MEMORANDUM OPINION
Currently before the Court are three antitrust cases filed by the direct purchasers (and certain assignees of direct purchasers) of Ovcon 35 (“Ovcon”), a brand-name oral contraceptive marketed by Warner Chilcott. 1 Plaintiffs allege that Defendant Barr Pharmaceuticals, Inc. (“Barr”), a manufacturer of Ovcon, entered into an illegal agreement with Warner Chilcott to delay the market entry of Barr’s generic version of Ovcon in exchange for $20 million. 2 According to Plaintiffs, this agreement violated Section 1 of the Sherman Act, 15 U.S.C. § 1, by denying direct purchasers of Ovcon the benefits of generic competition and causing them to pay higher prices for Ovcon. Plaintiffs have moved for partial summary judgment on the issue of whether Barr’s agreement with Warner Chilcott constituted a per se unreasonable restraint of trade. Barr has filed a cross-motion for summary judgment, arguing (among other things) that its agreement with Warner Chilcott should be examined under a rule of reason analysis, and that the procompetitive benefits of the agreement outweighed any of its alleged anti-competitive effects.
After a searching review of the parties’ motions, including the mountainous attachments thereto, applicable statutory authority and case law, and the entire record herein, the Court holds that the agreement between Barr and Warner Chilcott must be evaluated under the rule of reason and cannot be condemned as a per se unlawful restraint of trade. The Court further holds that genuine issues of material fact exist with respect to the proper definition of the relevant product market in this case, and that these factual issues preclude entry of summary judgment. Accordingly, the Court shall DENY Plaintiffs’ Motion for Partial Summary Judgment, and shall GRANT-IN-PART and DENY-IN-PART Defendant’s Motion for Summary Judgment, for the reasons that follow.
I. BACKGROUND
A. Factual Background
This case arises in the context of the manufacturing and sale of brand-name
The parties offer conflicting descriptions of the Warner Chilcott — BMS supply rela
Plaintiffs advance a very different view concerning BMS’s performance under its contract with Warner Chilcott, which Plaintiffs characterize as “adequate.” Pis.’ Resp. Stmt. ¶ 8. Plaintiffs argue that, “[o]n average, BMS provided Warner Chilcott with more than three months of Ovcon inventory.” Id. Plaintiffs also argue that Warner Chilcott’s supply problems were self-induced because Warner Chilcott purposefully “bled down” its Ovcon inventory when it incorrectly anticipated FDA-approval (and a corresponding product launch) of a chewable version of Ovcon. Id. ¶ 10. Plaintiffs conclude that, based on evidence in the record, Warner Chilcott sought to enter into an agreement with Barr because it knew that the market entry of a generic version of Ovcon would substantially diminish its sales and profits. See, e.g., Pis.’ Mot., Ex. 9 at 2 (5/13/08 Board Minutes) (“[t]he biggest risk to the Company is the introduction of a generic version of Ovcon”); Def.’s Resp. Stmt., Ex. C at 4, 201:23-25 (Depo. Tr. of Roger Boissonneault) (discussing the market entry of Barr’s generic Ovcon and indicating that Warner Chilcott “would lose 50 percent of [its] business in the first year. That’s the general metric for a generic coming into the marketplace for an oral contraceptive”); Pis.’ Mot., Ex. 10 at 1 (1/20/03 Email from W. Poll to J. Smith) (estimating that Ovcon sales would increase from $61 million in 2003 to $78 million in 2005 if no generic were introduced, and would decrease to $18 million if a generic were launched in 2003). 6
The parties’ conflicting views are also reflected in their divergent characterizations of Warner Chilcott’s plans to develop a chewable version of Ovcon. According to Plaintiffs, Warner Chilcott planned to convert Ovcon patients to a chewable version of Ovcon that would not have a generic equivalent as a way of protecting its Ovcon share. Pis.’ Stmt. ¶ 63; Pis.’ Opp’n, Ex. 12 at 2 (3/15/02 Report) (describing a strategy to “delay generic entry,” “protect Ovcon,” and indicating that “[p]hysieians will NOT be asked to write ‘Ovcon Chewable’ initially,” but “[i]f generic becomes available, new strategy will ask physicians to write ‘Chewable’ ”).
