In an eagerly-watched case that will have a major bearing on future medical research, the US Supreme Court has ruled that human genes cannot be patented, but synthetic, or complementary, DNA can be.
The Court made its verdict after looking at patents granted to Myriad Genetics on the breast cancer genes BRCA1 and BRCA2. These were challenged by the Association for Molecular Pathology, represented by the American Civil Liberties Union (ACLU) which argued that genes are products of nature and cannot be patented, although patents have been issued for over 30 years.
The already high-profile case exploded into the public domain recently when the actress Angelina Jolie decided to undergo preventative surgery) and fact that Myriad has a monopoly on the tests which cost in the region of $3,000 put the Supremes very firmly in the spotlight.
Product of nature not patent eligible
Justice Clarence Thomas wrote in an opinion backed unanimously by other Court members that "we hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated". Overturning an appeal court ruling in favour of Myriad, he said that "Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention".
Initially it seemed bad news for Myriad but Justice Thomas also wrote that complementary DNA (cDNA) can be patented "because it is not naturally occurring". The company noted that while the Supreme Court ruled that five of its claims covering isolated DNA were not patent eligible, the cDNA ruling means that Myriad has "more than 500 valid and enforceable claims in 24 different patents" conferring strong protection for its BRACAnalysis test.
Myriad chief executive Peter Meldrum said "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 moving forward".
The ACLU saw things a little differently. Claiming "victory", Sandra Park of the association's Women's Rights Project said that by invalidating these patents, "the Court lifted a major barrier to progress in further understanding how we can better treat and prevent diseases".
She added that while the ACLU disagrees with the cDNA finding, "the decision as a whole represents a huge shift in patent law. The Supreme Court's ruling shields parts of the human body from the assertion of private property rights", Ms Parks said, adding that "because cDNA is not required for genetic testing, laboratories will now be able to offer testing of the BRCA genes to their patients".
Decision 'will help, not hinder,' biotech
She went on to state that "we celebrate the Court's ruling as a victory for civil liberties, scientific freedom, patients, and the future of personalised medicine", adding that in fact, "the decision will help, not hinder, the biotechnology industry". Ms Parks noted that most of the sector "is focused on using genes as a starting point to create new tools, tests, and therapeutics. While all of these applications could be patented, the genes themselves should remain in the public storehouse of knowledge".
Commenting on the ruling, Jim Greenwood, chief executive of the Biotechnology Industry Organization, said that cDNA is "the commercially most important form of DNA used in biotechnology" and the decision offers "urgently-needed certainty for research-driven companies that rely on cDNA patents for investment in innovation".
However, he added that "in other respects, it represents "a troubling departure from decades of judicial and Patent and Trademark Office precedent supporting the patentability of DNA molecules that mimic naturally-occurring sequences". Mr Greenwood claimed that the Court’s decision "could unnecessarily create business uncertainty for a broader range of biotechnology inventions".
Ruling restricts US firms
He concluded by saying that the USA "is now the only developed country to take such a restrictive view of patent eligibility, signalling an unjustified indifference towards our global economic and scientific leadership in the life sciences".
On this side of the pond, Philip Webber, a biotech expert at patent and trade mark attorney Dehns, said "the decision will have no direct effect on European patents, although it will hit European companies who have US gene patents". He added that the ruling "goes directly against the practice of the European Patent Office which accepts the patentability of all forms of DNA [and] whilst there might now be more public pressure on the EPO to change its practice, I can't see that happening in the short term at least".
Myriad investors did not seem to have decided whether the ruling was good or bad news. The stock soared by around 12% to a four-year high of $38.27 but ended the day down 5.6% to $32.01.