Posts Tagged ‘Therasense’

Apotex Petitions Supreme Court to Review Therasense Standards

Thursday, May 21st, 2015

Magnesium SaltIn Apotex, Inc. v. UCB, Inc., Appeal No. 2013-1674 (Fed. Cir. August 15, 2014) the court affirmed the district court’s ruling that one actor, Dr. Sherman, the chairman of Apotex had committed inequitable conduct by engaging in what the court found was a perfect storm of misrepresentations during the prosecution of U.S. Pat. No. 6,767,566 that claimed a method to make the magnesium (Mg) salt of Moexipril. The Fed. Cir. found that Dr. Sherman, the named inventor on the application withheld prior art, mischaracterized the cited art in arguments and via a Rule 132 Declaration, and included examples in the application that had not been performed. In fact, this was characterized as an attempt to patent a competitor’s drug.  The  competitor, UCB, had listed in the Orange Book, as the hydrochloride salt – although the court found that Dr. Sherman was aware that the process disclosed in the listed patent, U.S Patent No. 4,743,450, would yield the Mg salt of Moexipril, which imparted substantial stability. The Fed. Cir. agreed with Apotex that Dr. Sherman had no duty to disclose his own suspicions or beliefs regarding the prior art (that he suspected that the ‘450 process would in fact yield the stable Mg salt) but rested its holding on its opinion that Dr. Sherman “affirmatively and knowingly misrepresented material facts regarding the prior art.” Slip op. at 15.

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Takeaways from Seattle Summer 2014 Seminars

Monday, August 25th, 2014

A guest post by Donald Chisum and Janice Mueller.

In August 2014 the Chisum Patent Academy held two back-to-back seminars in its Seattle, Washington facility to discuss and debate current developments in patent law. Each roundtable seminar group was limited to ten persons; sessions were led by treatise authors and educators Donald Chisum and Janice Mueller.

Attendees included experienced patent litigators and prosecutors from law firms and corporations in the U.S., Canada, Germany, and India. Each seminar met for three days. Seattle’s great summer weather, coffee, and lively discussion were enjoyed by all.

Here’s a recap of the takeaways from the seminars:

2014 Supreme Court Decisions: Moderation? The year 2014 was an undoubtedly high water mark in terms of the number of pertinent SCOTUS patent law decisions–six directly on patent law issues plus a copyright case (Petrella) that could alter the laches defense for patent infringement claims. Commentary and initial responses, including those by the PTO, suggest that the cases represent a significant move toward constricting the availability of patent rights. Yet, in-depth discussions of the cases during our seminars detected a tone of moderation. For example, Alice has been read as broadly precluding patents on “software.” However, language in Alice strongly suggests that claims to technical advances, even broad claims that involve computer implementation, remain patent eligible. Unfortunately for patent applicants and owners, it will take time and resources to establish such eligibility through appeals from PTO rejections and summary district court invalidations.

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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).

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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.]

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