BAYER SCHERING PHARMA AG v. SANDOZ, INC. Nos. 08 Civ. 03710(PGG), 08 Civ. 08112(PGG).
813 F.Supp.2d 569 (2011)
BAYER SCHERING PHARMA AG and Bayer Healthcare Pharmaceuticals, Inc., Plaintiffs, v. SANDOZ, INC., Watson Pharmaceuticals, Inc., and Watson Laboratories, Inc., Defendants.
United States District Court, S.D. New York.
September 28, 2011.
August T. Horvath, Paul Wendell Garrity, Kelley Drye & Warren, Ronald William Meister, Thomas Kjellberg, Cowan, Liebowitz & Latman, P.C., New York, NY, Joseph A. Hynds, Lisa N. Phillips, Steven M. Lieberman, Rothwell Figg Ernst & Manbeck, PC, Cedric Chia Yang Tan, Kristen Marie Cooklin, Kilpatrick Townsend and Stockton LLP, Washington, DC, Steven Jerome Moore, Kelley Drye & Warren, LLP, Stamford, CT, Mark T. Jansen, Nancy Lynn Tompkins, Townsend and Townsend and Crew LLP, Byron R. Chin, Kilpatrick Townsend & Stockton LLP, San Francisco, CA, for Defendants.
MEMORANDUM OPINION & ORDER
PAUL G. GARDEPHE, District Judge.
These actions arise from Defendants' filing of Abbreviated New Drug Applications concerning two of Plaintiffs' brand-name oral contraceptive prescription drugs: Yasmin and Yaz. As a result of two prior decisions
In a March 29, 2010 Memorandum Opinion and Order, this Court dismissed Sandoz's Sherman Act counterclaims but granted leave to amend. Bayer Schera Pharma AG v. Sandoz, Inc., Nos. 08 Civ. 03710(PGG), 08 Civ. 8112(PGG), 2010 WL 1222012, *1 (S.D.N.Y. Mar. 29, 2010).
In its original Sherman Act counterclaims, Sandoz posited two separate markets for Yaz and Yasmin based on the active ingredients of each drug: for Yasmin,
In its amended counterclaims, Sandoz now alleges a product market encompassing both Yasmin and Yaz—specifically, a market of "oral contraceptives commonly prescribed also to treat PMDD [premenstrual dysphoric disorder] and associated symptoms."
I. MOTION TO DISMISS STANDARD
"To survive a motion to dismiss, a [counterclaim] must contain sufficient factual matter, accepted as true, to `state a claim to relief that is plausible on its face.'" Ashcroft v. Iqbal, 556 U.S. 662,
"In considering a motion to dismiss for failure to state a claim pursuant to Rule 12(b)(6), a district court may consider the facts alleged in the complaint, documents attached to the complaint as exhibits, and
II. RELEVANT PRODUCT MARKET
A. Pleading Standard
As in its original counterclaims, Sandoz's amended Sherman Act counterclaims allege four types of antitrust violations: (1) monopolization in violation of § 2 of the Sherman Act
"`In order to survive a motion to dismiss, a claim under Sections 1 and 2 of the Sherman Act must allege a relevant geographic and product market in which trade was unreasonably restrained or monopolized.'" Arista Records LLC v. Lime Group LLC,
"The relevant market for purposes of antitrust litigation is the `area of effective competition' within which the defendant operates." AD/SAT, Div. of Skylight, Inc. v. Associated Press,
AD/SAT, a Division of Skylight, Inc., 181 F.3d at 228 (emphasis in original) (quotation omitted).
"`A relevant product market consists of `products that have reasonable interchangeability for the purposes for which they are produced—price, use and qualities considered.'" PepsiCo, Inc. v. Coca-Cola Co.,
"The alleged product market `must bear a rational relation to the methodology courts prescribe to define a market for antitrust purposes—analysis of the interchangeability of use or the cross elasticity of demand....'" Arista Records LLC, 532 F.Supp.2d at 575 (quoting Todd v. Exxon Corp.,
"`Cross-elasticity' is related to interchangeability, and requires a consideration of the extent to which a change in the price of one product will alter demand for another product." Intellective, Inc., 190 F.Supp.2d at 610.
