Posts Tagged ‘Federal Circuit’

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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Promega v. Life Technologies – “Too Much Of Nothing?”

Tuesday, January 20th, 2015

Although much more attention has been focused on the portion of this recent Fed. Cir. decision that held a defendant could “induce itself” into infringement under s. 271(1)(f), by sending one part of a kit to be assembled abroad, the s. 112, para. 1 portion of the decision deserves some attention. This is particularly true in the written description requirement (WDR) era the biotech industry has been living in since the Ariad decision enshrined the WDR as an effective claim killer.  Promega Corp. v. Life Technologies, App. No 2013, -1029, -1376 (Fed. Cir., December 15, 2014) (a copy is available at the end of this post).

Trying to make a long decision short, Promega asserted patents claiming kits having primers that would co-amplify a set of at least three STR loci wherein the set of loci are selected from the sets of loci consisting of D3S1539, D19S253…etc. As you might imagine, Life Technologies, these claims were treated as closed, and Life Technologies easily avoided infringing them.

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Mayo Meet Alice Meet Myriad – Fed. Cir. Appreciates “Abstract Art”

Thursday, December 18th, 2014

On December 20th, a panel of the Fed. Cir. of Judges Dyk, Clevinger and Prost – Dyk writing – found that six claims in Myriad’s dwindling arsenal of BRACA1 and 2 patents were invalid as claiming non-statutory subject matter. (University of Utah Res. Foundation et al. v. Ambry Genetics Corp., Appeal No. 2014-1361, -1366 (Fed. Cir., Dec. 20, 2014)). (A copy of the decision is found at the end of this post.) The decision makes more sense than some commentators have given it credit for, but it still reads like the plot of the last Matrix installment.

First, the panel invalidated four composition of matter claims directed to ssDNA segments useful to amplify the BRACA genes or portions thereof, when used as PCR primers, or to identify specific areas of the genes if used as probes. These were claims in US Pat. Nos. 5,747,282 and 5,837,492.

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