Is the “Blocking Patent” Doctrine Part of the Obviousness Analysis?

Last year, in a lengthy split decision, a Fed. Cir. panel affirmed the district court’s ruling that four “add-on” patents that Acorda owned were invalid as obviousness in view of a number of prior art references (Acorda Ther., Inc. v. Roxanne Labs., Inc., Appeal No. 2017-2078, 2017-2134 (Fed. Cir., Sept. 10, 2018). An earlier Elan patent licensed to Acorda was held to be valid and infringed, but it expired on July 30, 2018 (U.S. Pat. No. 5,540,938). This patent broadly claimed the use of a sustained release dosage form or 4-aminopyridine (4-MP) to treat multiple sclerosis (MS). On April 4th, surely encouraged by Judge Newman’s dissent, Acorda petitioned the Supreme Court for a writ of cert.

Acorda’s patents comprised “regimen- type claims” that specified that 4-MP should be administered (a) in a 10 mg dose twice a day (2) at that stable dose for the entire treatment period of at least 2 weeks (3) to achieve 4-MP serum levels of 15-35 ng/ml and (4) to improve walking by MS patients. Acorda received FDA approval to market 4-MP as Ampyra(c) and the four patents, e.g., U.S. Pat. No. 8,007,826 were listed in the Orange Book.

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Athena III – Should the Discovery of a Naturally-Occurring Correlation Encompass Recognition of its Practical Utility?

The origin of the idea that natural phenomena, like the law of gravity, cannot be patented, even by their discoverer, is well-settled law. In Gottschalk v. Benson, the Supreme Court stated, in dictum: “Phenomena of nature, though just discovered, mental processes and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” The Court went on to quote from Funk Bros.: “He who discovers a hitherto unknown phenomenon of nature has not claim to a monopoly of it which the law recognizes. If there is to be invention from such a discovery, it must come from the application of the law of nature to a new and useful end.” The Court concluded that, in Funk Bros., “we dealt with a ‘product’ claim while the present case deals with a ‘process’. But the think the same principle applies.”

In the legal eyes of the Federal Circuit, discovery of a natural correlation, such that the presence of autoantibodies to MuSK in a patient’s blood can be correlated to a diagnosis of MG, a neurological condition, encompasses the recognition by the researcher that an assay to detect these autoantibodies would be likely to be indicative of MG, if the “newly discovered” autoantibodies could be detected and if the detection using any available techniques, such as ELISA, yielded an accurate diagnosis. (This is beginning to feel like the hindsight reconstruction of the claimed diagnostic test that would be prohibited in an obviousness analysis.) But not all natural correlations are useful, e.g., can be turned into useful diagnostic procedures using conventional analytical and statistical tools.

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Senate Committee Releases Outline for Section 101 Reform

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.

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Athena’s Petition for Rehearing En Banc – Not All Diagnostic Claims are Equal Under s. 101

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.)

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