Supreme Court Grants Myriad’s Petition for Cert.

Posted on December 3, 2012 by Warren Woessner

I feel a bit like Al Pacino in “The Godfather – Part 3” when he shouts, “Just when I thought I was out, they pull me back in!” (Repeated memorably by Silvio Dante in “The Sopranos”.) Now the Supreme Court has granted cert. to resolve one question: “Are human genes patentable?” In isolation, presumably, since I have been explaining to patent “civilians” for years that no one can patent a gene – or any other chemical – as it occurs in situ in the human body and then demand a royalty from anyone using the gene to live.

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USPTO Director Kappos Resigns

Posted on November 26, 2012 by Warren Woessner

USPTO Director David Kappos has announced that he will leave the Office early next year, perhaps by the end of January. He became the Director in 2009, leaving his position as essentially Head Patent Counsel at IBM.

He brought much-needed patent law expertise to the Office and began a number of initiatives designed to improve examination efficiency, as well as to expedite prosecution of applications claiming “green technology.” His Office provided guidance to Examiners and practitioners following each of a series of major judicial decisions, including KSR, Bilski, Ariad and now, Mayo. He was also “tasked” with opening three satellite offices – in Detroit, Silicon Valley and Denver.

As if this weren’t enough to keep him and his staff busy, he also oversaw the generation of pages of detailed regulations to implement the AIA, the most comprehensive “reform” of 35 USC since 1952. I called him the hardest working man in patent “biz”. His legacy is already in place, and he will be missed.

Parting note from Director Kappos:

It has been an immense privilege to lead the USPTO, our nation’s innovation agency, over the last three and a half years—and it is with deep gratitude for your dedication and hard work that I write to inform you that I will be leaving the Agency around the end of January 2013.

I cannot thank you enough for your hard work over the years—and I wish you all the very best ahead.

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Perkinelmer v. Intema – Biomarker Claims Not Patent Eligible

Posted on November 21, 2012 by Warren Woessner

In Perkinelmer, Inc. v. Intema, Ltd., Appeal no. 2011-1577 (Fed. Cir. November 20, 2012), a panel of the Fed. Cir. reversed the district court and invalidated all of the claims of US Pat. No. 6,573,103 as patent-ineligible in view of Myriad and/or Mayo v. Prometheus. The claims were found to both “claim a law of nature” and to recite “the mental process of comparing data to determine a risk level.” Slip op. at 11. [A copy is provided at the end of this post.]

The claims were directed to an improved method to diagnose Down’s syndrome by measuring known biomarkers and/or ultrasound data taken during both the first and the second trimester of pregnancy, and then subjecting the data to multivariate analysis based on reference parameters to determine the odds that the fetus has Down’s syndrome. The method was “improved” because some markers are more predictive at different stages of pregnancy.

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Edwards Lifesciences v. Corevalve – Pig Valve Implants Enabling

Posted on November 19, 2012 by Warren Woessner

In Edwards Lifesciences AB v. Corevalve, Inc. (now a part of Medtronic), Appeal No. 2011-1215-1257 (Fed. Cir. Nov. 13, 2012), Corevalve challenged the validity of US Pat. No. 5,411,552 directed to a “transcather heart valve” on the basis that the valve had only been implanted in pigs as of the effective filing date of the patent, and that not all of the experimental implants were successful. The Fed. Cir. disagreed, and Edwards provides a succinct review of the standards for enablement based on animal testing.

The panel began by reminding the parties that “[t]he enablement requirement is met if the description [in the specification] enables any mode of making and using the invention.” Johns Hopkins Univ. v. CellPro, Inc. 152 F.3d 1342, 1361 (Fed. Cir. 1998). In other contexts, this statement permits claims based on “benchtop” syntheses, even if the claimed compound or process is being produced or practiced on a pilot plant scale. “The most efficient commercial embodiment need not be disclosed. Durel Corp. v. Osram Sylvania, Inc., 256 F.3d 1298 (Fed. Cir. 2001).”

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