Federal Judge invalidates Myriad’s DNA patent sequence claims

In the Southern District of New York on March 29, 2010, a District Court Judge rejected the prevailing opinion on the patentability of DNA sequences.  The Public Patent Foundation and the ACLU sued in 2009 to challenge certain claims in Myriad Genetics Inc.’s breast cancer patents (5,747,282, 5,837,492, 5,693,473, 5,709,999, 5,710,001, 5,753,441, 6,033,857).

The plaintiffs argued that the patents were invalid as patentable subject matter under 35 U.S.C. 101, and that the USPTO’s policy of permitting DNA sequence patents violated Article I Section 8, Clause 8 and the First Amendment of the U.S. Constitution.

35 U.S.C. 101 states “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”

Within the patents in question, the isolated DNA sequences and the claimed comparisons of DNA sequences were challenged.  Both sets were found to be unpatentable subject matter by U.S. District Judge Robert W. Sweet.  The isolated DNA sequences were not patentable subject matter because they exist in nature.  The claims specific to the comparisons of DNA sequences were also found not to be patentable subject matter because they constituted “abstract mental processes.”

Individual DNA sequences were found not to fall within the purview of 101 because isolating and purifying DNA didn’t mean that the same physical embodiment of biological information that was isolated as a process didn’t already exist in nature.  The judge criticized the lawyer’s trick that permitted the patenting of processes to get around the idea that directly patenting DNA in human bodies does not patentable subject matter.  The court found that there were not enough “markedly different characteristics” between the isolated DNA and what occurs in nature.

The comparison method claims quickly failed the CAFC’s “machine or transformation test” because the methods were neither tied to a machine, nor did they tangibly transform anything.  Process claims that fail the “machine or transformation” test are considered to be “abstract mental processes.”  As a result the claims comparing DNA sequences as processes were found to be unpatentable subject matter.

Judge Sweet’s decision didn’t address the constitutionality question raised by the plaintiffs citing “constitutional avoidance.”

The result of Judge Sweet’s decision means that the decision will likely now go to the CAFC, who will likely reverse or narrow the District Court decision.  The next step after that is up to the Supreme Court, where the hot-button issue will likely be heard in the next few terms.  It is uncertain as to how the Court will decide this issue, but the decision will have far-reaching implications for DNA patents.  Upholding the decision may increase access to DNA treatments by removing royalty or licensing costs.  On the other hand, investment in complex DNA treatment research may become less likely because of the difficulty securing patent protection.  Whatever the future holds, yesterday’s decision is certainly a marked departure from the current approach to DNA sequence patents.