[Ip-health] KEI files amicus brief in BRCA gene patent case

Krista Cox krista.cox at keionline.org
Wed Jan 18 08:43:01 PST 2012


Last Friday, KEI submitted an amicus brief to the Supreme Court of the
United States in the BRCA1/BRCA2 gene patent case.  The full brief is
available at the link below.  Our blog is reprinted below.

http://keionline.org/node/1347

KEI files amicus brief in BRCA gene patent case


Since May 2009, the ACLU and Public Patent Foundation (PUBPAT) have been
litigating a case involving the patent eligibility of two human genes,
BRCA1 and BRCA2, associated with ovarian and breast cancer. ACLU and
PUBPAT, representing the petitioners, Association for Molecular Pathology,
among others, have argued that human genes are not patentable and that
patents on such objects stifle diagnostic testing and further research.

It has been estimated that 1 out of every 8 women in the United States will
develop invasive breast cancer at some point in her life and although a
diagnostic test exists to identify mutations on BRCA1 and BRCA2, many women
do not have the testing done because of the high monopoly price. Those that
do have the test cannot receive a second opinion and other scientists or
researchers cannot improve upon the test--even when it was shown that
Myriad's test was flawed and failed to identify all known mutations,
particularly for minority women. The legal issues, however, go far beyond
the immediate question of the breast cancer gene patents, and depending
upon how the case is decided, the courts may make it more difficult to
obtain certain patents on human genes. One issue involves the patentability
of isolated DNA and whether isolation of a naturally occurring product can
receive patent protection; at the Federal Circuit level, the Solicitor
General intervened arguing against patent eligibility for isolated DNA.
This issue also involves a question of whether isolated DNA is "markedly
different" from that found in nature. Other issues include the patent
eligibility of cDNA, how broadly such claims can be drawn if patent
eligible, and whether fragments of genes are patent eligible. If the
Solicitor General recommends certiorari in this case, it may do so only the
issue of isolated DNA.

Previously, a District Court Judge Sweet ruled in favor of the plaintiffs
and held the claims-at-issue were not patent eligible because they were
directed toward products of nature. Subsequently, the defendants in the
case appealed to the Federal Circuit where a three judge panel had a
three-way split in reasoning, but ultimately held by a narrow 2-1 decision
that isolated DNA could receive patent protection. Prior KEI coverage on
the case is available here (Judge Sweet on non-patentability of genes and
TRIPS), here (recapping oral arguments at the Federal Circuit) and here (on
the Federal Circuit opinion).

After the Federal Circuit ruling and subsequent refusal for rehearing, a
petition for writ of certiorari to the Supreme Court of the United States,
filed by the ACLU on December 7, 2011 and docketed December 14, 2011 is
available here. Myriad's opposition to the petition for writ of certiorari
was filed on January 13, 2012.

On Friday, January 13, 2012, KEI filed an amicus brief to the Supreme Court
of the United States in the case, Association for Molecular Pathology, et.
al. v. Myriad Genetics, Inc., et. al., Docket No. 11-725. This brief
supports the Plaintiffs-Petitioners' petition for writ of certiorari.

KEI's amicus brief notes that the question of whether isolated human genes
are patentable will impact the future of patent law and have impacts on
public health. Like the petition for writ of certiorari, KEI notes the
lower court decision resulted in a fractured opinion and that even the
Executive Branch appears divided over the issue. KEI argues the grant of
such patents contravenes the Constitutional obligation to "promote the
Progress of Science and useful Arts," and in its final section KEI explains
that where patents are inappropriate, unnecessary, insufficient or
burdensome, non-patent mechanisms can be used to stimulate, subsidize and
reward investments in new science and product development relating to human
genes. Among the non-patent mechanisms that are available are innovation
inducement prizes.

The table of contents to KEI's brief, with respect to the argument section,
is reprinted below:

I. THE QUESTION OF WHETHER HUMAN GENES ARE PATENTABLE RAISES FUNDAMENTALLY
IMPORTANT CONSEQUENCES FOR THE FUTURE OF PATENT LAW.

A. The Legal Community Needs Guidance With Regard to the Applicability of
Section 101 to DNA
B. Even the Executive Branch is Fragmented and Divided With Regard to
Patentablity of Genes
C. The question as to whether human genes or isolated DNA is patent
eligible will have far­ reaching effects on genetic research, medical
innovations, the future of patent law and public health

II. THE GOAL OF THE PATENT SYSTEM IS TO ENCOURAGE PROGRESS AND THE IMPACT
OF THE PATENT ELIGIBILITY OF HUMAN GENES IS CRITICAL TO THE PROGRESS OF
SCIENCE AND USEFUL ARTS AND TO THE PUBLIC HEALTH

A. Where Patent Protection Improperly Preempts All Other Uses, Progress of
Science Is Hindered
B. Products of Nature, Laws of Nature and Natural Phenomena, Such as the
Claims-At-­Issue Are Not Patent Eligible

III. NON­PATENT MECHANISMS CAN AND SHOULD ENCOURAGE PROGRESS WHERE PATENTS
ARE AN INAPPROPRIATE, UNNECESSARY, INSUFFICIENT, OR BURDENSOME REWARD


-- 
Krista Cox
Staff Attorney
Knowledge Ecology International
www.keionline.org
(202) 332-2670



More information about the Ip-health mailing list