See also
Pis.’ Opp’n, Ex. 27 at 3 (8/25/03 Brand Plan) (“The major threat this year to Ovcon is the inevitable launch of a generic by Barr
Whether motivated by supply concerns (as Barr suggests) or generic entry concerns (as Plaintiffs suggest), on September 10, 2003, Warner Chilcott and Barr signed a Letter of Intent. Def.’s Stmt. ¶ 13. The Letter of Intent contemplated an agreement that would grant Warner Chilcott an option to acquire a five-year exclusive license to Barr’s rights under its Abbreviated New Drug Application (“ANDA”) for a generic version of Ovcon pending before the FDA, and obligate Barr to exclusively supply Warner Chilcott’s requirements of Ovcon. Id. Barr subsequently submitted the Letter of Intent to the Federal Trade Commission (“FTC”) for review. Def.’s Opp’n, Ex. 80 at 1 (4/30/03 Letter from M. Kovner to Pre-merger Notification Office and the Director of Operations and Civil Enforcement). Although Barr claims that the “letter of intent met with no objection from the FTC’s Merger Division,” Dei’s Opp’n at 8, the FTC Bureau of Competition sent a letter to Barr stating that
we [the FTC] are concerned that this transaction, if consummated, has the potential to significantly reduce competition by eliminating the only generic alternative to Ovcon. Accordingly, we intend to seek information relating to the Ovcon transaction.
Def.’s Opp’n, Ex. 84 at 1 (2/17/04 Letter from B. Albert to M. Kovner). 7
Notwithstanding the FTC’s concerns, on March 24, 2004, Warner Chilicott and Barr executed the contemplated agreement, and according to its terms, Warner Chilcott made an initial $1 million payment to Barr.
8
Pis.’ Stmt. ¶ 3. Barr announced the Agreement in a press release dated March
In November 2005, various plaintiffs, including the FTC, a number of states, and the Plaintiffs in the above-captioned actions, filed Complaints against Warner Chilcott and Barr alleging that their Agreement violated the antitrust laws. Id. ¶ 7. On September 25, 2006, Warner Chil-cott signed a waiver that terminated the exclusivity provisions of the Agreement. Id. As a result, Barr was able to market a generic version of Ovcon in the United States, and did so in October 2006 with the launch of Balziva, a lower-priced generic equivalent of Ovcon. Id. ¶ 8; Def.’s Resp. Stmt. ¶ 8.
Within months of Balziva’s introduction, sales of Ovcon declined substantially, and Warner Chilcott reported that “OVCON net sales during the quarter declined $19.4 million, or 80.7%, compared with the prior year quarter. The decline in OVCON revenue was due to the introduction of a generic version of OVCON 35 in late October 2006, which led to an 80.4% decline in filled prescriptions for OVCON 35 compared to the same quarter last year.” Pis.’ Stmt., Ex. 14 at 1 (5/11/07 News Release). Barr does not deny the accuracy or existence of Warner Chilcott’s report, but argues that the report fails to describe other factors exacerbating the decline in Ovcon sales. Def.’s Resp. Stmt. ¶ 9. For example, Barr explains that Warner Chilcott terminated the widespread practice of “sampling” (the promotional practice of providing free samples of brand-name products to attract new patients) once Bal-ziva was introduced into the market. 10 Def.’s Resp. Stmt. ¶ 9; Def.’s Stmt. ¶¶ 25-27. In any event, Barr currently supplies Warner Chilcott (non-exclusively) with tablets that Warner Chilcott sells as Ovcon, and with tablets that Warner Chilcott sells to Watson Pharmaceuticals, Inc. that are marketed as “Zenehent,” another generic form of Ovcon. 11 Pis.’ Stmt. ¶ 100.
B. Procedural Background
The above-captioned cases originally began with the filing of eight separate ac
Plaintiffs reached a settlement agreement with Warner Chilcott that was approved by the Court on July 10, 2008, which dismissed Warner Chilcott as a Defendant in these cases.
