A weekly summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit and the opinions designated precedential or informative by the Patent Trial and Appeal Board.
Fitbit, Inc. v. Valencell, Inc., No. 2019-1048 (Fed. Cir. (PTAB) July 8, 2020). Opinion by Newman, joined by Dyk and Reyna.
Apple petitioned the Patent Trial and Appeal Board for IPR of claims 1–13 of a patent owned by Valencell. The Board granted Apple’s petition in part, instituting review of only claims 1, 2, and 6–13. Fitbit then filed an IPR petition challenging claims 1, 2, and 6–13, and moved for joinder with Apple’s IPR. The Board granted Fitbit’s petition and motion for joinder.
During the IPR, the Supreme Court decided SAS Institute v. Iancu, holding that all claims challenged in an IPR petition must be reviewed by the Board if the petition is granted. The Board therefore re-instituted the IPR to add claims 3–5. The Board then issued a Final Written Decision finding all claims except claims 3–5 to be unpatentable. Following that decision, Apple withdrew from the proceeding, and Fitbit alone appealed the Board’s decision as to claims 3–5.
On appeal, Valencell argued that Fitbit did not have a right to appeal the Board’s determination as to claims 3–5 because Fitbit’s IPR petition did not challenge those claims. Valencell argued that Fitbit had waived its arguments by not presenting them in the IPR petition. The Federal Circuit disagreed, stating: “We conclude that Fitbit’s rights as a joined party applies to the entirety of the proceedings and includes the right of appeal, conforming to the statutory purpose of avoiding redundant actions by facilitating consolidation, while preserving statutory rights, including judicial review.”
Turning to the Board’s determination that claims 3–5 were not proved to be unpatentable, the Federal Circuit vacated and remanded. Regarding claim 3, the Federal Circuit upheld the Board’s claim construction, but the court noted that the Board “did not review the patentability of claim 3, as construed, on the asserted grounds of obviousness.” Instead, the Board had viewed the question of patentability as turning on Fitbit’s proposed claim construction, which the Board had rejected. The Federal Circuit ruled that the Board’s approach was improper and remanded for a determination of patentability.
Regarding claims 4 and 5, the Board found that a term lacked antecedent basis, rendering the meaning of the claims “speculative.” However, both Fitbit and Valencell agreed as to the error and its correction. Nonetheless, the Board declined to accept the parties’ shared view. Addressing these circumstances, the Federal Circuit held that the Board “erred in declining to accept the parties’ uniform position and correct the error.” The Board’s treatment of the error as a basis for assessing patentability was “not a reasonable resolution, and does not comport with the Agency’s assignment to resolve patentability issues.” The Federal Circuit therefore remanded.
Genentech, Inc. et al. v. Immunex Rhode Island Corp. et al., No. 2019-2155 (Fed. Cir. (D. Del.) July 6, 2020). Opinion by Moore, joined by O’Malley and Hughes.
Genentech manufactures and sells Avastin, 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. Amgen received approval and then sent a letter pursuant to 42 U.S.C. § 262(l)(8)(A) notifying Genentech of its intent to market the biosimilar version no earlier than 180 days from the date of the letter. Later, Amgen filed various supplements to its application.
More than 180 days after the notice letter, Amgen decided to commercially launch its biosimilar and begin marketing it immediately. Genentech then filed an emergency motion and a motion for a temporary restraining order in the district court, arguing that Amgen’s supplements resulted in new and distinct applications that required new notices under § 262(l)(8)(A). The district court denied the motions, reasoning that Amgen’s earlier notice satisfied the statute’s requirements.
On appeal, the Federal Circuit held that the statute “makes clear that the biosimilar applicant must provide notice to the reference product sponsor prior to commercially marketing the biological product.” Amgen had notified Genentech of its intent to commercially market its biological product. Amgen’s later supplements, which related to adding a manufacturing facility and changing the product label, did not change the biological product. Therefore, Amgen had provided Genentech notice consistent with the statute.
Hunting Titan, Inc. v. DynaEnergetics Europe GmbH, No. IPR2018-00600 (PTAB POP July 6, 2020). Opinion by Boalick, joined by Iancu and Hirshfeld.
The Patent Trial and Appeal Board’s Precedential Opinion Panel (POP) ruled that the Board may raise a ground of unpatentability that an IPR petitioner did not advance or insufficiently developed against proposed substitute claims, but should do so “only under rare circumstances.” The POP also ruled that the patent owner must be given notice and an opportunity to respond to the new theories of unpatentability.
The IPR petition presented grounds of unpatentability based on both anticipation and obviousness. During trial, the Patent Owner presented substitute claims in a Motion to Amend. In opposing the motion, the Petitioner challenged the patentability of the proposed substitute claims based only on obviousness. In its Final Written Decision, the Board found that both the original claims and the proposed substitute claims were anticipated.
The POP ordered rehearing to address the Board’s reliance on anticipation grounds when assessing the proposed substitute claims, since the Petitioner had asserted only obviousness grounds. Specifically, the POP addressed whether and when the Board may “raise a ground of unpatentability that a petitioner did not advance or insufficiently developed against substitute claims proposed in a motion to amend.” The POP concluded that the Board may raise such a ground, but should do so “only under rare circumstances” that were not presented in this case. The POP noted that such circumstances include where “the petitioner has ceased to participate in the proceeding altogether,” where the petitioner “chooses not to oppose the motion to amend,” or where unasserted evidence of unpatentability “is readily identifiable and persuasive such that the Board should take it up in the interest of supporting the integrity of the patent system.”
The POP also ruled that “due process requires that a patent owner receive notice of how the prior art allegedly discloses the newly-added limitations of each proposed substitute claim, as well as a theory of unpatentability asserted against those claims. And the patent owner must have the opportunity to respond to those factual allegations and legal theories.”