Section 101 at the AIPLA Midwinter Meeting

February 2nd, 2015

Although the primary focus of this four day meeting was licensing, there were two simultaneous tracks that contained at least a section of the effect/uncertainty of the recent judicial decisions and PTO Guidelines on licensor/licensee relationships. (I spoke at one of them, and my short slideshow is posted on the AIPLA website, along with a longer “law review”-type article that is, by now, a bit out of date.)

What got me out of bed this morning was the “President’s Forum –What’s Next for Patent Eligibility: Federal Circuit and the USPTO Gloss.” It was chaired by Sharon Israelson, current AIPLA president and included Jerry Selinger – who is heading up an AIPLA working group on the issue, Myra McCormack of J&J, Nate Kelly, Solicitor, USPTO and Jim Crowne of AIPLA. Of course, this was too many speakers for an hour-long forum.

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Myriad Settles – Questions Remain

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

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”

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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