CQV Co., Ltd. v. Merck Patent GmbH, No. 2023-1027 (Fed. Cir. (PTAB) Mar. 10, 2025). Opinion by Cunningham, joined by Chen and Mayer.
CQV petitioned the Patent Trial and Appeal Board for post-grant review of a Merck patent relating to alpha-alumina flakes with particular characteristics. CQV asserted that various combinations of prior art rendered the challenged claims obvious.
During the proceedings, the parties disputed the prior art status of a product relied on by CQV. CQV asserted that the product qualified as prior art and presented statements about the availability of the product, testimony of past purchases of the product, and evidence of Merck’s manufacturing of and incentive to sell the product. The Board held that CQV’s evidence failed to establish that the product was prior art. Accordingly, the Board considered the instituted grounds without referring to the product, ultimately ruling that CQV failed to show that the challenged claims were unpatentable. CQV appealed.
On appeal, Merck challenged CQV’s Article III standing to appeal. But the Federal Circuit ruled that CQV established the requisite injury in fact because CQV established “at least one customer’s purchase and use of [allegedly infringing products] in the United States, Merck’s communications with that customer, and CQV’s indemnity agreement with that customer.”
Turning to the merits, the Federal Circuit ruled that it “cannot discern whether the relevant evidence was properly evaluated,” so the court remanded to the Board for further consideration and explanation of its analysis. The Federal Circuit explained that “the Board erred by failing to consider the whole record,” including “highly material and unrebutted evidence” that “the Board discarded without explanation.” Because the Federal Circuit could not “reasonably discern whether the Board followed a proper path” in determining whether the product at issue qualified as prior art, the court vacated the Board’s decision and remanded.
Sierra Wireless, ULC, et al. v. Sisvel S.p.A., Nos. 2023-1059, -1085, -1089, -1125 (Fed. Cir. (PTAB) Mar. 10, 2025). Opinion by Moore, joined by Schall and Taranto.
Sisvel owns a patent related to “a data transmission method and a data retransmission method which can reduce loss in data transmission” in a wireless communication system. Sierra Wireless, Honeywell, and Telit filed an IPR petition challenging all ten claims in the patent.
In a divided opinion, the Patent Trial and Appeal Board held claims 1, 2, and 6–8 to be unpatentable as anticipated by and obvious in view of the “Sachs” reference. The Board held that the remaining claims—dependent claims 3–5, 9, and 10—were not shown to be unpatentable. The parties appealed and cross-appealed the Board’s determinations.
The Federal Circuit began its analysis by focusing on Sisvel’s cross-appeal. Sisvel argued that the Board erred in holding claims 1, 2, and 6–8 to be unpatentable for two reasons. First, Sisvel argued that the Board erroneously construed limitations 1[c] and 1[d] as conditional. Second, Sisvel argued that the Board’s finding of unpatentability was not supported by substantial evidence. The Federal Circuit agreed with Sisvel on both counts. The court rejected the Board’s view “because the plain and unambiguous language of claim 1 requires that a method, to come within the claim, must perform both limitations 1[c] and 1[d] where their preconditions apply.” The Federal Circuit thus vacated the Board’s decision as to these claims.
As to the dependent claims, which the Board held to be unpatentable, the Federal Circuit decided it “need not reach” the arguments relating to those claims. The court ruled that it “do[es], however, agree with Appellants that the Board abused its discretion by relying on the testimony of Sisvel’s expert Mr. Bates, absent a finding that he is qualified as an ordinarily skilled artisan.”
According to the Federal Circuit, “Mr. Bates’ experience does not, on its face, satisfy the Board’s requirements for a skilled artisan.” Thus, the Board’s failure to provide reasoning for its decision to credit Mr. Bates’ testimony was an abuse of discretion. The Federal Circuit thus vacated and remanded, explaining: “Whether Mr. Bates’ experience suffices to meet the requirements for a person of skill in the art is a question of fact that we will not decide in the first instance, and thus we vacate for Board consideration of this issue.”
In re: Xencor, Inc., No. 2024-1870 (Fed. Cir. (PTAB) Mar. 13, 2025). Opinion by Schroeder (sitting by designation), joined by Hughes and Stark.
Xencor filed a patent application claiming certain methods of “treating a patient by administering an anti-C5 antibody.” An examiner rejected the claims for lack of written description. Xencor appealed to the Patent Trial and Appeal Board, and eventually the application was considered by the Appeals Review Panel (ARP) of the Board.
The ARP addressed two pertinent claims—claim 8 (a Jepson claim) and claim 9 (a method claim)—and ruled that the phrase “treating a patient” in the preambles of both claims was limiting. The ARP also found that the claim language “treating a patient” was not supported with adequate written description.
Xencor appealed, arguing that “the method claim’s preamble of ‘treating a patient’ is not limiting, that the preamble of the Jepson claim does not require written description, and that in the alternative, written description was satisfied for the preambles of both claims.”
The Federal Circuit first addressed the method claim and upheld the ARP’s decision. The court ruled that the entire preamble was limiting. Xencor admitted that the “administering” part of the preamble was limiting but argued that the other parts were non-limiting. The Federal Circuit ruled, however, that “the treating of the patient is done by administering the anti-C5 antibody” and that “this is not a mere statement of purpose or a statement of intended result that does not affect the performance of the claimed method.”
