Case 1:16-cv-00152-LPS Document 100 Filed 06/07/17 Page 1 of 7 PageID #: 1623
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`M O R R I S , N I C H O L S , A R S H T & T U N N E L L L L P
`1201 NORTH MARKET STREET
`P.O. BOX 1347
`WILMINGTON, DELAWARE 19899-1347
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`(302) 658-9200
`(302) 658-3989 FAX
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`MARYELLEN NOREIKA
`(302) 351-9278
`mnoreika@mnat.com
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`The Honorable Leonard P. Stark
`United States District Court
`for the District of Delaware
`844 N. King Street
`Wilmington, DE 19801
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`May 31, 2017
`- Original Filing Date
`June 7, 2017 - Redated Filing Date
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`VIA ELECTRONIC FILING
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`Re:
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`Cosmo Technologies Limited, et al. v. Mylan Pharmaceuticals Inc., et al,
`C.A. Nos. 16-152-LPS, C.A. No. 15-669-LPS
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`Dear Chief Judge Stark:
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`Pursuant to the Court’s May 25, 2017 Order (D.I. 97) in the above-identified case, I write
`to submit a joint status report on behalf of the parties.
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`Plaintiffs’ Position
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`Plaintiffs do not believe the developments in the trial against Actavis and Alvogen
`resolve the infringement issues in the second wave cases against Mylan and Lupin
`(“second wave Defendants”).
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`Plaintiffs disagree with Defendants Mylan and Lupin that Plaintiffs will necessarily fail
`to meet their burden of proof on infringement based on the ruling in the first-wave trial against
`Actavis and Alvogen.
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`REDACTED - PUBLIC VERSION
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`Cosmo Ex 2003-p. 1
`Mylan v Cosmo
`IPR2017-01035
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`Case 1:16-cv-00152-LPS Document 100 Filed 06/07/17 Page 2 of 7 PageID #: 1624
`The Honorable Leonard P. Stark
`May 31, 2017
`Page 2
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`First, as compared to Plaintiffs’ case against Actavis and Alvogen, there are factual
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`differences in Plaintiffs’ infringement cases against Defendants Lupin and Mylan. Mylan and
`Lupin have different formulations with different components and different methods of
`manufacture than Actavis and Alvogen.
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`Second, to the extent that Defendants Mylan and Lupin are now arguing that Plaintiffs’
`infringement contentions are somehow deficient, Plaintiffs disagree. As a preliminary matter,
`Plaintiffs note that, while all parties raised various disputes over the course of fact discovery,
`Defendants never complained about the sufficiency of Plaintiffs’ infringement contentions
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` And, for example, when Defendant Lupin
`requested that Plaintiffs supplement their interrogatory responses related to validity issues,
`Plaintiffs did so. Raising an issue with the sufficiency of Plaintiffs’ infringement contentions
`now is not timely. But notwithstanding Defendants’ arguments on the sufficiency of Plaintiffs’
`infringement contentions, Plaintiffs’ infringement contentions adequately provide notice to
`Mylan and Lupin, in accordance with the applicable federal and local rules, that Mylan’s and
`Lupin’s ANDA products meet every limitation of the asserted claims
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`During the expert discovery period that begins tomorrow and is scheduled to continue
`through August 31, 2017, the parties will exchange expert reports and take depositions to
`supplement their respective infringement positions further, in accordance with Rule 26(a)(2)(C)
`and the Court's Scheduling Order. Courts have recognized that infringement contentions
`function to place an opposing party on notice of the infringement theory, but are not intended to
`further circumscribe the proof that a party may rely upon to make its case at trial. In other
`words, while the overall infringement positions in contentions and expert reports need to be
`consistent, they do not need to be coextensive. E.g., Fenner Investments, Ltd. v. Hewlett-
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`Cosmo Ex 2003-p. 2
`Mylan v Cosmo
`IPR2017-01035
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`Case 1:16-cv-00152-LPS Document 100 Filed 06/07/17 Page 3 of 7 PageID #: 1625
`The Honorable Leonard P. Stark
`May 31, 2017
`Page 3
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`Packard Co., C.A. No. 6:08-cv-273, 2010 WL 786606, at *2 (E.D. Tex. Feb. 26, 2010); Shire
`LLC v. Impax Labs., Inc., C.A. No. 10-5467 RS (MEJ), 2013 WL 1786591 (N.D. Cal. Apr. 25,
`2013). Further, Mylan and Lupin will be able to respond to Plaintiffs’ evidence of infringement
`in their rebuttal reports. Importantly, Plaintiffs are not seeking to introduce new infringement
`theories against Defendants, but instead are supporting their existing theories and taking into
`account the guidance provided by the Court in connection with its ruling in the case against
`Actavis and Alvogen,
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` See, e.g., Power
`Integrations, Inc. v. Fairchild Semiconductor Int'l, Inc., 763 F. Supp. 2d 671, 690-92 (D. Del.
