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. (3) At that point, Judge Hughes was added to the panel; and (4) Judge Hughes sided with Chief Judge Moore’s position. The modified panel then issued a new opinion with Judge Moore’s prior dissent effectively becoming the majority, and Judge Linn now writing in dissent. What made this more surprising was that the Federal Circuit had not provided any indication of Judge Hughes’ substitution.
Novartis petition for certiorari addresses both the procedural judicial shell game and the substantive written description question. Questions presented:
1. Whether 28 U.S.C. § 46 and principles of sound judicial administration preclude a court of appeals from adding a new judge to form a new panel and redecide a case after an original three-judge panel has already decided the case and entered its judgment.
2. Whether 35 U.S.C. § 112 should be interpreted consistent with its plain text as requiring that a patent specification contain a “written description of the invention” in a form that need only be understandable to “any person skilled in the art,” or whether the court of appeals properly read in a heightened requirement that allows it to deem the specification inadequate on de novo review and displaces the perspective of a person skilled in the art.
Novartis Petition for Cert 2023. The Supreme Court will decide the Amgen enablement case later this term, but recently denied certiorari in the written description case of Juno v. Kite.
My thoughts: I think that Chief Judge Moore probably has the best argument on the merits of the written description question. If you are going to claim some particular element of the invention (and use it to overcome the prior art), that element should be introduced at some level in the original specification. But, written description is a question-of-fact, what that means is that the appellate court cannot simply substitute its decision in place of that of the district court. Rather, the district court’s finding of facts should be affirmed barring some clear error or abuse of discretion. The case is close enough here that I would not find a clear error by the district court judge. The panel switch also smells very bad to me.
Pundits will tell you that the use of top Supreme Court counsel helps get the court’s attention. That bonus is probably mostly because of their skill at framing the case, but their reputation within the Court probably also plays a role. In this case though Novartis appears to go overboard and included a host of top Supreme Court counsel, including Deanne Maynard (MoFo), Willy Jay (Goodwin Procter), and Thomas Hungar (Gibsun Dunn), all of whom have successfully argued numerous cases before the Court.