If they ever get around to making movies about drug discovery and development, perhaps someone will take on PCSK9. It has a neat origin in mutated humans, a race to the clinic, big money and big hopes, dramatic uncertainty (will it actually give better cardiovascular outcomes? Stay tuned!), and now it has courtroom scenes, too.
That’s because a couple of years ago, Amgen tried enforcing a patent claim to a whole class of PCSK9 antibodies (one particular epitope), which still lands right on top of Regeneron and Sanofi. Last spring, a jury found that the companies had indeed infringed Amgen’s patent, and the judge involved told everyone to come up with some sort of royalty agreement. Sanofi and Regeneron tried to get that verdict overturned, but on Tuesday, the judge denied the motion. Yesterday, the court granted an injunction request by Amgen: Sanofi and Regeneron are now enjoined to stop selling their competing drug (Praluent). That’s a pretty rare event – Matthew Herper at Forbes was asking for examples, and they can be counted on one hand. Needless to say, an appeal is being filed with what I can imagine is great speed and vigor – the injunction itself does not take effect for 30 days, to allow for this filing to take place. Whether or not it stays in force during the appeals process, I don’t know enough law to say.
There are several issues to argue here. The big one is, of course, whether Amgen’s patent claim really does hold up. I’m not going to speculate on that, or not yet – case law, as I rather dimly understand it, points both ways on something like this, and I have not studied the jury’s decision in any detail. That was by choice: any big patent case that’s decided by a jury is going to end up in the Court of Appeals for the Federal Circuit anyway – that’s what it’s there for. The question right now is whether or not Praluent is still going to be on the market while that all works itself out.
Here’s a law professor (Jacob Sherkow) who’s puzzled by the injunction (that’s the first of a series of tweets on the subject). The current standard for this sort of thing was set by Ebay v. MercExchange in 2006, a Supreme Court ruling that specifically addresses injunctions in patent disputes. The Ebay case didn’t actually set new standards – it reaffirmed the traditional “four-factor” test that had been applied in such cases, reversing a new CAFC ruling that said that injunctions should actually be granted more broadly in patent infringement cases. Those factors are: (1) that the patent holder has “suffered an irreparable injury”; (2) that the legal remedies available are inadequate to compensate for said injury; (3) that a “remedy in equity” is warranted, when you consider the hardships that both parties could suffer; and (4) that the public interest “would not be disserved” by issuing a permanent injunction. Sherkow believes that these factors are not actually in Amgen’s favor, and that the judge seems to have disregarded the four-factor test to such a degree that this injunction won’t hold up.
We’ll see. One thing’s for sure, though, the one that’s always for sure in these situations: the billable hours will pile up, and the lawyers will do just fine. Amgen’s legal team in particular is probably quite well-compensated; they’ve been very active in court over the years, prompting Matt Herper to term them “a law firm with a biotech company attached”. When it comes to PCSK9, the flasks and pipets have been put aside – it’s a briefcase war now.