"Because market definition is a deeply fact-intensive inquiry, courts hesitate to grant motions to dismiss for failure to plead relevant product market." Todd, 275 F.3d at 199-200. "There is, however, no absolute rule against the dismissal of antitrust claims for failure to allege a relevant product market." Id. at 200. Plaintiffs
B. Sandoz's Alleged Product Market is Implausible
In its amended counterclaims, Sandoz now defines the relevant market for both Yasmin and Yaz as "oral contraceptives commonly prescribed also to treat PMDD and associated symptoms." (Yasmin Am. Cntrcl. ¶ 49; Yaz Am. Cntrcl. ¶ 52) According to Sandoz, "there currently happens to be only one molecule that performs the dual function that defines the market." (Sandoz Br. 5) That molecule combination is drospirenone and ethinylestradiol. (Yasmin Am. Cntrcl. ¶ 49; Yaz Am. Cntrcl. ¶ 52) In addition to Yasmin and Yaz, two generic drugs—Barr's Ocella, and Teva's Gianvi—offer that molecule combination and, according to Sandoz, make up the relevant market.
Bayer does not object to the geographic market Sandoz alleges—the United States—but argues that the relevant product market alleged in Sandoz's amended counterclaims is "just as implausible and irrational as [Sandoz's] original alleged market." (Bayer Reply Br. 1; see also Bayer Br. 5-6) In particular, Bayer argues that "Sandoz ... fails to account for most of the widely available substitutes for Yasmin and YAZ." (Id.)
As an initial matter, it must be acknowledged that Sandoz has not simply alleged a broader relevant product market in its amended counterclaims. Instead, it pleads allegations that directly contradict assertions made in its original counterclaims. Sandoz originally alleged that both Yasmin and Yaz are unique. (Yasmin Cntrcl. ¶ 73) ("There are no products that are reasonably interchangeable [with Yasmin for the] consumer."); Yaz Cntrcl. ¶ 70 ("[t]here are no [oral contraceptive] products that are reasonably interchangeable [with Yaz for] customers suffering from PMDD.") Now, Sandoz alleges that the two drugs "are prescribed interchangeably for treatment of PMDD and acne in combination with birth control." (Yasmin Am. Cntrcl. ¶ 42; Yaz Am. Cntrcl. ¶ 45) While Sandoz's unexplained about-face doubtless bears more on its credibility than on the plausibility of its newly pleaded relevant product market—which will rise or fall on its own merits—Sandoz's contradictory pleadings counsel that this Court closely scrutinize
With respect to the prophylactic effects of Yasmin and Yaz, Sandoz concedes that "`[d]ozens of oral contraceptives are available worldwide; most are comparable in terms of efficacy in their primary indication (preventing pregnancy) and safety.'" (Yasmin Am. Cntrcl. ¶ 36; Yaz Am. Cntrcl. ¶ 39) (citations omitted) Accordingly, the critical question with respect to Sandoz's newly pleaded product market is whether there are substitutes for Yasmin and Yaz available to women seeking not just contraception but relief from PMDD and "associated symptoms."
Sandoz acknowledges that "[o]ther drugs exist for the treatment of PMDD, which is typically treated with an anti-depressant." (Yasmin Am. Cntrcl. ¶ 46; Yaz Am. Cntrcl. ¶ 49) One class of anti-depressants—selective serotonin re-uptake inhibitor drugs—are prescribed for PMDD but are "not an acceptable substitute for many women who need both birth control and anti-PMDD medication because of the risk of drug interactions and/or additional serious side effects." (Id.) Sandoz also generally alleges that "several [non-SSRI] drugs, including the antidepressant St. John's Wort, which is commonly taken as a `natural' treatment for PMDD, are known to decrease the efficacy of oral contraceptives in birth control." (Id.)
These allegations are not sufficient to demonstrate that there is no combination of drugs that can serve as a functional substitute for Yasmin and Yaz. Accepting the factual allegations concerning SSRI anti-depressants and St. John's Wort as true, Sandoz does not plead facts demonstrating that there are no other anti-depressants or other drugs available to treat a woman on birth control medication who is suffering from PMDD and "associated symptoms" such as PMS. Indeed, other than SSRI anti-depressants and St. John's Wort—which is not an FDA-approved drug but simply an herbal remedy—Sandoz does not address any specific drug or treatment used for PMDD and PMS. In particular, Sandoz does not address non-SSRI anti-depressants and non-steroidal anti-inflammatory drugs, such as ibuprofen and aspirin, that are widely used for PMS.
