Will MorphoSys’ Darzalex patent case against Janssen make it to trial, or be stopped at summary judgment?
Update: See our later post on the Court’s preliminary summary judgment rulings here.
The Darzalex® patent case commenced by MorphoSys ($MOR) against Janssen ($JNJ) is headed towards trial. Before that, however, the parties recently filed a series of summary judgment motions, and on December 3, 2018, the Court heard oral argument. Will the Court moot the trial by granting Janssen’s motions to invalidate the patents?
First, the parties exchanged summary judgment briefs with respect to infringement, but the core issues do not appear to be in dispute. The Court previously construed the claims to require that “human” antibodies must be derived exclusively from human material, whereas “humanized” antibodies can be chimeric, and derived in part from mouse material, for example. Given that there is not dispute that Janssen’s antibody, daratumumab, is “humanized,” it cannot infringe the “human” claims. Given that MorphoSys has claims covering both “human” and “humanized” antibodies, the case does not appear likely to turn on this issue.
Second, and more importantly, Janssen moved for summary judgment that all the asserted patents are invalid for lack of written description, for not being enabled and for indefiniteness. Patents are technically contracts between an inventor and the people of the United States of America. In exchange for disclosing his or her invention to the people, the inventor enjoys an essential monopoly on using that invention for approximately 20 years. After that, theoretically, anyone can use it.
Part of that quid pro quo, however, requires that the inventor actually disclose what the invention is so that he or she is not awarded a patent on something the inventor did not invent. This is the written description requirement. Another part of that quid pro quo is that the inventor disclose how to make the invention, so that he or she is not awarded a patent on something that would require undue experimentation to replicate. This is the enablement requirement.
Both of these requirements typically arise within the context of biotech patents covering proteins and antibodies. The pharmaceutical company typically discloses one or two representative antibodies (the species), but then claims patent protection over a broad genus of antibodies covering those representative species. In this way, pharma companies typically try to corner the patent market on a new type of inhibitor.
The reason for this is that antibody patents typically describe the protein by what it does (binds to certain antigens) rather than what it is (series of amino acids.) That form of functional claiming gives rise to these patents covering literally millions of different possible proteins. The strategy makes tremendous sense, but succeeding at it is not easy.
Janssen has moved to invalidate the patents for lack of written description and for being not enabled. Janssen’s principal argument is that the representative antibodies disclosed in the patents are not sufficiently “representative” of the entire genus claimed. This issue recently came to a head in the PCSK9 patent case between Amgen and Regeneron. The Federal Circuit issued an important decision that essentially made it more difficult to satisfy the written description requirement for antibody patents covering a broad genus of proteins. That creates risk for MorphoSys in this suit.
Janssen also argues that the patents are invalid for being indefinite. If a patent covers an invention characterized by a certain metric, such as a required molecular weight, then people out there in the world need to know how to measure that metric. If the patent is not clear on that point, then competitors may not be able to discern if they are infringing or not. This typically arises where some known methods for measuring the claimed metric show infringement whereas others do not. Here, the patents described the claimed antibodies based on where they bind to CD38. Janssen argues that the patents do not sufficiently describe how to measure the claimed binding.
These are strong defenses. But they also require considerable expert opinion. For instance, whether representative antibodies are “representative” of a claimed genus is based upon how a person of ordinary skill—namely, a scientist in this field—would read and understand the patents. Equally, whether “undue experimentation” is required to come up the claimed genus of antibodies is something that demands fairly rigorous expert opinion.
Because of this, there is a strong possibility that the Court denies Janssen’s motions, and sends the case to trial. That, however, would not mean that the Court views Janssen’s to be weak. But, rather, the Court views the better course is to let the experts battle it out in front of the jury, where credibility determinations can be weighed, and the jury can watch the experts be cross-examined. By contrast, granting Janssen’s motions for summary judgment essentially requires deciding thorny scientific questions on paper.
MorphoSys has also moved for partial summary judgment on Janssen’s defense of inequitable conduct, which was discussed in greater detail in our earlier post. MorphoSys previously attempted to bifurcate the case and exclude Janssen’s inequitable conduct argument from the first trial. Having failed that, MorphoSys is now trying to knock it out on summary judgment before getting to the jury.
There are lot motions for summary judgment here, and a lot of issues. But most of these issues boil down to the same, principle defense by Janssen. Janssen’s story goes like this: MorphoSys explored antibodies to CD38. Though it eventually described four such antibodies in its patents, none of those antibodies ever made it out of the laboratory. Despite that, MorphoSys received patents covering an enormous genus of millions of possible antibodies that bind to CD38.
Janssen argues that, no matter how you slice it, this cannot add up. Four antibodies do not warrant a patent covering such a broad genus of anti-CD38 antibodies. Janssen claims that its own antibody, daratumumab, looks nothing like the four antibodies described in MorphoSys’ patents, and Genmab, rather than MorphoSys, did the hard work of discovering that protein. Whether you call it lack of written description or enablement, Janssen’s essential point is that MorphoSys did not invent daratumumab.
Indeed, Janssen also argues that the description in the patents of MorphoSys’ four antibodies is itself suspect. Janssen points to evidence that MorphoSys knew the data supporting those antibodies was unreliable, but despite that, never corrected it or informed the Patent Office. This is the heart of Janssen’s inequitable conduct defense. But it speaks to the same underlying point, which is Janssen’s contention that no matter how you square it, MorphoSys did not invent daratumumab.
Technically, Janssen needs to prevail on only one of its invalidity defenses in order to avoid paying any royalties to MorphoSys. It may lose on enablement, indefiniteness and inequitable conduct, but still win on lack of written description, and still prevail in the case. Patents are probably less frequently invalidated for enablement or indefiniteness, and inequitable conduct requires certain elements of proof unrelated to the other defenses. Written description is possible rise to the surface as one of Janssen’s most tractable defenses.
All that being said, prevailing on summary judgment on issues such as this is hard. The trial is still scheduled for February 2019, which will come up very fast. The Court heard oral argument on December 3, and will likely be reluctant to delay the trial at all.
Moreover, only Janssen stands to win the case on these pending summary judgment motions. That is because it has filed case-dispositive motions—namely, that all the patents-in-suit are invalid. If Janssen wins even one of its invalidity summary judgment motions, the case is essentially over and ripe for appeal. By contrast, MorphoSys has moved for partial summary judgment on certain issues—such as enablement and inequitable conduct. But even if it prevails on all of its motions for summary judgment, the case will still proceed to trial. Put another way, Janssen is trying to win the case before trial, whereas MorphoSys is attempting to narrow down the issues before trial.
Indeed, the Court is likely to use these series of summary judgment motions to essentially weed out the weaker arguments so that the trial can be streamlined for the issues that the Court believes are at the core of the dispute. But, as discussed above, even if the Court denies Janssen’s invalidity summary judgment motions, or even some of them, that will not necessarily be a strong indicator that it will not prevail at trial.