Posts Tagged ‘inequitable conduct’

American Calcar v. Amer. Honda Motor Co. – Therasense Goes Out For a Test Drive

Tuesday, September 30th, 2014

On Friday, in American Calcar v. Amer. Honda Motor Co., App. No. 2013-1061 (Fed. Cir., September 26, 2014) a divided Fed. Cir. panel affirmed the district court’s ruling, following remand, that three patents on a multimedia system for vehicle information and control were invalid due to inequitable conduct (IC) by Calcar’s founder, Mr. Obradovich. The patents were all part of one family and the “priority patent” is U.S. Pat. No. 6,009,355. The primary evidence of inequitable conduct was the failure by Obradovich to disclose the owner’s manual of an Acura model that Calcar used as the basis of its specification. (A copy of the decision can be found at the end of this post.)

The Fed. Cir. had reversed the court’s earlier finding of inequitable conduct for a number of reasons, including judicial error in relying on jury findings of IC rather than ruling from the bench on equitable grounds, applying the “reasonable examiner” standard instead of the “but for” Therasense standard to resolve materiality, and use of a “sliding scale” to find intent based on a strong showing of materiality.

(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…)

Supplemental Examination Decision Tree – Lots of Dead Branches?

Tuesday, January 31st, 2012

Well, I wish it were that simple, but I keep trying to conjure examples that would lead me to use supplemental examination to “purge inequitable conduct (IC)” that I discover after my patent issues, and which could provide the basis for a successful IC attack on the patent. (Even the Office doesn’t presume that charges of inequitable conduct will go away post-Therasense.)

Issues of hard-core fraud on the patent office (e.g., faked experimental data in declarations and the like) aside, it would seem that I would first need to become aware of deceptive/evil intent involved with submission or failure to submit an item of information (IOI). If there is not some level of deceptive intent (knowingly withholding an IOI or making an incomplete submission), there will be no finding of IC by the court, even if the IOI (e.g., the publication) is “but for” material.

Now the deciding gets more difficult. If the IOI is “but for” material, you are going to have to narrow the claims. So I see no need to do other than file a narrowing reissue application. Remember, there is no longer a requirement to state that the overly broad claims were obtained “without deceptive intent.” Likewise, if the IOI is “but for” material and there is no evidence of deceptive intent, narrowing reissue is certainly the way to go. An example might be a 102(b) reference that was discovered years after the patent issued.

(more…)