On Friday, October 6, Amgen filed a complaint in the Central District of California seeking a declaratory judgment against Genentech that Mvasi® (bevacizumab-awwb), Amgen’s recently approved biosimilar of Avastin®, does not infringe 27 patents, that those patents are invalid, and that one of the patents is unenforceable for inequitable conduct. This is the second lawsuit between the companies regarding this biosimilar product: Genentech filed a complaint for declaratory judgment against Amgen in the District of Delaware this past February based on alleged violations by Amgen of the patent dance provisions of the BPCIA following FDA’s acceptance of Amgen’s aBLA, but the district court dismissed the complaint just a few weeks later.
The complaint alleges certain events during the parties’ patent dance exchanges and negotiations under the BPCIA. Amgen alleges that in March 2017 Genentech provided Amgen with a list of 27 patents, pursuant to 42 U.S.C. § 262(l)(3)(A), that Genentech believed could reasonably be asserted against Amgen. According to Amgen, it fully responded to Genentech’s list by providing a statement under § 262(l)(3)(B) that detailed on a claim-by-claim basis why each patent was not infringed, invalid and/or unenforceable, but Genentech’s statement in response under § 262(l)(3)(C) was non-compliant with the statute because Genentech allegedly failed to properly respond to 13 patents (as well as 3 additional claims of two other patents) on Genentech’s (3)(A) list. In September, Amgen allegedly asked Genentech to remove these patents from its (3)(A) list, but Genentech allegedly refused to do so. Amgen alleges that later that month the parties held an in-person meeting to engage in good-faith negotiations under § 262(l)(4) regarding which patents on Genentech’s (3)(A) list shall be the subject of an action for patent infringement under § 262(l)(6), and Genentech again refused to withdraw any patents or claims from its (3)(A) list. Amgen asserts that on September 29, 2017, the parties’ negotiations under § 262(l)(4) ended without an agreement on a final and complete list of which, if any, patents on Genentech’s (3)(A) list shall be the subject of an action for patent infringement under § 262(l)(6). Amgen’s complaint apparently seeks resolution of the disputes regarding the 27 patents on Genentech’s (3)(A) list.
In addition to alleging non-infringement and invalidity of all 27 patents-in-suit, Amgen asserts that U.S. Patent No. 6,407,213 is unenforceable due to inequitable conduct, based on alleged “deliberate and material misrepresentations and omissions” about certain prior art references during prosecution. This patent is also the subject of numerous pending IPR petitions, filed by Celltrion, Boehringer Ingelheim, Pfizer and Samsung Bioepis. Several of the other patents-in-suit, including U.S. Patent Nos. 6,870,034, 7,622,115 and 7,807,799, are also the subject of pending IPRs or terminated IPRs.
Stay tuned to Big Molecule Watch for further updates.
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