MITCHELL S. GOLDBERG, District Judge.
This is a consolidated case for patent infringement brought by Plaintiff Amgen Inc. ("Amgen") against Defendants Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals of New York LLC (together, "Amneal), Piramal Healthcare UK Ltd. ("Piramal"), Watson Laboratories, Inc., Actavis, Inc., and Actavis Pharma, Inc. (together, "Watson"), and Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. (together, "Zydus," and collectively with all other defendants, "Defendants").
Presently before the court are two motions filed around the start of trial: (i) Amgen's Motion for Reargument of the Court's February 27, 2018 Memorandum and Order which construed the meaning of the Markush groups in the '405 patent; and (ii) Zydus' Motion in Limine to preclude the introduction of a new theory of infringement—the doctrine of equivalents—which was not asserted against it before trial. (D.I. 323, D.I. 307). For the reasons set forth below, Amgen's Motion for Reargument is denied, and Zydus' Motion in Limine is granted.
In its Motion for Reargument, Amgen contends that the court "misconstrued [its] position on claim construction" and "misapprehended the claim construction issue." (D.I. 323 at 1-2). A brief recitation of the procedural history in this matter and the court's prior rulings on claim construction are necessary to provide the proper context for Amgen's motion.
The '405 patent issued from U.S. Patent Application No. 12/942,646 (the "'646 application"), filed on November 9, 2010. (D.I. 293-1, Ex. 1 ¶ 7). The parties have agreed that infringement in this case will be decided based on claim 1 of the '405 patent, which states:
(D.I. 294-1, Ex. 7 at 4; D.I. 336).
The Honorable Gregory M. Sleet held a Markman hearing in this matter in the spring of 2017. The only claim construction dispute presented to and resolved by Judge Sleet at that time was the meaning of "relative to the total weight of the composition," which appears in claim 1's "wherein clause." (D.I. 186). By the fall of 2017, however, the parties had another claim construction dispute that had not been resolved. That dispute involved the Markush groups for the binder and disintegrant elements in claim 1.
On January 24, 2018, Amgen's expert, Dr. Davies, was deposed. Dr. Davies testified that Defendants with unlisted binders or disintegrants still literally infringed, because the "comprising language" in the preamble of claim 1 permitted unlisted binders or disintegrants. (D.I. 356 at 1067:16-23). Despite the fact that there was no claim construction to support this opinion, Amgen did not seek a second claim construction from the court or make clear that, for those defendants against whom it had only asserted literal infringement, it would now also assert the doctrine of equivalents in the alternative. (D.I. 354 at 458:18-23).
On February 5, 2018, the parties filed a Proposed Joint Pretrial Order, which made clear that the claim construction dispute over the Markush groups was still in play.
In its part of the Proposed Joint Pretrial Order, Amgen did not make all of the arguments Defendants expected. Instead, Amgen primarily argued that Defendants should be precluded from raising the claim construction dispute, because it was "not raised at the Markman hearing." (
At the pre-trial conference, Amgen argued that the claim construction dispute should not be resolved, because it was untimely. (Hr'g Tr. at 79-80). Amgen also directed the court to the case law it cited in the Proposed Joint Pretrial Order regarding the term "comprising." (
On February 20, 2018, Amgen submitted its letter (the "February Letter"). (D.I. 298). The introduction set forth three arguments: (i) Defendants "waived their right to assert these non-infringement defenses because they failed to raise these issues long ago during claim construction briefing as set forth in the Scheduling Order;" (ii) "the claims at issue—which use the open-ended transitional phrase `comprising'—do not exclude additional excipients that function as diluents, binders, or disintegrants;" and (iii) even if the Markush groups were not open-ended, Amgen could still assert the doctrine of equivalents. (
On February 27, 2018, the court issued its Memorandum construing the meaning of the Markush groups for the binder and disintegrant elements of claim 1. (D.I. 300). Relying primarily on
On March 6, 2018, Amgen filed its Motion for Reargument asserting that the court misunderstood its position on claim construction. (D.I. 323 at 1-2). Amgen now urged that the point of the Markush groups is not to determine literal infringement of a claim element, but to "define the binders and disintegrants considered in the weight percentage calculations." (
(
"The decision to grant a motion for reargument lies within the discretion of the district court."
Contrary to Amgen's contentions, the court does not misunderstand its position on claim construction. (D.I. 323 at 1-2). Before the Motion for Reargument, Amgen's arguments consistently focused on whether the Markush groups were "not closed sets" due to the term "comprising" in the preamble. (D.I. 294-1, Ex. 8 at 1; D.I. 294-1, Ex. 7 at 226; D.I. 323). Since filing the Motion for Reargument, Amgen has confirmed that "our position was and always has been that the `comprising' at the beginning of claim 1 opens things up to things beyond the Markush groups." (D.I. 356 at 1064:13-16). This is the argument the court carefully considered and rejected in its February 27, 2018 Memorandum. (
Amgen never fairly presented the proposed construction it now seeks, i.e., that the Markush groups "define the binders and disintegrants considered in the weight percentage calculations." (D.I. 323 at 2). The single sentence on which Amgen's Motion for Reargument rests was obscured in the middle of a paragraph analogizing the language of claim 1 to the language of patents a court construed as open to unrecited elements due to the term "comprising." (D.I. 298 at 3). Thus, Amgen's Motion for Reargument essentially raises a new argument. The court's colloquy with Amgen's counsel clearly confirms this point:
(D.I. 356 at 1070:17-23).
A new argument is not the proper subject of a motion for reargument.
Even if the court were to consider Amgen's new construction, however, it fails on the merits. This is because Amgen's claim construction requires the court to ignore the criticality of the weight ranges for the binder and disintegrant elements, which does not comport with the prosecution history. (D.I. 333 at 1).
