September 7, 2021 - Last Week in the Federal Circuit

Last Week in the Federal Circuit (August 30-September 3): Candor at the Patent Office

The Federal Circuit returned to a full week of in-person arguments last week.  But that didn’t keep it from issuing a range of decisions in patent and non-patent cases.  Below we provide our usual weekly statistics and our case of the week—our highly subjective selection based on whatever case piqued our interest.

Precedential opinions:  8

Non-precedential opinions:  5

Rule 36:  10

Longest pending case from argument:  Lubby Holdings LLC v. Chung, No. 19-2286 (484 days)

Shortest pending case from argument (non-Rule 36):  Bristol-Myers Squibb Company v. Sigmapharm Laboratories, No. 20-2229 (1 day)

Case of the week: Belcher Pharmaceuticals, LLC v. Hospira, Inc., No. 20-1799

Panel: Judges Reyna, Taranto, and Stoll, with Judge Reyna writing the opinion

You should read this case if: you have a matter involving allegations of inequitable conduct before the U.S. Patent & Trademark Office

This week’s case addresses a district court’s finding of inequitable conduct. Belcher submitted a New Drug Application for an injectable epinephrine formulation. In response to feedback from the FDA, Belcher raised the pH range in its manufacturing process to match the range used by another manufacturer for its already-approved epinephrine formulation.

After submitting the drug application, Belcher filed a patent application covering its epinephrine formulation. The patent application explained that raising the processing pH range was “contradictory to one skilled in the art” and produced “unexpected” results. This argument won the day, with the examiner stating that the allegedly critical pH range led to allowance.

Despite the examiner’s statements, Belcher’s Chief Science Officer later admitted that he knew prior art epinephrine formulations had the same pH range. In fact, Belcher’s drug application had referred to this range as “old” and had recognized that the prior art discussed the alleged unexpected result. Yet even though the officer was integrally involved in prosecuting the patent application, Belcher never disclosed this information to the Patent Office. The district court found that withholding this material information while arguing the criticality of the claimed pH range indicated a deceptive intent.

The Federal Circuit affirmed the district court’s finding of inequitable conduct. The Court explained that withholding a material reference with the intent to deceive the Patent Office qualifies as inequitable conduct. Because Belcher did not dispute that its claims would have been obvious based on the withheld prior art, the Court held that the withheld art was “necessarily material to patentability.”

The Court also affirmed the district court’s intent finding. Intent requires that the only reasonable inference that can be drawn is that the applicant (1) knew of the reference, (2) knew of its materiality, and (3) made a deliberate decision to withhold it from the USPTO. The Federal Circuit found no clear error in the district court’s findings on those issues. The district court had found that Belcher’s Chief Science Officer knew about the prior art epinephrine product and relied on this knowledge when dealing with the FDA, but then argued the criticality of the claimed pH range during patent prosecution. Given those findings, the Federal Circuit affirmed the district court’s conclusion that it was implausible the officer believed the undisclosed information to be irrelevant.

 

The Federal Circuit returned to a full week of in-person arguments last week.  But that didn’t keep it from issuing a range of decisions in patent and non-patent cases.  Below we provide our usual weekly statistics and our case of the week—our highly subjective selection based on whatever case piqued our interest.

 

Precedential opinions:  8

 

Non-precedential opinions:  5

 

Rule 36:  10

 

Longest pending case from argument:  Lubby Holdings LLC v. Chung, No. 19-2286 (484 days)

 

Shortest pending case from argument (non-Rule 36):  Bristol-Myers Squibb Company v. Sigmapharm Laboratories, No. 20-2229 (1 day)

 

 

Case of the week: Belcher Pharmaceuticals, LLC v. Hospira, Inc., No. 20-1799

 

Panel: Judges Reyna, Taranto, and Stoll, with Judge Reyna writing the opinion

 

You should read this case if: you have a matter involving allegations of inequitable conduct before the U.S. Patent & Trademark Office.

 

This week’s case addresses a district court’s finding of inequitable conduct. Belcher submitted a New Drug Application for an injectable epinephrine formulation. In response to feedback from the FDA, Belcher raised the pH range in its manufacturing process to match the range used by another manufacturer for its already-approved epinephrine formulation.

 

After submitting the drug application, Belcher filed a patent application covering its epinephrine formulation. The patent application explained that raising the processing pH range was “contradictory to one skilled in the art” and produced “unexpected” results. This argument won the day, with the examiner stating that the allegedly critical pH range led to allowance.

 

Despite the examiner’s statements, Belcher’s Chief Science Officer later admitted that he knew prior art epinephrine formulations had the same pH range. In fact, Belcher’s drug application had referred to this range as “old” and had recognized that the prior art discussed the alleged unexpected result. Yet even though the officer was integrally involved in prosecuting the patent application, Belcher never disclosed this information to the Patent Office. The district court found that withholding this material information while arguing the criticality of the claimed pH range indicated a deceptive intent.

 

The Federal Circuit affirmed the district court’s finding of inequitable conduct. The Court explained that withholding a material reference with the intent to deceive the Patent Office qualifies as inequitable conduct. Belcher did not challenge the district court’s finding that it withheld prior art that was “material to patentability.”

 

The Court thus focused on the intent requirement. Intent requires that the only reasonable inference that can be drawn is that the applicant (1) knew of the reference, (2) knew of its materiality, and (3) made a deliberate decision to withhold it from the USPTO. The Federal Circuit found no clear error in the district court’s findings on those issues. The district court had found that Belcher’s Chief Science Officer knew about the prior art epinephrine product and relied on this knowledge when dealing with the FDA, but then argued the criticality of the claimed pH range during patent prosecution. Given those findings, the Federal Circuit affirmed the district court’s conclusion that it was implausible the officer believed the undisclosed information to be irrelevant.