Archive for the ‘Patentable Subject Matter’ Category

PLANET BLUE v. NAMCO – Abstract at the “Point of Novelty”

Monday, September 29th, 2014

In McRO, Inc. d.b.a. Planet Blue v. Namco Bandai Games America, civ. No. CV 12-10322-GW (FFMx) (C. D. Cal., Sept. 22, 2014), the granted Defendant’s motion for judgment on the pleadings that US Patent numbers 6,307,576 and 6,611, 278, were invalid as attempts to claim an abstract idea. (A copy of the decision is available at the end of this post.)

The claims were directed to automatically animated lip synchronization and facial expression of 3D animated characters. The court read the claims in view of the admitted state of the prior art and located a single “point of novelty”: “[T]he idea of using rules, including timing rules, to automate the process of generating keyframes.” “So what the claim adds to the prior art is the use of rules, rather than artists to set the morph weights and transitions between phonemes [e.g., the change in the shape of the lips as words are spoken.]”

(more…)

Genetic Technologies v. LabCorp. – Mayo Redux.

Tuesday, September 16th, 2014

It was Mayo redux with a vengeance in the September 23, 2014 decision in Genetic Technologies Ltd. v. Laboratory Corp. of Amer. Holdings et al., Civil Action No. 12-1736-LPS-CJB (D. Del. 2014).  Magistrate Judge Burke released an opinion invalidating claim 1 of Genetic Technologies U.S. Patent No. 7,615,342 as claiming non-patentable subject matter under s. 101 that could have been stenciled from the PTO s.101 Guidelines. Claim 1 was directed to a method to predict potential sprinting, strength or power performance in a human. The claim had an “analyzing step” to look for variations in the ACTN3 gene of the human, a “detecting step” to determine the presence of two 577R alleles at a loci of the ACTN3 protein and (c) a “predicting step” positively associating two copies of the allele with the performance elements.

Citing Mayo v. Prometheus and PerkinElmer v. Intema copiously, the correlation between the alleles and athletic performance was held to be a natural law and the analyzing and detecting steps were the “employment of … routine conventional process[es]” that were not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law. The “predicting step” was dismissed as “’no more than an instruction [to] apply the [natural] law.’ Prometheus, 132 S Ct at 1297.”

(more…)

FDA’s New Biosimilars Guidance

Monday, August 11th, 2014

The following has been posted with the permission of their authors James E. Valentine and James C. Shehan of Hyman, Phelps & McNamara as part of their FDA Law Blog.

***

August 09, 2014

FDA’s New Biosimilars Guidance Has Sponsors Provide Information to Win Reference Product Exclusivity; Liberal Criteria Opens the Door to More Exclusivities Being Awarded

By James E. Valentine* & James C. Shehan

On August 5, 2014, FDA announced the availability of its most recent biosimilars guidance entitled, “Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act” (“FDA Draft Guidance”). The Draft Guidance puts some sponsors of BLAs past, present, and future, on notice that FDA wants them to submit certain information for their biologics to be considered for “reference product exclusivity.”  But that’s a burden that sponsors will likely gladly bear, because FDA’s proposed broad interpretation of structural modification, a key term in determining whether a related product differs enough from a sponsor’s structurally related product to merit its own exclusivity, makes more products eligible for exclusivity than is required under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”).

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.

(more…)