Greenblum & Bernstein, P.L.C.
PRACTICE GROUP NEWSLETTER
Recent News in Intellectual Property
In This Issue
· Federal Circuit Holds That Isolated Genes Are Still Patentable
· Federal Circuit Affirms Validity of Argatroban® Patent
· Lilly Settles Gemzar® USITC Section 337 Investigation
The Court of Appeals for the Federal Circuit (“the Federal Circuit”), in Association for Molecular Pathology, et al. v. USPTO and Myriad Genetics, Inc. et al., reversed-in-part, in a split-decision, the summary judgment by the U.S. District Court for the Southern District of New York (“New York District Court”) that certain Myriad patents directed to BRCA1 and 2 genes (that purportedly account for most forms of breast and ovarian cancer) are invalid as the subject matter is not patentable. According to the Federal Circuit, the New York District Court ruling “in effect created a categorical rule excluding isolated genes from patent eligibility.”
The Myriad patents-at-issue claim compositions of matter - isolated genes, methods of analyzing genes and gene screening processes, all of which the New York District Court held invalid. These patents-at-issue are U.S. Patent 5,747,282 (“the ’282 patent”); U.S. Patent 5,837,492 (“the ’492 patent”); U.S. Patent 5,693,473 (“the ’473 patent”); U.S. Patent 5,709,999 (“the ’999 patent”); U.S. Patent 5,710,001 (“the ’001 patent”); U.S. Patent 5,753,441 (“the ’441 patent”); and U.S. Patent 6,033,857 (“the ’857 patent”). The lawsuit was filed by, inter alia, the American Civil Liberties Union against Myriad seeking to have the gene patents-at-issue invalidated. The Plaintiffs in this case argued that that gene patents, such as the Myriad patents-at-issue, significantly impede, rather than promote, scientific progress citing Plaintiff researchers (from Oncormed and the University of Pennsylvania Genetic Diagnostic Laboratory) who allegedly had to stop their activities when they received Myriad cease and desist letter(s).
In early 2010, the New York District Court held Myriad’s BRCA 1 and 2 patents-at-issue invalid on the grounds that the genes, although isolated, were not changed in a fundamental manner; that is the nature of DNA sequence or the genetic information that the genes contain were not altered.
On appeal, the Federal Circuit affirmed the New York District Court with respect to invalidity of the method of analyzing claims “because they claim only abstract mental processes.” The Federal Circuit, however, reversed the New York District Court with respect to the claims directed to the isolated genes and screening processes. Specifically, the Federal Circuit, disagreed with the Plaintiffs and the New York District Court, holding that isolated genes were patentable subject matter and further observing that isolated BRCA 1 and 2 genes have a utility in that they can, for example, be modified in the lab to form cDNAs, that may be used to develop genetic probes and markers, which requires isolated genes.
The Federal Circuit also acknowledged the question of whether gene patents promote or impede scientific progress, but deferred to Congress. “If the law is to be changed, and DNA inventions excluded from the broad scope of [patent law] contrary to the settled expectation of the inventing community, the decision must come not from the courts, but from Congress,” wrote Judge Lourie for the majority.
This is not the end of this long standing dispute, as the parties have sought en banc review of the decision and will likely appeal to the Supreme Court.
Federal Circuit Affirms Validity of Argatroban® Patent
The Federal Circuit, in Mitsubishi Chemical Corp. v. Barr Labs., affirmed the holding by the U.S. District Court for the Southern District of New York (”New York District Court”) that Mitsubishi’s U.S. Patent No. 5,214,052 (“the ‘052 patent”) is valid. The ‘052 patent contains method and formulation claims directed to a: (1) “method for dissolving an arginineamide, comprising dissolving [argatroban] and/or its salt in a solvent containing ethanol, water and a saccharide”; and (2) “pharmaceutical composition for injection, comprising [argatroban] and/or its salt together with ethanol, water and a saccharide.” Argatroban® (also the name of the active ingredient) is an anticoagulant that is a small molecule direct thrombin inhibitor.
Mitsubishi filed suit in response to Barr’s ANDA, containing a Paragraph IV certification, for a generic version of Argatroban® alleging that the claims of the ‘052 patent were invalid as anticipated and/or obviousness.
After a 2010 trial, the New York District Court held the claims of the ‘052 patent not invalid, and issued an injunction prohibiting Barr from marketing a generic version of Argatroban® until the 2014 expiration of the ‘052 patent.
