Supreme Court asked to Review Federal Circuit’s Judicial Shell Game

by Dennis Crouch

Novartis Pharms v. HEC Pharm (Supreme Court 2023)

Some drug treatments perform better if the patient starts with a loading dosage before shifting to the regular daily amount. But, loading dosages can be risky because of the high dosage and because of the greater likelihood of mistakes.  Novartis was able to configure a multiple sclerosis treatment plan without the loading dosage.  Its claims require the administration of fingolimod “at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.” US Patent No. 9,187,405. The problem for Novartis is that its original priority application filings did not say anything positive or negative about a loading dosage, and the court eventually rejected the priority claims and thus invalidated the patent claims.

Novartis almost walked away a winner.  In the ANDA litigation, Judge Jordan (D.Del.) found the claims valid and infringed by HEC. On appeal Federal Circuit Judge O’Malley penned the majority opinion affirming the Novartis win. Judge Linn sided with O’Malley, with Chief Judge Moore in dissent.

But then an odd sequence of events occurred: (1) in February 2022, HEC filed a petition for panel rehearing; (2) but before the panel could rule on the motion, Judge O’Malley retired. 

Continue reading Supreme Court asked to Review Federal Circuit’s Judicial Shell Game at Patently-O.