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.
Athena Diagnostics, Inc., et al. v. Mayo Collaborative Services, LLC, No. 17-2508 (Fed. Cir. (D. Mass.) Feb. 6, 2019). Opinion by Lourie, joined by Stoll. Dissenting opinion by Newman.
The Federal Circuit affirmed the district court’s decision that certain patent claims are invalid under 35 U.S.C. § 101 because they are directed to a natural law and lack an inventive concept.
Athena accused Mayo of infringing a patent directed to methods for diagnosing neurological disorders by detecting antibodies to a protein called muscle-specific tyrosine kinase (MuSK). Mayo moved to dismiss the complaint for failure to state a claim, arguing that certain claims were invalid under 35 U.S.C. § 101. Applying the Supreme Court’s test for subject matter eligibility established in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), and Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014), the district court determined that the claims were directed to a law of nature, specifically the naturally occurring “interaction of 125I-labeled MuSK with MuSK autoantibodies in bodily fluid.” The district court also determined that the claims lacked an inventive concept, “as the recited steps involved only standard techniques in the art.” The district court thus dismissed Athena’s complaint, and Athena appealed.
Addressing step one of the Mayo/Alice test, the Federal Circuit agreed with Mayo that the claims are directed to a natural law, namely, “the correlation between the presence of naturally-occurring MuSK antibodies in bodily fluid and MuSK-related neurological diseases,” which “exists in nature apart from any human action.” The claimed advance was only in the discovery of the natural law, and the additional steps recited in the claims “only apply conventional techniques to detect that natural law.” In so ruling, the Federal Circuit rejected Athena’s argument that the claims “preempt no natural law” and therefore are not directed to a natural law. The court explained that while preemption is sufficient to render a claim ineligible, it is not necessary. Turning to step two of the Mayo/Alice test, Athena argued that the claims provide an inventive concept: “an innovative sequence of steps involving man-made molecules.” The Federal Circuit disagreed, ruling that “the recited steps here were conventional both as an ordered combination and individually.”
In dissent, Judge Newman stated that diagnostic claims meeting the statutory novelty, nonobviousness, specificity, and enablement requirements are within the patent system, regardless of whether the diagnosed event occurs in the human body. In her view, the claims at issue are directed to “a multi-step method of diagnosis, not a law of nature.” Judge Newman emphasized that the Federal Circuit’s decisions on patent-ineligibility of diagnostic methods are not consistent, and the majority opinion here “enlarge[s] the inconsistencies and exacerbate[s] the judge-made disincentives to development of new diagnostic methods, with no public benefit.”
Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 17-1694 (Fed. Cir. (PTAB) Feb. 7, 2019). Opinion by Newman, joined by Dyk and Chen.
The Federal Circuit dismissed Momenta’s appeal of a PTAB decision upholding the patentability of all claims of U.S. Patent No. 8,476,239 for absence of standing/jurisdiction and for mootness.
Momenta petitioned for inter partes review of the ’239 patent at a time when it was developing a biosimilar counterpart of the product covered by the patent. The PTAB instituted review, and sustained the patentability of all claims. Momenta appealed, and Bristol-Myers Squibb (BMS) moved to dismiss the appeal stating that Momenta’s proposed product had failed its clinical trials and had been withdrawn. Momenta responded that it had not abandoned its intent to produce a counterpart of the patented product, that the ’239 patent was an obstacle to these activities, and that it is injured by the estoppel provision, 35 U.S.C. § 315(e). Momenta noted that it was discussing with its collaboration partner, Mylan, whether to proceed with a commercial formulation for their biosimilar product. BMS responded that a third party’s possible future development of a product does not give Momenta constitutional standing.
The Federal Circuit reiterated that, “It is established that the ‘case’ and ‘controversy’ restrictions for standing do not apply to matters before administrative agencies and boards, such as the PTO.” The Supreme Court has explained that parties initiating an IPR proceeding “need not have a concrete stake in the outcome; indeed, they may lack constitutional standing.” Judicial review of agency action, however, “remains subject to the constitutional foundation of injury-in-fact, lest the court occupy only an advisory role.” The Federal Circuit, therefore, dismissed the appeal. When Momenta abandoned development of its biosimilar, it “no longer ha[d] the potential for injury, thereby mooting the inquiry.”
Continental Circuits LLC v. Intel Corp., et al., No. 18-1076 (Fed. Cir. (D. Az.) Feb. 8, 2019). Opinion by Lourie, joined by Linn and Taranto.
The Federal Circuit concluded that the district court erred in its claim construction and, accordingly, vacated the district court’s judgment of noninfringement and remanded for further proceedings.
Continental sued Intel and others for infringing four patents directed to a multilayer electrical device having a tooth structure and methods for making the same. The asserted claims include limitations regarding the “surface,” “removal,” or “etching” of “a dielectric material” or “epoxy,” and their construction depended on resolving whether they should be limited to a repeated desmear process. The district court concluded that Intel had met the exacting standard required to read this limitation into the claims. The district court found that the specification characterized the invention as using a repeated desmear process, and the prosecution history corroborated the construction.
On appeal, the Federal Circuit ruled that the district court erred in limiting the claims to require a repeated desmear process. The Federal Circuit first looked to the plain language of the claims, noting that none recited a repeated desmear process. The court next considered the specification, concluding that the statements relied on by the district court describe a preferred embodiment and do not rise to the level of a clear and unmistakable disclaimer. Turning next to the prosecution history, the Federal Circuit disagreed that a clear disavowal exists in that record. Additionally, as to the product claims at issue, the court further ruled that the repeated desmear process was not an essential part of the claimed invention, and thus it was improper to read this process limitation into the product claims.