Posts Tagged ‘Therasense’

Ohio Willow Wood Co. v. Alps South, LLC – Inequitable Conduct Lives!

Monday, November 18th, 2013

In October, I spoke at AIPLA with James Carmichael, who used to head up the “Fraud Squad” at the PTO. He noted that there had only been three Fed. Cir. decisions upholding findings of inequitable conduct (IC) since Therasense, two of which involved attorney misconduct. Now there is a fourth. The Fed. Cir. panel of Judges Dyk, Bryson and Reyna vacated and remanded a district court’s finding of no IC, but they wrote at a level of factual detail which virtually instructed the district court to change its mind. (Ohio Willow Wood Co. v. Alps South, LLC, Appeal no. 2012-1642, 2013-1024 (Fed. Cir. November 15, 2013) a copy is available at the end of this post).

(more…)

Supreme Court Will Not Review Therasense Standards – Yet

Wednesday, October 16th, 2013

On October 15, 2013, after reviewing the Government’s Amicus Brief (a copy is available at the end of this post), the Supreme Court denied the petition for cert. filed by Sony Computer Entertainment, one of the defendants in 1st Media, LLC v. Electronic Arts Inc., App. No. 2010-1345 (Fed. Cir. Sept. 13, 2012). Sony had alleged inequitable conduct due to the inventor’s and the patent attorney’s failure to disclose relevant references during prosecution of a chain of applications relating to multi-media entertainment systems. Pre-Therasense, the district court had tried the IC charges prior to the case-in-chief, and found IC without deciding if there was “but-for” materiality. The Federal Circuit reversed due to the failure of the district court to prove the element of specific intent to deceive the PTO. The Fed. Cir. decision contains this memorable quote: “Moreover it is not enough to argue carelessness, lack of attention, poor docketing or cross-referencing, or anything else that might be considered negligent or even grossly negligent.” Slip op. at 12-13. [Ed.’s note: These factors are starting to sound like the elements of a defense against a charge of IC.]

(more…)

Top Ten Biotech IP Stories of 2012

Friday, December 28th, 2012

I admit, I am a sucker for lists, esp. Top Ten Lists, and a few days ago, sat through a half hour of “local news” wherein the anchors breathlessly related the Top Ten Rhode Island News Stories of 2012. Well, readers, you deserve no less that my Top Ten List of IP “Stories” that broke, sometimes over us, in 2012. So that this post is not endless, I will write it from very abbreviated notes and leave it to you to dig the details out of the patents4life archives – or to just back up through the posts of 2012. Also, past Prometheus and Myriad, the list does not mean to prioritize the events reported.

(more…)

In re Rosuvastatin Calcium Patent Litigation – Making “Therasense” out of Confusion

Thursday, December 20th, 2012

Recently, a divided three judge panel sorting out a multi-party Hatch-Waxman suit, ruled that the patentee, Shinonogi, had not committed inequitable conduct in obtaining the patent that was subsequently reissued so as to obtain narrow claims focused on Rosuvastatin, or Crestor®, the popular cholesterol lowering drug. The majority of the panel also held that the patent was properly reissued due to error without deceptive intent. Although the deceptive intent element has been removed from the reissue statute by the AIA, it will remain relevant to earlier-filed reissues for some time to come. The opinion was subtitled AstraZenca UK Ltd v. Aurobindo Pharma Ltd, 2010-1460 to 1473 (Fed. Cir., December 14, 2012) and involved multiple “generic company” defendants. (A download is available at the end of this post.)

After finding the Crestor claim non-obvious over a Sandoz reference that disclosed a sulfonylated analog, the panel spent 7 pages discussing IC and 10 pages discussing whether or not the reissue application was properly filed. In terms of IC, Fed. Cir. panels continue to be reluctant to find IC in cases in which multiple parties create “a string of mishaps, mistakes, misapprehensions and misjudgment,” particularly if the “purported culprits” are “inexperienced and overworked,” to use the language of the district court, that also found no IC. It probably helped that the only two “purported culprits” were both Japanese patent attorneys apparently working in Japan, although it is hard to fathom how they carried out the prosecution of a U.S pharma application and then reissued the resulting patent with no input from U.S. counsel, but none are mentioned. The Japanese attorneys had failed to file an IDS during prosecution of the ‘440 patent, and then filed for reissue, listing the two references on an IDS, and obtained the ‘314 reissued patent with claims essentially limited to Crestor.

(more…)