Mylan Institutional LLC et al v. Aurobindo Pharma Ltd et al
ORDER ADOPTING 101 Report and Recommendations ORDERING Defendants to submit a brief within 14 days of this order and Plaintiffs to respond within 7 days after service of brief.. Signed by Judge Robert W. Schroeder, III on 2/7/2017. (sm, )
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF TEXAS
MYLAN INSTITUTIONAL LLC,
APICORE US LLC,
§ Case No. 2:16-CV-00491-RWS-RSP
AUROBINDO PHARMA LTD, et al.,
ORDER ADOPTING REPORT AND RECOMMENDATION
Before the Court is the Report and Recommendation (Docket No. 101) filed by Magistrate
Judge Payne on November 21, 2016 recommending that Plaintiffs’ motion for a preliminary
injunction (Docket No. 20) be granted. Aurobindo objects to the Report and Recommendation,
contending that it includes four incorrect conclusions of law. The Court disagrees for the following
First, Aurobindo argues that the Report incorrectly determines that Aurobindo failed to
raise a substantial question regarding noninfringement of the ’992 and ’616 patents. Docket No.
106 at 2-6. The Report explains, however, that “it is undisputed that Aurobindo’s process performs
every step and includes every element recited in claim 1 of the ’992 and ’616 patents except silver
oxide.” Docket No. 101 at 21. Aurobindo’s process uses manganese oxide, which is likely to be
found equivalent to silver oxide by a fact-finder. Id. at 21-24. The Court finds Aurobindo’s
arguments to the contrary unpersuasive for the extensive reasons explained in the Report. Id. at
Second, Aurobindo contends that the Report incorrectly finds that Aurobindo failed to raise
a substantial question concerning validity of the ’050 patent. Docket No. 10-6 at 6-8. However,
the numerous prior art references presented by Aurobindo suggest that those skilled in the art
were unable to achieve isosulfan blue purity levels of greater than 95 percent. On the basis of
a thorough review of the prior art and live testimony from the expert witnesses, the Court
concludes that the Report correctly finds that there is not a substantial question regarding validity
of the ’050 patent. See Docket No. 101 at 26-47.
Aurobindo’s third objection is that the Report incorrectly concludes that Plaintiffs
established a causal nexus between Aurobindo’s alleged infringement and Plaintiffs’ alleged harm.
Docket No. 106 at 8-10. As the Report explains, however, Aurobindo’s causal nexus arguments
are largely irrelevant to a product such as the accused isosulfan blue product, which would not be
on the market if Aurobindo had not obtained Food and Drug Administration approval for a product
that will likely be found to be covered by the patents-in-suit. See Docket No. 101 at 49-50. The
Report’s conclusion is consistent with other courts who have evaluated the causal nexus
requirement in the context of pharmaceutical products. See, e.g., Janssen Prod., L.P. v. Lupin Ltd.,
109 F. Supp. 3d 650, 697-701 (D.N.J. 2014).
Fourth, Aurobindo argues that the Report incorrectly finds irreparable harm. However, the
Report identifies hallmark examples of irreparable harm that are demonstrated by the preliminary
record, including lost sales, lost research and development opportunities, price erosion, and the
fact that Apicore must now directly compete with an infringer. Docket No. 101 at 47-49. These
findings were more than adequately supported by the record evidence.1
See, e.g., Docket No. 20-29 ¶¶ 5, 7, 9-22; Docket No. 79-11 ¶¶ 5-6, 9, 12-25, 32-23; Hr’g Tr. At
156:11-158:4, 159:22-163:9, 176:19-25; Docket No. 20-2 ¶¶ 39-46, 53-55, 60; Hr’g Tr. at 40:181
Finally, Aurobindo does not object to the Report’s findings with respect to Aurobindo’s
infringement of the ’050 patent or the validity of the ’992 and ’616 patents. Accordingly, the Court
affirms those findings. See United States v. Wilson, 864 F.2d 1219, 1221 (5th Cir. 1989) (findings
to which no specific objections are made do not require de novo review).
Plaintiffs’ Motion for Preliminary Injunction (Docket No. 20) will be GRANTED
following Plaintiffs’ submission of an adequate injunction bond. See Fed. R. Civ. P. 65.
Defendants will be enjoined from manufacturing, selling or offering for sale, using, or importing
the accused isosulfan blue product within the United States until further order of the Court.
Defendants are ORDERED to submit a brief of no more than five pages providing
a supported and reasoned amount of an appropriate injunction bond within 14 days of this
Order. Plaintiffs are ORDERED to file any response within seven days after service of
Defendants brief. The matter remains referred to Magistrate Judge Payne for further proceedings.
SIGNED this 7th day of February, 2017.
ROBERT W. SCHROEDER III
UNITED STATES DISTRICT JUDGE
41:2, 44:5-45:24, 47:20-51:2; Docket No. 20-14 ¶¶ 9, 12, 14, 29-32, 34-35; Docket No. 56-4 ¶¶ 68; Docket No. 79-18 ¶ 4, 14-25, 32-34; Hr’g Tr. at 182:5-184:19.
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