SUPREME COURT OF THE UNITED STATES RULING:
ASSOCIATION FOR MOLECULAR PATHOLOGY ET. AL.
MYRIAD GENETICS, INC., ET. AL.
June 13, 2013 decision
Written by Susanne Somersalo, Ph.D., Patent Attorney, Gearhart Law
Back in the 1990’s, Salt Lake City-based Myriad Genetics discovered the location and sequence of two human genes, the mutation of which can cause increased risk of breast and ovarian cancer. Myriad obtained several patents based on these discoveries including claims toward the healthy and mutated gene sequences.
Myriad harnessed the patent protection by developing a test for the mutations and insisted others cease providing similar tests. In 2009 the American Civil Liberties Union (ACLU) filed a suit against Myriad and the Univeristy of Utah to invalidate the patents.
The question that finally was decided by the Supreme Court on June 13th 2013 was whether isolated DNA is patentable subject matter.
A representative claim of Myriad’s patents reads: "An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2." Myriad patents have another claim for an isolated DNA coding for BRCA2 polypeptide. BRCA1 and BRCA2 polypeptides are the gene products of the "healthy" BRCA genes. The patents also have claims toward isolated DNA coding for the mutated polypeptides, which are known to be related to susceptibility to cancer.
The court ruled that an isolated DNA is a product of nature and therefore not patentable subject matter. Even if during the process of isolating DNA from the human genome the chemical bonds that bind molecules together in the gene structure are severed, isolated DNA is still not patentable, because a claim such as Myriad’s does not express anything of the chemical bonds.
The court’s ruling continues logically to conclude that complementary DNA (cDNA) is patentable subject matter. cDNA includes only the coding sequences of the gene; all the non-coding introns have been cleaved out. Thus cDNA does not exist in nature, it is made by man.
This ruling will change the practice of the USPTO which has issued patents for isolated DNA molecules since 1982. However, this may not be such a drastic change as one would initially think.
Myriad gene sequences were patented before the Human Genome Project HUGO published the human genome. Today, all the human genes are sequenced and published and therefore even without this Supreme Court decision the USPTO could not issue patents for any human gene where the sequence is known. Such patent claims would be rejected as being not novel over the genes publicly available in the HUGO databases.
Of course, the decision covers more than just human genes. Any isolated DNA from any source is now not patentable. Different uses for microbes are invented every day and the industry has been filing patent applications for isolated microbe DNA. From now on, only cDNA can be protected. But again, the databases of sequenced microbe DNA grow continuously and so DNA claims for these are likely to be barred anyway because they are already in the public domain. Similarly, the genomes of a constantly increasing number of important crop plants have been published; one would not be able to patent an isolated rice or wheat gene, for example.
And finally, the fact is that a patentee does not very often rely only on isolated DNA being protected. Usually, the patent would include method claims, cDNA-claims, polypeptide claims and so on.
In conclusion, the Supreme Court has had the final word and the case that has been lingering in the court system for years is finally solved. The result does not seem to be surprising, nor is it devastating.
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