[Ip-health] Nicholas Doyle- AU Intellectual Property Brief: Federal Circuit Limits Patentability of Materials Used in Genetic Testing

Thiru Balasubramaniam thiru at keionline.org
Thu Feb 5 07:00:02 PST 2015


http://www.ipbrief.net/2015/02/03/federal-circuit-limits-patentability-of-materials-used-in-genetic-testing/

Federal Circuit Limits Patentability of Materials Used in Genetic Testing
Submitted by Nicholas Doyle <http://www.ipbrief.net/author/nick-doyle/> on
February 3, 2015 – 9:06 PM

In a decision that could have important ramifications for the USPTO’s
subject matter eligibility procedures, the Federal Circuit concluded that
even synthesized materials may not be patent eligible if they have a
structure that is similar to anything found in nature.

Myriad Genetics produces a test, called BRACAnalysis, which compares a
patient’s genetics (such as Angelina Jolie’s
<http://www.wcvb.com/health/doctors-credit-angelina-jolie-effect-for-increased-genetic-testing/29036134>)
to a set of standard, mapped genes called the breast cancer susceptibility
gene (BRCA1 and BRCA2). According to the CDC
<http://www.cdc.gov/cancer/breast/young_women/knowbrca.htm>, women with
mutations of BRCA1 or BRCA2 are seven times more likely to get breast
cancer and thirty times more likely to get ovarian cancer before the age of
seventy.

In 1998, Myriad was awarded patents for BRCA1, BRCA2, and short strands of
DNA called primers that target BRCA1 and BRCA2 in the patient’s DNA. This
allowed Myriad to essentially monopolize this area of clinical testing. In
2013, the Supreme Court in *AMP v. Myriad Genetics*
<http://www2.bloomberglaw.com/public/desktop/document/Assn_for_Molecular_Pathology_v_Myriad_Genetics_Inc_No_12398_2013_>
ruled
that Myriad’s patents for BRCA1 and BRCA2 were not eligible because “a
naturally occurring DNA segment is a product of nature and not patent
eligible merely because it has been isolated.”

The decision by the Supreme Court in *AMP* opened up the BRCA testing
market; and, in March 2014, Myriad filed a lawsuit claiming that a
competitor, Ambry Genetics, had violated Myriad’s remaining patents
pertaining to the BRACAnalysis testing system. The District Court of Utah
ruled that there were “substantial questions as to whether Myriad’s ideas
cover something eligible for a patent,” and denied Myriad’s motion to block
competing sales. Myriad appealed this decision to the Federal Circuit. In *In
re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation*
<http://www.cafc.uscourts.gov/images/stories/opinions-orders/14-1361.Opinion.12-15-2014.1.PDF>,
the Federal Circuit went beyond upholding the District Court’s decision to
allow competing sales, ruiling that Myriad’s patents were invalid
<http://www.bloomberg.com/news/2014-12-17/myriad-loses-appeals-court-bid-to-block-breast-cancer-tests-1-.html>.
Specifically, the DNA primers, which were synthetically created, were ruled
patent ineligible because the structures of those primers were identical to
those found in nature. As a result of this decision, the rule of law is now
that, regardless if the substance in question is of natural or synthetic
origin, if it is structurally and functionally similar to anything found in
nature, it is patent ineligible
<http://patentlyo.com/patent/2014/12/federal-circuit-invalid.html>.

The ramifications of this decision go beyond USPTO procedure and into the
realm of the consumer. Biological testing of this nature will become
cheaper as a result of this decision because all patents to naturally
occurring and synthetic materials that are functionally and structurally
similar to anything found in nature are potentially invalid. Therefore, one
company will not be able to set the price of these tests. On the other
hand, there will be less incentive for companies and academics to research
and develop new and better tests for both existing and novel ailments.
While it is encouraging that the state of clinical biology is such that
once cutting-edge diagnostic tools are now so routine as to not even
warrant a patent, the lack of incentive could stymie development and
prolong the arrival of tomorrow’s cutting-edge.



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