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Bayer Intellectual Property GMBH v. Taro Pharmaceutical Industries Ltd.

United States District Court, D. Delaware

April 2, 2019

BAYER INTELLECTUAL PROPERTY GMBH, BAYER AG and JANSSEN PHARMACEUTICALS, INC., Plaintiffs,
v.
TARO PHARMACEUTICAL INDUSTRIES LTD., TARO PHARMACEUTICALS U.S.A., INC., et al., Defendants.

          SUPPLEMENTAL MARKMAN OPINION & ORDER

          Honorable Timothy B. Dyk United States Circuit Judge.

         This opinion and order further addresses the meaning of the term “rapid-release tablet” in claims 1-4 of U.S. Patent No. 9, 539, 218 (“the '218 patent”). Before the court are Joint Pretrial Order, ECF No. 150, Stipulation Regarding Infringement, ECF No. 152, and the parties' briefs on supplemental claim construction, Bayer's Br., ECF No. 153; Mylan's Br., ECF No. 154.

         I

         On May 19, 2017, Bayer Intellectual Property GmbH, Bayer AG, and Janssen Pharmaceuticals, Inc. (collectively, “Bayer”) filed suit against Mylan Pharmaceuticals Inc. (“Mylan”), alleging infringement of claims 1-4 of the '218 patent. The alleged act of infringement is Mylan's submission of an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration (“FDA”), seeking approval to engage in the commercial manufacture, use, or sale of its proposed rivaroxaban tablets prior to the expiration of the '218 patent.[1]

         Claim 1 of the '218 patent recites:

         1. A method of treating a thromboembolic disorder comprising

administering [rivaroxaban] no more than once daily for at least five days in a rapid-release tablet to a patient in need thereof, wherein the thromboembolic disorder is selected from the group consisting of pulmonary embolisms, deep vein thromboses, and stroke.

         '218 patent, col. 10, l. 63-col. 11, l. 5 (emphasis added). Claims 2, 3, and 4 are dependent claims and recite the method of claim 1, wherein the thromboembolic disorder is pulmonary embolisms, deep vein thromboses, and stroke, respectively. Id. col. 11, ll. 6-11.

         Earlier in this case, Bayer argued that the patent expressly defines the term “rapid-release tablet” as “a tablet which, according to the USP release method using apparatus 2 (paddle), has a Q value (30 minutes) of 75%.” Joint Claim Construction Br. 3, ECF No. 82. Mylan argued that the term should be construed as “a tablet that is not a modified- (e.g., sustained- or retarded-) release tablet.” Id. On July 3, 2018, the court agreed with Bayer and adopted Bayer's proposed construction in a Markman order construing the term “rapid-release tablet” in the claims as “a tablet which, according to the USP release method using apparatus 2 (paddle), has a Q value (30 minutes) of 75%.” Markman Order, ECF No. 91. The parties now dispute whether “a tablet which, according to the USP release method using apparatus 2 (paddle), has a Q value (30 minutes) of 75%” covers tablets that release more than 75% of the active ingredient within 30 minutes.

         On March 20, 2019, this court held a final pretrial conference and determined that this claim construction dispute should be resolved by the court prior to trial. Therefore, the court ordered the parties to submit simultaneous supplemental claim construction briefs on whether the court's construction of “rapid-release tablet” covers tablets that release more than 75% of the active ingredient within 30 minutes.

         On March 27, 2019, the parties submitted supplemental claim construction briefs and attached expert testimony on the issue. Bayer's Br; Mylan's Br. The parties agreed that no evidentiary hearing is necessary on this issue. After reviewing the parties' filings, the court agrees that no evidentiary hearing is necessary to resolve this claim construction dispute.

         The parties also filed a stipulation regarding infringement, which the court entered on March 25, 2019. Stip. Regarding Infringement. Pursuant to that stipulation, if the court agrees with Bayer's proposed supplemental construction of “rapid-release tablet, ” the parties stipulate that “Mylan literally infringes each of claims 1-4 of the '218 patent.” Id. ¶ 3. If the court agrees with Mylan's proposed supplemental construction of “rapid-release tablet, ” the parties stipulate that “Mylan does not literally infringe any claim of the '218 patent.” Id. ¶ 5.

         II

         The “rapid-release tablet” language of the claims is ambiguous. The court's original claim construction was ...


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