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What is the status of Amgen’s PCSK9 patent lawsuit against Regeneron?

Zachary Silbersher

Regeneron ($REGN) and Sanofi recently released positive topline results from the ODYSSEY clinical trial for Praluent®.  In addition was the announcement that prices for Praluent® may be cut.  Investors who may have grown skeptical with the new PCSK9-inhibitor class may now be interested again, which may include the pending patent lawsuit between Amgen ($AMGN) and Regeneron.  In March 2016, Amgen prevailed at trial, won an injunction against Regeneron, but then had win subsequently overturned on appeal.  The case is now on remand back to the trial court.  To the extent the recent positive Praluent® data revives interest in the class, what is happening in the case?

The litigation has returned to the district court in Delaware, where a new Judge will preside over the case.  The Honorable Sue L. Robinson originally presided over the case, but has since retired from the bench.  The case will now be presided over by the Honorable Richard G. Andrews.  Because of that, the parties recently filed a joint status report that both provided a history of the case as well as recommendations for how the case should proceed on remand.

As expected, both Amgen and Regeneron disagree over how the case should proceed.  To put it simply, Amgen wants to move fast, whereas Regeneron wants to move slow.  Amgen has proposed a schedule that would bring the case to trial by late May 2018, whereas Regeneron’s schedule indicates trial would not happen until at least 14 months from now.  Regeneron has argued that the original case was litigated under a very aggressive schedule, with modified briefing on scores of important issues, which ultimately led to the patent errors that need to be reversed on appeal.  By contrast, Amgen argues that this is a limited remand, and there’s not much to do other than re-try certain precise issues.  But at the end of the day, Regeneron appears to be playing for time, whereas Amgen is not.

One of the principle issues disputed by the parties is whether Regeneron can collect more discovery on post-priority date PCSK9 antibodies.  The key issue on remand, summarized here, is whether the example antibodies disclosed in Amgen’s patents are representative of the broad genus of antibodies actually covered by the patent’s claims.  If the answer is no, then Regeneron wins.  If the answer is yes, then Amgen does. 

During the original trial, Regeneron wanted to show its own antibody (Praluent®) to the jury in order to show how different it was from the example antibodies disclosed in Amgen’s patents.  But the court barred Regeneron from doing that.  The Federal Circuit subsequently held that decision was error.  On remand, Regeneron will now be allowed to show the jury other PCSK9 antibodies, including Praluent®.  Regeneron therefore wants to collect as much information of these antibodies as possible.  Amgen argues that Regeneron already has all the information it needs.  It claims Regeneron collected substantial information before trial, and it should not be allowed to collect any more.  By contrast, and perhaps more to the point, Regeneron wants evidence on relevant antibodies that has come into existence since the last trial, which occurred in March 2016.  That is not necessarily unreasonable.

At stake for the parties here is time.  If Regeneron is permitted to collect more discovery on post-priority date antibodies, both from Amgen or other third-parties, that will take time.  That means document requests, subpoenas, depositions, updated expert reports, more expert depositions.  That’s months of time.  Amgen argues that Regeneron never appealed any of the prior court’s orders denying it discovery on more post-priority date evidence, and therefore, it should not be allowed to collect it on remand.  That appears to be true.  Yet, the court will also likely be mindful that what is ultimately at stake here for the court is whether to remove a potentially life-saving drug from the market.  Doing so without permitting full discovery on the issue of liability will probably be weighed by the court.

The parties also dispute whether Regeneron should be permitted to move for summary judgment.  Regeneron wants to move for summary judgment, whereas Amgen wishes to skip  it and go straight to trial.  At stake in this dispute is also a matter of time.  Summary judgment briefing, hearing, decision, could easily take six months, if not more.  And if the court denies summary judgment, the parties would still have to go to trial.  Also at stake here is juries versus judges.  Explaining to a jury highly-convoluted concepts about PCSK9 antibodies, and pairing them with cloyingly abstract concepts, such as whether disclosed species are adequately representative of an entire genus, is a challenge.  Yet, Amgen did it before in this case, and is likely confident that it can do it again.  Also, the side that gets to stand up and say, “we got a patent on this!” usually has a leg up at any jury trial.  Regeneron, by contrast, likely rightly believes that it has better chances of convincing the judge that this is a concrete, straightforward question of law that should be decided in its favor on summary judgment.

Amgen has pointed to one interesting tidbit that suggests that, even though it lost on appeal, it may still win this case.  In the original case, Regeneron was prevented from showing post-priority date PCSK9 antibodies to the jury.  But Amgen reminds the court that Amgen was also prevented from showing the jury that type of evidence.  In other words, Amgen has its own post-priority date evidence to could water down Regeneron’s.

Finally, damages remains in dispute.  There remains the possibility that Amgen prevails on liability, but cannot convince the court to grant an injunction that removes Praluent® from the market.  In that case, Amgen will get a royalty on Praluent®’s sales.  If that royalty is high enough, it could be material.  One factor that will make it higher is whether Regeneron is proven to be a “willful” infringer, in which case the royalty will be enhanced – and potentially a tripled. 

At the first trial, the court found that Regeneron was not a willful infringer.  But that decision was based on old law.  Since then, the law has changed, and it has relaxed.  Proving willfulness under the old Seagate standard was a high bar that was rarely met.  Under the new Halo standard, willfulness is more easily proven.  Amgen argues that, in light of this change in the law, it should be permitted another shot to show Regeneron is a willful infringer.  On the other hand, Halo issued in June 2016, long before the appeal in this case.  Thus, Regeneron argues that Amgen had the opportunity to appeal the court’s prior finding of no willfulness, but did not do so.  And thus, that finding is now locked in, and Amgen doesn’t get another shot. 

The court will likely hold a conference in the near-term and/or issue a decision on these disputes, and set the schedule.  That schedule will be the first insight into how the new Judge views this case.