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

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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Chisum Patent Academy Close To Full

January 5th, 2015

The Chisum Patent Academy has three seats remaining in its March 5-6, 2015 Advanced Patent Law Seminar in Cincinnati, Ohio. The two-day roundtable seminar is limited to a total of ten participants to maximize opportunities for interactive discussion and debate.  All sessions are led by treatise authors and educators Donald Chisum and Janice Mueller. Coverage focuses on recent significant patent decisions of the Federal Circuit and U.S. Supreme Court. Topics currently planned for discussion include:

  • The Supreme Court’s Alice Corp. decision on patent-eligible subject matter and Federal Circuit decisions applying Alice Corp.;
  • The Supreme Court’s grant of certiorari in Commil USA concerning the intent requirement for inducing infringement;
  • The Supreme Court’s grant of certiorari in Kimble v. Marvel to review the propriety of post-patent expiration royalties;
  • The Supreme Court’s pending decision in Teva v. Sandoz on standard of review for patent claim construction;
  • The Federal Circuit’s grant of en banc review in SCA Hygiene to determine whether the Supreme Court’s Petrella decision changed the law of laches as a defense to patent infringement;
  • “Patent Practice Gone Wrong”:  Lessons from Patent Malpractice, Exceptional Case and Rule 11 Sanctions, and Inequitable Conduct Cases;
  • Patent Claim Construction and Definiteness in the Wake of Nautilus (and Anticipating Teva); and
  • Inter Partes Review: Two-Year Snapshot and Lessons from Case Studies.

No advance preparation is expected or required. The Supreme Court of Ohio Commission on Continuing Legal Education has approved the seminar for 12.0 hours CLE instruction.

For additional details on the venue, topics, and registration form, click here or e-mail info@chisum.com