'Research Plan' for DNA Diagnostic Test Fails Ariad Written Description Requirement

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A patent on a diagnostic test to discover genetic mutations indicating predisposition to an iron disorder was merely a “research plan” and lacked evidence of possession of the invention, the U.S. Court of Appeals for the Federal Circuit ruled April 29 (Billups-Rothenberg Inc. v. Associated Regional and University Pathologists Inc., Fed. Cir., No. 2010-1401, 4/29/11).

The court affirmed summary judgment of invalidity for lack of written description support because the patent was filed prior the identification of either the gene or the mutation at issue, and at best disclosed a “general location” of the mutation.

The court also affirmed invalidity of a second patent, this time for anticipation by a patent granted to a competitive research team, even though the prior patent discounted the relevant discovery.

Competing Research on Genetic Mutations.

Billups-Rothenberg Inc. owns patents (5,674,681 and 6,355,425) involving a genetic test for Type I hereditary hemochromatosis, a disorder characterized by excessive iron absorption by the body.

The “High Fe” or HFE gene is involved in regulating iron absorption. The Billups patents cover testing for hemochromatosis, with each including claims for detecting a different mutation in the HFE gene. In 1994, at the time of the '681 patent application, though, the inventors had not isolated the gene or the mutation it covered, later known as C282Y.

Other researchers had more success, leading to a patent (6,025,130), filed in 1996, that disclosed C282Y and another mutation, S65C, in the HFE gene. Bio-Rad Laboratories Inc. is the assignee of the '130 patent and licenses it to a genetic testing service at the University of Utah, Associated Regional and University Pathologists Inc. d/b/a ARUP Laboratories.

The researchers' work continued, and ARUP eventually developed a test that detected the C282Y and S65C mutations in samples from patients. Billups's work continued as well, and in 1999 the company filed the application leading to the '425 patent covering S65C.

Billups sued ARUP for patent infringement by the tests related to both mutations.

Senior Judge Mariana R. Pfaelzer of the U.S. District Court for the Central District of California denied Billups's motion for summary judgment of infringement and granted ARUP and Bio-Rad's motion for invalidity. She concluded that the asserted claims of the '681 patent were invalid for lack of written description under 35 U.S.C. §112, para. 1, and the asserted claims of the '425 patent were invalid as anticipated by the '130 patent.

Billups appealed.

First Patent Fails Written Description Requirement.

Judge Arthur J. Gajarsa affirmed the lower court as to both patents.

Relying primarily on the en banc court's recent decision in Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 598 F.3d 1336, 94 USPQ2d 1161 (Fed. Cir. 2010) (en banc) (79 PTCJ 623, 3/26/10), Gajarsa concluded that Billups did not have possession of the invention when it filed the '681 patent application in 1994.

“Given the lack of knowledge of sequences for the hemochromatosis gene and its mutations in the field, the limited extent and content of the prior art, and the immaturity and unpredictability of the science when the '681 patent was filed, Billups cannot satisfy the written description requirement merely through references to later-acquired knowledge,” he said.

The Ariad ruling requires that the patent specification set forth “either a representative number of species falling within the scope of the genus or structural features common to the members of the genus,” the court said. By contrast, “The '681 patent does not identify even a single species that satisfies the claims. In this case, the eventual discovery of only one species--the C282Y mutation--within the claimed genus does not constitute adequate written description of that genus.”

Billups further argued that the functional claim language of the '681 patent satisfies the written description requirement by its correlation with adequate structure--the general location of the C282Y mutation--combined with the knowledge of a skilled artisan at the time. Though Ariad did explain that such a correlation can meet the written description requirement, the court said, the district court was correct in finding that a “general location disclosure is too imprecise.”

The court thus affirmed the judgment that the asserted claims of the '681 patent were invalid for lack of written description support.

Second Patent Anticipated.

The court also affirmed summary judgment of invalidity of the '425 patent for anticipation, under 35 U.S.C. §102.

Billups contended that the '130 patent merely correlates the S65C mutation and hemochromatosis, while the '425 patent claims a genetic predisposition to and diagnosis of an iron disorder.

Indeed, Billups argued and the court acknowledged that the '130 patent specification indicated some uncertainty about the correlation because of a small sample size tested. However, Gajarsa said, the patent describes “detection of the S65C mutation as an input for the diagnosis of hemochromatosis” and a test kit for all the mutations, including S65C.

“Although the '130 patent discounts the utility of the S65C mutation in diagnosing hemochromatosis, we have held that a 'reference is no less anticipatory if, after disclosing the invention, the reference then disparages it,' ” he explained, quoting from Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516 (Fed. Cir. 1998).

Finally, the court noted that the decision may have been different had Billups shown that the relevant teachings of the '130 patent were not enabled, but the plaintiff failed to do so. Consequently, the court said, “Even though the inventors of the '425 patent performed experiments revealing greater diagnostic utility of the S65C mutation than initially suspected, the use of the S65C mutation as a diagnostic tool was already contemplated by the '130 patent.”

Summary judgment of invalidity of the '425 patent as anticipated was therefore affirmed as well.

Judges Richard Linn and Kimberly A. Moore joined the opinion.

Robert D. Fish of Fish & Associates, Irvine, Calif., represented Billups. ARUP was represented by Brian C. Cannon of Quinn Emanuel Urquhart & Sullivan, Redwood Shores, Calif.