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Bayer Schera Pharma AG v. Sandoz

September 28, 2010

BAYER SCHERA PHARMA AG AND BAYER HEALTHCARE PHARMACEUTICALS INC., PLAINTIFFS,
v.
SANDOZ, INC., WATSON PHARMACEUTICALS, INC., AND WATSON LABORATORIES, INC., DEFENDANTS.



The opinion of the court was delivered by: Paul G. Gardephe, U.S.D.J.

MEMORANDUM OPINION AND ORDER

In this action, Bayer Schera Pharma AG and Bayer Healthcare Pharmaceuticals Inc. (collectively "Bayer") allege that Defendants' proposed marketing of generic versions of Bayer's brand-name oral contraceptive Yasmin will infringe on Bayer's patent rights. Bayer initiated this litigation after Defendants Watson Pharmaceuticals, Inc. and Watson Laboratories, Inc. (collectively "Watson"), and Defendant Sandoz, Inc. filed Abbreviated New Drug Applications ("ANDAs") with the U.S. Food and Drug Administration ("FDA") to market generic versions of Yasmin. (See Cmplt. ¶¶ 14, 15) Bayer alleges that Defendants' ANDA filings constitute infringement and inducement of infringement of U.S. Patent No. 5,569,652 ("the '652 patent"), which Bayer holds. (Cmplt. ¶¶ 20, 21, Ex. 1)

Defendants have moved for judgment on the pleadings pursuant to Fed. R. Civ. P. 12(c). (Docket No. 78) Under well established Federal Circuit precedent, Bayer cannot state a patent infringement claim based on Defendants' ANDA filings unless it can show that the '652 patent claims a use for Yasmin that has been approved by the FDA under Bayer's New Drug Application ("NDA") for Yasmin. For the reasons stated below, this Court has determined that the '652 patent does not claim a use for Yasmin that has been approved by the FDA. Accordingly, Defendants' motion for judgment on the pleadings will be GRANTED.

BACKGROUND

Watson and Sandoz each filed ANDAs seeking permission to market a generic version of Yasmin (Cmplt. ¶¶ 14, 15), and both submitted Paragraph IV certifications to the FDA alleging that Bayer's patents are invalid or will not be infringed by the use, manufacture, or sale of a generic version of Yasmin. (Id. ¶¶ 18, 19) Watson and Sandoz each sent statutorily-required ANDA notice letters to Bayer in March 2008. (Id. ¶¶ 18, 19) On April 17, 2008, Bayer filed the instant action against Defendants for infringement of the '652 patent. (Id. ¶¶ 20, 21) Pursuant to21 U.S.C. § 355(j)(5)(B)(iii), Bayer's filing of this action triggered an automatic thirty-month stay on the FDA's approval of Defendants' respective ANDAs.The thirty-month stay as to each ANDA expired earlier this month.*fn1

Bayer's Complaint asserts claims against Defendants for infringement and inducement of infringement of the '652 patent under 35 U.S.C. § 271(e)(2)(A), which provides that it "shall be an act of infringement to submit [an ANDA] for a drug claimed in a patent or the use of which is claimed in a patent." (See Cmplt. ¶¶ 22-32, 36-46) Bayer also alleges that the Defendants' intended sale of a generic version of Yasmin will induce infringement of the '652 patent in violation of 35 U.S.C. § 271(b), which provides that whoever "actively induces infringement of a patent shall be liable as an infringer."

35 U.S.C. § 271(b).

Bayer alleges that the '652 patent -- the "patent-in suit" -- claims a use for Yasmin that has been approved by the FDA. (Cmplt. ¶ 21; Bayer Br. 1-2, 12-24) In support of this argument, Bayer notes that -- in connection with its NDA for Yasmin -- it notified the FDA that the '652 patent claims the drug for which it sought approval. As a result, the FDA listed the '652 patent in its Approved Drug Products with Therapeutic Equivalence Evaluations text ("the Orange Book"). (Cmplt. ¶¶ 20-21)

Claim 11 of the '652 patent -- which is the central patent claim at issue in this case*fn2 -- asserts the following "method-of-use" claim for Yasmin:

A method of simultaneously achieving, during pre-menopause or menopause, a contraceptive effect, an anti-androgenic effect, and an anti-aldosterone effect in a female patient in need thereof comprising administering an effective amount of dihydrospirorenone and an effective amount of an estrogenic compound, wherein said effective amount of dihydrospirorenone is effective to simultaneously achieve a gestagenic effect, anti-androgenic effect, and an anti-aldosterone effect in said female patient. (Cmplt., Ex. 1 ('652 Patent, Claim 11))*fn3

DISCUSSION

I. MOTION TO DISMISS STANDARD

"To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to 'state a claim for relief that is plausible on its face.'"*fn4

