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Patent Term Extension Only Applies to Approved Product

In a case relating to a patented method for treating multiple sclerosis, the US Court of Appeals for the Federal Circuit found that patent term extension (PTE) only applies to methods of using the approved product as defined under the relevant statute, 35 U.S.C. § 156, even if the patent claim is broad enough to cover methods of using additional compounds. Biogen International GMBH v. Banner Life Sciences LLC, Case No. 20-1373 (Fed. Cir. Apr. 20, 2020) (Lourie, J.). Biogen holds the New Drug Application (NDA) for the active ingredient dimethyl fumarate (DMF) which has been approved for the treatment of multiple sclerosis. Upon administration to a patient, DMF is metabolized into a second compound, monomethyl fumarate (MMF). The compounds are virtually identical except that DMF has two methyl (CH3) groups (red in the below diagrams) and MMF has only one. The two compounds also have the same “active moiety.” Biogen owns a patent directed to a method of treating...

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Inherent Claim Limitation Necessarily Present in the Prior Art Invalidates Patent

Addressing the issue of obviousness, the US Court of Appeals for the Federal Circuit affirmed the district court’s finding that a patent was invalid based on inherency because the claim limitation was necessarily present in the prior art. Hospira, Inc. v. Fresenius Kabi USA, LLC, Case Nos. 19-1329, -1367 (Fed. Cir. Jan. 9, 2020) (Lourie, J). The patent at-issue is directed to premixed pharmaceutical compositions of dexmedetomidine that do not require reconstitution or dilution prior to administration and remains stable and active after prolonged storage. Hospira makes and sells dexmedetomidine products, including a ready-to-use product called Precedex Premix covered by the patent at-issue. Fresenius filed an Abbreviated New Drug Application (ANDA) seeking approval by the Food and Drug Administration (FDA) to market a generic ready-to-use dexmedetomidine product. Hospira brought suit alleging infringement under the Hatch-Waxman Act. After a five-day bench...

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