AMGEN INC. et al v. ADELLO BIOLOGICS LLC
Filing
156
OPINION. Signed by Chief Mag. Judge Mark Falk on 10/24/2019. (ld, )
NOT FOR PUBLICATION
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
AMGEN INC., et al.,
Civil Action No. 18-3347 (CCC)
Plaintiffs,
v.
KASHIV BIOSCIENCES, LLC, et al.,
OPINION
Defendants.
FALK, U.S.M.J.
Before the Court is the motion of Plaintiffs, Amgen Inc. and Amgen
Manufacturing Limited (together herein, “Amgen”), for leave to amend their
infringement contentions. [ECF No. 141.] Defendants Kashiv Biosciences, LLC;
Amneal Pharmaceuticals, LLC; and Amneal Pharmaceuticals, Inc. (collectively,
“Defendants”) oppose the application, in part. No oral argument is necessary. For the
reasons stated below, the motion is GRANTED.
RELEVANT BACKGROUND
This is a patent infringement suit involving three patents covering Amgen’s
filgrastim-based biological drug product, referred to by the brand name Neupogen®.
The suit is brought pursuant to the Biologics Price Competition and Innovation Act of
1
2009 (“BCPIA”). Defendants seek approval to license a “biosimilar” of Amgen’s
product pursuant to an abbreviated regulatory pathway available under the BCPIA. See
42 U.S.C. § 262(k).
On August 3, 2018, Amgen served its Initial Disclosure of Asserted Claims and
Infringement Contentions.
On February 7, 2019, Amgen served Amended Infringement Contentions.
On August 22, 2019, Plaintiff proposed its current motion seeking to file second
amended infringement contentions. The proposed amendments are: (1) to narrow the
disputed issues in the case by no longer asserting claims in U.S. Patent No. 8,952,138
(which was actually dismissed from the case on September 16, 2019) and reducing the
number of asserted claims for U.S. Patent No. 9,856,287 (“the ‘287 patent”); (2) to
“clarify and provide additional detail regarding Amgen’s infringement theories in light
of the parties claim construction proposals . . . .”; and (3) to correct an inadvertent “cutand-paste error” in the February 7 contentions.
On September 12, 2019, Defendants advised that they consent to the first
proposed amendment; they oppose proposed amendments 2 and 3. Defendants contend
that Amgen’s application lacks “good cause” as contemplated by the Local Patent
Rules; is allegedly Amgen’s “latest effort to unfairly obtain litigation advantages by
adopting new and (often contradictory) positions”; and should either be denied or, at a
minimum, deferred until after claim construction has been heard by the Court.
Amgen counters that there is ample good cause for its proposed amendments,
2
including that no fact depositions have been taken; discovery is still open; and a claim
construction hearing has not been scheduled yet, let alone decided. It further claims
that the amendments would actually simplify claim construction and correct a
ministerial error that occurred when revising prior versions of the contentions.
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.
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. (emphasis added).
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 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 Amgen has been diligent and shown good cause for its
proposed amendments, 1 and that none of the amendments will cause undue prejudice to
1
As discussed on page 2, supra, proposed Amendment 1 is not opposed; what remains
4
Defendants.
A.
Good Cause
With respect to Amendment 2, Amgen explains that based upon discovery
received in the case and its review of the parties’ claim construction submissions, it
wishes to “provide a more detailed explanation” of infringing activity without adding
any new infringing instrumentalities. The parties have sought to seal the specifics of
this information and have redacted it from the Court’s public docket. A motion to seal
is currently being briefed. In short and generic language, Amgen’s proposed
Amendment 2 involves describing the relationship between “thiol-pair ratio” and “thiolpair buffer strength” and a series of mathematical calculations – the end result being that
Amgen claims that Amendment 2 shows that the relationships of the two are the same
regardless of which of a series of disclosed equations are used.
The receipt and review of discovery and claim construction materials is sufficient
good cause to allow an amendment of infringement contentions in a case positioned like
this; that is, with discovery still open, with the proposed amendments appearing
designed to simplify -- as opposed to expand and complicate -- claim construction, and
in light of the acknowledgment that contentions should not be treated as final, early in
the case and before much discovery has been exchanged.
With respect to Amendment 3, Amgen explains that, in preparation of its
February 7, 2019, amended contentions, counsel made an “inadvertent cut-and-paste
are proposed Amendments 2 and 3.
5
error” in the text of the contentions – specifically, that certain text regarding the ‘187
patent was copy and pasted into contentions relating to a claim in the ‘287 patent.
Defendants oppose this amendment on the basis that they find it “hard to accept” that
Amgen did not sooner realize this mistake had occurred; that such a mistake is actually
a large change to infringement positions; and that any attorney-error of the sort is not a
basis under the Local Rules to amend contentions. The Court disagrees.
Rule 3.7 specifically states that it contains a “non-exhaustive” list of bases to
allow amendment of contentions, and courts have acknowledged inadvertence and
mistake as grounds to support amendment of contentions. See, e.g., TFH Publ. Inc., 705
F. Supp. 2d at 366; Int’l Dev., LLC, 2010 U.S. Dist. LEXIS 106616 at *3. Moreover, it
would be a waste of judicial resources to push forward with claim construction as it has
been submitted. It is impractical and unreasonable to ask the District Court, currently in
a state of judicial emergency, to evaluate claim construction as is - knowing well that it
contains what one side claims is an error - only to have a previously known and raised
request to amend be immediately brought after time and resources are dedicated to
construing the disputed claims.
B.
No Prejudice
In deciding whether Amgen’s proposed amendments would prejudice
Defendants, the Court considers whether the proposed 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, 705 F. Supp. 2d at 366.
6
There is no undue prejudice in this case for a number of reasons.
First, discovery is still open. Fact depositions have not commenced. Opening
expert reports are not due for some time. A claim construction hearing has not been
scheduled - and obviously claim construction has not been decided. Given the state of
the Court’s general docket and the fact that this District is in a judicial emergency,
motions and a trial are far away.
Second, Defendants claim that any amendments would result in “significant
prejudice” and require the expenditure of resources to respond to the amendments.
While there could be some resulting prejudice, denial of leave to amend requires that
additional work required be substantial or “undue.” See, e.g., AS Am., Inc. v. Masco
Corp. of Ind., 2013 WL 4084237, at *3 (D.N.J. Aug. 13, 2013) (“[a]lthough
defendant’s amendment may require some additional work on plaintiff’s part, the
additional work is not significant or vexatious.”). Here, undue prejudice has not been
shown. Amgen’s amendments reduce the number of claims at issue in the case, and
moreover, Amgen has stated that it would not oppose any defense application to amend
non-infringement contentions based on the amendments allowed in this motion.
Third, no party identifies any additional discovery would be needed as a result of
the proposed amendments.
Fourth, there is no pending motion or dispositive motion that would impacted by
the amendments. The amendment will not prolong the case.
For the above reasons, there is no undue prejudice to Defendants, and the
7
amendments will be allowed.
CONCLUSION
For the reasons stated above, Amgen’s motion for leave to amend its
infringement contentions is GRANTED.
s/Mark Falk_____________
MARK FALK
Chief U.S. Magistrate Judge
Dated: October 24, 2019
8
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?