See Meijer, Inc. v. Warner Chilcott Holdings Co. III, Ltd.,
Plaintiffs filed a Motion for Partial Summary Judgment (“Pis.’ Mot.”) on November 14, 2007. See Meijer, Inc. v. Barr Pharmaceuticals, No. 05-2195, Docket No. [149]; Walgreen Co. v. Barr Pharmaceuticals, No. 06-494, Docket No. [88]; CVS Pharmacy, Inc. v. Barr Pharmaceuticals, No. 06-795, Docket No. [95]. Barr filed a Motion for Summary Judgment (“Def.’s Mot”) on November 28, 2007. See Meijer, Inc., No. 05-2195, Docket No. [157]; Walgreen Co., No. 06-494, Docket No. [96]; and CVS Pharmacy, Inc., No. 06-795, Docket No. [103]. Plaintiffs filed their Opposition to Barr’s Motion for Summary Judgment (“Pis.’ Opp’n”) on December 21, 2007, and Barr filed its Opposition to Plaintiffs’ Motion for Partial Summary Judgment (“Def.’s Opp’n”) on January 2, 2008. Plaintiffs replied to Barr’s Opposition (“Pis.’ Reply”) on January 18, 2008, and Barr replied to Plaintiffs’ Opposition (“Def.’s Reply”) on February 1, 2008. 12 Accordingly, the parties’ motions are fully briefed and ripe for resolution. 13
II. LEGAL STANDARD
A party is entitled to summary judgment if the pleadings, depositions, and affidavits demonstrate that there is no genuine issue of material fact in dispute and that the moving party is entitled to judgment as a matter of law.
See
Fed.R.Civ.P. 56(c);
Tao v. Freeh,
Although a court should draw all inferences from the supporting records submitted by the nonmoving party, the mere existence of a factual dispute, by itself, is not sufficient to bar summary judgment.
See Anderson v. Liberty Lobby, Inc.,
III. DISCUSSION
The parties’ motions require the Court to address three primary issues. First, the Court must determine whether Barr’s agreement with Warner Chilcott is a per se unreasonable restraint of trade or whether the agreement should be reviewed under a rule of reason analysis. Second, assuming the rule of reason applies, the Court must determine whether Barr is entitled to prevail under that analysis as a matter of law. Third, the Court must consider Barr’s three perfunctory arguments included at the end of its Motion that Plaintiffs lack standing to assert their claims. The Court shall address each of these issues in turn.
A. Per Se or Rule of Reason Standard
Plaintiffs allege that Barr’s conduct violated Section 1 of the Sherman Act which prohibits “[e]very contract, combination in the form of trust or otherwise, or conspiracy, in restraint of trade or commerce among the several States.... ” 15 U.S.C. § 1. Although this language appears to prohibit every agreement “in restraint of trade,” the Supreme Court has interpreted this Section to prohibit only “unreasonable restraints.”
State Oil Co. v. Khan, 522
U.S. 3, 10,
Even though the rule of reason “is the accepted standard for testing whether a practice restrains trade in violation of § 1 [of the Sherman Act],”
Leegin,
In the present case, the parties dispute whether the rule of reason or the per se rule applies to the Agreement between Barr and Warner Chilcott. Under the terms of the Agreement, Warner Chilcott exercised an option that prevented Barr from selling generic Ovcon products (itself or through a third-party) in the United States for five years, and obligated Barr to supply Warner Chilcott with Ovcon during the same period:
Exclusivity. During the First License Term, except as provided in the Supply Agreement, neither Barr nor its Affiliates shall, either itself or with or through a Third Party, (a) market, commercialize, distribute or sell a Licensed Product [defined to include the contemplated generic version of Ovcon] in the Territory [defined to include the United States] or (b) import or export a Licensed Product for the purposes of clause (a).
Def.’s Mot., Ex. 86 § 3.3 (3/24/04 Option and Option and License Agreement).
Commitment to Supply. During the term of this Agreement ... Barr shall use Commercially Reasonable Efforts to supply [Warner Chilcott], and [Warner Chilcott] shall purchase from Barr, all of [Warner Chilcott’s] requirements for Finished Product [defined to include the contemplated generic version of Ovcon] pursuant to purchase orders delivered from time to time ... neither Barr nor any of its Affiliates shall have the rightto manufacture or supply any Licensed Product for or to any other Person.
Id., Ex. 85 § 2.1 (3/24/04 Finished Product Supply Agreement).
