Biotech companies got a break today when a U.S. appeals court handed down a long-awaited ruling on gene patents in a case prompted by a suit involving Myriad Genetics of Salt Lake City. In a split decision (2-1), the court ruled broadly that genes can be patented. This was contrary to a lower court's decision last year, which found that genes cannot be patented because they are "products of nature." (The dissenting appeals judge sided with the lower court.) At the same time, five of Myriad's specific patent claims were thrown out for being too abstract.
The judges diverged on several issues, at times veering off into three distinct legal arguments. The net effect of this complex ruling is to validate gene patents as a legal concept but reject claims made by Myriad for diagnostically using the genes BRCA1 and BRCA2 to identify mutations that carry a high risk for breast and ovarian cancer.
Writing for the majority, Judge Alan Lourie concluded that Myriad's basic patents on BRCA1 and BRCA2 sequences were valid because they applied to "isolated DNA," or complementary DNA (cDNA)—not DNA as found in the body.
Isolated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule. ... Although isolated DNA must be removed from its native cellular and chromosomal environment, it has also been manipulated chemically so as to produce a molecule that is markedly different from that which exists in the body.
For this reason, Lourie decided, Myriad's "composition of matter" patents are not products of nature and are therefore sound, as would most likely be other claims on isolated genes. He flatly rejected the position of the Obama Administration, whose Justice Department had filed a brief siding with those who argue for a sweeping rejection of gene patents. The judge tweaked the Justice Department, noting that its brief contradicts the policy of U.S. Patent and Trademark Office, which has backed gene patents for more than 2 decades. Lourie wrote: "We are left to guess about the status of any possible continuing interagency disagreements about the issue."
At the same time, the court rejected five of Myriad's claims on ways to use the genes—"methods claims"—specifically, by comparing an individual's DNA sequence with a control or normal sequence to look for high-risk mutations. The language used in Myriad's patent, the court found, did not describe a specific method of transforming material into a useful invention. Instead, the court found, the claims "are directed to the abstract mental processes of comparing two nucleotide sequences"-therefore not valid.
Myriad made the most of the good news and slighted the bad. In a prepared statement today, Myriad President and CEO Peter Meldrum said: "We strongly support the court's decision that isolated DNA and cDNA are patent-eligible material. ... We believe this decision is in the best interests of the agriculture, biotechnology and pharmaceutical industries." Myriad noted that the court had rejected five of the six Myriad methods claims in dispute, but pointed out that 237 other methods claims for its cancer risk test, BRACAnalysis, were not affected.
The American Civil Liberties Union (ACLU), which along with the advocacy group PUBPAT of New York City, supported the case against Myriad, called the decision "a blow" to the their effort to free scientific research from legal restrictions.
Daniel Ravicher, executive director of PUBPAT, put a positive spin on the ruling in a prepared statement:
All the judges today agreed that our clients had standing to bring this case and that analyzing gene sequences for alterations is not patentable.
The judges disagreed with each other on whether pieces of the human genome are patentable, and we agree with [the dissenting opinion of] Judge Bryson who explained they are not because no one 'invents' genes. Inventions are things like new genetic tools or drugs, all of which can be patented because they are not genes themselves.
Robert Cook-Deegan, director of the Center for Genome Ethics, Law & Policy at Duke University in Durham, North Carolina, called today's ruling "a very interesting decision" that's likely to lead to further legal action: "I wouldn't be surprised if both sides appealed to the Supreme Court."