BRCA1- & BRCA2-Based Hereditary Cancer Test Pat. Litig. v. Ambry Genetics Corp., No. 2014-1361, -1366, 2014 U.S. App. LEXIS 23692 (Fed. Cir. Dec. 17, 2014) (Dyk, J.). Click Here for a copy of the opinion.
In another decision concerning patents of Myriad Genetics, the Federal Circuit invalidated six claims in three patents related to breast cancer susceptibility genes, BRCA1 and BRCA2, which produce tumor suppressing proteins. If a mutation is found in either of these genes, then cells are more likely to develop tumors.
In 2013, Myriad sued Ambry Genetics Corporation in the U.S. District Court for the District of Utah alleging infringement of fifteen patents related to BRCA genes. Myriad sought a preliminary injunction, which was denied, and an appeal followed. The preliminary injunction motion asserted six claims in three patents, as follows:
- Claims 16 and 17 of USPN 5,747,282 ("the '282 patent");
- Claims 29 and 30 of USPN 5,837,492 ("the '492 patent"); and
- Claims 7 and 8 of 5,753,441 ("the '441 patent").
The '282 patent and '492 patent claims are directed to "DNA primers", which are strands of nucleic acid serving as a starting point, or the "ends", of DNA. The '414 patent claims are directed toward a method of screening for an alteration or mutation of a BRAC1 gene. Myriad's preliminary injunction motion was denied because its asserted claims were likely unpatentable subject matter.
With respect to the '282 and '492 patents, Myriad argued that DNA primers were patentable because they were not naturally occurring insofar as the claimed primers were either synthetically replicated or "single stranded." Myriad also argued that the claimed primers served a "fundamentally different function" than primers occurring in nature as part of a DNA strand. The Federal Circuit rejected both arguments. Citing Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013), in which naturally occurring DNA segments were found to be unpatentable under §101, the Federal Circuit found that the claimed DNA primers are identical to the "ends of DNA strands found in nature." Further, the Court found that the primer of the claims was not performing a different function than its function in nature, as both the claimed and naturally occurring primers function by binding to complementary nucleotide sequences and tapping "the innate ability of DNA to bind to itself." Finally, the court found that synthetically replicating DNA primers identical to those occurring in nature was insufficient to create patent eligibility.
With respect to the '441 patent, the claimed method was for screening a human germline for an alteration of a BRCA1 gene. Citing the recent Supreme Court decision in Alice Corp. v. CLS Bank Int'l, the Federal Circuit applied a two step test asking (1) whether the alleged invention is a patent ineligible concept, and (2) whether the techniques to be used – either alone or in combination with unpatentable elements – transform the nature of the claim into a patent eligible application. As to the first step of the test, the Federal Circuit determined that the method claims would impede research of the BRCA genes given the breath of the claims. The method claims were not restricted in purpose to the detection of cancer, and as such were unpatentable as abstract ideas. As to the second step of the Alice test, the Federal Circuit found that the claimed method did nothing beyond identifying what practitioners already know about screening. However, the Federal Circuit noted the potential patentability of other '441 patent screening claims that were not at issue, which were specifically limited to the detection of particular gene mutations that the '441 patent inventors had themselves identified.
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