On April 18th, the Senate Judiciary Subcommittee on Intellectual Property released a “Draft Outline of Section 101 Reform” that is intended to provide the basis of legislative amendments to the requirements for patent reform. Apart from the proposal to effectively eliminate the phrase “new and” from s. 101, the Outline proposes that “exclusive categories of statutory subject matter which alone should not be eligible for patent protection.”
These include categories that are relatively non-controversial such as “fundamental scientific principles” (such as gravity, I presume) as well as categories that still leave room for interpretation by the PTO and the courts, such as “products that exist solely and exclusively in nature.” This “in nature” requirement could be read as overturning the Funk Bros. opinion and resurrecting Bergy II — the CCPA holding that cultures of pure strain microorganisms were found to not be natural products.
In my last post on s. 101, discussing “Cleveland Clinic II” I asked, “Why can’t a diagnostic conclusion be a practical application of a natural law?” and rhetorically answered: “Because the Federal Circuit says it can’t.” In Cleveland Clinic I (Cleveland Clinic Foundation v. True Health Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2007), the panel held patent ineligible claims to a method for assessing a test subjects’ risk of having cardiovascular disease (CVD) by comparing levels of a marker, MPO, in a sample from the subject with levels from control subjects diagnosed as not having the disease. Elevated levels of MPO in the test subject over the control subjects’ MPO levels “is indicative of the extent of the test subject’s risk of having CVD.”
In Athena Diagnostics, Inc. v. Mayo Collab. Services, LLC, Appeal no. 2017-2508 (Fed. Cir., 2019), a divided panel held that a method for diagnosing MG by detecting a marker for MG – autoantibodies against “MuSK”- using immunoassay techniques involving labelled MuSK, such as ELISA – is also a patent-ineligible natural phenomenon. Judge Newman dissented. (Please read my posts of Feb. 7, 2019 for much more about Athena at the Fed. Cir.)
Because the Federal Circuit says it can’t, that’s why! In Cleveland Clinic Foundation v. True Health Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2017), the panel held patent-ineligible claims to a method of assessing a test subject’s risk of having cardiovascular disease (CVD) by comparing levels of a marker MPO in a sample from the subject with levels from control subjects diagnosed as not having the disease wherein elevated levels of MPO in the test subject over the control subjects’ MPO levels “is indicative of the extent of the test subject’s risk of having cardiovascular disease”. In that decision, the panel found that the method claims are directed to a patent-ineligible natural law ‘that blood MPO levels correlate with CVD, “holding that the claimed method ‘starts and ends’ with observation of ‘naturally occurring phenomena’, as in Ariosa….” The panel jumped right to Step 2B of the Mayo/Alice test and found that the claims “recited no further inventive concept sufficient to transform the nature of the claims into a patent eligible application of the natural law.”
In this case, “Cleveland Clinic II,” (Appeal 2018-1218 (Fed. Cir., April 1, 2019) the Clinic appealed the 101 rejection of claims that did not recite a diagnostic conclusion:
- A method of detecting elevated MPO mass in a patient sample comprising;
- obtaining a sample from a human patient having [CVD]; and
- detecting elevated MPO mass in said plasma sample, as compared to a control MPO mass level from the general population or apparently healthy subjects, by contacting said plasma sample with anti-MPO antibodies and detecting binding between MPRO in said plasma samples and said anti-MPO antibodies.
These claims were designed to track Example 29 – Claim 1 of the May 4, 2016 PTO Guidance on patent-eligible subject matter:
- A method of detection JUL-1 [a marker for the autoimmune disease “julitis”], said method comprising:
- obtaining a plasma sample from a human patient; and
- detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.
In Endo v. Teva, Appeal 2017-1240 (Fed. Cir., March 19, 2019), a Fed. Cir. panel of Judges Stoll, Wallach and Clevenger unanimously found patent-eligible claims to a method of treating pain with oxymorphone, based on the inventor’s discovery that there was a significant correlation between plasma AUC for the drug and a patient’s degree of renal impairment (U.S. Pat. No. 8,808,737). As Judge Stoll wrote:
“[U.S. Pat. No. 8,808,737] relates to his discovery that patients with renal impairment in need of pain relief can be treated in a new different way than other patients. Specifically, the inventor discovered than patients with moderately or severely impaired kidney function [as measured by creatinine clearance levels] need less oxymorphone than usual to achieve a similar level of pain management” [emphasis added].
The claim is not a model of elegant drafting, but it got the job done:
- A method of treating pain in a renally impaired patient, comprising the steps of:
- Providing a solid oral controlled release dosage form, comprising:
- About 5 mg to about 80 mg of oxymorphone or a pharmaceutically acceptable salt thereof as the sole active ingredient and
- A controlled release matrix;
- Measuring a creatinine clearance rate of the patient and determining it to be [within one of four ranges representing renal impairment from healthy control to severe renal impairment; and
- Orally administering to said patient, in dependence on which creatinine clearance rate is found, a lower dosage of the dosage form to provide pain relief;
Wherein after said administration to said patient the average AUC of oxymorphone over a 12-hour period is less than about 21 ng hr/ml. [emphasis added].