Plaintiffs characterize the prohibition on Barr’s ability to compete with Warner Chilcott as a horizontal market allocation agreement because the provision “(i) was horizontal, i.e., between actual or potential competitors [ ] and (ii) allocated all sales of Ovcon 35 Products in the United States to Warner Chilcott for five years.” Pis.’ Reply at 2. Plaintiffs argue that “[a]s a result of the Agreement, customers were forced to purchase [Ovcon] only from Warner Chilcott, and Warner Chilcott earned artificially inflated profits from sales of Ovcon that it would not have made in the absence of the Agreement.” Pis.’ Mot. at 11. In contrast, Barr refers to the Agreement as a “mixed vertical and horizontal commercial arrangement! ]” with predominantly vertical supply provisions, Def.’s Opp’n at 34, and argues that the Agreement is not “ ‘manifestly anti-competitive’ or a ‘naked restraint’ for which no analysis is required to determine the economic impact.” Id. at 26. Further, Barr argues that the Agreement produced procompetitive benefits, such as increasing the output of Ovcon 35 products or A-B rated generics plus branded Ovcon 35, see Def.’s Opp’n at 29 n. 16, and led to substantial discounting of Ovcon 35 that would not have existed but for the agreement, id. at 29.
Both parties cite extensive case law supporting their characterizations of the Agreement. Plaintiffs cite cases for the proposition that horizontal market allocation agreements are
per se
illegal under well-established Supreme Court precedent.
See, e.g., Palmer v. BRG of Georgia, Inc.,
In contrast, Barr cites cases standing for the proposition that exclusive supply relationships are consistently analyzed under a rule of reason, and that such agreements often produce procompetitive benefits.
See, e.g., Jefferson Parish Hospital District No. 2 v. Hyde,
. Notwithstanding Plaintiffs’ desire to characterize the Agreement between Barr and Warner Chilcott as a horizontal market allocation agreement, the law does not allow a party to simply isolate one particular provision or restraint within an overall agreement and argue, in isolation, that the restraint is subject to
per se
condemnation. That improvident approach has been foreclosed by Supreme Court cases admonishing lower courts to avoid forcing conduct into a particular “category” and applying the
per se
rule.
See Broadcast Music, Inc.,
Because the economic effects of the Agreement depend on the proper definition of the market (and the competitive effects therein), the Agreement cannot be condemned as a
per se
unreasonable restraint of trade. The
per se
rule is reserved for restraints that are anticompetitive in all or nearly all instances, not those that are anticompetitive depending on particular market dynamics.
See Broadcast Music, Inc.,
For these reasons, the Court cannot conclude that the Agreement between Barr and Warner Chilcott produced the presumptive anticompetitive effects necessary to condemn the agreement as a
per se
restraint of trade. The Court is not persuaded otherwise by
In re Cardizem CD Antitrust Litig.,
Nor is the Court impressed by Plaintiffs’ other legal argument, relegated to a footnote in Plaintiffs’ Reply brief, that “[a]n exclusive supply agreement is evaluated under the rule of reason
only
when the parties to the agreement are not actual or potential competitors.” Pis.’ Reply at 4 n. 6 (emphasis in original). Setting aside that the cases cited by Plaintiffs offer no support for this cursory argument, Plaintiffs’ analysis fails to recognize that exclusive dealing agreements are analyzed under the rule of reason precisely because they occur in a variety of contexts (between potential competitors or not) and produce both anti-competitive or procompetitive effects depending on case-specific facts. As a result, although the relationship between the buyer and seller as parties to an agreement may be one relevant consideration in a court’s analysis of an exclusive supply relationship, a court must apply a rule of reason inquiry that focuses on a broad range of considerations.
See Jefferson Parish,
For all of these reasons, the Court finds that Barr’s Agreement with Warner Chil-cott is appropriately reviewed under a rule of reason analysis.
18
The Court shall
B. Rule of Reason Analysis 1. Whether Proof of a Relevant Antitrust Market Is Necessary
A rule of reason analysis almost always begins with the definition of the relevant market, without which there is little context to discuss competition, anti-competitive effects, or procompetitive benefits.
See Geneva Pharms. Tech. Corp. v. Barr Labs. Inc.,
Relying on the Supreme Court’s decision in
Federal Trade Commission v. Indiana Federation of Dentists,
the purpose of the inquiries into market definition and market power is to determine whether an arrangement has the potential for genuine adverse effects on competition, [so] “proof of actual detrimental effects, such as a reduction of output,” can obviate the need for an inquiry into market power, which is but a “surrogate for detrimental effects.”
