deceptive intent Archives

I Hear Ya – No Intent to Deceive, No Inequitable Conduct

The US Court of Appeals for the Federal Circuit affirmed a district court’s finding that the asserted patents were not unenforceable for inequitable conduct, determining that statements made by counsel to the US Patent & Trademark Office (PTO) to revive an abandoned application were not shown to have been made with deceptive intent. Freshub, Inc. v. Amazon.com, Inc., Case No. 2022-1391 (Fed. Cir. Feb. 26, 2024) (Reyna, Taranto, Chen, JJ.)

Freshub sued Amazon for infringement of patents directed to voice processing technology. Amazon denied infringement and defended on the basis that the patents should be declared unenforceable based on inequitable conduct by Freshub’s parent company, Ikan Holdings, during prosecution of the application at the PTO. Amazon alleged that Ikan improperly revived an earlier-abandoned parent application from which the asserted patents descend.

The predicate facts are as follows: In June 2011, the PTO issued a final office action rejecting the claims of the parent application. Ikan failed to respond to the office action, rendering the application abandoned in January 2012. In January 2017, Ikan petitioned the PTO to revive the application. In support of its revival petition, Ikan’s counsel asserted that “[t]he entire [five-year] delay in filing the required reply . . . was unintentional.” “[R]elying on petitioner’s duty of candor and good faith,” the PTO granted the petition, eventually resulting in issuance of the three patents-in-suit.

At trial, a jury found that Amazon did not infringe the asserted patents. The district court subsequently conducted a bench trial on inequitable conduct and found that Amazon had failed to prove inequitable conduct by clear and convincing evidence. Freshub appealed, arguing that it was entitled to judgment as a matter of law that Amazon infringed. Amazon cross-appealed, seeking reversal of the district court’s inequitable conduct ruling.

The Federal Circuit affirmed the district court’s determination of failure to prove inequitable conduct, finding that Amazon had not shown by clear and convincing evidence that Ikan misrepresented or omitted material information with the specific intent to deceive the PTO. The Court focused its analysis on deceptive intent, finding that the district court did not commit clear error in rejecting Amazon’s inequitable conduct defense.

The Federal Circuit noted that the record was minimal due to the passage of time and the limited testimonial and documentary evidence available, as well as the many unchallenged claims of attorney-client privilege. Nevertheless, both parties presented evidence concerning Ikan’s intent between 2012 and 2017.

To support its position, Freshub relied on the 2017 statement by Ikan’s counsel asserting that Ikan’s delay in filing its reply to the PTO’s final office action was unintentional. The Federal Circuit found this evidence probative, even without the presentation of additional evidence to further explain why the period of non-response was so long. On the other hand, Amazon presented specific evidence that it contended demonstrated deceptive intent. For example:

The 2017 statement to revive the parent application was made by the same counsel that prosecuted the application at the time of its 2012 abandonment.
Ikan’s counsel [...]

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

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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I Hear Ya – No Intent to Deceive, No Inequitable Conduct

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

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