Although Sandoz need not address every conceivable, far-fetched alternative to Yasmin and Yaz for the treatment of PMDD and associated symptoms, it must allege sufficient facts about other treatments to make its proposed product market plausible. See Hack v. President & Fellows of Yale College,
In sum, Sandoz has failed to plead sufficient facts to demonstrate that no two-drug combination is an acceptable substitute for Yaz or Yasmin. See, e.g., B.V. Optische Industrie De Oude Delft v. Hologic, Inc.,
C. Sandoz's Attempted Monopolization Claim Fails
Sandoz has also alleged a claim of attempted monopolization in violation of Section 2 of the Sherman Act. "[T]o demonstrate attempted monopolization[,] a plaintiff must prove (1) that the defendant has engaged in predatory or anticompetitive conduct with (2) a specific intent to monopolize and (3) a dangerous probability of achieving monopoly power." Spectrum Sports, Inc. v. McQuillan,
Accordingly, for purposes of its attempted monopolization counterclaim, Sandoz need not plead that Bayer actually possesses monopoly power; facts demonstrating that Bayer has a dangerous probability of achieving monopoly power in the relevant market are sufficient. "Monopoly or market power has been defined as the power to control prices or exclude competition in the relevant market. Market power
In connection with its attempted monopolization counterclaim, Sandoz alleges that the relevant market is the entire oral contraceptive market in the United States. (See Yasmin Am. Cntrcl. ¶¶ 88, 93 (alleging Bayer's "attempt to monopolize the U.S. oral contraceptive marketplace overall" and "attempt to monopolize oral contraceptive product sales in the United States"); Yaz Am. Cntrcl. ¶ 89) Bayer does not argue that Sandoz's pleaded market for its attempted monopolization counterclaim is improper, but instead contends that Sandoz has not pled facts demonstrating that it is dangerously probable that Bayer will achieve a monopoly in the U.S. oral contraceptive market.
Sandoz's allegations concerning its attempted monopolization claim are conclusory and speculative. For example, while Sandoz alleges that Bayer's "[s]ales of oral contraceptives ... constitute approximately half of all oral contraceptive sales in the United States" (Yasmin Am. Cntrcl. ¶ 34; Yaz Am. Cntrcl. ¶ 37), this allegation is contradicted by later assertions in the amended counterclaims that the combined market share of Yasmin and Yaz—as of 2008—is 29%. (Yasmin Am. Cntrcl. ¶ 44; Yaz Am. Cntrcl. ¶ 47) While Sandoz "believes that since the 29% share figures were published in 2008, Bayer's sales and share of oral contraceptives have continued to increase" (Sandoz Br. 21), this is speculation. Similarly, while Sandoz argues that the sales of Barr's generic drug Ocella should be included in calculating Bayer's market share, accepting that assertion arguendo, Sandoz has provided no information concerning Ocella's sales or market share. In sum, Sandoz's allegation that Bayer controls half of the oral contraceptive market in the United States is conclusory and speculative.
The 29% market share figure for which Sandoz has provided support is not sufficient to support a claim of actual monopolization. AD/SAT, Div. of Skylight, Inc., 181 F.3d at 229 ("we have held that a 33 percent market share does not approach the level required for a showing of dangerous probability of monopoly power") (citing Nifty Foods Corp. v. Great Atlantic and Pacific Tea Co.,
In its opposition brief, Sandoz cites no cases in support of its attempted monopolization claim and merely refers the Court to its counterclaim allegations that (1) Bayer controls "approximately half of all oral contraceptive sales in the United States," and (2) "[t]he oral contraceptive industry is mature and is dominated by a small number of large producers." (Sandoz Br. 21-22 (citing Yasmin Am. Cntrcl. ¶¶ 34-38, 44-45))
As discussed above, Sandoz has not pleaded facts demonstrating that Bayer controls 50% of the oral contraceptive market in the United States. Moreover, Sandoz's bare allegation that the oral contraceptive market is "dominated by a small number of large producers" does not support its claim that there is a dangerous probability of Bayer obtaining monopoly power. Indeed, the presence of other large competitors in the market undermines Sandoz's claim. Cf. Foam Supplies, Inc. v. Dow Chem. Co., No. 4:05CV1772 CDP, 2007 WL 4210354, at *5 (E.D.Mo. Nov. 27, 2007) ("The fact that Dow has large competitors as opposed to numerous very small competitors indicates that Dow lacks monopoly power or the ability to obtain such power.") (citing In re IBM Peripheral EDP Devices Antitrust Litig.,
Because Sandoz has not pleaded facts demonstrating that it has a plausible attempted monopolization claim, that claim will be dismissed. See Iqbal, 129 S.Ct. at 1949.
For the reasons stated above, Bayer's motion to dismiss the Fourth Amended Counterclaim in the Yasmin action (08 Civ. 3710) and the Fifth Amended Counterclaim in the Yaz action (08 Civ. 8112) are granted. In light of this Court's earlier dismissal with leave to replead, these counterclaims are now dismissed without leave to re-plead. The Clerk of the Court is directed to terminate the motions (Yasmin (08 Civ. 3710) Dkt. No. 152; Yaz (08 Civ. 8112) Dkt. No. 87).
- No Cases Found