MICROSPHERIX LLC v. MERCK & CO., INC. et al
Filing
140
MEMORANDUM OPINION. Signed by Chief Mag. Judge Mark Falk on 6/28/2021. (ams, )
NOT FOR PUBLICATION
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
MICROSPHERIX LLC,
Plaintiff,
v.
MERCK SHARPE & DOHME CORP.,
et al.,
Defendants.
Civil Action No. 17-3984 (CCC)
MEMORANDUM OPINION
FALK, U.S.M.J.
This is a patent infringement case. Defendants (collectively referred to as
“Merck”) market and sell an implantable progestin contraceptive under the trade name
Nexplanon®. Plaintiff, Microspherix, contends Nexplanon infringes three patents: U.S.
Patent No. 9,636,401; U.S. Patent No. 9,636,402; and U.S. Patent No. 8,821,835. Before
the Court is Merck’s motion seeking to amend its invalidity contentions. The application
is opposed. No argument is needed. See Fed. R. Civ. P. 78(b).
Background 1
The initial complaint was filed on June 5, 2017. On August 7, 2018, the case was
stayed pending inter partes review instituted against the asserted patents. The IPR
proceedings concluded in August 2020, and the stay was lifted by Order entered on
August 10, 2020. While the IPR proceedings were ongoing, an additional patent was
issued to Microspherix – U.S. Patent No. 10,493,181. 2
The parties are aware of the case’s full background. This section is limited to what is
necessary to decide the motion. Information is drawn from the parties’ submissions;
direct citations are at times omitted.
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When the stay was lifted, Defendants joined the newly issued ‘181 patent to this case
through a counterclaim seeking a declaratory judgment of non-infringement. In October
2020, the parties filed a stipulation of dismissal as to this count, thereby removing the
‘181 patent from this case.
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On August 17, 2020, Merck sent Plaintiff proposed amended invalidity
contentions. After a back and forth about whether Plaintiff would consent to the
amended contentions, Plaintiff declined to consent on February 19, 2021.
On March 5, 2021, Merck filed the present motion to amend. Its position is that
the proposed amended contentions arise from: (1) a prior art search conducted in
connection with the ‘181 patent issued during the pendency of the stay; and/or (2)
Microspherix’s § 112-related arguments put forth during the IPR proceedings. Merck
contends the amendments are minor; discovery is still open; the case is still in the early
stages; and that there is no discernable prejudice. Microspherix contends the
amendments are untimely, “not important,” and prejudicial.
Legal Standard
“The Local Patent Rules exist to further the goal of full, timely discovery and
provide all parties with adequate notice and information with which to litigate their case.”
King Pharm., Inc. v. Sandoz, 2010 WL 2015258, at *4 (D.N.J. May 20, 2010). The
Patent Rules “are designed to require the parties to crystallize their theories of the case
early in the litigation and to adhere to those theories once they have been disclosed.”
Celgene Corp. v. Natco Pharma Ltd., 2015 WL 4138982, at *4 (D.N.J. July 9, 2015).
Nevertheless, the Patent Rules are not “a straightjacket into which litigants are locked
from the moment their contentions are served . . . [a] modest degree of flexibility exists,
at least near the outset.” Astrazeneca AB v. Dr. Reddy’s Labs, Inc., 2013 WL 1145359
(D.N.J. Mar. 18, 2013).
Local Patent Rule 3.7 governs requests to amend contentions. The Rule allows for
amendments “only by order of the Court upon a timely application and showing of good
cause.” Id. Good cause “considers first whether the moving party was diligent in
amending its contentions and then whether the non-moving party would suffer prejudice
if the motion to amend were granted.” Astrazeneca, 2013 WL 1145359, at *3.
Rule 3.7 provides a “non-exhaustive” list of examples that may, absent undue
prejudice to the adverse party, support a finding of good cause: “(a) a claim construction
by the Court different from that proposed by the party seeking amendment; (b) recent
discovery of material prior art despite earlier diligent searches; (c) recent discovery of
nonpublic information about the Accused Instrumentality which was not discovered,
despite diligent efforts, before the service of Infringement contentions; (d) disclosure of
an infringement contention by a Hatch-Waxman Act party asserting infringement . . . that
requires response by the adverse party because it was not previously presented or
reasonably anticipated . . . .” Id.
