Wyeth v. Mylan Pharmaceuticals Inc., 101409 WVNDC, 1:07CV91

Docket NºCivil Action 1:07CV91
Opinion JudgeIrene M. Keeley United States District Judge
Party NameWYETH, Plaintiff, v. MYLAN PHARMACEUTICALS, INC., Defendant.
Case DateOctober 14, 2009
CourtUnited States District Courts, 4th Circuit, United States District Courts. 4th Circuit. United States District Court (Northern District of West Virginia)

WYETH, Plaintiff,



Civil Action No. 1:07CV91

United States District Court, Northern District of West Virginia

October 14, 2009



Pending before the Court are the parties’ cross motions for summary judgment. The plaintiff, Wyeth, seeks summary judgment as to whether the defendant, Mylan Pharmaceuticals, Inc.’s (“Mylan”), proposed production and marketing of a generic version of Effexor® XR will infringe on Wyeth’s patents for that drug. Wyeth also seeks a judgment that its patents are not invalid for failure to name one or more inventors. Mylan seeks summary judgment as to whether Wyeth’s patents are invalid for lack of enablement. For the reasons explained below, the Court DENIES Wyeth’s motion regarding infringement (dkt. no. 160), DENIES Mylan’s motion regarding enablement (dkt. no. 162), and GRANTS Wyeth’s motion regarding inventorship (dkt. no. 178).


In May 2007, Mylan filed an Abbreviated New Drug Application (“ANDA”), seeking approval from the United States Food and Drug Administration (“FDA”) to market a generic form of Effexor® XR, Wyeth’s successful extended-release version of Effexor®, its popular anti-depressant drug. According to Wyeth, Effexor® XR, which is taken only once a day, uses venlafaxine hydrochloride as the active ingredient and reduces several undesirable side effects commonly associated with immediate-release Effexor®, including the incidence of nausea and vomiting. In addition to filing its ANDA, Mylan filed a “paragraph IV certification” with the FDA alleging that the three patents issued to Wyeth for Effexor® XR are invalid and would not be infringed by Mylan’s manufacture, use or sale of the new drug described in its ANDA.1

Wyeth responded to Mylan’s ANDA by filing this lawsuit under the Hatch-Waxman Act, which “gives a drug patent owner the right to bring an action for infringement upon the filing of a paragraph IV certification.” Bristol-Myers Squibb Co. v. Royce Laboratories, Inc., 69 F.3d 1130, 1135 (Fed. Cir. 1995) (citing 35 U.S.C. § 271(e)(2)(A)). Wyeth alleges that Mylan’s proposed drug infringes on certain claims in three of its patents, specifically claims 20-25 of U.S. Patent No. 6,274,171 B1 (“the ‘171 patent”), claims 1, 2, 13, and 14 of U.S. Patent No. 6,403,120 B1 (“the ‘120 patent”), and claims 1-6 of U.S. Patent No. 6,419,958 B2 (“the ‘958 patent”) (collectively, the “patents in suit”). These patents are related and share essentially identical specifications.2

All of the asserted claims of the patents in suit are “method claims,” setting forth methods for using the extended release formulation of venlafaxine hydrochloride. Each claim is directed to one of two methods - either (1) “a method for providing a therapeutic drug plasma concentration over a twenty four hour period with diminished incidences of nausea and emesis,” see, e.g., Claim 20 of the ‘171 patent; or (2) “a method for eliminating the troughs and peaks of drug concentration in a patient’s blood plasma attending the therapeutic metabolism of plural daily doses of venlafaxine hydrochloride,” see, e.g., Claim 24 of the ‘171 patent.

Following briefing and a hearing on the parties’ proposed claim constructions, on May 22, 2009, the Court entered an Order that construed the contested claim terms as follows:

1. “Extended release formulation” means “a drug formulation (other than a hydrogel tablet) that releases the active ingredient at a slower rate than the immediate release formulation of the active ingredient such that the dosing frequency is once-a-day rather than the plural daily dosing for the immediate release formulation.”

2. “A method for eliminating the troughs and peaks of drug concentration in a patient’s blood plasma attending the therapeutic metabolism of plural daily doses of venlafaxine hydrochloride” means “a method in which the extended release formulation is administered once in a 24-hour period, resulting in a venlafaxine blood plasma concentration that rises to a maximum value, followed by a generally protracted decrease over the remaining period while maintaining during that 24-hour period levels of venlafaxine in blood plasma that are sufficient to provide relief from the condition being treated, thereby eliminating the multiple sharp peaks and troughs resulting from multiple daily dosing of the same total daily dose of the immediate release formulation as reflected in a graph of venlafaxine blood plasma concentration versus time.”3

3. “Diminished incidences of nausea and emesis” means “a decrease in the number of patients suffering from nausea and vomiting compared to patients receiving the same total daily dose of an immediate release formulation that is administered at least twice a day.”

