Haug Partners Successfully Defends Takeda’s Vyvanse® Patents Before the Federal Circuit

Today the Federal Circuit affirmed the December 27, 2022 judgement issued by Judge Stanley R. Chesler of the District of New Jersey in favor of Takeda Pharmaceuticals, protecting Takeda’s patented Vyvanse® product from generic competition.  Judge Chesler found that 14 asserted claims from 9 patents covering Vyvanse® are not invalid and infringed by Norwich Pharmaceuticals.  Haug Partners represented Takeda at the 3-day bench trial in November.  Ed Haug, Chairman of Haug Partners, argued the matter before the Federal Circuit yesterday.

Arguing to a Federal Circuit panel comprised of Chief Judge Moore, Judge Mayer, and Judge Hughes, Mr. Haug argued that the trial was a “classic battle of the experts” involving nine experts and that “Norwich lost that battle on each and every expert.”  The panel “d[idn’t] see how the district court clearly erred in finding [Norwich] failed to prove that a skilled artisan would have been motivated to modify d-amphetamine” based on Norwich’s asserted prior art.  Focusing on the district court’s expert credibility determinations, the Court stated that “Dr. Klibanov [Takeda’s expert] offered testimony and the district court expressly found that more credible than [that of Norwich’s expert].”  With respect to another Norwich expert, the Court stated: “He’s not credible.  That’s it.  Done.”  Remarking on the large number of arguments set forth in Norwich’s appeal, the Court explained to Norwich, “at some point … you have to tell your client this is a waste of the Court’s time and a waste of the client’s money.”  The Court also stated that “I think the district court [Judge Chesler] did a great job in this case, it was really difficult and I think what was accomplished was impressive.”

For the entire life of these patents, Haug Partners has successfully defended Takeda’s blockbuster Vyvanse® product against several ANDA filers and has defeated each and every challenge on the merits.  The Vyvanse® patents expired in February 2023, but Takeda maintains pediatric exclusivity through August 2023.  Haug Partners is proud to help Takeda enjoy every day of its earned patent and pediatric exclusivity on this important pharmaceutical product.