In so doing, the New York District Court rejected Barr’s argument that the claims of the ‘052 patent were anticipated by a Japanese article published in 1986 by a Mitsubishi employee, Toshihiro Yamamoto (“the Yamamoto article”). The dispute focused on the proper English translation of a single sentence in the prior art Yamamoto article describing the preparation of an argatroban solution that was administered to laboratory rats.
Barr argued that the Yamamoto article disclosed dissolution of argatroban in a solution containing HCl, D-sorbitol and ethanol, and this anticipated the method claims of the '052 patent. The New York District Court, however, sided with Mitsubishi as to the proposer translation; that is, “In 7.5% D-sorbitol-4% ethanol, an argipidine solution dissoved under hydrochloric acid acidity (pH 1.5 to 1.7) was intraperitoneally administered at a dosage of 1 ml/kg, 15 minutes before common carotid artery occlusion.” The New York District Court based its decision in-part on corroborating testimony from Yamamoto that the article teaches dissolution of argatroban in HCL, followed by formulation of a composition comprising the dissolved argatroban with D-sorbitol and ethanol.
On appeal, the Federal Circuit, in discussing the New York District Court’s holding on the correct translation of the Yamamoto article, noted that the accuracy of the translation fell into an area that was not typically a proper ground of appeal. The Federal Circuit, specifically, stated “[t]he fact-finder's selection of a particular translation as the best translation of a foreign language reference raises pure questions of fact. The district court's selection of the appropriate translation in this case was based in large part on a credibility determination, and such determinations are ‘virtually never’ overturned for clear error. Although Barr contends that [Mitsubishi’s] translation should be disregarded because it was prepared for purposes of litigation, that is not a sufficient reason to conclude that the district court's choice of [that] translation was clearly erroneous.”
The Federal Circuit further observed that “the district court took note of the fact that [the] Yamamoto [article’s] description of the argatroban solution was quite cryptic because, as both experts agreed, Yamamoto focused on the pharmacological activity of the argatroban molecule, rather than on argatroban’s solubility or on treating the rats,” and that “[i]n order to anticipate, the teaching of a reference must be clear and unambiguous.”
Similarly, with respect to the formulation claims, the Federal Circuit agreed with the New York District Court’s finding that the solution disclosed in the Yamamoto article is not a “pharmaceutical composition for injection,” i.e., “a composition that is suitable for treating medical conditions by injection,” on the grounds that, for a pharmaceutical composition to be suitable for injection into human patients, it must have a pH above 3; whereas the composition of the Yamamoto article has a pH between 1.5 and 1.7.
Lilly Settles Gemzar® USITC Section 337 Investigation
In a rare attempt to invoke the U.S. International Trade Commission procedures in an Orange Book matter, Eli Lilly and Company sought to institute a Section 337 USITC investigation, which Lilly has recently settled. In Investigation No. 337-TA-766 entitled “Certain Gemcitabine and Products Containing Same,” Lilly requested the exclusion of generic versions of its popular anti-cancer drug Gemzar®. Specifically, Lilly alleged that a number of respondents, including SKGF client Intas Pharmaceuticals Ltd., manufactured abroad, and subsequently imported and sold within the United States, generic versions of Gemzar® that were allegedly made by using Lilly’s patented process technology.
Lilly filed its USITC complaint after the Gemzar® Orange Book listed patents had either expired or were declared invalid by the Federal Circuit. (See G&B Updates, August 2010 and October 2010). The USITC instituted the Investigation in March 2011 after a “lengthy pre-institution process where the Commission questioned whether Lilly’s allegations were pled with particularity, … The Administrative Law Judge [accordingly] established a 16-month target date, and the parties underwent extensive fact discovery.” Then, before fact discovery had been completed, the parties moved to terminate the investigation in view of the settlement, and the Administrative Law Judge terminated the Investigation by order on August 16, 2011.
Although the terms of the settlement remain confidential, this Investigation represents one of the few attempts by an Orange Book plaintiff to use the USITC to protect revenue streams on pharmaceutical drugs facing generic drug competition after completion of the litigation on the Orange Book listed patents. As noted by the USITC, “unlike the wave of smartphone and mechanical-based technology proceedings currently before the Commission, innovator pharmaceutical-based Section 337 investigations have only constituted about 2.5% of all investigations instituted since 1976.” This Investigation is likely an indicator of things to come, and development of this trend could lead to new USITC investigations in a new technology discipline requiring generic drug manufacturers to address and evaluate non-Orange Book patent portfolios more closely.