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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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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