Aldosterone is defined as "[a] steroid hormone secreted by the adrenal cortex that regulates the salt and water balance in the body." Dorland's Medical Dictionary for Health Consumers (2007), http://medical-dictionary.thefreedictionary.com/aldosterone (last visited Sept. 24, 2010). "Anti-aldosterone" effect refers to an inhibitory effect on the "renin-angiotensin-aldosterone system," which influences electrolyte balance in the body and impacts a number of bodily functions, including fluid retention. (Bayer Ex. 3 (Shulman Decl.), ¶¶ 13-14)

Anti-androgenic is defined as "[a] substance that blocks the action of androgens, the hormones responsible for male characteristics." Dorland's Medical Dictionary for Health Consumers (2007), http://medical-dictionary.thefreedictionary.com/antiandrogen (last visited Sept. 24, 2010). "Anti-androgenic" effect refers to the inhibition of the action of testosterone and other androgens on androgen receptors, which apparently can lead to a reduction in facial hair or acne. (Bayer Ex. 3 (Shulman Decl.), ¶¶ 13-14)

Ashcroft v. Iqbal, 556 U.S. --, 129 S.Ct. 1937, 1949 (2009) (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007)). To meet this standard, a complaint's factual allegations must permit the Court, "draw[ing] on its judicial experience and common sense," "to infer more than the mere possibility of misconduct." Id. at 1950. "In considering a motion to dismiss . . . the court is to accept as true all facts alleged in the complaint," Kassner v. 2nd Ave. Delicatessen Inc., 496 F.3d 229, 237 (2d Cir. 2007) (citing Dougherty v. Town of N. Hempstead Bd. of Zoning Appeals, 282 F.3d 83, 87 (2d Cir. 2002)), and must "draw all reasonable inferences in favor of the plaintiff." Id. (citing Fernandez v. Chertoff, 471 F.3d 45, 51 (2d Cir. 2006)). However, "threadbare recitals of a cause of action, supported by mere conclusory statements, do not suffice [to establish entitlement to relief]." Iqbal, 129 S.Ct. at 1949. Motions for judgment on the pleadings pursuant to Fed. R. Civ. P. 12(c) are considered under the same standards "'applicable to a motion under Rule 12(b)(6).'" King v. Am. Airlines, Inc., 284 F.3d 352, 356 (2d Cir. 2002) (quoting Burnette v. Carothers, 192 F.3d 52, 56 (2d Cir. 1999)).

II. THE ANDA FRAMEWORK

"The Hatch-Waxman Act strikes a balance between two potentially competing policy interests -- inducing pioneering development of pharmaceutical formulations and methods and facilitating efficient transition to a market with low-cost, generic copies of those pioneering inventions at the close of a patent term." Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 601 F.3d 1359, 1360 (Fed. Cir. 2010) (citing Andrx Pharms., Inc. v. Biovail Corp., 276 F.3d 1368, 1371 (Fed. Cir. 2002)).

"The Hatch-Waxman Act . . . requires a pioneer drug manufacturer to notify the FDA of all patents that 'claim [ ] the drug for which the [NDA] applicant submitted the application.'" Eli Lilly & Co. v. Teva Pharm. USA, Inc., 557 F.3d 1346, 1348 (Fed. Cir. 2009) (quoting 21 U.S.C. §§ 355(b)(1) & (c)(2)). "The FDA lists such patents in its Approved Drug Products With Therapeutic Equivalence Evaluations, known as the 'Orange Book.'" Id. Pursuant to the Hatch-Waxman Act, "a generic manufacturer infringes a patent . . . by filing an ANDA to obtain approval for a generic drug product claimed by a valid and unexpired patent." Id. (citing 35 U.S.C. § 271(e)(2)).

"A manufacturer that seeks to market a generic drug may submit an ANDA for approval by the [FDA], rather than submitting a full New Drug Application ('NDA') showing the safety and efficacy of the generic drug." Eli Lilly & Co., 557 F.3d at 1348. "The ANDA process streamlines FDA approval by allowing the generic manufacturer to rely on the safety and efficacy studies of a drug already in the Orange Book upon a showing of bioequivalence." Novo Nordisk A/S, 601 F.3d at 1361.

"As part of the approval process, an ANDA applicant must make a certification addressing each patent listed in the Orange Book that claims the drug." Eli Lilly & Co., 557 F.3d at 1348. In that certification, "the generic manufacturer must select one of four alternatives permitting use of the patented product or process: (I) no such patent information has been submitted to the FDA; (II) the patent has expired; (III) the patent is set to expire on a certain date; or (IV) the patent is invalid or will not be infringed by the manufacture, use, or sale of the generic drug." Novo Nordisk A/S, 601 F.3d at 1361 ...


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