Plaintiffs’ arguments are unavailing. The Court first expresses its disbelief that Plaintiffs would rely on
In re Schering-Plough Corporation
even though that decision was overruled and vacated by the Eleventh Circuit precisely because of its erroneous application of
Indiana Federation of Dentists
— a fact that Plaintiffs failed to raise in its briefing.
See Scher-ing-Plough Corp. v. Fed. Trade Comm’n,
Plaintiffs next argue that proof of a relevant market is unnecessary in this case based on Warner Chilcott’s alleged market power, offering the following syllogism: “Warner Chilcott had market power in selling Ovcon 35; that prevention of generic competition maintained that market power; and (equivalently) that Ovcon 35 Products constitute a relevant product market.” Pis.’ Opp’n at 23. This reasoning is a somewhat novel application of antitrust principles. Antitrust plaintiffs
Assuming Plaintiffs’ approach is even cognizable, the two sources of evidence that Plaintiffs’ proffer in support of then-argument are insufficient: (1) “evidence showing the likely and actual effects that unimpeded generic Ovcon 35 competition would (and ultimately did) have on the average prices for Ovcon 35 products ...” and (2) evidence that “the Agreement, by delaying the entry of generic Ovcon 35, maintained Warner Chilcott’s ability to charge substantially above marginal cost for Ovcon 35 Products without losing substantial sales.” Pis.’ Opp’n at 21. The mere showing that the
average
price of Ovcon (combined with Ovcon generics) was lower after generic entry says little about Warner Chilcott’s market power. Generic drugs normally enter the market at a price lower than their branded equivalents.
See
Def.’s Mot., Ex. 8 ¶ 30 (Expert Report of Daniel L. Rubinfeld) (“[t]o successfully sell their products, generic suppliers generally must offer prices that are lower than their brand-name counterparts”);
In re Remer-on,
Further, the Court agrees with Barr that Plaintiffs’ argument, if accepted, would lead to the anomalous result that every branded drug manufacturer would necessarily have market power simply by
pricing proof may of course be indicative of monopoly power. However, absent from plaintiffs’ proffer is any analysis of Barr’s costs. Hence, we do not know whether the allegedly elevated prices led to an abnormally high price-cost margin. Nor do plaintiffs present direct evidence that defendants restricted output, asking us to infer the basis for the higher prices.
Geneva Pharms. Tech. Corp. v. Barr Labs., Inc.,
Plaintiffs here provide no evidence of excessive price-cost margins or restricted output but merely rely on the fact that later generic manufacturers could enter the market more cheaply than Remeron’s price in order to establish monopoly power ... Plaintiffs provide no evidence that Organon reduced the price of Remeron after generic entry in order to compete with the cheaper generic price.
In re Remeron,
2. The Relevant Antitrust Market
A relevant antitrust market is defined as all “commodities reasonably interchangeable by consumers for the same purposes,”
United States v. E.I. du Pont de Nemours & Co.,
Plaintiffs argue that the relevant market in this case consists only of Ovcon and its generic equivalents.
See
Pis.’ Opp’n at 23. Barr, in contrast, argues the market is much broader, and includes “a variety of oral contraceptive products.”
20
As a starting point, Barr asserts that Ovcon products are functionally interchangeable with non-Ovcon oral contraceptives; that is, Ovcon and non-Ovcon oral contraceptives are “roughly equivalent.”
Queen City Pizza, Inc. v. Domino’s Pizza, Inc.,
Ovcon 35 (containing 35ug ethinyl es-tradiol and 0.4 mg norethindrone) is not unique among oral contraceptive products. It is one of many oral contraceptives with similar dosages of active ingredients, ethinyl estradiol and norethindrone. Furthermore, there is no evidence demonstrating any clinical (e.g., side-effects or patient tolerance) or pharmacological differences between Ovcon 35 and the numerous other oral contraceptive products available ... Ovcon 35 is thus medically interchangeable or substitutable for a host of other oral contraceptive products.
