IP News

The Federal Circuit first held that Fitbit was able to appeal the Board's decision because 35 U.S.C. §319 allows "any party" to an IPR to appeal a decision. Fitbit, 2020 U.S App. LEXIS 21131 at 4. Additionally, because of the Supreme Court's ruling in Thryv, the Federal Circuit had no authority to review the Board's decision to institute Fitbit's IPR, even though Fitbit petitioned for IPR over a year after being sued in district court.

Moving to the merits of the appeal, the court upheld the Board's adoption of Valencell's proposed claim construction, but then vacated the Board's decision with respect to claims 3-5 for failing to conduct an obviousness analysis under the proposed claim construction. The court reminded the Board that a determination of patentability does not end if the challenger's proposed construction is not adopted. Instead, "claim construction is only the first step in establishing the meaning and scope of a claim, whereby patentability is assessed for the claim as construed." Id. at 14

Lastly, the court turned to the Board's decision finding claims 4 and 5 not unpatentable. The Board found that these claims lacked an antecedent basis because of an error during prosecution that was not caught by the examiner or applicant. The court held that the Board has the authority to correct such a claim when the prosecution history shows an obvious drafting error. As a result, the court remanded the case to the PTAB to determine the merits of patentability in light of the claim construction and proper antecedent basis of claims 4 and 5.

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Federal Circuit: Notice to Market Bio Product Not Negated By New Applications

Genentech, Inc. et al. v. Immunex Rhode Island Corp. No. 2019-2155, 2020, U.S. App. LEXIS 20850 (Fed. Cir. July 6, 2020)

Genentech manufactures and sells bevacizumab under the trade name "Avastin." Avastin is a biological product used to treat certain types of cancer. Amgen filed a biologics license application with the FDA, seeking approval to market a biosimilar version of Avastin under the name "Mvasi." The FDA approved Mvasi in September 2017 then sent a letter in October 2017 pursuant to 42 U.S.C. §262(l)(8)(A) notifying Genentech of its intent to market Mvasi version no earlier than 180 days from the date of the letter. By July 2019, Amgen had filed four supplements and decided it would launch and market Mvasi immediately.

Genentech and City of Hope filed an emergency motion and a motion for a temporary restraining order based on Amgen's alleged failure to comply with the notice requirement of 42 U.S.C. §262(l)(8)(A). The District Court of Delaware denied Genetech's motion.

On appeal, the Federal Circuit held that 42 U.S.C. §262 "makes clear that the biosimilar applicant must provide notice to the reference product sponsor prior to commercially marketing the biological product." Genentech, 2020 U.S. App. LEXIS 20850 at 3-4 (emphasis in original). Amgen had notified Genentech of its intent to commercially market its biological product as early as October 2017. Amgen's later four supplements, which related to new applications, adding a manufacturing facility, and changing the drug label, did not change the biological product marketed as Mvasi. Thus, the court found Amgen had provided Genentech notice consistent with the statute and upheld the denial of the temporary restraining order because Genentech had failed to establish a likelihood of success on the merits of its claim.

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Howard Shire is Editor-in-Chief of The Intellectual Property Strategist and a Partner in the New York office of Troutman Pepper. He can be reached at [email protected]. Shaleen J. Patel is an Associate in the Intellectual Property Department of Troutman Pepper, resident in the Boston office. He can be reached at [email protected].