Courts have also considered the following in determining whether good cause
exists: reason for the delay; importance of the information to be excluded; the danger of
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unfair prejudice; and the availability of a continuance and the potential impact of a delay
on judicial proceedings. See, e.g., Int’l Development, LLC v. Simon Nicholas Richmond
and Adventive Ideas, LLC, 2010 WL 3946714, at *3 (D.N.J. Oct. 4, 2010).
In sum, amendment will be permitted when there is “(1) a timely application, (2)
there is a showing of good cause, and (3) the adverse party does not suffer undue
prejudice.” Celgene Corp., 2015 WL 4138982, at *4.
Decision
The Court is satisfied that good cause has been shown for the proposed
amendments, and that none of the amendments will cause undue prejudice to
Microspherix. As such, the motion is GRANTED.
i.
Timeliness and Good Cause
Merck claims their amendments are timely and good cause has been shown
because: (1) with respect to the new prior art references, they fit within Rule 3.7(b)
because they were uncovered by a search firm during the IPR-generated stay; and (2)
with respect to the § 112 arguments, are the result of the IPR proceedings and arguments
and positions taken therein.
Microspherix disputes what Merck could have previously uncovered with respect
to the prior art references and claims that the Section 112 defenses do not really arise out
of the IPR proceedings and should have been known earlier. Merck disagrees, noting that
it retained a private search firm, both before prior versions of its invalidity contentions
and now, and that this retention alone and the resulting discovery provide good cause
under the rules. See e.g., Uniloc USA, Inc. v. Apple, Inc., 2020 WL 3128908, at *2 (N.D.
Cal. June 12, 2020); see also L. Pat R. 3.7(b). The parties also engage in a back-andforth about their communications after Merck raised the possibility of amending its
contentions following the IPR. While they blame each other, the fact is these
communications dragged on for months and delayed bringing the issue to a head.
What the Court is left with is essentially a dispute about which side delayed in
pushing the amendment issue – as one side tells it, Merck let it slip for months; the other
side contends Microspherix delayed and dragged feet on whether it would consent to a
post-IPR amendment. Either way, what can’t be disputed, is that Merck raised the issue
of amendment very quickly after the IPR proceedings concluded – within a calendar
week. Likewise, there is nothing in the record to refute Merck’s positions that a patent
issued during pendency of the IPR; that a search firm was retained as a result and
uncovered additional prior art references while the IPR was ongoing; that a firm’s late
discovery of prior art can be good cause to amend contentions (see 3.7(b)); and that there
was a fulsome IPR review that could reasonably be construed to provide a basis for
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additional Section 112 positions. As such, the Court concludes that the concept of
amending the contentions was raised in a timely fashion and that there is good cause to
support the request.
ii.
Undue Prejudice
In deciding whether Merck’s proposed amendments would prejudice
Microspherix, the Court considers whether the amendments would (1) require the
opposing party to expend significant additional resources; or (2) significantly delay
resolution of the dispute. See, e.g., TFH Publications v. Doskocil Mfg. Co., Inc., 705 F.
Supp. 2d 361, 366 (D.N.J. 2010). Neither is an issue here.
Despite its age, the case is nowhere near motion practice or a trial. The case was
stayed for two years while IPR proceeded. The jointly agreed-to case management
schedule was limited to the early stages of the case and did not even contain a discovery
end-date. It is not clear that much, if any, discovery has occurred. There are no
dispositive motions pending. Claim construction has not occurred. Trial is not imminent.
There is no 30-month stay that is involved in this case and no request for emergent or
injunctive relief has been made. The only impact of the amendments would be perhaps a
revising of certain claim construction submissions and a small amount of discovery. This
does not rise to the level of prejudice or a “significant delay” that would materially alter
when this case is reached. Moreover, no showing that the amendments would cause a
dramatic increase in cost or expense has been shown.
For the reasons stated above, Merck’s motion to amend its invalidity contentions
is GRANTED.
SO ORDERED.
s/Mark Falk________________
MARK FALK
United States Magistrate Judge
Dated: June 28, 2021
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