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
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Federal
Circuit Holds That Isolated Genes Are Still Patentable
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. |