PATENT CASE OF THE WEEK
Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, Appeal No. 2017-2508 (Fed. Cir. Feb. 6, 2019)
In an appeal from an order of the United States District Court for the District of Massachusetts, the Federal Circuit affirmed that certain claims of a patent directed to methods for diagnosing neurological disorders were ineligible for patenting under 35 U.S.C. § 101. Specifically, the Court found that the “district court correctly concluded that the claims at issue are directed to a natural law and lack an inventive concept...” The patent covers a method for diagnosing disorders “by detecting antibodies to a protein called muscle specific tyrosine kinase (‘MuSK’).” This is yet another case in which methods for diagnosing diseases have been found patent ineligible, with Mayo as the challenger, following the Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012).
The Court first reviewed the test for subject matter eligibility established in Mayo and Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014). In particular, it noted “[l]aws of nature are not patentable, but applications of such laws may be patentable. A claim to otherwise statutory subject matter does not become ineligible by its use of a law of nature. … But, on the other hand, adding “conventional steps, specified at a high level of generality,” to a law of nature does not make a claim to the law of nature patentable.
Athena argued that the relevant claims in issue were not directed to a natural law because they recited “innovative, specific, and concrete steps that do not preempt a natural law.” Athena argued that its invention related to a new laboratory technique that made use of man-made molecules. In response, Defendant Mayo argued that the claims were directed to a natural law and the fact that the test made use of man-made molecules was irrelevant, analogizing the facts in Mayo v. Prometheus.
The Court sided with Mayo, finding the claims are directed to a natural law “because they recite only the natural law together with standard techniques for observing it. That the routine steps are set forth with some specificity is not enough to change that conclusion.” The Court also found “that the steps of the claims not drawn to ineligible subject matter, whether viewed individually or as an ordered combination, only require standard techniques to be applied in a standard way.
Concerning the fact that man-made molecules were involved, the Federal Circuit agreed that this was irrelevant—“the use of a man-made molecule is not decisive if it amounts to only a routine step in a conventional method for observing a natural law.” The Court noted that in two other cases, including Mayo, the claimed method made use of man-made molecules, and held “that use of a man-made molecule in a method claim employing standard techniques to detect or observe a natural law may still leave the claim directed to a natural law.”
Consequently, the Court held that the claims at issue were ineligible under § 101 because the claims recited only a natural law together with conventional steps to detect that law, and thus also lacked an inventive concept.
The Court was careful to distinguish claims that “recite a natural law and conventional means for detecting it, and applications of natural laws, which are patent-eligible.” The Court reiterated that “Claiming a natural cause of an ailment and well-known means of observing it is not eligible for patent because such a claim in effect only encompasses the natural law itself. But claiming a new treatment for an ailment, albeit using a natural law, is not claiming the natural law.” Thus, patents directed to diagnosing ailments are more likely to fall into this exception to patentability.
Judge Newman dissented. Her position is aptly summarized at the beginning of her opinion: “Until discovery of the diagnostic method described in [the patent], some 20% of patients suffering from the neurological disorder Myasthenia Gravis were not capable of being diagnosed. My colleagues rule that this new diagnostic method is not patent eligible, although new and unobvious. However, ‘[t]his new and improved technique, for producing a tangible and useful result, falls squarely outside those categories of inventions that are “directed to” patent-ineligible concepts.’ … The court again departs from the cautious restraints in the Supreme Court’s Mayo/Alice application of laws of nature and abstract ideas. This court’s decisions on the patent-ineligibility of diagnostic methods are not consistent, and my colleagues today enlarge the inconsistencies and exacerbate the judge-made disincentives to development of new diagnostic methods, with no public benefit. I respectfully dissent.”
The opinion can be found here.
ALSO THIS WEEK
Continental Circuits LLC v. Intel Corporation, Appeal No. 2018-1076 (Fed. Cir. Feb. 8, 2019)
In an appeal from a district court decision, the Federal Circuit reversed on an issue of claim construction. At issue was a process for making electronic devices, and whether or not the process required a “repeated desmear” or only a single desmear. The district court had found that the defendants “had ‘met the exacting standard required’ to read a limitation into the claims,” and held that the claims required a repeated desmear process. The Federal Circuit reversed, finding insufficient evidence of disavowal or disparagement of a single desmear process. The Court found that the “preferred embodiment” was not necessarily limited to a repeated desmear process. The Court also addressed the extent to which process limitations can be read into product claims, citing Andersen Corp. v. Fiber Composites, LLC, 474 F.3d 1361, 1375 (Fed. Cir. 2007).
The opinion can be found here.
Momenta Pharmaceuticals Inc. v. Bristol-Myers Squibb Company, Appeal No. 2017-1694 (Fed. Cir. Feb. 7, 2019)
The Federal Circuit dismissed an appeal from an inter partes review decision for lack of Article III standing and for mootness. The IPR had upheld all claims of a pharmaceutical patent covering a commercial immunosuppressant, to which Appellant/Petitioner Momenta had been attempting to develop a biosimilar counterpart. During the course of the appeal, Momenta informed the SEC of its termination of an agreement to co-develop the counterpart drug following its failure in Phase I clinical trials. The Court acknowledged a relaxed standing requirement for statutory appeals from administrative decisions, but reiterated that some particularized interest or injury-in-fact is “a hard floor of Article III jurisdiction that cannot be removed by statute.” The Court rejected as speculative Momenta’s argument that it may someday receive royalties if its former partner should resume development activities, and found that Momenta lacked standing to invoke federal appellant jurisdiction. While warning that “[s]tanding and mootness may not be coextensive in all cases,” the Court also found the appeal to be mooted by Momenta’s discontinuance of any potentially infringing activity.
The opinion can be found here.
In re: Google LLC, Appeal No. 2018-152 (Fed. Cir. Feb. 5, 2019)
The Federal Circuit denied Google’s combined petition for panel rehearing and rehearing en banc of the Court’s earlier denial of Google’s petition for writ of mandamus concerning whether venue was appropriate in the Eastern District of Texas. The district court originally held that venue was proper based on the fact that Google owns servers that operate in the district, despite the fact that no Google employee physically interacts with the servers, and the servers were installed by third parties. In its previous denial of Google’s petition for mandamus, the Court noted that it denied the petition in part based on the “many specific details” of Google’s contracts with internet service providers and its “strong control” over the servers. While the panel denying Google’s petition for rehearing here made no comment on the merits, Judge Reyna, in dissent, explained that the implications of this denial could be far-reaching due to the tension between the statute and the “realities of the continued change in the nature of the marketplace and how goods and services are traded.” The dissent also notes that the district court’s holding could be read as yet another expansive reading of § 1400(b), essentially re-establishing nationwide venue in direct conflict with TC Heartland, by standing for the proposition that owning and controlling computer hardware involved in some aspect of company business (e.g., transmitting data) alone is sufficient to establish venue.
The opinion can be found here.
