United States District Court, D. Delaware
HONORABLE LEONARD P STARK UNITED STATES DISTRICT JUDGE
considered the parties' briefing (D.I. 358, 458, 514) and
having conducted an evidentiary hearing and heard oral
argument on June 21, 2019, IT IS HEREBY ORDERED
THAT Plaintiffs motion for a preliminary injunction
(D.I. 357) is GRANTED.
IS FURTHER ORDERED THAT the parties shall submit a
joint status report by Friday, June 28, 2019. That status
report shall address, in addition to anything else the
parties wish to raise, (a) whether the trial date should be
accelerated; (b) how long the parties are likely to need for
their trial presentations; (c) the amount of bond the Court
should require Plaintiff to post; and (d) whether any
discovery disputes remain ripe and require judicial
Court's decision to grant the preliminary injunction was,
as stated as the conclusion of the hearing, for the following
want to note I carefully considered all the materials that
were in the record, including the voluminous record that you
all created before today and, of course, everything that was
cited in court today. That includes, but is not limited to,
the various declarations of the witnesses, the deposition
testimony, many documents, and the testimony that I got to
hear live today.
legal standards I think are not disputed, but let me just try
to quickly note them for the record.
preliminary injunction, of course, is an extraordinary remedy
that should be granted only in limited circumstances.
Deciding whether to grant a preliminary injunction requires
consideration of whether the moving party can prove the
following. A reasonable likelihood of success on the merits,
irreparable harm if the injunction is not granted, a balance
of hardship tipping in its favor, and the injunction's
favorable impact on the public interest. Although the factors
are not applied mechanically, a movant must establish the
existence of both of the first two factors to be entitled to
a preliminary injunction.
context of this suit, which is a patent infringement action,
with respect to the likelihood of success on the merits,
Novartis as the moving party must show both, one, it is
likely to prove that the proposed generic product will
infringe the asserted patent claim on which the motion is
based, and, two, that defendants' challenges to the
validity of the patent lack substantial merit.
applied that law to the facts as best as I could, my decision
is to grant the motion for a preliminary injunction. Let me
try to explain why.
turning to likelihood of success on the merits, I find that
Novartis has met its burden to demonstrate a likelihood of
success on the merits. Infringement is not contested for
purposes of the preliminary injunction motion, so I need not
address it any further. The issue, of course, is invalidity,
and on invalidity, I have made a preliminary assessment as
I'm required to do on defendants' three challenges.
Anticipation by Kappos 2006, lack of adequate written
description, and lack of enablement or utility.
level I think it is fair to say that there is a
"substantial question of patentability." [But] I
don't think that that is a fair description when that
phrase is used in the manner that I understand it to be
pertinent to the preliminary injunction analysis. That is, I
don't think that defendants' invalidity contentions
as argued here today are frivolous. If I were to permit
summary judgment practice in this case, the defendants'
invalidity defenses might very well survive a summary
judgment motion. It's even possible, despite what I'm
about to say, that defendants might prevail on one or more of
their invalidity theories after trial, but having considered
the evidence and the arguments before me at this stage, my
finding is that defendants are not at all likely to prevail
at trial on invalidity.
is, I am persuaded by Novartis that at trial, defendants will
likely fail to persuade me by clear and convincing evidence
that the asserted claims of the '405 patent are invalid
due to anticipation by Kappos 2006, or due to lack of
adequate written description, or due to lack of enablement
made that finding, I believe that plaintiff has done what the
law requires it to do on likelihood of success on the merits
when confronted with a challenge to the validity of its
patent at the preliminary injunction stage. That's my
understanding of what the Federal Circuit has told us is the
legal standard at this stage. For instance, in the Titan
Tire decision, 566 F.3d at page 1372, a 2009 decision,
Federal Circuit told us that what the Court must do is
"determine whether it is more likely than not that the
patent challenger will be able to prove at trial by clear and
convincing evidence that the patent is invalid." And,
again, my finding for reasons I'm going to now try to
explain is for the plaintiff, applying that standard.
relevant to my finding on likelihood of success on the merits
is that the defendants have proposed the wrong person of
ordinary skill in the art, the wrong POSA. I am persuaded
instead by plaintiff that the PTAB's definition of a POSA
is correct here. It is a team that includes not just a
clinician, but also a pharmacologist. I've been using a
shorthand here, as I hope you will appreciate. As a formal
matter, I'm adopting the specific definition of a POSA
proposed by the plaintiff.
reached this conclusion for at least the following reasons.
The patent contains parts that would be best understood by a
pharmacologist even though the claims are principally
directed to treatment and therefore to a clinician.
instance, a pharmacologist is needed to understand the link
between the EAE discussion of the specification and human
dosing. Some of the prior art listed on the face of the
patent and considered by the PTO is .. . pharmacological work
relating to fingolimod. The invention as a whole is directed
to a team which would necessarily include a pharmacologist
for all the reasons that plaintiff has given, which are all
well supported in the record.
did not present any evidence from a pharmacologist or from
the perspective of a pharmacologist. Therefore, they did not
provide any evidence from the perspective of a POSA. Their
expert, Dr. Hoffman, candidly admitted he doesn't know
how a pharmacologist would interpret the patent. This alone I
think is likely a sufficient basis to find that defendants
are not likely to prevail on their invalidity challenges at
trial. But I am not resting my decision solely or even
principally on my finding regarding a POSA.
now turn to the three specific invalidity defenses that
defendants have argued, and I find again that defendants are