Pfizer wins patent dispute over Abboject epinephrine shot
Belcher’s chief science officer deceived the US Patent and Trademark Office (USPTO) in order to obtain a patent, the US Court of Appeals for the Federal Circuit has ruled in a win for Pfizer’s subsidiary, Hospira.
The Federal Circuit handed down the decision on Wednesday, September 1,
Belcher accused Hospira of infringing its patent, US number 9,283,197, with its adrenaline shot, Abboject, but the court this week affirmed an earlier ruling that the patent was unenforceable due to “inequitable conduct”.
In June 2019, the US District Court for the District of Delaware concluded that Belcher’s chief science officer, Darren Rubin, withheld material information from the US Patent and Trademark Office with the “requisite deceptive intent”.
On appeal, the Federal Circuit affirmed the district court’s finding that the patent didn’t cover a new invention, and that the USPTO would not have approved the patent in 2014 if Belcher had disclosed all the required information.
The court agreed with the district court’s finding that each of the three pieces of information relating to the prior art that Rubin withheld disclosed two aspects of the asserted claims: the pH range and the impurity levels. Hospira successfully agreed that the disputed prior art was covered by patents owned by JHP, Helenek and Sintetica.
Background
The district court in 2019 also concluded that clear and convincing evidence demonstrated that Rubin acted with requisite intent to deceive the office and that he used “emphatic language” to argue that the claimed pH range covered by the patent was a “critical” innovation.
The district court found implausible Rubin’s testimony that he withheld information regarding the prior art because he believed that they were irrelevant.
The court further found that Rubin’s “repeated efforts to evade questioning and inject attacks on the prior art into his answers raised serious questions as to his credibility”.
The district court concluded that the facts, taken together, persuaded it that Rubin’s deceptive intent was “the only reasonable inference that can be drawn”.
The Federal Circuit further rejected Belcher’s argument that the withheld art, including the JHP product, as immaterial.
Belcher’s counter argument
Belcher argued that while Rubin was acting in a “self-serving manner in order to . . . maintain an existing patent,” that behaviour by itself is not enough to establish that he had a deceptive intent.
According to Belcher, the record provides corroboration that his mental state was a genuine belief about the irrelevance of the references, rather than a desire to deceive the PTO.
The Federal Circuit concluded: “We conclude that the district court did not clearly err in making its factual findings regarding materiality and intent, nor did it abuse its discretion in ultimately deciding that the ’197 patent is unenforceable for inequitable conduct. We have considered Belcher’s remaining arguments and find them unpersuasive.”
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