Bipartisan “Draft Bill” to Amend ss. 100, 101 and 112 Released for Comment

On Wednesday, Senators Tillis and Coons, along with Reps. Collins, Johnson and Stivers released a draft, bipartisan bill to amend ss.100 and 101 to void the “judicial exceptions” to patent eligibility. Section 112(f) was also amended to tighten up the language (“for a combination” was eliminated).

On April 18th, I posted the “Draft Outline of Section 101 Reform.” I noted that the draft attempted to define “exclusive categories of statutory subject matter which alone should not be eligible for patent protection.” However, the draft’s proposed categories included “products that exist solely and exclusively in nature”- but did not mention claims reciting naturally-occurring processes, such as diagnostic tests. This was especially troubling since the draft outline would blacklist “mental activities” and the courts and the PTO routinely disregard steps in method claims that involve thinking, such as the mental activity of the actor who interprets the results of the test as indicative of a medical condition.

The “draft bill text” rejects this definitional attempt to define patent-ineligible subject matter. It amends s. 101 to eliminate the requirement that the patent eligible invention or discovery be “new,” and adds section 100(f) that states: “The term ‘useful’ means any invention or discovery that provides specific and practical utility in any field of technology through human intervention.”

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Novartis v. West-Ward – Lead Compound Analysis v. Motivation to Combine

In Novartis Pharm. v. West-Ward Pharm., Appeal no. 2018-1434 (Fed. Cir., May 12, 2019), a three judge panel of Stoll, Plager and Clevenger affirmed the district court’s ruling that the claims of Novartis’ U.S. Pat. No. 8,410,131, directed to using a rapamycin analog 40-O-(2-hydroxyethyl) rapamycin (“everolimus”) to treat renal cell carcinoma (RCC) were valid over two prior art Novartis patents disclosing this analog and disclosing that it is generally useful to treat “tumors” and two papers disclosing phase I studies of another rapamycin analog, temsirolimus, which showed some efficacy against RCC.

The panel held that the district court erred in finding that the POSA “would have been motivated to pursue everolimus as one of several potential treatment options for…advanced RCC.” The panel continued:

“This finding should have affirmatively answered the question whether there would have been a motivation to combine. Yet, the district court continued its analysis and found that West-Ward ‘failed to prove by clear and convincing evidence that a POSA would have been motivated to select everolimus.’ The district court erred in applying this heightened standard. ‘[O]ur case law does not require that a particular combination must be the preferred, or the most desirable combination described in the prior art in order to provide motivation for the current invention.”

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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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