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.
Posts Tagged ‘Therasense’
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.
On September 13th, the Fed. Cir. reversed a district court ruling that the inventor and the attorney who prosecuted a chain of applications claimed multi-media entertainment systems had committed inequitable conduct by failing to disclose three “relevant” references at various times. This was a pre-Therasense decision, and the judge had held the IC part of the trial prior to the case-in-chief. Thus, Therasense, “but-for materiality” had not been considered – the district court appears to have used the “reasonable examiner” standard.
The panel distinguished Aventis v. Hospira, 675 F.3d 1324 (Fed. Cir. 2012) as based on an “affirmative conduct by the applicants showing not only specific awareness of materiality [but-for materiality had been established at trial], but careful and selective manipulation of where, when and how much of the most material information to disclose…. Evidence of such selective disclosure is not present here.” Slip op. at 13-14.
On April 9, 2012, The Fed. Cir. affirmed a holding by the district court that rendered two (then) Sanofi add-on patents on infusion vehicles for docetaxel unenforceable due to inequitable conduct. The inventors, particularly inventor/project manager Fabre, were found to have intentionally decided not to submit two material pieces of prior art to the PTO.
“Materiality” was not an issue on appeal, since the district court had invalidated the patents using the disclosures of the uncited references. Since the references were material under the “clear and convincing standard”, they had to be material under the PTO’s lower ”preponderance of the evidence” standard.
The section on intent is more interesting. The references were not “knock-out” s. 102(b) disclosures of the invention, but rather were used to support invalidation based on s. 103. This left the contemporary relevance of the reference open to some debate, and both the district court and the Fed. Cir. relied heavily on the testimony of inventor Fabre who, unfortunately, testified in detail about his reasons for not submitting the references.