Epinephrine – USA

Epinephrine – USA

On Feb. 03, 2022, Delaware Court found the patent infringement case exceptional and awarded attorney fees to Hospira.


This case was related to Belcher Pharmaceuticals Epinephrine product covered by US 9,283,197 patent (expiring on Aug. 15, 2034). In Mar. 2020, District court found patent unenforceable under inequitable conduct and Federal Circuit affirmed in Sep. 2021. You can find both the summaries here and here on this blog.


Now, Defendant Hospira moved for a determination that this case is exceptional and for attorneys’ fees and related costs under 35 U.S.C. § 285. Court ultimately found that the case is exceptional based on 3 things: inequitable conduct, weak litigating position and unreasonable litigation conduct.


With respect to ‘inequitable conduct’, Court said that the finding certainly makes this case stand out from all the other cases. Belcher’s CSO admitted that he withheld information from Belcher’s patent attorney and from the PTO. That withheld information included three prior art references, some of which were but-for material to patentability. And he withheld that information from the PTO even though he knew that Belcher had disclosed some of that same information to the FDA. Court said that it doesn’t automatically … follow from a finding of inequitable conduct
that a case is exceptional and that fees should be awarded, but here it very much does follow, and it is not the only thing that makes this case exceptional.


With respect to ‘weak litigation position’, Court agreed with Hospira that Belcher’ s infringement case was exceptionally weak. The asserted claims here required a concentration of L-epinephrine of 1.0 to 1.06 milligrams per milliliter, but Hospira’s NDA product has a concentration that is quite less. Moreover, early on in the case, Hospira moved for Rule 11 sanctions, arguing that Belcher’ s infringement case was frivolous because of the tremendous difference between the claimed concentration and the concentration in Hospira’ s product. Court denied the motion at that time. But the case actually ended up where Hospira had warned it might end up. Court said that that’s not the sole basis for the exceptionality finding, but it certainly is strong support.


With respect to ‘unreasonable litigation tactics’, Court said that during the supplemental Markman proceedings, Belcher proposed a claim construction for the pH term that directly contradicted the construction it was proposing in parallel proceedings before another District Court. Moreover, before trial, Belcher stipulated that certain products were prior art. But after trial, Belcher attempted to escape from its stipulations without offering any good reason why it should be permitted to do so.


Court said that the inequitable conduct is far and away the most important [of the three reasons] . . . this case stand[s] out … but the other reasons are also the extraordinary weakness of Belcher’s infringement case and that they were on notice of that weakness from very early on in the case, as well as the unreasonable litigation tactics. For all those reasons, Hospira has more than met its burden of proving by a preponderance of the evidence that this case is exceptional. Court thus awarded attorney fees but declined to award expert fees and appeal fees. Court said that there has been no finding, not even any allegation…of fraud on the Court. It’s not as if the plaintiff brought in an expert to waste time at trial and try to deceive the Court by…lying to the Court. With respect to appeal fees, Court said that as an initial matter, the appeal itself was not exceptional. Plaintiff was well within its rights to appeal and actually narrowed that appeal to only challenging the inequitable conduct finding. There was nothing frivolous or vexatious or even unreasonable about those decisions by the plaintiff.


Leave a Reply

Leave a Reply

Your email address will not be published. Required fields are marked *

All content provided on this blog is for informational purposes only. By using the blog, you agree that the information on this blog does not constitute legal or other professional advice on author's or on his company's behalf.

Copyrights 2023 Pharma IP Circle. All Rights Reserved