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Fed Circuit Mulls Prometheus, But PTO Starts to Implement It

By Mari Serebrov
Washington Editor

WASHINGTON – While the Federal Circuit is still digesting the Supreme Court's ruling on patents involving laws of nature and natural correlations, the Patent and Trademark Office (PTO) has translated its Mayo Collaborative Services v. Prometheus Laboratories Inc. decision into temporary guidance for patent examiners.

The guidance instructs examiners on determining the patent eligibility of method claims involving natural principles. Echoing the Supreme Court ruling in Prometheus, the PTO said such claims must be more than a law of nature and a general instruction to simply apply it.

A claim that focuses on the use of a natural principle must include elements or steps to show "the inventor has practically applied, or added something significant to, the natural principle itself," according to the guidance. A statement of a naturally occurring correlation, even if it's a newly discovered correlation, fails the test.

The guidance also advises examiners to "establish the broadest reasonable interpretation of the claims when read . . . from the view of one of ordinary skill in the art." While they should evaluate each claim limitation, examiners must consider the claim as a whole.

"It is improper to dissect a claimed invention into discrete elements and then evaluate the elements in isolation because it is the combination of claim limitations functioning together that establish the boundaries of the invention and limit its scope," the PTO said.

Earlier this year, the Supreme Court unanimously overturned Prometheus' personalized medicine-type patent claims, calling them "drafting efforts designed to monopolize the correlations" between metabolites in the blood and the dosing of thiopurine drugs for such autoimmune diseases as Crohn's and ulcerative colitis. (See BioWorld Today, March 21, 2012.)

In releasing the interim guidance this month, the PTO said a comprehensive, updated guidance will be needed once the Court of Appeals for the Federal Circuit provides more insight when it reconsiders two somewhat related cases. The Supreme Court remanded the two cases – the Association of Molecular Pathology v. Myriad Genetics and WildTangent v. Ultramercial – to the appellate court with instructions to rethink them in light of the Prometheus decision. (See BioWorld Today, March 27, 2012.)

The Federal Circuit is set to hear oral argument next week on the challenge to Myriad's claims on the BRCA1 and BRCA2 genes, used in diagnostics for breast and ovarian cancer. While Ultramercial involves Internet processes rather than personalized medicine, it raises issues about the scope of knowledge held in prior art.

Editor's note: BioWorld will host a webinar July 17, 2012, on "Patenting Personalized Medicine After Prometheus." For more information, visit bioworld.com or call (800) 477-6307 or (404) 262-5476.

AHRQ Proposes Registry of Registries

To increase the value of patient registries, the Agency for Healthcare Research and Quality (AHRQ) is proposing a registry of registries that would function much like ClinicalTrials.gov does for clinical trials.

Since patient registries are a type of observational study, sponsors are not required to post them on ClinicalTrials.gov. And when some sponsors have tried to post them, they've found the trial database can't capture the unique characteristics of the registries.

Noting an increased investment in patient registries in recent years, AHRQ said the lack of a central database for the studies could result in a duplication of efforts and insufficient dissemination of unpublished findings.

As currently conceived, the central registry would:

• be compatible with ClinicalTrials.gov;

• provide a searchable database of patient registries in the U.S.;

• facilitate the use of common data fields and definitions in similar health conditions;

• provide a public repository of searchable summary results;

• offer a search tool to locate data that researchers can request for use in new studies;

• serve as a recruitment tool for researchers and patients interested in participating in patient registries.

While participation in the central registry might be voluntary at first, AHRQ said it could become mandatory.

To get the project rolling, the agency posted a notice in the Federal Register Wednesday, seeking comments on a proposed information collection for the registry.

K-V Sues FDA

K-V Pharmaceuticals Inc. is suing the FDA over its lack of enforcement of the company's seven-year orphan drug exclusivity for Makena because of pricing concerns for the drug used to prevent premature births.

In response to a public outcry last year over the initial $1,600 per injection price for Makena (hydroxyprogesterone caproate), the FDA said it would use its enforcement discretion, giving compounding pharmacies the go-ahead to continue making cheap alternatives despite K-V's exclusivity. (See BioWorld Today, May 2, 2011.)

This is a case of the FDA putting the "supposed financial interests of Medicaid, other third-party payers and some patients above the medical interest of all patients for whom Makena is indicated," K-V said in the lawsuit filed this week in the U.S. District Court for the District of Columbia.

A sampling of the compounded drugs and their components showed they don't meet the quality requirements set for Makena, the drugmaker added.

The company, which has had its share of quality problems, is dependent on sales of Makena and said it faces bankruptcy within three months to six months if the FDA continues to ignore the drug's exclusivity. (See BioWorld Today, Oct. 14, 2009.)

The suit seeks to force the agency to enforce the exclusivity, prohibit further imports of unapproved active pharmaceutical ingredients used by the compounding pharmacies and stop interstate shipments of the unapproved compounded drugs.