inequitable conduct Archives

Burdens Can’t Be Avoided No Matter How They’re Dressed Up

By Mike Baldwin on Jan 5, 2023
Posted In Patents

Addressing a multitude of issues, the US Court of Appeals for the Federal Circuit affirmed the district court’s ruling dismissing infringement of one patent and finding a trade dress invalid but reversed the invalidation of the other patent and vacated dismissal of an inequitable conduct defense. Mosaic Brands, Inc. v. Ridge Wallet LLC, Case Nos. 22-1001, -1002 (Fed. Cir. Dec. 20, 2022) (Newman, Prost, Stark, JJ.)

Mosaic Brands sued Ridge Wallet alleging infringement of a patent relating to a combination money clip and card holder adapted to retain paper currency and to removably store flexible cards such as credit cards, as well as Mosaic’s associated trade dress. Ridge denied the allegations and counterclaimed that Mosaic infringed a Ridge patent directed to a nearly identical wallet. In response to the counterclaim, Mosaic raised inequitable conduct as an affirmative defense.

During claim construction, the district court construed the terms “lip” and “varying thickness” in Mosaic’s patent. Following claim construction, the parties stipulated to noninfringement of Mosaic’s patent. The district court also found the trade dress of Mosaic’s wallet to be functional and thus invalid. As to Ridge’s patent, the district court granted summary judgment of invalidity based on a prior art product sold by Mosaic, and further denied summary judgment that Ridge had obtained its patent through inequitable conduct. Mosaic filed a motion for reconsideration regarding the inequitable conduct defense and to clarify remaining merits issues. The district court exercised its discretion to address the defense and identify deficiencies. The district court noted that Mosaic had only met a portion of its burden and later proceedings would present an opportunity to present more evidence of inequitable conduct. Both parties appealed.

The Federal Circuit first addressed a potential issue of appellate jurisdiction since the assertion of inequitable conduct was an affirmative defense and not a counterclaim yielding a final judgment to review. The Court found it had jurisdiction because the inequitable conduct defense merged and became final when the judgment denying summary judgment for inequitable conduct was entered.

Turning to the merits, the Federal Circuit addressed the two claim terms appealed by Mosaic. Mosaic argued that the district court’s interpretation of “lip” was too narrow because it required the lip to be made of “extruded plastic.” The Court quickly dispatched this argument by citing the specification of Mosaic’s patent, which described the lip as being made of extrudable plastic and extolled the benefits of such material. The Court focused on the context of how the patent used the phrase “the present invention” and found it to be limiting. As to the other claim term (“varying thickness”), Mosaic advocated for a plain and ordinary meaning of the term. The Court rejected Mosaic’s argument, finding that Mosaic failed to provide intrinsic evidence or meaningful explanation of how the district court’s construction differed from the plain and ordinary meaning. As such, the Court found that the district court made no error in either construction.

Turning to the appeal of Ridge’s patent, the Federal Circuit found that [...]

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Material Information Submitted to FDA but Withheld from PTO Gives Rise to Inequitable Conduct

By Paul Devinsky on Sep 16, 2021
Posted In Patents

The US Court of Appeals for the Federal Circuit found prior art submitted to the US Food and Drug Administration (FDA), yet withheld from the US Patent & Trademark Office (PTO) during prosecution of an asserted patent, sufficient evidence for a finding of inequitable conduct. Belcher Pharmaceuticals, LLC v. Hospira, Inc., Case No. 20-1799 (Fed. Cir. Sept. 1, 2021) (Reyna, J.)

The patent in issue relates to injectable formulations of l-epinephrine. Epinephrine is a hormone that has been on the market since approximately 1938 and is used for a variety of medical purposes. It is also known that l-epinephrine degrades into a more potent isomer known as d-epinephrine. L-epinephrine also degrades into an impurity known as adrenalone through a process called oxidation.

In 2012, Belcher first submitted a New Drug Application (NDA) for a 1 mg/mL injectable l-epinephrine formulation. The NDA was literature-based, meaning that Belcher did not perform any clinical or non-clinical studies on its epinephrine formulation to support its application. Among the materials submitted to the FDA was an article by Stepensky et al to support its statement that “racemization of the enantiomerically pure L-Epinephrine isomer in injectable formulations of epinephrine is a well-known process.” It also submitted data from Swiss pharmaceutical company Sintetica SA’s formulation that had a pH range of 3.1 – 3.3 and undetectable levels of adrenalone. Ultimately, Belcher pursued a formulation with a similar pH range of 2.8 – 3.3.

In 2014, Belcher filed a patent application that was ultimately issued as the asserted patent. The patent taught that increasing the in-process pH to 2.8 – 3.3 unexpectedly reduced the racemization of l-epinephrine to d-epinephrine at release by approximately two thirds. The asserted claims covered pharmaceutical epinephrine formulations having a pH between 2.8 – 3.3 and certain concentrations of l-epinephrine, d-epinephrine and adrenalone at the time of release and 12 months later.

The prosecution of the application involved a single office action in which the pending claims were rejected in view of Helenek. The examiner explained that Helenek taught 1 mg/ml of epinephrine injection that, among other things, had a pH range of 2.2 – 5.0. Belcher overcame this rejection by arguing that Helenek did not render obvious the claimed range of 2.8 – 3.3 because the claimed range was unexpectedly found to be critical to reduce racemization of l-epinephrine.

Hospiria also submitted an NDA seeking approval of an injectable l-epinephrine formulation, which included a certification under 21 U.S.C. § 355(b)(2)(A)(iv)(Paragraph IV) that the asserted patent’s claims were invalid, unenforceable and/or not infringed by Hospira’s NDA product. Belcher subsequently sued Hospira for patent infringement.

During trial, Darren Rubin, Belcher’s Chief Science Officer, testified that in his role at Belcher, he was involved in the drafting and development of the NDA and in the prosecution of the asserted patent—including drafting the claims and specification and responding to the examiner’s office action. Darren admitted he knew of Stepensky before the application was filed and that he possessed a label for a 1 mg/mL epinephrine product marked [...]

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Choosing Advocacy over Candor Renders Patent Unenforceable

By Paul Devinsky on Mar 19, 2020
Posted In Patents

The US Court of Appeals for the Federal Circuit upheld the district court’s finding that the patents-in-suit were unenforceable due to inequitable conduct because of a failure to disclose information related to an offer for sale of the claimed invention made more than one year prior to the critical date. GS Cleantech Corp v Adkins Energy LLC, Case Nos. 16-2231, 17-1838; GS Cleantech Corp. et al. v. Big River Resources Galva, LLC et al., Case No. 17-1832 (Fed Cir. March 2, 2020) (Wallach, J.)

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