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Interference Decision Finding Patent Specifications To Have Presented “New Evidence” Was Harmless Error

Client Alert | 1 min read | 12.11.07

In In re Garner (No. 2007-1221; Interference No. 105,455; December 5, 2007), the Federal Circuit affirms the decision of the U.S. Patent and Trademark Office Board of Patent Appeals and Interferences (“Board”), ruling against applicant Garner in a patent interference. Garner attempted to provoke an interference by copying claims from a patent issued to Quate and Stern (“Quate patent”). As the Quate patent had an earlier effective filing date than the Garner application, Garner, as the junior party, had the burden of establishing prior invention under 37 C.F.R. § 41.202(d)(1) (“Board Rule 202(d)(1)”). The Board found Garner’s initial filing insufficient to establish a prima facie showing of priority and issued a show-cause order under Board Rule 202(d)(2). In response to the show-cause order, Garner submitted several pieces of evidence, including the specification of his provisional application and the specification of his utility application. The Board rejected Garner’s submission, ruling that he had presented “new evidence” without the necessary showing of good cause.

On appeal, Garner argued that the Federal Circuit must review de novo the Board’s interpretation of its regulations and that the specifications he submitted in response to the show-cause order should not be considered new evidence. The panel rejects Garner’s assertion concerning de novo review, stating that it reviews regulations under a substantial deference standard. Using this standard, the panel determines that Garner’s patent specifications could not constitute new evidence given that they were already in the record pursuant to Board Rule 202(a)(5), and, therefore, the Board’s interpretation of Board Rule 202(d)(2) was erroneous. The panel, however, rules that the Board’s error was harmless, as consideration of Garner’s patent specifications would not have changed the Board’s decision on priority.

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Client Alert | 4 min read | 04.10.25

Hikma and Amici Curiae Ask Supreme Court to Revisit Induced Infringement by Generic “Skinny Labels”

In Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., C.A. No. 20-1630 (D. Del.), brand manufacturer Amarin brought an induced infringement claim against Hikma’s generic icosapent ethyl product, which lists Amarin’s Vascepa® as the reference listed drug. Vascepa was originally approved by the U.S. Food and Drug Administration (“FDA”) to treat severe hypertriglyceridemia, and later, Amarin obtained patents and approval for Vascepa as a treatment to reduce cardiovascular risk in certain patient populations. Hikma’s Abbreviated New Drug Application (“ANDA”) for generic icosapent ethyl included a Section viii statement that Hikma was not seeking approval for the patented cardiovascular indication along with a “skinny label” that included only the indication for severe hypertriglyceridemia....