Mishell Report ¶ 24. Based on the above, Barr argues that Plaintiffs’ attempt to limit the relevant antitrust market to “the sale and purchase of Ovcon 35 and any AB rated generic,” Def.’s Mot. at 35 (quot
Plaintiffs do not dispute that there are other oral contraceptives that perform similar functions, but their experts argue that Ovcon is “not treated as interchangeable by practicing physicians.” Derman Report ¶ 8A. In particular, Richard Der-man explains that some formulations of oral contraceptives
have higher failure rates in certain classes of women, and they differ widely in their safety and side-effect profiles ... The differing efficacy, safety and side effect profiles of different oral contraceptives play a critical role in the process of selecting the most appropriate oral contraceptive for a particular patient.
Derman Report ¶ 30. See also Def.’s Mot., Ex. 8 ¶ 35 (Expert Report of Daniel L. Rubinfeld) (hereinafter “Rubinfeld Report”) (“In addition to Ovcon, there are numerous other related oral contraceptive and other combined hormonal contraceptive products ... While these products may be chemically similar to Ovcon, and they all have a common indication (i.e., the prevention of pregnancy), the FDA does not consider these products bioequivalent, and there is variation in the dosage of the active ingredients”). Even with these clinical variations, however, Plaintiffs’ own experts concede that physicians may choose to prescribe non-Ovcon oral contraceptives based on price or promotional differences, suggesting that the drugs can be substituted for each other despite their variations:
Consider specifically the case of oral contraceptives and Ovcon 35. All the possible therapeutical alternatives are apparently effective, but they are differentiated in side effect profiles. Given the differences in the alternatives, promotion and sampling can play an important role in the physicians’ selection of product. Ovcon 35, with its heavy sampling, has been successful in getting many physicians to select it ... However, absent Ovcon 35 sampling, physicians may have selected an alternative, perhaps a comparably priced, sampled brand name [oral contraceptive] or perhaps a less expensive generic.
Def.’s Mot., Ex. 6 ¶¶ 29, 60 (Expert Report of Keith Leffler) (hereinafter “Leffler Report”). Because Ovcon and non-Oveon oral contraceptives may be substituted for each other despite their variations, Barr is correct to argue that they are functionally interchangeable.
While a finding of functional interchangeability may be probative of whether different products are in the same relevant market, it is certainly not dispositive.
See FTC v. Swedish Match,
Plaintiffs introduce evidence from which a jury could find that Warner Chilcott “was able to profitably keep the average prices of Ovcon at least 5% higher than the average price reached for Ovcon and its generic equivalents once generic competition was introduced into the market.” Pis.’ Stmt. ¶ 111. Plaintiffs’ expert, Jeffrey Leitzinger, explains that
prior to the entry of Barr’s generic Ov-con 35 product, Warner Chilcott’s average net price of its branded Ovcon 35 Product sold to Class members was approximately $39 per monthly dose. Upon the entry of Barr’s Ovcon 35 Product, Barr’s average net price to Class members was approximately $32 per monthly dose. Once Watson entered with the second generic Ovcon 35 Product, the average net price of its generic Ovcon 35 Product was approximately $20 per monthly dose.
Pis.’ Opp’n, Ex. 73 at 27 (Expert Report of Jeffrey J. Leitzinger) (hereinafter “Leit-zinger Report”). See also Leffler Report ¶ 66 (explaining that the market entry of two generic alternatives to Ovcon caused “the generic price to fall between $.61 and $.56 per pill, or a discount of about 57% to 61% of the pre-generic entry Ovcon 35 price”).
Plaintiffs’ experts also explain that Warner Chilcott was able to maintain prices that were higher than its generic equivalents because there is an economically “insignificant” amount of switching among oral contraceptives:
Switching among [oral contraceptives], while common, is insignificant in magnitude. When a low priced generic enters the market, it captures a trivial share of the sales of the branded products that are not A-B rated. Such minimal switching indicates the absence of significant economic substitution ... The patterns of sales and prices of Ovcon 35 when other branded oral contraceptives enter the marketplace and when generics enter with lower prices also show the absence of price competition and economic substitution among the drugs in the oral contraceptive therapeutic category. A number of significant [oral contraceptive] products have entered the market since 2000 ... If alternative contraceptives were significant economic substitutes for Ovcon 35, Ovcon 35 would be expected to lose significant sales in response to their entry. This simply did not occur.
Leffler Report ¶¶ 34-36. See also Ru-binfeld Report ¶ 61 (“entry by generic alternatives to other branded oral contraceptives has not affected the growth of Ovcon’s sales”).
