Pfizer's Hospira escapes adrenaline patent claims based on PTO omissions

(Reuters) - A Pfizer unit's win against Belcher Pharmaceuticals' claims that its adrenaline shot Abboject infringed a Belcher adrenaline patent was upheld by the U.S. Court of Appeals for the Federal Circuit on Wednesday.

Belcher's patent was invalid because the company purposely omitted important information from its application that would have kept the U.S. Patent and Trademark Office from awarding the patent if it had had the information, U.S. Circuit Judge Jimmie Reyna wrote for a unanimous three-judge panel.

Belcher's chief science officer Darren Rubin represented to the PTO that its formulation was a novel invention that was contrary to prior art and solved problems that "seemed impossible," while also telling the U.S. Food and Drug Administration about earlier formulations with similar specifications, Reyna said.

Belcher and its attorney Peter Lancaster of Dorsey & Whitney didn't immediately respond to a request for comment, nor did Pfizer subsidiary Hospira's attorney Matthew Freimuth of Willkie Farr & Gallagher.

Largo, Florida-based Belcher applied for FDA approval of an injectible formulation of adrenaline in 2012, and applied for a patent related to the drug in 2014, which was issued in 2016. The drug has several potential uses, including countering allergic reactions, treating cardiac arrest, and providing relief for asthma and COPD.

Belcher sued Lake Forest, Illinois-based Hospira in 2017, alleging its application for U.S. Food and Drug Administration approval of Abboject infringed Belcher's patent.

After a two-day bench trial, U.S. District Judge Leonard Stark in Delaware ruled last year that the patent was invalid based on inequitable conduct, finding Rubin withheld three pieces of information that would have prevented the U.S. Patent and Trademark Office from awarding the patent.

Belcher argued on appeal that, among other things, the prior art was immaterial, and that Rubin withheld it because he genuinely believed it was irrelevant based on other features of the prior art that differed from Belcher's drug.

Reyna, joined by U.S. Circuit Judges Richard Taranto and Kara Stoll, wrote on Wednesday that the information Rubin withheld was material to the decision to issue the patent and that he intended to mislead the PTO.

The prior art disclosed epinephrine formulations with the same pH range as Belcher's drug that would have made the patent obvious, Reyna said. He also noted that the Delaware court found the relevant parts of the patent invalid based on one of the pieces of prior art, an earlier epinephrine product from another company.

Reyna also said that the "single most reasonable inference" was that Rubin intended to deceive the PTO. He noted Rubin's "about-face" from telling the FDA that the drug's claimed pH range was "old" to telling the PTO that it was a "critical innovation" that yielded "unexpected results," and rejected Belcher's "post hoc rationale" for withholding the information.

The case is Belcher Pharmaceuticals LLC v. Hospira Inc, U.S. Court of Appeals for the Federal Circuit, No. 20-1799.

For Belcher: Peter Lancaster of Dorsey & Whitney

For Hospira: Matthew Freimuth of Willkie Farr & Gallagher

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