`2010) (Stark, J.) (finding that the Pennypack factors weighed against striking theory of
`infringement by the doctrine of equivalents in supplemental expert report); Abbott Labs. v. Lupin Ltd.,
`C.A. No. 09-152-LPS, 2011 WL 1897322, at *3-5 (D. Del. May 19, 2011) (Stark, J.) (finding that the
`Pennypack factors weighed against excluding Lupin’s invalidity defenses, and nothing that “courts favor
`the resolution of disputes on their merits”). Moreover, there is no plausible prejudice here. Had Plaintiffs
`stated expressly in their contentions that
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`there would have been nothing more
`Defendants could have done or learned during fact discovery. Defendants will receive the assessment of
`Plaintiffs’ expert in expert discovery, precisely as the applicable rules and case schedule contemplate.  
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`Third, Defendants Mylan and Lupin are not unduly prejudiced by Plaintiffs’ streamlining
`of their infringement case at this stage.1 Expert discovery is just beginning, with the first of three
`rounds of expert reports scheduled to be exchanged tomorrow, and expert discovery is not
`scheduled to close until August 31, 2017. Trial is not scheduled to begin until October 30, 2017
`– about five months from now. Streamlining the case at this stage will still result in substantial
`conservation of costs and resources going forward for all parties and for the Court.
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`Mylan’s Position
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`As the Court is aware, Mylan has consistently urged Plaintiffs from at least as early as
`April 6, 2016
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` See, e.g., D.I. 92, Exhibits 3, 4;
`D.I. 66, Exhibit 3. Today, on the literal eve of the parties exchanging expert reports2, Plaintiffs
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` This pattern of asserting patents and claims
`throughout litigation only to unilaterally drop them just days before deadlines, after the parties
`have expended significant time and resources, is entirely improper. These patents and claims
`should never have been asserted, or at the very least, dropped long ago.
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`1
`The exclusion of critical evidence, such as evidence that will be relied on by Plaintiffs'
`experts on infringement, is an extreme sanction not normally imposed absent a showing of
`willful deception or flagrant disregard of a court order by the proponent of the evidence. See,
`e.g., Abbott Labs., at *3-5; Power v. Fairchild, 763 F. Supp. 2d at 692.
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`Expert reports were originally due on May 25, 2017. But with that date falling in the
`middle of the Actavis/Alvogen trial, the parties agreed to move the exchange to June 1, 2017.
`D.I. 95.
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`Cosmo Ex 2003-p. 3
`Mylan v Cosmo
`IPR2017-01035
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`Case 1:16-cv-00152-LPS Document 100 Filed 06/07/17 Page 4 of 7 PageID #: 1626
`The Honorable Leonard P. Stark
`May 31, 2017
`Page 4
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`But, even with this narrowed set of asserted claims, this Court’s ruling during the
`Actavis/Alvogen case resolves the remaining issues in dispute. During that trial, this Court
`granted Actavis/Alvogen’s motion for judgment of noninfringement on partial findings following
`the conclusion of Plaintiffs’ case in chief on infringement.
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` The same finding is
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`warranted here.
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`Here, Plaintiffs rely on the exact same evidence in alleging infringement
`, as their infringement contentions illustrate:
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`Thus, Plaintiffs’ assertion of these claims suffer from a material failure of proof, the same failure
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`Cosmo Ex 2003-p. 4
`Mylan v Cosmo
`IPR2017-01035
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`Case 1:16-cv-00152-LPS Document 100 Filed 06/07/17 Page 5 of 7 PageID #: 1627
`The Honorable Leonard P. Stark
`May 31, 2017
`Page 5
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`of proof this Court identified during the Actavis/Alvogen trial as supporting judgement under
`Rule 52(c).
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` This despite the fact that Mylan
`produced tablet samples six weeks prior to Plaintiffs’ service of these infringement contentions.
`To the extent Plaintiffs intend to introduce never before disclosed infringement theories through
`their experts, such approach is in direct contravention of the Local Patent Rules.3 See Default
`Standard, 4(c). As a result, and in light of this Court’s ruling in the Actavis/Alvogen case,
`Plaintiffs’ lack of any proof of infringement is dispositive.
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`Plaintiffs’ position regarding the sufficiency, or insufficiency, of their infringement
`contentions misses the mark. Mylan’s position is that Plaintiffs should be held to the theories
`and factual bases espoused in their infringement contentions. The contentions themselves are not
`necessarily deficient, but the infringement theory Plaintiffs put forth has been squarely rejected
`by this Court in the Actavis/Alvogen case.
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` Try as they may to separate from the Actavis/Alvogen
`case, the infringement theory was the same. And because of that, the result should be the same.
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`Mylan appreciates this Court’s Order for a joint status report and how these recent
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`developments impact this case. As always, Mylan is available to discuss further at the Court’s
`convenience.
`Lupin’s Position
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`In the Lupin case, Plaintiffs are currently continuing to assert
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` During the parties’ discussions on May 30 , Lupin provided to Plaintiffs its
`position on the impact of the findings in the Actavis/Alvogen cases, including the reasoning for
`its position. Plaintiffs declined to offer any detail on their position, beyond saying that Plaintiffs
`had not yet provided their expert reports on infringement and implying that they will be adding
`evidence not included in their infringement contentions.
