Posts Tagged ‘Myriad’

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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Australia: Cancer Voices v Myriad Opinion Affirmed

Friday, September 5th, 2014

This is a guest post from Paul Cole.

An opinion was handed down earlier today by the Federal Court of Australia – Full Court (Allsop C.J., Downsett, Kenny, Bennett and Middleton J.J., D’Arcy v Myriad Genetics Inc [2014] FCAFC 115 (5 September 2014))(1). In an outcome strikingly at variance with that before the US Supreme Court, it affirmed the opinion of Nicholas J. that claims for isolated nucleic acids are for a manner of manufacture for purposes of s.18(1)(a) of `Australian Patents Act 1990 and s.6 of the Statute of Monopolies (Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65 (15 February 2013)(2) [The links for footnoted items can be found at the end of the post.]

In its opening remarks, the Full Court held that expressions such as “the work of nature” or “the laws of nature” are not found in the statute, nor are they useful tools of analysis. Adopting the reasoning of Frankfurter J. in Funk Brothers Seed Company v Kalo Inoculant Company, [1948] USSC 22; 333 US 127 (1948), it confuses the issue to use such terms. They could fairly be employed to challenge almost any patent.

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101 Rejections Under the Guidelines: Mayo and Myriad “Go Viral”

Thursday, September 4th, 2014

This is a guest post from Hans Sauer, Deputy General Counsel, Intellectual Property for BIO.

“Recently, I set out to find real-world examples of recent rejections under the USPTO Guidance, to do my own sampling rather than rely on reported anecdotes. In just two hours of not very systematic searching, I was able to identify dozens of cases that have these new rejections, and I have attached some of the more interesting ones for you. [These can be found at the end of this post.] I focused mainly on applications with product claims, and pulled up method claims only incidentally.

“As expected, these new “product of nature” rejections go far beyond nucleic acid claims. Interesting examples include multipart vaccine preparations, industrial enzymes, organic crop protection products, a pharmaceutical composition and method of treatment involving an anticancer molecule from a marine sponge, and even a method for washing laundry. We’re also now seeing rejections of monoclonal antibody claims, which is something we were worried would happen. Perusing the attached rejections only takes a half hour; it’s a quick way to get an impression of what’s going on.”

Scanned from a Xerox multifunction device

Scanned from a Xerox multifunction device[1]

Scanned from a Xerox multifunction device[2]

Scanned from a Xerox multifunction device[3]

 

USPTO TRIPs over Myriad-Mayo guidance

Thursday, July 31st, 2014

Timothy W. Roberts, Chartered Patent Attorney; MA (Oxon); LL.D (honoris causa, Sheffield University)

Paul G. Cole,  Chartered Patent Attorney;  MA (Oxon); LLM, NottinghamTrent; Visiting Professor, Bournemouth University

The above UK-based European Practitioners have today filed comments at the USPTO arguing that the USPTO’s Myriad-Mayo Guidance is inconsistent with the provisions of Article 27 of the TRIPs Agreement.

They argue that the ruling of Justice Thomas in Myriad is TRIPs-compliant only on the narrow holding that mere isolation of a DNA sequence unaccompanied by new, improved or extended utility does not give rise to eligibility. Any broader interpretation of the ruling e.g. to exclude natural products selected or isolated by the hand of man and possessing new or improved utility would be inconsistent with the express provisions of the Agreement. It will be recollected that Justice Ginsburg during oral argument in Myriad was concerned that the US was at risk of adopting a rule quite different from that of other industrialised nations and would be placing itself in an isolated position. Only the suggested interpretation, they argue,  would avoid those concerns, and they submit that the Court had these considerations in mind when it handed down its limited and cautious opinion in Myriad.

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