Korlym®: Can Corcept defeat Teva’s motion to dismiss?

Zachary Silbersher

Earlier this year, Teva ($TEVA) filed an ANDA to distribute a generic version of Korlym®, and soon thereafter, Corcept Therapeutics ($CORT) commenced a Hatch-Waxman patent suit in federal court in New Jersey.  On June 15, 2018, Teva moved to dismiss the case.  What is this motion all about? And will Teva’s motion prevail?

As we previously discussed here, Corcept originally listed two patents in the Orange Book for Korym®, the ‘348 patent and the ‘495 patent.  Corcept’s lawsuit alleged that Teva’s proposed generic would infringe both the ‘348 and ‘495 patents.  In response, Teva filed a motion to dismiss Corcept’s case.  Teva’s motion essentially argues that Corcept’s case should be dismissed at the outset. 

What is Teva’s motion about?

The first takeaway is that, motions like the one filed by Teva are relatively rare.  Moving to dismiss a patent complaint for failure to state a claim is not a typical move.  (Moving to dismiss for improper venue, or for ineligible patents, or to transfer, are more common.)  Moving to dismiss for failure to state a claim in a patent is a very difficult motion to win.  That’s primarily because you are trying to dismiss the case before any discovery has been collected.  In deciding the motion, the Judge is supposed to assume that all of Corcept’s factual allegations in its complaint are true.  Thus, Teva is essentially saying, even Corcept could prove every fact made in its complaint, and even if it could collect all the necessary evidence to prove those facts, there would still be no infringement.  Yet, by making this rare motion, Teva does not appear to be making a bold and courageous move.  Rather, Corcept’s case appears to be potentially that weak that, this is one of those rare cases where a motion like Teva’s makes sense. 

All that said, to make a full assessment of Teva’s argument, we necessarily need to review Corcept’s response, which has not yet been filed.

Teva’s motion argues that it is simply implausible for Corcept to allege that Teva’s proposed generic will infringe either the ‘348 or ‘495 patents.  To show this, Teva compares its proposed generic to the claims of each patent.  In Hatch-Waxman litigation, for certain issues like those in this case, the generic’s proposed product is basically embodied in the proposed label for that product.  Here, like the case with most generics, Teva claims to have copied the label for Korlym®, in all material respects.  That label shows what Teva’s proposed generic is indicated for (treatment of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome), and the label also provides instructions for administration (one daily dose of mifepristone ranging from 300 mg to 1200 mg for the proposed indication.)

From there, Teva argues that nothing within Teva’s proposed label shows it will infringe either of the patents.  The ‘348 patent is directed to optimizing mifepristone blood levels.  Mifepristone is the active ingredient in Korlym®.  But the patent requires administering mifepristone to a patient, testing serum levels, and the adjusting the dose until blood levels are at least 1300 ng/mL.  Teva argues, however, that nothing within its proposed label, or Korlym®’s label, includes any instructions for doing this optimization.  Similarly, the ‘495 patent is directed to differentially diagnosing two types of Cushing’s syndrome.  Teva argues that there is nothing in its proposed label that provides any instructions on differentially diagnosing between two different Cushing’s syndromes. 

Teva argues it is not a direct infringer

Based on this analysis, Teva makes the following arguments.  First, it argues that the patents are method patents.  That means, they cover a method of doing something, as opposed to a molecule, a formulation, or something else tangible.  Teva argues that, because the patents are directed to methods of administering mifepristone, then someone has to actually do that to infringe the patents.  Yet, Teva is a pharmaceutical company, and it does not actually treat patients.  Thus, it cannot directly infringe either patents.  This is a very standard argument for generics to make when faced with allegations of infringement of method/treatment patents.  Teva is most likely to prevail on this point.

Teva argues it is not an indirect infringer

The more difficult question is whether Teva infringes the patents indirectly.  Even assuming that Teva does not actually practice the methods required by the patents (by, for instance, actually treating patients,) Teva may still infringe the patents if it intentionally instructs or encourages doctors to do so.  This is called “induced” infringement.  How do you determine if a pharmaceutical company is inducing doctors to infringe a patent?  The standard way to answer that question is to look at the proposed label. 

