[Ip-health] Sen. Leahy asks for Bayh-Dole march-in rights for BRCA testing

Krista L. Cox krista.cox at keionline.org
Thu Jul 18 00:18:56 PDT 2013

Press release:

Full letter:

July 12, 2013

Doctor Francis S. Collins, M.D., Ph.D
Director, National Institutes of Health
United States Department of Health and Human Services
9000 Rockville Pike
Bethesda, Maryland 20892

Dear Doctor Collins,

I write to urge you to consider using march-in rights under the Bayh-Dole
Act to ensure access to genetic testing for breast and ovarian cancer.

Early genetic testing for markers that indicate an elevated risk for breast
cancer and ovarian cancer can save lives and reduce healthcare costs.
 Myriad Genetics has developed a test for which it has testified that, if a
woman tests positive, she has up to an 87 percent risk of developing breast
cancer and up to a 44 percent risk of developing ovarian cancer.  According
to Myriad's testimony, pre-symptomatic individuals who test positive can
reduce their risk of developing these cancers by more than 50 percent.

Myriad's genetic test, which was developed with federally-funded research,
is truly important for public health.  Myriad is the only provider of this
test because it is covered by patent protection.  Unfortunately, testimony
before the United States Patent and Trademark (USPTO) revealed that Myriad
does all of this testing in-house, and charges between $3,000 and $4,000.
 The American Society for Clinical Pathology testified that "[m]illions of
women are potentially affected by either of these mutations [that indicate
an increased risk for breast or ovarian cancer], and for many of them this
test at that price is simply cost-prohibitive."

Last month, the Supreme Court announced its decision in Association for
Molecular Pathology v. Myriad Genetics Inc.  The court's unanimous opinion
held that Myriad's patent claims on isolated deoxyribonucleic acid (DNA) do
not cover patent eligible subject matter, but that the claims to
complementary DNA (cDNA) are patentable.  As a result, Myriad may continue
to be the only company able to provide women with the genetic testing they
need to make important health care decisions.

Myriad's patents were based in part on federally-funded research.
 Federally-funded research is playing an increasingly important role in our
patent system.  The Bayh-Dole Act encourages the commercialization of
inventions created with federal funds by permitting the recipient to take
title to the inventions, generally without reimbursing the government.

But the Bayh-Dole Act also gives the government tools, known as "march-in
rights," to provide greater access to the subject invention in appropriate
situations.  The government can require the patent holder to grant a
license to the patent on reasonable terms.  If the patent owner refuses,
the government can directly license the patent in limited circumstances,
including if it "is necessarily to alleviate health or safety needs which
are not reasonable satisfied" by the patentee.

The health benefits of genetic testing for breast and ovarian cancer are
clear.  The healthcare cost savings are equally clear.  I am concerned,
however, that the health needs of the public are not reasonably satisfied
by the patentee in this situation because testimony presented to the USPTO
made clear that many women are not able to afford the testing provided by
Myriad.  I encourage you to consider using your march-in rights in this

Thank you for your consideration.

Patrick Leahy

cc:Hon. Kathleen Sebelius

Krista L. Cox
Staff Attorney
Knowledge Ecology International
(202) 332-2670

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