When construing patent claims, the court considers "[t]he claims, the specification, and the prosecution history."
The amendments in the prosecution history of the '405 patent further shows that Amgen acted consistent with its understanding that the weight ranges are critical to the invention. Amgen claimed the same specific weight ranges in every patent amendment, regardless of whether a Markush group was present or not. Specifically, in the amendments dated November 15, 2011 and December 15, 2014, which did not have Markush groups for the binder and disintegrant elements, Amgen claimed "from about 1% to about 5% by weight of at least one binder" and "from about 1% to about 10% by weight of at least one disintegrant." (JTX 5 at-258). In the Examiner's Amendment dated March 25, 2015, Amgen claimed those same weight ranges but added Markush groups. (
Amgen also argues that its claim construction is necessary to give meaning to the example in the '405 patent. (D.I. 323 at 7). The court is not persuaded. As the following table shows, if the court looked no further than the face of the patent, claim 1 covers the example:
Amgen argues that claim 1 does not cover the example, because it was common knowledge to a person of ordinary skill in the art ("POSA") that pregelatinized starch could have one or more functions. (D.I. 323 at 8). According to Amgen, a POSA would read the pregelatinized starch in the example as a binder, but pregelatinized starch is not listed in the Markush group for binders. (
The '405 patent, however, does not teach that pregelatinized starch has more than one function. It teaches that pregelatinized starch has only one function — as a diluent. The '405 patent contains three Markush groups and each Markush group contains several members, but no member is present in more than one group. (D.I. 294-1, Ex. 7 at 4).
In addition, as Amgen stated in the prosecution history, "the skilled person realizes that binders are used in small amounts and diluents in big amounts." (JTX 5 at-351). The example contains 33.378% by weight of pregelatinized starch, which is a "big" amount when compared to claim 1's "about 5%" weight limit for binders. Finally, if a POSA treated the pregelatinized starch in the example as a binder, then the example would be left with an insufficient amount of diluent to meet the limitations of claim 1. It would have only 40.978% of diluent, when claim 1 requires a minimum of about 45% by weight of a diluent." (D.I. 324 at 5).
For all of these reasons, the patent teaches that the pregelatinized starch in the example is acting as a diluent, not a binder. Therefore, Amgen's argument regarding the example is without merit. (D.I. 323).
"A district court judge is granted broad discretion in determining what is admissible under the Federal Rules of Evidence."
Zydus filed a Motion in Limine seeking an order precluding Amgen from asserting the doctrine of equivalents against it. (D.I. 307). Amgen filed a response the same day and then, unprompted, filed a supplemental response twenty-seven days later. (D.I. 301; D.I. 350). The supplemental response was unsolicited and filed without any procedural grounds permitting such filing. And all of the arguments in the supplemental response are based on facts that Amgen had in its possession at the time it filed its original response. There is no reason why Amgen could not have raised these arguments previously. Consequently, the court will disregard Amgen's supplemental response. (D.I. 350).
Zydus argues that Amgen should be precluded from asserting the doctrine of equivalents against it, because Amgen did not assert that theory before trial. (D.I. 308 at 1). Amgen does not dispute that, before trial, it only asserted literal infringement against Zydus. (D.I. 310 at 2 ("Prior to the [claim construction order], Amgen had asserted literal infringement by Zydus.")). Amgen makes several arguments, however, as to why it should now be permitted to assert this new theory.
First, Amgen argues that it has to assert a new infringement theory against Zydus, because Zydus "intends to raise a new non-infringement defense to literal infringement." (
During discovery, Amgen's expert, Dr. Davies, opined that where other defendants used pregelatinized starch as a diluent, the cold water soluble portion functioned as a binder. (D.I. 353 at 169:18-23;
Second, Amgen suggests there would be no prejudice in allowing it to now assert the doctrine of equivalents against Zydus, because Amgen will use the same evidence and expert opinions against Zydus that it has used against other defendants. (D.I. 310 at 2). The court disagrees that there will be no prejudice. There are multiple ways Zydus could have taken a different approach to litigation had Amgen timely asserted the doctrine of equivalents against it, from having its own expert opine on the theory to pursuing different avenues of discovery. (D.I. 353 at 170:8-171:7). As demonstrated at trial, none of the defendants to whom Amgen has asserted its theory regarding pregelatinized starch have responded with the same defenses. There is no reason to assume that Zydus would have adopted their arguments. The fact that other defendants have had the opportunity to test Amgen's theories regarding pregelatinized starch does not cure the prejudice to Zydus.
Third, Amgen argues that the court's claim construction Memorandum, issued in the week before trial, left it with the belief that "it was free to assert infringement by equivalents" against any defendant. (D.I. 310 at 2). Amgen has unreasonably misconstrued the court's ruling. The operative Opinion does state that "Amgen is not precluded from relying on the doctrine of equivalents to prove that a defendant infringed the binder or disintegrant limitations, even though the Markush group for those elements are closed." (D.I. 300 at 8). But this ruling did not give Amgen the right to assert new infringement theories without proper notice. It simply stated that Amgen was not prevented from asserting infringement theories it had previously preserved.
Finally, Amgen argues that it "should be permitted to adjust its infringement theory and testimony to meet the constructions in the [claim construction Memorandum]," and asks for leave of the court to do so. (D.I. 310 at 2). Amgen, however, waited until the eve of trial to make this request, which left no time for Zydus to take any discovery that could have cured the prejudice against it. Amgen had several days to act after the court issued the Memorandum.
For the foregoing reasons, Amgen's Motion for Reargument of the Court's February 27, 2018 Memorandum and Order (D.I. 323) is denied. Zydus' Motion in Limine to preclude the assertion of the doctrine of equivalents against it (D.I. 307) is granted. An order consistent with this memorandum opinion will be entered.