Posts Tagged ‘biotechnology law’

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.”

BIO Provides Supplemental Comments on PTO s.101 Guidelines

Tuesday, October 21st, 2014

BIO recently generated a letter to the PTO on the March 6th Guidelines on the patent-eligibility of subject matter in the life sciences, particularly “natural products.” BIO invited a group of in-house and private practitioners to comment on the Guidelines and a number of them – including myself – signed off on the letter. Following appearances by a Mr. Hirschfeld at a number of industry conferences and symposia, the biotech/pharma community felt that there is a realistic chance the initial Guidelines will be released in revised form in the near future.

Supplemental comments on USPTO Myriad guidance (10-14)

EPO – New Guidance On Added Subject Matter

Thursday, October 9th, 2014

A guest post from Paul Cole.

Readers will be aware that added subject matter issues have for a long time been a thorny issue for EPO Examination practice.

On 7 February 2014 a symposium on EPO practice regarding Art. 123(2) EPC took place at the EPO’s Munich headquarters. Twenty-five senior patent professionals from Europe, Japan and the USA took the opportunity to share experiences with EPO examiners, lawyers, and procedural experts in an effort to enhance understanding of how examiners apply Art. 123(2) EPC, and raise awareness among examiners of the problems encountered by users.

Margot Fröhlinger, Principal Director Patent Law and Multilateral Affairs, Heli Pihlajamaa, Director Patent Law, and Alfred Spigarelli, Director Patent Procedures Management opened the plenary session with an overview of EPO practice. John Hornickel from the American Intellectual Property Law Association (AIPLA), Yasuda Ryosuke from the Japan Patent Attorney Association (JPAA), and Gabriele Leißler-Gerstl from the European Patent Institute (EPI), presented the US, Japanese and European perspective on Article 123(2) EPC. The results were presented in a final plenary session.

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