The Prior Art

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."

PubPat Releases Claim Construction Dictionaries

Does the word "user" mean a person or a machine? And when you say "connected," does that necessarily mean directly connected?

If your eyes are rolling back in your head while you're reading this, consider yourself normal. If you're getting excited, then you might love claim construction hearings, those patent litigation proceedings during which lawyers argue about the meaning of words—especially the meaning of everyday words. Other than the trial itself, the claim construction process is the most important part of a patent lawsuit, one that's been required since the Supreme Court's Markman decision in 1995. How a court decides to define a particular term can put an accused product definitively within, or outside of, the patent claims at issue in a lawsuit.

Now, the Public Patent Foundation has released a free "Claim Construction dictionary" that the group predicts could well reduce the expense and difficulty of conducting research on patents. In fact, David Garrod, who edited the dictionary, believes they could make researching patent claims—whether in connection with a claim construction hearing, or an infringement opinion—"dramatically cheaper."