The Federal Circuit next considered whether the application satisfies the written description requirement for “treating a patient.” The court ruled that substantial evidence supported the ARP’s determination that it does not. In particular, “because the specification did not limit the treatment to any specific disease, ‘treating a patient’ means treating all patients and all diseases.” And the specification “was inadequate to demonstrate possession of a method of treating any particular disease/condition with the claimed anti-C5 antibodies, let alone all diseases/conditions within [certain] enumerated classes.”
As to the Jepson claim, the question presented was “whether the preamble of a Jepson claim requires written description, and if so, whether Xencor’s application contained sufficient written description for said preamble.” The Federal Circuit ruled that “a Jepson claim preamble requires written description.” The court explained: “The invention is not only the claimed improvement, but the claimed improvement as applied to the prior art, so the inventor must provide written description sufficient to show possession of the claimed improvement to what was known in the prior art.”
The court also explained that “to provide adequate written description for a Jepson claim, the applicant must establish that what is claimed to be well known in the prior art is, in fact, well known in the prior art.” Here, Xencor failed to establish that the limitation in the Jepson preamble, the anti-C5 antibodies, was well known in the prior art. Thus, the Federal Circuit affirmed the ARP’s decision.
Merck Sharp & Dohme B.V., et al. v. Aurobindo Pharma USA, Inc., et al., No. 2023-2254 (Fed. Cir. (D.N.J.) Mar. 13, 2025). Opinion by Dyk, joined by Mayer and Reyna.
Merck obtained a patent directed to a class of 6-mercapto-cyclodextrin derivatives. Merck then sought and obtained a reissue patent that included all the original claims and added twelve narrower claims relating to sugammadex, the active ingredient in Merck’s drug BRIDION®.
Merck then filed a patent term extension (PTE) application under the Hatch-Waxman Act, seeking the maximum five-year PTE for the reissue patent based on the original patent’s issue date. The PTO granted the five-year PTE for the enforcement time lost in connection with regulatory review of sugammadex.
In the meantime, Aurobindo and others filed Abbreviated New Drug Applications with the FDA to obtain approval to sell generic versions of BRIDION. Merck treated those filings as acts of infringement and thus filed suit.
In the lawsuit, Aurobindo argued that Merck’s reissue patent was not entitled to a five-year PTE and had therefore expired. The formula for calculating PTE is provided in 35 U.S.C. § 156(c), which states that the term of a patent “shall be extended by the time equal to the regulatory review period . . . occur[ring] after the date the patent is issued.” In calculating the PTE award for Merck’s reissue patent, the PTO used the issue date of the original patent, while Aurobindo argued that the PTO should have used the issue date of the reissue patent.
The district court disagreed with Aurobindo, finding that its interpretation of § 156(c) would undermine the purpose of the Hatch-Waxman Act. The court ruled that “the patent” in § 156(c) must refer to the original patent, not the reissued patent. Aurobindo appealed.
The Federal Circuit affirmed. The Federal Circuit interpreted the term “the patent” based on “the specific context in which that language is used, and the broader context of the statute as a whole.” Based on that analysis, the court concluded that “in the context of reissue patents, the Hatch-Waxman Act contemplates PTE for those patents and only those patents with claims directed to drug products whose period of exclusivity was delayed by FDA review.” Here, because the original patent included the same claims directed to a drug product subject to FDA review, the reissue patent was entitled to PTE based on the original patent’s issue date.
The Federal Circuit noted that “difficult questions arise in cases where the original patent did not include any claims directed to the drug product and was later reissued to include broader claims directed to such products.” The court noted that “those questions are not presented by this case.”
Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., et al., No. 2024-2351 (Fed. Cir. (N.D.W. Va.) Mar. 14, 2025). Opinion by Lourie, joined by Moore and Stark.
Regeneron owns a patent covering a biologic product called EYLEA®. After Amgen filed an Abbreviated Biologics Application seeking to market a biosimilar called ABP 938, Regeneron filed an action for infringement.
After filing the lawsuit, Regeneron moved for a preliminary injunction. The district court conducted claim construction and construed the claims to require that a claimed “VEGF antagonist” be a separate component from a claimed “buffer.” Because Amgen’s ABP 938 product does not contain a separate buffer, the district court determined that Regeneron had not demonstrated a likelihood of success in showing that Amgen infringed. The court therefore denied Regeneron’s motion for a preliminary injunction.
Regeneron appealed, challenging the district court’s claim construction. In particular, Regeneron challenged the applicability of the principle set forth in the Federal Circuit’s Becton decision that “where a claim lists elements separately, the clear implication of the claim language is that those elements are distinct components of the patented invention.”
Regeneron argued that the Becton presumption is inapplicable because in a separate litigation the district court had construed the claimed buffer as encompassing the active ingredient in the asserted claims. The Federal Circuit disagreed. First, the court ruled that contrary to Regeneron’s arguments, the district court “did properly engage with the claims, consistent with Phillips and established claim construction principles.” Second, Regeneron’s argument “conflates two independent claim construction inquiries,” and the prior litigation did not involve the claim construction issue presented here.
The Federal Circuit next addressed whether the evidence overcomes the implication of separateness under Becton. The court stated that “to overcome Becton, there must be evidence that shows that the impliedly distinct components, instead, can be satisfied by a single component.” The court also stated that while “such evidence may be intrinsic or extrinsic,” “it is difficult to envision Becton’s clear implication of separateness being overcome without at least a suggestion of non-separateness in the intrinsic evidence.”
The Federal Circuit ruled that the claims and specification of Regeneron’s patent did not overcome Becton, but instead “only reinforce that the claimed components are distinct.” Thus, the Federal Circuit concluded that the district court did not abuse its discretion in denying Regeneron’s motion for a preliminary injunction.