Posts Tagged ‘Supreme Court’

Myriad Settles – Questions Remain

Tuesday, January 27th, 2015

Yesterday, Myriad announced it has settled the BRCA assay litigations that had been ongoing—and not going well– with Pathway Genomics, Invitae and Gene by Gene (and I assume….Ambry and Labcorp). Although I was just about at the brink of shouting “Stop The Madness” – the settlements mean that the IP community will not learn if Myriad had any patent-eligible claims in any of their assay patents. Would claims directed to mutations at specific positions of the BRCA1 or 2 genes have passed muster as that elusive “inventive concept” that both the Fed. Cir. and the S. Ct. extracted from Mayo as the standard by which to judge assays reciting abstract ideas or natural phenomena (which one is it?)?

You can read an article about the settlement on the GenomeWeb page by clicking here.

TEVA v. SANDOZ – THE DISSENT AND THE ZONE OF UNCERTAINTY

Wednesday, January 21st, 2015

In Teva v. Sandoz, decided yesterday by a 7-2 decision of the S. Ct., the lengthy dissent by Justices Alito and Thomas invoked the dreaded “zone of uncertainty” – a dangerous bar of shifting legal sands that defendants should not have to cross. This legal quicksand was recently invoked in Nautilus v. Biosig to justify raising the requirements of s. 112(2) from insolubly ambiguous to reasonably certainty, and has its roots in Markman and Festo, 535 U.S. 722, 731 (2002). Justice Thomas writes:

“So damaging is this unpredictability that we identified uniformity as an ‘independent’ reason justifying our allocation of claim construction to the court… The majority’s rule provides litigants who prevail in district court to take advantage of this uncertainly by arguing on appeal that the district court’s claim construction involved subsidiary findings of fact. At best, today’s holding will spawn costly [and meritless] – collateral litigation over the line between law and fact.” Slip. op. at 16 [dissent].

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Teva v. Sandoz: “Just the facts, Ma’am”

Wednesday, January 21st, 2015

Effectively reversing Cybor Corp., which flatly stated that a lower court’s claim construction is a question of law which is to be reviewed de novo by the Fed. Cir., yesterday the Supreme Court held 7-2 that questions of fact resolved by a district court prior to claim construction must be given deference by the Fed. Cir. and only reversed if clearly erroneous.

The basic dispute arose over whether or not the term “molecular weight” was adequately defined — it could be calculated three different ways — or if the information in the specification, including a graph showing the peak average molecular weight met the requirements of s. 112(2). The experts disputed a discrepancy between value shown on the graph’s legend and the value at the actual peak of the curve. Teva’s expert testified that difference was small and was due to the conversion of the data from a chromatogram to the m.w. distribution curve in the figure. The District Court agreed, but the Fed. Cir. rejected these factual findings, without explaining why it was “clearly erroneous.” The Supreme Court vacated the Fed. Cir’s. Judgment of s. 112(2) invalidity and remanded, thus endorsing a “clear error” and not a de novo standard for review.

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The “Top Ten” IP Stories of 2014 (Most “Definitely”)

Tuesday, December 30th, 2014

I don’t think I can recall a more action-packed year for intellectual property law in my career, much less during the almost six years that I have been writing this blog. I am trying to write this while in transit, so there will be few footnotes or cites, but they are easy enough to find in my past posts, or online. I am not even sure that I outlined ten stories before I started typing, but here goes — in no particular order.

1,2,3 and 4. Mayo meet Alice meet Myriad - The Tortuous Path of s.101.

Although only Alice was decided in 2014, the excitement really started with the unexpected release of the PTO “Life Sciences” Guidelines in March (No. 1 Story). The draft Guidelines directed Examiners to reject claims to products of nature unless they were significantly different in structure from the products in their natural states, and declared that simple “If A, then B” diagnostic claims were patent-ineligible as attempts to patent natural phenomena.

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