By Kevin E. Noonan --
"You consider that to be important?" he asked.
"Is there any point to which you would wish to draw my attention?"
"To the curious incident of the dog in the night-time."
"The dog did nothing in the night-time."
"That was the curious incident," remarked Sherlock Holmes.
"The Adventure of the Silver Blaze," The Memoirs of Sherlock Holmes, Sir Arthur Conan Doyle
Like Sherlock Holmes' quiet dog, the significance of the Supreme Court's patent eligibility jurisprudence following their decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. and Alice Corp. v. CLS Bank Int'l is that there hasn't been any. The Court has shown a similar reticence towards wading into the uncertain waters created by the Federal Circuit regarding the safe harbor created by the Hatch-Waxman Act, codified at 35 U.S.C. § 271(e)(1). Last Monday was the most recent instance of the Court's refusal to address how the lower courts have implemented these statutory provisions in denying certiorari in Cleveland Clinic Foundation v. True Health Diagnostics LLC and Classen Immunotherapies, Inc. v. Elan Pharmaceuticals Inc.
The claims at issue in Cleveland Clinic relate to methods for detecting myeloperoxidase (MPO) in a bodily sample (U.S. Patent Nos. 7,223,552, 7,459,286, and 8,349,581) and methods for treating a patient having cardiovascular disease (U.S. Patent No. 9,170,260); the claims of the '522 patent are representative:
11. A method of assessing a test subject's risk of having atherosclerotic cardiovascular disease, comprising comparing levels of myeloperoxidase in a bodily sample from the test subject with levels of myeloperoxidase in comparable bodily samples from control subjects diagnosed as not having the disease, said bodily sample being blood, serum, plasma, blood leukocytes selected from the group consisting of neutrophils, monocytes, subpopulations of neutrophils, and sub-populations of monocytes, or any combination thereo[f]; wherein the levels of myeloperoxidase in the bodily from the test subject relative to the levels of [m]yeloperoxidase in the comparable bodily samples from control subjects is indicative of the extent of the test subject's risk of having atherosclerotic cardiovascular disease.
14. A method of assessing a test subject's risk of developing a complication of atherosclerotic cardiovascular disease comprising: determining levels of myeloperoxidase (MPO) activity, myeloperoxidase (MPO) mass, or both in a bodily sample of the test subject, said bodily sample being blood, serum, plasma, blood leukocytes selected from the group consisting of neutrophils and monocytes, or any combination thereof; wherein elevated levels of MPO activity or MPO mass or both in the test subject's bodily sample as compared to levels of MPO activity, MPO mass, or both, respectively in comparable bodily samples obtained from control subjects diagnosed as not having the disease indicates that the test subject is at risk of developing a complication of atherosclerotic cardiovascular disease.
15. The method of claim 14, wherein the test subject's risk of developing a complication of atherosclerotic cardiovascular disease is determined by comparing levels of my[elo]peroxidase mass in the test subject's bodily sample to levels of myeloperoxidase mass in comparable samples obtained from the control subjects.
The Federal Circuit affirmed the District Court's grant of True Health's motion to dismiss under Fed. R. Civ. Proc. 12(b)(6) for failure to state a claim with regard to the diagnostic method patents, because the claims of these patents were directed to patent-ineligible subject matter (i.e., "laws of nature"). Cleveland Clinic's certiorari petition contained these two Questions Presented:
1. Whether the court below erred in holding, contrary to Mayo, that a method involving natural phenomena is ineligible for patent protection if it claims known techniques that have been adapted for a new use and purpose not previously known in the art.
2. Whether Mayo authorizes a district court to invalidate valuable patent rights on the pleadings when there are disputed questions of fact, a disputed question of claim construction or scope, and/or an undeveloped evidentiary record, notwithstanding the presumption of patent validity and settled procedural and Seventh Amendment safeguards that ordinarily prevent the resolution of such disputed questions on the pleadings.
The Classen case involves whether the § 271(e)(1) safe harbor applies for activities post-FDA approval. According to Petitioners, "[t]he [Federal Circuit] applies the safe harbor to use of a research tool employed for 'non routine' submissions to the FDA but does not apply the safe harbor to uses of the research tool that are deemed 'routine' submission to the FDA" and as a result reaches inconsistent outcomes. The Classen petition sets forth the issue as follows:
The Supreme Court decision in Merck v. Integra, 125 S.Ct. 2372 (2005) left uncertainty as to the enforceability of research tools under 35 U.S.C. §271(e)1. The Supreme Court commented in Footnote 7 on p. 2382, "We therefore need not and do not-express a view about whether, or to what extent, 35 U.S.C. §271(e)1 exempts from infringement the use of "research tools" in the development of information for the regulatory process." The CAFC has come to different conclusions on research tools used after marketing approval. Two CAFC panels arrived at opposite rulings (Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012), (Momenta Pharm., Inc. v. Teva Pharm. USA, Inc., 809 F.3d 610, 620 (Fed. Cir. 2015). In the current case the two separate CAFC panels came to a different opinion on the applicability of Telectronics Pacing Sys. v. Ventritex, Inc., 982 F.2d 1520, 1523–24 (Fed. Cir. 1992) to a research tool.
In the current case, in contrast to Momenta, the court ruled use of the research tool was "non-routine" and raises different questions than Momenta:
1. The CAFC has developed a litmus test to determine when 35 U.S.C. §271(e)1 applies to research tools used after marketing approval. The litmus test was introduce[d] in Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011) "The statute does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained. Id at 1070." In subsequent cases including the current case the CAFC has struggled with defining what constitutes "non-routinely" reported and thus protected by the safe harbor. The litmus test classifies something as "routine" if it is FDA required for ongoing FDA approval but "non-routine" if the post[-] marketing use is not required by the FDA. Is the CAFC's litmus test for research tools consistent with the law?
2. In this case, as opposed to Momenta's case, the court granted safe harbor because Elan's submissions to the FDA were deemed "non-routine" because they were necessary to update the Skelaxin product label and to change the FDA-approval process for generic versions of Skelaxin (Appx. 42a). What if the FDA recommends but does not require its use, is use still "routine"? Is this arbitrary?
3. As written and intended by Congress the safe harbor of 35 U.S.C. §271(e)1 is applied when (the whole) "invention" is used to for submission of data to the FDA. Is the CAFC's decision in this case to extend the safe harbor under 35 U.S.C. §271(e)1, to inventions where one or more but not all steps of an invention creates or uses data submitted to the FDA, consistent with the law?
4. Is the CAFC's decision to extend the safe harbor in this case to sale of product, where the product is claimed by process claims and where the process may utilize data submitted to the FDA, consistent with the law?
Denying certiorari petitions cannot be used to interpret the Court's views on whether the lower courts are properly applying its precedent; the Court frequently permits an issue to "percolate" through the courts and then chooses a case that, in their view provides a suitable vehicle for further clarification of the law. The Court has recently used this practice in other contexts (Gill v. Whitford; Benisek v. Lamone). In the meantime, however, patentees and the public await the time when the Court will deign to weigh in on either of these questions.