PharmaPatents Timely Insight on Emerging Legal Developments

Category Archives: Inequitable Conduct

Federal Circuit Finds Inequitable Conduct In False Rule 131 Declaration

Posted in Federal Circuit Decisions; Inequitable Conduct

In Intellect Wireless, Inc. v. HTC Corp., the Federal Circuit affirmed the district court decision holding Intellect’s patents unenforceable due to inequitable conduct. This is a rare case where the applicant was found to have submitted a false declaration, and did not cure that misrepresentation. Continue reading this entry

Federal Circuit Invalidates Prandin Patent Claim As Obvious

Posted in 103; Federal Circuit Decisions; Inequitable Conduct

In its third look at the Novo Nordisk A/S patent related to Prandin®, in Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories Ltd., the Federal Circuit affirmed the district court’s finding that claim 4 of U.S. Patent No. 6,677,358 is invalid as obvious, but reversed the district court’s finding that the patent is unenforceable due to inequitable conduct. This decision illustrates both the difficulty of sustaining a patent based on unexpected results and the difficulty of invalidating a patent based on inequitable conduct.Continue reading this entry

Federal Circuit Requires Specific Intent To Deceive For Inequitable Conduct

Posted in Federal Circuit Decisions; Inequitable Conduct

In 1st Media, LLC v. Electronic Arts, Inc., the Federal Circuit reversed the district court’s finding that the patent at issue was unenforceable due to inequitable conduct, “[because the record contains no evidence of a deliberate decision to withhold [the] references from the PTO as required under Therasense.” This case may be welcomed by patent practitioners and applicants burdened by the specter of inequitable conduct charges, but reminds me that the USPTO still has not revised its Duty of Disclosure rule (36 CFR § 1.56) or guidance in view of the year-old Therasense decision.Continue reading this entry

Federal Circuit Affirms Unenforceability of Taxotere Patents

Posted in Federal Circuit Decisions; Inequitable Conduct

In Aventis Pharma S.A. v. Hospira, Inc., the Federal Circuit upheld the district court’s finding that two of the Orange Book listed patents for Sanofi Aventis’ cancer drug Taxotere are unenforceable for inequitable conduct.  The Federal Circuit found that the district court’s analysis followed the framework required by its 2011 en banc decision in Therasense, even though the district court rendered its decision before that case was decided en banc.Continue reading this entry

Supplemental Examination: Airing Your Dirty Laundry?

Posted in Inequitable Conduct; Patent Reform; USPTO Proposed Rule Changes

As I was reviewing the USPTO’s  proposed rules to implement the Supplemental Examination provisions of the America Invents Act, one issue that crossed my mind is the problems that could arise if a patent holder’s initial Request for Supplemental Examination is not granted. In this article, I discuss that potential problem and some possible solutions.Continue reading this entry

USPTO Will Issue Guidance On Therasense

Posted in Inequitable Conduct; Patent Office Practice

On the heels of the Federal Circuit’s en banc decision in Therasense, the USPTO has announced that it will be issuing guidance “related to the prior art and information [applicants] must disclose to the Office in view of Therasense.”

According to the USPTO’s press release:

We are now studying the potential impact of Therasense . . . on Office practice, and we expect to soon issue guidance to applicants regarding the materials they must submit to the Office under their duty of disclosure.

As I noted in my case summary, the Therasense decision expressly rejected the “materiality” standard set forth in USPTO Rule 56 (37 CFR § 1.56). Thus, the USPTO may revoke or revise this rule, although new provisions might be promulgated through the notice and comment process.  Several provisions of MPEP Chapter 2000 are based on Rule 56, and may be revised as well.

It will be interesting to see whether the USPTO conforms its rules and guidance to the court’s decision, or tries to maintain a higher duty of disclosure.

Therasense Decision “Tightens” Inequitable Conduct Standard

Posted in Federal Circuit Decisions; Inequitable Conduct

On May 25, 2011, the Federal Circuit issued its long-awaited en banc decision in Therasense, Inc. v. Becton, Dickinson & Co. After a panel affirmed the district court’s finding of inequitable conduct, the court agreed to rehear the appeal en banc in order to revisit the law of inequitable conduct. The court’s decision “tightens the standards” for proving inequitable conduct, holding that evidence of “intent” must be considered independently from materiality, and that materiality generally must be proven by a “but-for” test, except in cases of “affirmative egregious misconduct.”

Continue reading this entry

Will The Federal Circuit’s Therasense Decision Solve The McKesson Problem?

Posted in Duty of Disclosure; Federal Circuit Decisions; Inequitable Conduct

This week the Federal Circuit heard oral arguments in its en banc rehearing of Therasense, Inc. v. Becton, Dickinson & Co. As reflected in the en banc order, the court took this case en banc in order to reconsider—and hopefully reform—the law of inequitable conduct. The court’s decision could solve the McKesson problem and rein in the threat of inequitable conduct charges that drives practitioners to submit references even when they are not believed to be relevant to patentability. 
 

Continue reading this entry

Time to Run Background Checks?

Posted in Federal Circuit Decisions; Inequitable Conduct

Two recent decisions from the Federal Circuit warn that misstatements in the background section of a patent application can constitute "misrepresentations of material fact" that can support a finding of inequitable conduct. These cases may have practitioners reviewing the background sections of pending applications and reconsidering the type of information included in the background sections of future applications.

Continue reading this entry