The Prior Art

Federal Circuit Hears Arguments in Myriad Case

Oral arguments were under way at the U.S. Court of Appeals for the Federal Circuit Monday morning in the closely watched Myriad Genetics appeal (Association for Molecular Pathology, et al. v. USPTO, et al.), with a panel of three Federal Circuit Judges (Lourie, Bryson, and Moore) weighing whether human genes qualify as patentable subject matter.

Ruling in a case brought by several doctors' groups, the ACLU, and the Public Patent Foundation, New York federal district court Judge Robert Sweet last year struck down Myriad's patents on two genes related to breast cancer, holding that they merely covered isolated DNA from the natural world and thus were not eligible for patent production under section 101 of the Patent Act.

In his 152-page opinion [ Download Myriad Opinion], Sweet wrote: "It is concluded that DNA's existence in an 'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to 'isolated DNA' containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter."

As The American Lawyer reported in February, acting Solicitor General Neal Kaytal was to argue for the appellees along with attorneys for the ACLU and the Public Patent Foundation, marking the first time that a Solicitor General has argued at the Federal Circuit.

In a case with implications for the entire biotechnology industry, Kaytal will attempt to explain why the government now thinks that genes should not be patentable, despite the fact that the USPTO has historically disagreed and has been issuing patents on isolated DNA for more than 30 years.

For a good background on the issues likely to be raised at oral argument, check out Joe Mullin's previous  coverage of the district court's ruling and Andrew Cohen's discussion of the case at The Altantic. For the even more ambitious, an audio recording of the argument will be made available on the Federal Circuit's website later today.

 

 

 

 

Citing Possible Bias, ACLU Asks Rader to Recuse Himself in Myriad Case

With the U.S. Court of Appeals for the Federal Circuit set to consider a landmark case over the validity of human gene patents, attorneys for the plaintiffs in the suit are asking the court's chief judge to recuse himself from the matter—before the panel that will hear it has even been selected.

In a motion filed quietly in late June, Christopher Hansen of the American Civil Liberties Union and Daniel Ravicher claim that remarks made by Federal Circuit Chief Judge Randall Rader at a biotechnology industry event show he may have a biased view of the case in question, Association of Molecular Pathology et. al. v. U.S. Patent and Trademark Office et. al, and should not be one of the three judges to decide the appeal.

Questioning Rader's objectivity is an unusual move that underscores just how high the stakes are in the case at issue, in which several doctors' groups have joined the ACLU and PubPat in seeking to invalidate patents on two genes related to breast cancer that are owned by Utah-based Myriad Genetics--and, more broadly, to challenge the legality of the thousands of genetic patents already in existence.

In ACLU Suit, Judge Rules Myriad's Genetic Patents Invalid

Last year, several doctors' groups, together with the ACLU and Public Patent Foundation, filed a lawsuit seeking to invalidate patents on two genes related to breast cancer and owned by Utah-based Myriad Genetics. The plaintiffs, who can be viewed as arguing more broadly against all genetic patents, claimed in the suit that such patents are not only illegal under the nation's patent laws, but also unconstitutional.

On Monday afternoon, the plaintiffs won. Ruling on summary judgment motions filed by both sides, New York federal district court Judge Robert Sweet ruled on summary judgment invalidated Myriad's patents on the BRCA1 and BRCA2 genes. In his 152-page opinion [PDF], Sweet wrote that the patents in question cover parts of the natural world and therefore don't conform to section 101 of U.S. patent laws, which those govern what qualifies as patentable subject matter.

Sweet agreed with the ACLU's basic argument that the "isolated" DNA that Myriad claimed to have patented is still a product of nature, and can't be covered by patents. He wrote: "It is concluded that DNA's existence in an 'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to 'isolated DNA' containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter."

Patent Litigation Weekly: Patent Bar, Doctors Face Off in Prometheus v. Mayo

The April/May issue of IP Law & Business featured a story about Robert Shafer, a Stanford University researcher whose free HIV database had become embroiled in a patent dispute that led Shafer to believe medical method patents are out of control.

Since that story’s publication, groups representing most of the American medical establishment have become involved in two major patent cases that turn on the same question that Shafer confronted: just what kinds of "technology" should be eligible for patent protection?

One of those cases, Prometheus Laboratories v. Mayo Collaborative Services et al., is now headed to the Federal Circuit; oral arguments are scheduled for August 5. Amicus briefs filed on both sides show clearly the divide between the patent bar and medical professionals on this issue.

Patent Litigation Weekly: PubPat and ACLU Aim to Take Down Gene Patents

This week, TPA takes a break from its usual surfing through federal court dockets in search of trolls and such to consider a potentially landmark suit against the PTO.

• Association for Molecular Pathology, et al. v. United State Patent and Trademark Office, et al., 09-cv-04515, S.D. New York, filed 5/12/2009.

For nearly 30 years, the U.S. Patent and Trademark Office has been granting patents on isolated portions of the human genome. That practice has resulted in thousands of human genes—as much as 20 percent of all human genetic material—being patented.

This week, genetic patents came under a full-bore legal assault when groups representing more than 100,000 doctors and researchers, working together with lawyers at the Public Patent Foundation and the American Civil Liberties Union, filed suit against the PTO and Myriad Genetics, a Utah-based genetic testing company.  It's a lawsuit two years in the making.

The suit's immediate goal is to invalidate seven patents that give Myriad the sole rights to administer tests and do research connected to a pair of genes closely connected to breast and ovarian cancer, BRCA-1 and BRCA-2 (pronounced "bracka-one" and "bracka-two.") Should the plaintiffs prove successful, though, their strike against the PTO would have far-reaching implications.

Dan Ravicher, the patent lawyer at the Public Patent Foundation who is working with the ACLU on the case, puts it bluntly:  "The intention is to take down patents on human genes."