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` Lupin has sought a declaratory judgment of noninfringement and invalidity with
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`Like Lupin, Mylan will oppose any attempt by Plaintiffs to introduce new theories or
`bases for infringement not included in their contentions served pursuant to the Local Rules in
`this case.
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`Cosmo Ex 2003-p. 5
`Mylan v Cosmo
`IPR2017-01035
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`Case 1:16-cv-00152-LPS Document 100 Filed 06/07/17 Page 6 of 7 PageID #: 1628
`The Honorable Leonard P. Stark
`May 31, 2017
`Page 6
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`respect to
`respect to these patents.
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` (D.I. 67) and maintains its request for a judgment with
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`Additionally, in a continued effort to sandbag Lupin, Plaintiffs refused to provide their
`positions on the impact of the Actavis/Alvogen trial until 5:08 pm on May 31, 2017, just prior to
`the 6:00 pm filing deadline for this joint status report, depriving Lupin of an opportunity to fully
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`consider and respond to Plaintiffs’ positions, despite having Lupin’s position the day before.
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`In view of Plaintiffs’ decision to proceed to trial on
`against Actavis and Alvogen, Lupin believes that Plaintiffs should be required to further limit the
`claims to only those they intend to pursue at trial, in order to prevent Lupin from wasting
`additional resources during expert discovery and trial preparations with respect to claims
`Plaintiffs do not intend to pursue at trial.
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`. Lupin
`believes that the finding in the Actavis/Alvogen case is dispositive in Lupin’s case.
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`In Lupin’s case, Plaintiffs argued, and the Court agreed, that the term
` should have the same construction as in the Actavis and Alvogen cases. See
`D.I. 96, D.I. 120. Similar to the proof presented in the Actavis and Alvogen cases, Plaintiffs’
`infringement contentions with respect to the
` term rely on
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`Lupin also asked the Court for permission to file a summary judgment motion of non-
`infringement with respect to all asserted claims of the ’651 patent, the ’799 patent, and the ’888
` of the ’716 patent. See,
`patent, and asserted claims
`D.I. 131. Despite opposing Lupin’s request just two weeks ago,
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`Cosmo Ex 2003-p. 6
`Mylan v Cosmo
`IPR2017-01035
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`Case 1:16-cv-00152-LPS Document 100 Filed 06/07/17 Page 7 of 7 PageID #: 1629
`The Honorable Leonard P. Stark
`May 31, 2017
`Page 7
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` Plaintiffs also
`criticize Lupin for not raising concerns about Plaintiffs infringement contentions.7 Plaintiffs
`conflate the sufficiency of their infringement disclosures with their burden of proof regarding
`infringement. Lupin has consistently stated that Plaintiffs have not met their burden of proof
`with regard to infringement. While Plaintiffs state that they provided “exemplary evidence” in
`their contentions, the evidence they cited is the same type of evidence—
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`—that this Court found insufficient in the Actavis/Alvogen trial.
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`Moreover, although Lupin provided samples of its tablets to Plaintiffs in October 2016,
`the tablets are not mentioned in Plaintiffs’ infringement contentions, served on August 31, 2016,
`and Plaintiffs did not supplement their contentions prior to the close of fact discovery on March
`31, 2017. See id. Lupin will receive Plaintiffs’ Opening Expert Report(s) on Infringement on
`June 1, 2017.8 During a meet-and-confer on May 30, 2017, Plaintiffs indicated that they intend
`to provide additional evidence of infringement with respect to the term
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` beyond what is cited in Plaintiffs’ contentions. Lupin will oppose any attempt by
`Plaintiffs to introduce new theories of infringement not included in their contentions at this stage
`of the case and believes that Plaintiffs cannot meet their burden of proof based on their
`contentions. On the record in this case, judgment in favor of Lupin is appropriate for the same
`reasons the Court set forth in the Actavis/Alvogen case.
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`Lupin appreciates this Court’s Order for a joint status report and how these recent
`developments impact this case. As always, Lupin is available to discuss further at the Court’s
`convenience.
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`Respectfully,
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`/s/ Maryellen Noreika
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`Maryellen Noreika (#3208)
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` Attorneys for Plaintiffs
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`MN/bac
`cc:
`Clerk of Court
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`All Counsel of Record
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`7
`Lupin asked Plaintiffs to supplement their response to Lupin’s interrogatory seeking
`Plaintiffs’ contentions regarding validity because Plaintiffs had not provided any substantive
`response despite having Lupin’s invalidity contentions for many months.
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`The exchange of opening expert reports was originally scheduled for May 18, 2017.
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`After two separate requests for extension by Plaintiffs, this exchange is currently scheduled for
`June 1, 2017.
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`Cosmo Ex 2003-p. 7
`Mylan v Cosmo
`IPR2017-01035
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