Here, again, Teva makes very strong and persuasive points.  It argues that nothing in its proposed label induces or instructs doctors to do anything resembling what is required in the ‘348 or ‘495 patents.  Teva’s proposed label is for one use (treatment of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome).  Yet, nothing in the label is for the use claimed in the ‘348 patent (optimizing mifepristone levels) or the ‘495 patent (differentially diagnosing two types of Cushing’s syndrome.) 

This is also a very strong argument.  It is very common in Hatch-Waxman litigations for brand pharmaceutical companies to assert method patents against the generic.  Typically, the generics make the same arguments made here by Teva—they are a pharma company, and they do not treat patients directly, and therefore, they cannot practice the patent directly.  For this reason, these cases typically revolve around whether the generic induces doctors to infringe the claimed method.  Yet, typically, there is a more palpable link between the claimed method and the proposed label.  For instance, the method patent might be directed to administering 500mg of the drug once daily, and the label will instruct administering between 250mg and 750mg of the drug at least once a day.  From there, the brand can make a passable argument that the generic is inducing infringement.

Here, by contrast, Teva’s got a point.  There’s really nothing in the label that speaks to the methods required by the patents.  There does not appear to be anything in the label that even suggests that doctors should differentially diagnose between two Cushing’s syndromes or optimize mifepristone blood levels in the manner required by the patent.  The sheer absence of any link between what the patents require and what the label requires is precisely why Teva has moved to dismiss for failure to state a claim.  These types of motions are rare because they are hard to win.  Yet, this is presumably the type of situation where it might actually work.          

Teva addresses one of Corcept’s anticipated arguments.  That is off-label use.  Thus, Corcept might argue that, putting aside what the label says, doctors might use Teva’s generic Korlym® to practice the patent in a manner not required by the label.  Doctors might use generic Korlym® to optimize mifepristone levels or distinguish between two types of Cushing’s syndrome.  And Teva does not deny that that won’t happen.  But, even if that happens, that does not mean that Teva infringes the patents.  Why?  Because, Teva is not doing anything to induce or encourage doctors to do that.  And the proof of that, according to Teva, is that nothing in its label suggests that it is.

It will be interesting to see how Corcept responds to Teva’s arguments regarding indirect infringement.  Technically, Teva’s label is not final word on the matter.  In other words, a pharmaceutical company can induce doctors in many ways—through instructions on the label, but also through marketing materials, advertisements or even talking points from pharmaceutical reps.  All of that latter stuff is not yet in evidence, and technically, the Judge cannot consider it on a motion to dismiss.  If Corcept were able to Teva may be inducing doctors elsewhere, other than its proposed lable, that would technically be a basis for the Judge to deny Teva’s motion to dismiss.  But that may be very difficult for Corcept to do.   That is because Teva is a generic.  It does not likely have any marketing, advertising or pharmaceutical reps in the field selling its proposed generic for Korlym®.  And so it is hard to see how Corcept will be able to make any hay from this.

Timing

Teva filed its motion on June 15.  Under New Jersey’s rules, Corcept is scheduled to file its response by June 29, and Teva can file a reply by July 6.  These dates can technically be extended based upon stipulations between the parties, which is not uncommon, so they are not set in stone.  The Court has calendared the motion for July 16, but that was an automatic calendaring, and so that date is not likely set in stone either.  It is also not clear yet whether the Judge will order oral argument.  For a case-dispositive motion like this one, it is a possibility. 

Update:  On June 28, Corcept filed an extension of time to submit its response to Teva's motion to dismiss.  Corcept's time to file its response is now July 23, and Teva can file its reply by July 30.  Under the rules, Corcept was permitted this extension as a matter of course, but any further extensions will require a court order, and thus will be harder to come by.

Corcept’s other patents

Even assuming that Teva prevails on this motion, that does not mean that Teva has a clear road to launch a generic version of Korlym®, and it will be available tomorrow.  In our previous posts, here and here, we discussed at least three additional patents in Corcept’s pipeline for Korlym®.  Those pending patent applications remain just as important—if not more important—to the entry date of Teva’s proposed generic than its motion to dismiss.  In fact, Teva’s motion to dismiss may become a sideshow to Corcept’s other pending patents for Korlym®.  We will follow up next week with another post on the status of those pending patents as well additional thoughts on a potential settlement.