4. “Spheroid” means “one or more particles that are generally shaped like a sphere, although they do not have to be perfectly round.”

5. “Encapsulated” means “filled into a pharmaceutically acceptable capsule.”

6. “Administering orally to a patient in need thereof” means “a patient in need of therapeutic blood plasma levels of venlafaxine, such as a patient suffering from one or more depressive or anxiety disorders, and the patient is being treated by a formulation that is swallowed.”

On June 10, 2009, Wyeth filed a motion for summary judgment in which it asserted that, based on this Court’s claim construction, Mylan’s proposed generic version of Effexor® XR directly infringes the asserted method claims of the patents in suit. Additionally, it contends that Mylan is liable for actively inducing infringement because, were its drug to be marketed, Mylan would advertise that the drug be used in an infringing manner and would instruct others in how to engage in an infringing use. Finally, Wyeth contends that Mylan is liable for contributory infringement because, if its proposed product is approved, Mylan would make and sell its generic drug.

Mylan also filed a motion for summary judgment, alleging that the patents in suit are invalid for lack of enablement. Based on the Court’s construction of the disputed claims, Mylan asserts that Wyeth’s patents are not fully enabled “commensurate with their broad scope.” Specifically, Mylan contends that the patents fail to teach and enable others to practice the full scope of the claimed invention because they teach and describe only one type of extended release formulation.


“Summary judgment is appropriate when there is no genuine issue as to any material fact and the movant is entitled to judgment as a matter of law.” Cooper Tech. Co. v. Dudas, 536 F.3d 1330, 1335 (Fed. Cir. 2008) (citing Fed.R.Civ.P. 56(c)). A court must view all facts in the light most favorable to the nonmoving party and draw all justifiable inferences in its favor. Auto. Techs. Int’l v. BMW of N. Am., Inc., 501 F.3d 1274, 1281 (Fed. Cir. 2007).

Once the moving party identifies those portions of the “the pleadings, the discovery and disclosure materials on file, and any affidavits [that] show that there is no genuine issue as to any material fact,” Fed.R.Civ.P. 56(c), the burden then shifts to the non-moving party to set forth “‘some evidence in the record sufficient to suggest that his view of the issue might be adopted by a reasonable factfinder.’” Glaverbel Societe Anonyme v. Northlake Marketing & Supply, Inc., 45 F.3d 1550, 1561 (Fed. Cir. 1995) (quoting Resolution Trust Corp. v. Juergens, 965 F.2d 149, 151 (7th Cir. 1992). The non-moving party, however, cannot rely on contradictions or conflicts within its own evidence. Barwick v. Celotex Corp., 736 F.2d 946, 960 (4th Cir. 1984).


A. Wyeth’s Motion for Summary Judgment on Infringement

According to Wyeth, given this Court’s construction of the disputed claims, there is no genuine issue of material fact as to whether Mylan’s generic form of Effexor® XR literally infringes on the asserted method claims of the patents in suit. It further contends that Mylan is liable for inducing infringement by proposing labels that would induce doctors, pharmacists and patients to use the drug in an infringing manner. Finally, Wyeth asserts that Mylan has engaged in contributory infringement by using labels that will knowingly and actively encourage others to infringe on Wyeth’s patents.

1. Direct Infringement of the Method Claims

An infringement analysis entails two steps. The first step is determining the meaning and scope of the patent claims asserted to be infringed. The second step is comparing the properly construed claims to the device accused of infringing.

Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff’d, 517 U.S. 370 (1996) (citations omitted).

Here, the Court has already determined the meaning and scope of the disputed claims, and thus must compare Mylan’s proposed generic version of Effexor® XR to those claims. Importantly, it must compare Mylan’s proposed product to the asserted method claims of the patents in suit rather than to Effexor XR®. See Zenith Labs, Inc. v. Bristol-Meyers Squibb Co., 19 F.3d 1418, 1423 (Fed. Cir. 1994).

When comparing the accused device to the claims, “the accused device infringes if it incorporates every limitation of a claim, either literally or under the doctrine of equivalents.” MicroStrategy Inc. v. Business Objects, S.A., 429 F.3d 1344, 1352 (Fed. Cir. 2005) (citations omitted).4 Thus, if “even one claim limitation is missing or not met, there is no literal infringement.” Id. Moreover, where a dependant claim is allegedly infringed, the Court cannot find literal infringement unless all of the elements and limitations in both the dependent claim and the independent claim on which it relies have been infringed. See ...

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