Posts Tagged ‘biotechnology law’

Mayo Meet Alice Meet Myriad – Fed. Cir. Appreciates “Abstract Art”

Thursday, December 18th, 2014

On December 20th, a panel of the Fed. Cir. of Judges Dyk, Clevinger and Prost – Dyk writing – found that six claims in Myriad’s dwindling arsenal of BRACA1 and 2 patents were invalid as claiming non-statutory subject matter. (University of Utah Res. Foundation et al. v. Ambry Genetics Corp., Appeal No. 2014-1361, -1366 (Fed. Cir., Dec. 20, 2014)). (A copy of the decision is found at the end of this post.) The decision makes more sense than some commentators have given it credit for, but it still reads like the plot of the last Matrix installment.

First, the panel invalidated four composition of matter claims directed to ssDNA segments useful to amplify the BRACA genes or portions thereof, when used as PCR primers, or to identify specific areas of the genes if used as probes. These were claims in US Pat. Nos. 5,747,282 and 5,837,492.

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Supreme Court to Review Post-Expiration Date Royalties in Kimble v. Marvell

Friday, December 12th, 2014

Despite a negative brief from the Solicitor General’s Office, on Friday the Supreme Court granted cert. in Kimbell v. Marvell, 727 F.3d 856 (9th Cir. 2013) (a copy can be found at the end of this post). The single question presented is “Whether the Court should overrule Brulotte v. Thys” (379 U.S. 29 (1964)). This decision held that a patentee’s use of a royalty agreement extending royalty payments beyond the expiration date of the patent is unlawful per se. This decision had, in some cases, been extended to void licensee’s contract obligations when “hybrid royalty payments” where involved, e.g., when royalties due to both the use of patent and non-patent rights were involved but had not be clearly delineated, and in the case of deferred payments for profits obtained before patent expiration, but paid after expiration. On the other hand, cases like Aronson, which provided for reduced royalties after a fixed period of time if no patent ever issued, were found to be enforceable, since such agreements did not involve patent licenses.

Brulotte has been widely criticized since it issued – after all, expired patents can be practiced for free by any and all – unless a licensee sees something of value and contracts away its rights – and the Supreme Court may well have taken this case due to the cogent summary of the issues by the 9th Circuit. The decision, due in 2015, will be of particular interest to the “patent and licensing offices” of universities, which have long struggled with questions of best practices in obtaining some royalty stream from early-stage technologies whose maximum earning potential may not be realized until the patents covering them have expired, or are about to expire.

Kimble v Marvel

Canadian Hospital To Travel The Long And Winding Road Of “Gene Patenting”

Monday, November 3rd, 2014

Arguing that human DNA is a natural product, the Children’s Hospital of Eastern Ontario (CHEO) has filed suit in Federal Court to invalidate patents claiming human DNA or diagnostic methods that use it. It has been reported that CHEO was threatened by a U.S. company holding Canadian patents on genes associated with long QT syndrome, an inherited heart rhythm disorder. Currently, the hospital sends samples to the U.S. for testing, at a cost of about $4500, but says it can perform the test for about half that amount in Canada.

Of course, this suit was inspired by the Myriad decision in which the U.S. Supreme Court held that isolated human genes or fragments thereof are unpatentable as “natural products,” but that cDNA is a patent-eligible product of human ingenuity. The Federal Circuit has twice held that methods involving comparing a patient’s BRCA DNA sequences with a reference DNA sequence to identify mutations in the patient’s DNA sequence are patent-ineligible as “abstract ideas.” However, assay claims with more detail about the mutations or the manipulative steps involved were before either court on appeal. In Mayo v. Prometheus, the Supreme Court held that a method for optimizing the dose of a known class of drugs by measuring the levels of a metabolite in the patient’s blood was patent-ineligible as an attempt to patent a “natural phenomenon.” It will be very interesting to see which, if any, of these tortuous legal trails the Canadian courts will follow.

You can find more information here and here.

Section 101 at AIPLA

Friday, October 24th, 2014

The increasingly intense conversation about patentable subject matter post-Mayo, Myriad and Alice got off to a slow start at the “Partnering for Patents” meeting held at the PTO on Wednesday. The meeting was a scattering of in-house PTO reports and wish-lists, with some “outside presenters.” Alan Hirschfeld spoke briefly about the Alice decision and the first round of PTO Guidelines, but he offered nothing in the way of new insights, simply reminding the audience that the Guidelines should not be considered final and that the process would be reiterative.

Over at the big AIPLA Annual Meeting in DC, Karen Canady moderated a session today that covered topics ranging from post-grant proceedings under AIA to ethics. Of course the s. 101 presentation by Donna Meuth of Eisai and David Wille of BakerBotts was of the most interest to me. Donna used an example of the rejection of claims involving natural products that Hans Sauer of BIO posted on this website. The claims to the compound, a composition containing it, and its use to treat three types of cancer were all rejected as involving a natural product and as impermissibly tying up the building blocks of human ingenuity. Of course, many in the audience noted that that was what patents were intended to do, but that was cold comfort to the applicant, who failed every one of the test factors in the Guidelines but one.

David Wille attempted a look into the thought processes of the judges applying Alice in district court decisions. He felt that the key to “success” may lie in keeping the focus on the manipulation of real matter, like checks, and emphasizing that the focused claims are not directed to fundamental economic practices, but to the transformation of specific types of data. I think he referred to success as passing the “technological arts test.” The significance of these lessons is far from clear, but they are a start. Still, I feel like the narrator in the Dylan song who laments: “It’s not dark out yet, but its getting there.”