What do the Court’s December 4 rulings mean for MorphoSys' Darzalex patent case?

Zachary Silbersher

Earlier this week, we blogged about the series of pending summary judgment motions in MorphoSys’ ($MOR) lawsuit accusing Janssen’s ($JNJ) Darzalex® of infringing its patents.  The Court heard oral argument on December 3.  The transcript of that hearing is not currently publicly available.  The Court, however, did issue oral rulings at the end of the hearing that hit the docket on December 4.  What do the rulings mean?

The big takeaway is that the Court dispensed with many of the peripheral motions, by ruling on them quickly, and has kept the focus on Janssen’s invalidity arguments, by reserving judgment for now.

For instance, MorphoSys filed two motions to strike; both were denied.  These motions to strike were essentially attempts by MorphoSys to preclude Janssen from making a certain arguments at trial on the ground that Janssen either raised these arguments too late in the case, or previously suggested that it was waiving them.  Either way, Janssen will be permitted to make them at trial.  This is not really a game-changer

Both parties filed Daubert motions; all of which were denied.  These motions were also attempts to preclude the other side’s expert from testifying to certain opinions at trial.  All these motions were denied, meaning that each party’s experts can pretty much testify to the full breadth of what they are prepared to do.  This is also not much of a game-changer.

So far, none of this is shocking or telling of much.  Keeping evidence out of a trial is hard; Judges are typically inclined to let most things in. 

MorphoSys also moved for summary judgment on Janssen’s inequitable conduct defense, described in more detail here.  This motion goes a bit more to the meat of the case.  But the motion was denied, which means that Janssen can present evidence to the jury that MorphoSys mispresented to the Patent Office the reliability of the data on which it claims it discovered four antibodies that purportedly bind to CD38.  Again, this doesn’t mean that Janssen is going to win on this argument; rather, just that MorphoSys lost its attempt to keep that argument away from the jury. 

This is not a negligible outcome.  MorphoSys has now tried twice to kick Janssen’s inequitable conduct argument out of the case—first, by bifurcating the case, and second, on summary judgment.  At the end of day, however, the jury is going to hear Janssen’s claims that MorphoSys allegedly mispresented key facts to the Patent Office in the course procuring its patents.  The reason this is important is because this case is going to a jury. 

The party who gets to stand up in court and say, “Hey, look, the Patent Office gave us a patent on this!”—that usually has sway with a jury.  But, now, Janssen will be able to tell its own story that the way MorphoSys obtained those patents was supposedly not so kosher.  This is a story that is also easier for a jury to follow, compared to the nitty-gritty, science-heavy arguments about lack of written description and enablement.

MorphoSys was also granted a motion for partial summary judgment on infringement, but this is not really a game-changer.  Janssen claims that its protein, daratumumab, is “humanized” and chimeric.  Because MorphoSys’s patents cover both “human” and “humanized” antibodies, MorphoSys moved to summary judgment that for the “human” claims, all the other limitations are already met. 

This is basically a way of narrowing the issues for trial, which the Court has granted.  The parties may dispute at trial whether daratumumab is “human” or only “humanized,” but the other elements of the claims will not need to be addressed. 

Interestingly, Janssen also moved for summary judgment that, because daratumumab is chimeric, it cannot infringe the patent claims covering a “human” antibody.  MorphoSys continues to argue that these claims may nevertheless be infringed.  Exactly why the Court did not grant Janssen’s motion on this point is unclear from the current public record, but may be an issue to keep an eye on if MorphoSys can somehow argue that its “human” antibody claims are less subject to Janssen’s invalidity arguments than the “humanized” claims. 

The Judge’s order is more telling for what it did not rule on.  The Court did not rule on Janssen’s big motion, namely, its invalidity motion—for lack of written description, enablement or indefiniteness.  These defenses are really becoming the centerpiece of this case.  Relatedly, MorphoSys asked the Court to rule in advance that Janssen’s enablement defense is too faulty to worth presenting to the jury.  The Court appears to have reserved judgment on that along with Janssen’s invalidity defenses. 

In real terms, Janssen’s argument is that MorphoSys did not invent daratumumab, and that’s probably going to be the main theme Janssen tries to convey to the jury at trial.  Given that the trial is coming up in February, the Court will likely issue an opinion shortly—within, presumably, a matter of days or weeks.  That opinion will presumably address Janssen’s invalidity arguments. 

If the Court grants Janssen’s invalidity motion, the case is essentially over.  On the other hand, there is a very real likelihood that the opinion itself may be very short, and the Court will deny Janssen’s invalidity summary judgment motions.  Again, that does not mean that Janssen lost the case, or lost those arguments.  Just that the Court has decided that this case cannot be decided on summary judgment, and it’s best to let the parties try their allegations and defenses to a jury.