Barr’s experts disagree. In particular, Gregory Bell explains that the amount of switching, as determined by his analysis, is substantial enough to suggest that the relevant market is comprised of Ovcon and at least several other oral contraceptives. See Def.’s Mot., Ex. 61 ¶ 31 (Expert Report of Gregory K. Bell) (hereinafter “Bell Report”). Barr also submits evidence that Warner Chilcott and other oral contraceptive manufacturers viewed other oral contraceptives as competition that constrained their pricing behaviors:
Q: When Ortho makes pricing decisions regarding ... Ortho Tri-CyclenLo, do you consider the prices of other branded oral contraceptives?
A: Yes.
Q: Why do you consider those other prices?
A: We consider the prices at the absolute price level and we also consider the magnitude and frequency of their price actions.
Q: So Ortho’s pricing decisions are based at least in part on the price movements of other oral contraceptives?
A: Yes. We evaluate the pricing actions of the competitive set when making ours.
Def.’s Mot., Ex. 41 at 94:25-95:12 (Depo. Tr. of David Lin).
Q: In the time that you were responsible for marketing Ovcon 35, did you ever try to differentiate Ovcon from other oral contraceptives on the basis of price?
A: No.
Q: Why not?
A: Well, because we didn’t have much to say. In fact, ... our pricing strategy with Ovcon was to be a fast follower. So, we tracked Ovcon’s price pretty much against whatever Ortho’s major pill was ... once Ortho switched their strategy, and so when they would take a price increase, we would fast follow with a price increase ... there were other products in the market that had a lower price, Yasmin, for example, so we wouldn’t have wanted to go out and make a big deal that Ovcon was less expensive, because then our other competitor, Yasmin, could come right in behind us and have gone there.
Def.’s Mot., Ex. 75 at 53:2-52:23 (Depo. Tr. of Katie MacFarlane). Consistent with these views, Barr’s experts explain that Warner Chilcott’s internal documents support a market definition that includes oral contraceptives besides Ovcon and its generic equivalents.
See, e.g.,
Def.’s Mot., Ex. 63 ¶ 13 (Expert Report of Jerry A. Hausman) (hereinafter “Hausman Report”) (describing a “Warner Chilcott internal document that provides background on the ‘OC Market,’ ” which it characterizes as “ ‘very crowded and fragmented.’ ”); Bell Report at 20 n. 70 (describing Warner Chilcott’s internal documents that “viewed the market in which Ovcon 35 competes as much broader than Ovcon 35 itself ... [and] defined its key competitors as TriCy-clen, Tri-Cyclen Lo, Evra, Yasmin, Nu-vaRing, and Cyclessa”). Warner Chilcott even initiated a bonus program for its sales representatives “based on how much they increase[d] the market share of Warner Chilcott products, where the market share ‘[was] based on the major oral contraceptives in the market in [an employee’s] territory.’ ” Hausman Report ¶ 19 (quoting Warner Chilcott internal document). The views of individuals in the industry, and particularly the internal documents of Warner Chilcott, are all probative areas of inquiry for determining the outer boundaries of the relevant product market.
See Spirit Airlines, Inc. v. Northwest Airlines, Inc.,
Plaintiffs, in turn, emphasize that a physician’s initial prescription choice is not based on price, and that once an initial determination has been made as to which oral contraceptive to prescribe, patients continue to use the same oral contraceptive regardless of price:
the physician typically will write the prescription for the oral contraceptive pill that the woman is already using because of the risk that switching to any other product could result in side effects. Consequently, even though there may be a number of different oral contraceptive pills a physician could have started a patient on, or in theory could switch a patient to, once the physician and patient find one that is well-tolerated, it is very unlikely that the patient will switch to a different oral contraceptive.
Dickey Report ¶ 29.
