Yesterday, a federal district judge made an important ruling in the ongoing patent dispute between Amgen’s cholesterol-lowering drug Repatha and Sanofi and Regeneron’s drug, Praluent. Early in 2016, Amgen’s patents covering the products had been found both valid and infringed, and now Judge Sue Robinson has granted Amgen’s request for an injunction against Sanofi and Regeneron, blocking the two companies from selling Praluent. (The injunction takes effect in 30 days, giving the companies time to appeal.)
This is very strange. Let’s be clear: Judge Robinson looked at a situation involving two competing, chemically distinct (though similar) drugs for the same condition and opted to kick one of them off the market, putting Amgen in a monopoly position and taking some number of patients off of the drug they’ve been taking. As far as Pharma Policy Twitter (h/t Forbes’ always-excellent Matthew Herper) can tell, an injunction of this type happens about once a decade – in 2008 with Amgen and Hoffman-LaRoche regarding an EPO product, and in 1996 with Novo Nordisk and Genentech over hGH products. (Please send along other examples, if you have them!)
A number of commentators have already weighed in on Judge Robinson’s order, with Professor Jake Sherkow providing a particularly thoughtful tweetstorm on the subject. I largely agree with Professor Sherkow’s analysis, but I want to emphasize two aspects of the case that have not yet received sufficient attention: the first is the decision to ask for the injunction, and the second is the practical effect the injunction will have on patients, on the market, and on the gathering of information about PCSK9 products going forward.
First, it wasn’t obvious that Amgen would even ask for Sanofi/Regeneron’s product to be taken off the market in the first place. They did not have to ask for an injunction and could have instead asked only for damages. This isn’t mere supposition – it’s exactly what Merck did in its patent infringement lawsuit against Gilead regarding their blockbuster Hepatitis C drugs. Just weeks ago, Merck won a $2.5 billion verdict against Gilead, and it did so without asking for an injunction. (I will note that Professor Sherkow and I discussed this exact Merck/Amgen question on Twitter more than 8 months ago, because we’re very cool and interesting.)
Asking for both an injunction and damages in patent cases between competitors is a common practice. An injunction, if granted, puts the patentholder in a much stronger bargaining position than the grant of court-determined damages. When a court grants an injunction, it doesn’t have to mean that the losing party won’t be able to sell its product – it just means that the patentholder can demand a larger amount of money in exchange for that ability. The parties will bargain against the backdrop of the legal rules. (Importantly, this could still happen here – the parties could settle. However, the fact that the case has made it as far as it has makes this a less likely possibility.)
But asking for an injunction in a case like this, where it means taking an already approved, available product off the market, is a different animal. Merck might well have faced a large public outcry if it attempted to take Gilead’s Sovaldi, a stunningly effective cure for Hepatitis C, off the market. And so even though Idenix, from whom Merck acquired its Hepatitis C drug, had asked for both an injunction and damages when it initially brought the lawsuit, the request for an injunction was dropped along the way.
Second, assuming that the injunction goes into effect, we should look for its impact on a number of factors, most notably including 1) patient care, 2) the price of/money spent on Amgen’s product, and 3) the continued development of evidence around the PCSK9 drugs. In terms of patient care, a number of patients currently on Praluent would have to switch to Repatha. At least some patients will undoubtedly go without the drug during a transition period. For patients whose insurers chose to cover Praluent over Repatha (relying on competition between the two products to extract discounts from the companies), their insurers will at the very least need to negotiate agreements to purchase Repatha.
Relatedly, we might well see either the list price of Amgen’s drug or at the very least the amount of money paid per dose of Repatha to go up. Amgen may recognize that raising its list price in the wake of an injunction against its only competitor isn’t a good PR move, especially in this drug pricing climate, but at the same time they will surely be able to command a higher reimbursement rate for the drug, as they no longer have to provide larger discounts to compete for formulary access with Praluent. Relatedly, patients may see their out-of-pocket costs go up.
Finally, it’s important to remember that both PCSK9 drugs were approved on the basis of a surrogate endpoint – their ability to lower LDL cholesterol – and not their ability to actually do things like reduce the rate of cardiovascular events among the treated population. But both drugs were approved on the condition that their sponsors continue studying those true endpoints, and the removal of Praluent from the market would disrupt not only that process of gathering information about the PCSK9 drugs, but would also disrupt the outcomes-based contracts Sanofi and Regeneron have signed with insurers like Cigna.
It’s very possible the Federal Circuit will reverse the grant of an injunction and remand for determination of damages. If not, we ought to be concerned about the precedent this case sets not only for other cases going forward, but also for patient care, market dynamics, and continued development of evidence about drugs.