Archive for the ‘Claim Construction’ Category

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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101 Rejections Under the Guidelines: Mayo and Myriad “Go Viral”

Thursday, September 4th, 2014

This is a guest post from Hans Sauer, Deputy General Counsel, Intellectual Property for BIO.

“Recently, I set out to find real-world examples of recent rejections under the USPTO Guidance, to do my own sampling rather than rely on reported anecdotes. In just two hours of not very systematic searching, I was able to identify dozens of cases that have these new rejections, and I have attached some of the more interesting ones for you. [These can be found at the end of this post.] I focused mainly on applications with product claims, and pulled up method claims only incidentally.

“As expected, these new “product of nature” rejections go far beyond nucleic acid claims. Interesting examples include multipart vaccine preparations, industrial enzymes, organic crop protection products, a pharmaceutical composition and method of treatment involving an anticancer molecule from a marine sponge, and even a method for washing laundry. We’re also now seeing rejections of monoclonal antibody claims, which is something we were worried would happen. Perusing the attached rejections only takes a half hour; it’s a quick way to get an impression of what’s going on.”

Scanned from a Xerox multifunction device

Scanned from a Xerox multifunction device[1]

Scanned from a Xerox multifunction device[2]

Scanned from a Xerox multifunction device[3]

 

Lightning Ballast II – Judge Lourie Tries to Get to “The Facts of the Matter”

Monday, February 24th, 2014

After reading all 88 pages of this very scholarly opinion which left patent law right where it was post-Cybor – no matter how much weight the parties and amici felt stare decisis deserved – I went back and read Judge Lourie’s concurrence. It is mercifully brief and tries to cast some of the substantive issues in real-world contexts. He writes like a “Dutch uncle” – which the dictionary defines as one who “admonishes sternly and bluntly.” Whether or not you agree with his conclusions, he gets his points across like arrows in “The Hunger Games.”

He reduces the debate about the proper reading of Markman II simply by saying that the distinction between calling claim interpretation a “question of law” vs. a “question for the court” is not a substantial one. Whether or not the Supreme Court will disagree if cert. is granted is a question for another day.

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