See also
Pis.’ Opp’n, Ex. 104 at 207:16-207:19 (Depo. Tr. of Mitchell Lazar) (“[i]f a patient is doing well on a pill, the doctor is going to keep the patient on that pill”);
id.,
Ex. 77 at 37:9-37:13 (Depo. Tr. of Richard Dickey) (“Q: So you don’t take into account your patients’ sensitivities to the pricing of oral contraceptives in prescribing oral contraceptives? A: I do take that into account, but I would never make the decision based on the cost”); Derman Report ¶ 8B
The Court cannot resolve the parties’ disputed market definition on summary judgment. As reflected above, Plaintiffs have marshaled evidence from which a jury could find that Warner Chilcott was not price-constrained prior to the entry of generic competition because physicians do not prescribe oral contraceptives based on price, patients do not switch oral contraceptives based on price, and there is an insignificant amount of actual switching between oral contraceptives. Barr has marshaled competing evidence from which a jury could find that Ovcon is functionally interchangeable with non-Ovcon oral contraceptives, and that Warner Chilcott
was
price-constrained by competition from other manufacturers’ oral contraceptives, both in terms of setting the price of Ovcon and also having to expend significant funds for marketing and promotional efforts.
23
In the face of this conflicting evidence, the finder of fact must determine the proper scope of the relevant product market, not the Court.
See Coastal Fuels of Puerto Rico, Inc. v. Caribbean Petroleum Corp.,
3. Balancing Procompetitive Benefits unth Anticompetitive Effects
The balancing of competitive harms and/or benefits associated with Barr’s Agreement turns almost entirely on the contested market definition — a result that is not uncommon in antitrust cases.
See, e.g., FTC v. Whole Foods Market, Inc.,
Barr proffers, in turn, six procompeti-tive benefits:
(1) the agreement ensured a safe, stable, and reliable supply of Ovcon 35 for consumers;
(2) the agreement ensured continued, substantial sampling of Ovcon 35 by Warner Chilcott, resulting in low net prices to consumers;
(3) the agreement enabled Ovcon 35 to aggressively compete against the numerous other hormonal contraceptives in the marketplace;
(4) the agreement enabled Barr to produce Ovcon 35 in the face of a possible line extension contemplated by Warner Chilcott that would have moved patients away from the Ovcon tablet Barr was able to produce;
(5) the agreement removed the potential that Ovcon 35 would exit from the market altogether; and
(6) the agreement resulted in an overall increase in market share for Ovcon, i.e., output, for Ovcon products.
Def.’s Mot. at 3-4. Some of these benefits depend almost entirely on market definition. For example, a finding that the relevant market consists of Ovcon and its generic equivalents would eviscerate Barr’s argument that the Agreement allowed Ov-con to compete against other hormonal contraceptives in the marketplace. In the absence of a defined market, however, the Court shall decline to opine on the parties’ proffered procompetitive benefits or anti-competitive effects — or the balancing of the same — which shall be considered by the finder of fact at trial. 24
C. Direct Purchaser Standing
As a final matter, Barr includes a few perfunctory standing arguments in its Motion that do not require extended discussion. First, Barr argues that numerous Plaintiffs have brought suit based on assignment contracts from the wholesalers McKesson and Cardinal, but that Warner Chilcott’s distribution agreements with those wholesalers bar the assignment of any claims without Warner Chilcott’s written consent (which Warner Chilcott has not provided). Def.’s Mot. at 41-42 & n. 21. Barr argues that “[b]eeause McKesson is contractually barred from assigning any claims arising from its purchases of Ovcon 35 from Warner Chilcott, its assignment of claims” to Plaintiffs is void and Plaintiffs lack standing.
Id.
at 42;
id.
at 42 n. 21
Next, Barr argues that Plaintiffs Meijer and Meijer Distribution lack standing to sue because they received an assignment from wholesaler Kerr “nearly two years before their complaint was filed.” Def.’s Mot. at 42 (emphasis in original omitted). Barr further argues that, although Meijer and Meijer Distribution acquired another assignment “one year after they filed suit,” such an “after the fact” assignment is insufficient because plaintiffs must show standing at the time they file a complaint.
Id.
at 43 (citing
Lujan v. Defenders of Wildlife,
Kerr hereby conveys, assigns and transfers to Meijer all rights, title and interest in and to all causes of action and any resulting proceeds Kerr may have under the antitrust laws ... relating to Kerr’s purchases of any pharmaceutical products which were subsequently resold to Meijer during the period of January 1, 1987 to the Effective Date of this Agreement.
All sales transactions between Meijer and Kerr pertaining to pharmaceutical products occurring after the date of this Agreement shall incorporate, without further action of the parties, an assignment to Meijer by Kerr of all causes of action described in paragraph 2 above. