- Sanofi expects an appeals court ruling on an injunction against sales of its PCSK9 inhibitor Praluent (alirocumab) could come as soon as June, lawyers representing the French drugmaker said on a media call Friday.
- Earlier this week, Sanofi and its partner Regeneron won a temporary suspension of the ban pending a decision on the appeal, allowing Praluent to remain on the market for now.
- Sanofi's lawyers expressed optimism that a reversal of the original district court ruling can be obtained, pointing to the public health implications of taking patients off Praluent and leaving Amgen's rival drug as the only PCSK9 option on the market.
The original ruling banning sales of Praluent, which was handed down by Judge Sue Robinson of the U.S. District Court for the District of Delaware, surprised many in the industry. Patent litigation is common between drugmakers, but typically results in one company settling or paying royalties to the other.
A recent patent dispute between Merck and Gilead over an important compound, for example, resulted in a judge ordering Gilead pay $2.5 billion to Merck.
In the case between Amgen and the Sanofi/Regeneron team, however, Judge Robinson found Amgen suffered irreparable reputational harm and deemed monetary damages insufficient.
Sanofi and Regeneron appealed that ruling, bumping the case to the U.S. Court of Appeals for the Federal Circuit. Opening briefs from the Sanofi/Regeneron team are due by Feb. 17 and Sanofi's lawyers expect an oral hearing sometime in the spring and early summer.
From there, a ruling on the appeal could come anywhere between June and December, the lawyers said.
Broadly speaking, there are three basic options the appeals court could take:
- Reverse the lower court ruling — Sanofi and Regeneron win, the injunction is lifted and Amgen's patent is invalidated.
- Affirm the lower court ruling — Amgen wins and the injunction is either reimposed or the court rules on damages. In this event, Sanofi and Regeneron are likely to appeal for either an en banc hearing at the appeals court or move to the Supreme Court.
- Vacate lower court decision and remand the case to a new trial — Injunction is lifted but Amgen's patent remains valid. Amgen could again request an injunction in the new trial.
In Sanofi's eyes, the potential impact on patients of an injunction against Praluent should help its case moving forward.
"We think that that factor is a very important factor in the analysis of any injunction decision and we think it is going to heavily weigh in our favor throughout these proceedings," said John Conway, global head of intellectual property at Sanofi.
Conway also pointed to Judge Robinson's original ruling, which found the public interest factor to favor Sanofi and Regeneron. (Robinson found the three other factors to weigh in favor of Amgen.)
Praluent is currently available in a lower 75 mg dose, which Sanofi claims physicians favor as a starting point for patients trying to lowering LDL cholesterol. Repatha, on the other hand, is only available in a 140 mg or 420 mg dose.
Payers have balked at the price tag for both drugs as they wait for outcomes data showing the drug's effect on reducing the risk of cardiovascular events.
That data could soon be inbound: Amgen recently reported positive top line results from its FOURIER trial and Sanofi expects to read out its ODYSSEY trial this year. While sales have been slow, strong data from either trial could help propel the drug class.