By Kirell Lakhman

A New York District Judge yesterday ruled that Myriad Genetics' BRCA1 and BRCA2 patents are invalid. Below are some key points about the decision as reported by a handful of key news and specialty outlets.

Judge Robert Sweet's ruling, which found that the patents “are directed to a law of nature and were therefore improperly granted, … may lead to other challenges to gene-related patents," Bloomberg News reported yesterday.

But for the moment the decision "will not affect any patents not directly involved in the case, nor be binding on any other court, and it is highly unlikely that the USPTO will change its gene patent examination standards just because of this decision," according to a comprehensive report in the Genomic Law Report.

Indeed, "its legal effect is currently very limited," GLR said. "Another federal district judge would be free reach exactly the opposite conclusion tomorrow (if another comparable case were pending, which it isn’t). Things won’t get serious (legally) until the Federal Circuit rules, since its opinion will bind all federal courts except the Supreme Court."

The Wall Street Journal reported yesterday that Judge Sweet's ruling "doesn't bind other federal courts, and other judges may or may not adopt the decision in similar cases."

What Judge Sweet's ruling does do is "set the stage for years of litigation to determine where the line is between what’s eligible for patents and what is not," according to Bloomberg.

The ruling, made in response to a suit filed last May by the American Civil Liberties Union on behalf of groups including the Association for Molecular Pathology and American College of Medical Genetics, "is sure to be appealed to a court in Washington that specializes in patent law, and most likely to the Supreme Court."

The New York Times reported yesterday that the decision "is likely to be appealed," and that "if upheld [it] could throw into doubt the patents covering thousands of human genes and reshape the law of intellectual property."

The paper added that "many in the patent field had predicted the courts would throw out the suit."

The Wall Street Journal reported that Myriad CEO Peter Meldrum said "the company will appeal."

The Times said that the case "could have far-reaching implications" and reported a widely cited figure that says roughly 20 percent of human genes have been patented. "[M]ultibillion-dollar industries have been built atop the intellectual property rights that the patents grant," the paper said.

“If a decision like this were upheld, it would have a pretty significant impact on the future of medicine,” the Times quoted Kenneth Chahine, a visiting law professor at the University of Utah who filed an amicus brief on the side of Myriad.

The Wall Street Journal, in typical understatement, said the ruling "could have ramifications for diagnostics … companies that have relied heavily on gene-related patents to help them build their businesses," adding that the case is "likely to be followed closely by the medical industry."

The ruling also agreed with the plaintiff's argument that the USPTO strayed beyond the bounds of a 30-year-old Supreme Court ruling. Myriad, which holds the patents with the University of Utah Research Foundation, had asked the court to dismiss the case because "the work of isolating the DNA from the body transforms it and makes it patentable," the Times reported. It said such patents have been granted for decades since the Supreme Court upheld patents on living organisms in 1980.

But in court filings, the ACLU said that in granting the patents, the USPTO "went beyond what was allowed" in the 1980 decision, which is "credited with opening up the biotechnology industry," according to Bloomberg.

The news wire quoted Judge Sweet as saying "that, were an appeals court or the Supreme Court affirm his decision, the patent office would 'conform its examination policies' to the court rulings."

Sample sister publication GenomeWeb Daily News yesterday reported that "the suit, while focused on Myriad's patents, essentially challenged the constitutionality of patenting all genetic sequences on First Amendment grounds."

However, according to the Times, Judge Sweet said "that because the issues in the case could be decided within patent law, the constitutional question need not be decided."

The court also granted the US Patent and Trademark Office's request that "it be released as a defendant in the lawsuit because it had already ruled in favor of the plaintiffs," GenomeWeb Daily News reported.

'Pigs Fly'

The plaintiffs sought to invalidate 15 claims found in seven patents relating to the ability of mutations in the BRCA1/2 genes to predict a woman's risk of developing breast and ovarian cancer. They argue that the patents cannot be applied to rules of nature or natural phenomena or abstract ideas.

In his ruling, Judge Sweet "noted that the case hinged on the fact that the patents protect 'isolated DNA,' which is 'premised on the view that DNA should be treated no differently from any other chemical compound and that its purification from the body, using well-known techniques, renders it patentable by transforming it into something distinctly different in character," GenomeWeb Daily News reported.

However, Sweet said that because "DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature … [its] existence in an 'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes."

Therefore, he concluded, "the patents at issue directed to 'isolated DNA' containing sequences found in nature are deemed unpatentable subject matter."

The Times quotes Sweet as saying that "'many critics of gene patents considered the idea that isolating a gene made it patentable [is] a "lawyer’s trick" that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.'”

“This is ground-breaking,” Barbara Caulfield, a patent lawyer with Dewey & LeBoeuf in Palo Alto, Calif., told Bloomberg. Caulfield, who submitted arguments against the patents on behalf of the March of Dimes, said because of the ruling “[n]ow all naturally occurring gene patents are invalid by the reasoning of this opinion. This is really a sea change for patents in life sciences.”

In his ruling, Sweet said that “[t]he identification of the BRCA1 and BRCA2 gene sequences is unquestionably a valuable scientific achievement for which Myriad deserves recognition, but that is not the same as concluding that it is something for which they are entitled to a patent," Bloomberg said.

"Today's ruling is a victory for the free flow of ideas in scientific research," Chris Hansen, a staff attorney with the ACLU First Amendment Working Group, said in a statement released yesterday. "The human genome, like the structure of blood, air or water, was discovered, not created. There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas."

According to the Times, the University of Utah's Chahine, because of the ruling “[t]he industry is going to have to get more creative about how to retain exclusivity and attract capital in the face of potentially weaker patent protection.”

The paper also quotes Edward Reines, a patent lawyer who represents biotechnology firms, said that the ruling "could diminish the incentives for genetic research."

The Times reported that Reines, who was not involved in the case, said that “'[t]he genetic tools to solve the major health problems of our time have not been found yet. These are the discoveries we want to motivate by providing incentives to all the researchers out there.”

The paper said the decision could push more work aimed at discovering genes and diagnostic tests to universities. "'The government is going to become the funder for content discovery because it’s going to be very hard to justify it outside of academia,'" according to Bryan Roberts, a Silicon Valley venture capitalist, the paper reported.

I made a similar point last year.

According to a report in Sample sister publication Pharmacogenomics Reporter, Myriad CEO Peter Meldrum, told investors recently that “regardless of the outcome of this particular lawsuit, it will not have a material adverse effect on the company or on the future revenues of our products.”

Judging by Myriad's stock performance yesterday, the company's investors appear to agree.

On the legal side of the story, the Genomics Law Report, which calls the ruling "jaw dropping" and "breathtaking," said Myriad "will surely appeal to the Federal Circuit (it has a right to that appeal), a process that could take a year or more."

In its article, whose headline begins "Pigs Fly," GLR said its "initial guess is that that court will end up affirming Judge Sweet on some or all of the process claims, but will cut way back on his broad attack on gene patents. But that decision is way down the road."

Of course, GLR — and countless others, myself included — believed pigs couldn't fly.