Supreme Court gives a mixed ruling on the patentability of genes

The day after the US Supreme Court ruled that genes or isolated DNA fragments found in nature cannot be patented, the biotechnology industry is still standing. The 9-0 decision will invalidate a number of existing gene patents that the US Patent Office has granted over the years, but there was enough room for Myriad itself to say “We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test,” while the Public Patent Foundation, which along with the American Civil Liberties Union brought the original challenge, stated: “The Court rightfully found that patents cannot be awarded for something so fundamental to nature as DNA,” said Daniel B. Ravicher, executive director of PUBPAT. "Bottom line, diagnostic genetic testing is now free from any patent threat, forever, and the poor can now have their genes tested as freely as the rich."

The decision (written by Justice Clarence Thomas, and having an admirably clear summary of DNA, complementary DNA and the various manipulations thereof) turns on whether the act of isolating a genetic sequence (which can involve cutting or attaching molecular endpoints of the sequence) constitutes a “novel” act, or whether that is merely a step in the isolation process incidental to the isolation. Prior court rulings held that the isolation created novelty; the Supreme Court did not. On the other hand, cDNA, which involves copying parts of the native DNA but changing them as well, is patentable.

Commentary from various patent lawyers and others show that the decision will not create a black-and-white distinction of what inventions will be patentable going forward. Burrill Report noted that there is already a competitor to Myriad’s BRCA breast-cancer test, DNATraits (Houston), which has been handled testing only from non-US patients to date, but will now begin processing samples sourced from the US. Others noted that the gene sequencing for personalized medicine, which can entails a battery of genetic sequences, will proceed more rapidly; conversely, some worry that the incentive to develop these tests will be harmed by the ruling. “The United States is now the only developed country to take such a restrictive view of patent eligibility, signaling an unjustified indifference towards our global economic and scientific leadership in the life sciences,” said the Biotechnology Industry Organization (BIO).