Posts Tagged ‘patents’

Genetic Technologies v. Bristol Myers – 101 At Work

Wednesday, November 5th, 2014

In the recent memorandum opinion, the court invalidated claim 1 of U.S. Pat. No. 5,612,179, owned by Genetic Technologies, Ltd., as “impermissibly [claiming] a natural phenomenon.” (Genetic Technologies, Ltd. v. Bristol-Myers Squibb Company, C.A. No. 12-394-LPS (D. Delaware, Oct. 30, 2014), copy of which can be found at the end of this post).

If you have been following the Mayo/Myriad/Intema trail of tears, you could probably write 98% of this opinion “from memory.” A number of aspects of this very lengthy and predictable opinion stand out, however.

The claims were directed to a method of detection of at least one coding region allele of a multi-allelic genetic locus by amplifying genomic DNA via PCR, with a primer pair that spans a non-coding region sequence. The primer pair defines a DNA sequence which is in genetic linkage with the genetic locus and contains a sufficient number of non-coding region sequence nucleotides so that PCR produces an amplified DNA sequence characteristic of said allele; “and analyzing the amplified DNA sequence to detect the allele.” The claim was based on the discovery that there can be a correlation between variations in non-coding introns and coding region alleles; that is, that SNPs in non-coding DNA regions can also be in linkage disequilibrium with SNPs in coding regions of DNA . The genotypes of two SNPS in non-coding regions and two SNPs in a coding region are correlated so that the SNPs in the non-coding region can serve as “surrogate markers’ for the SNPs in the coding region.

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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.”

Partnering In Patents XXI Program At USPTO Oct 22nd

Tuesday, October 21st, 2014

Since I am suffering from section 101 fatigue, tomorrow I will be speaking at this program on indefiniteness post-Nautilus. However, this meeting gets interesting earlier in the afternoon when Andrew Hirschfeld presents on “Updates on 101 training and Examiner Guidance” (working title) followed by Michael Stein, the “AIPLA Speaker” whose topic is “Understanding Patent Eligibility After Alice, Practical Tips for Practitioners and Examiners.”

The big question for my computer law and software brethren is whether or not there is any patent eligibility post-Alice for the inventions claimed in most of their pending applications? A quick survey by one of my partners indicates that over 90% of the applications filed by one big “software company” in Class 705 (Data Processing; Financial, Business Practice, Management, or Cost/Price Determination) that have received Office Actions in August received 101 rejections. As a stock car race driver once said to me when he was boxed in and about to “take the wall,” “I had nowhere to go but up.”

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)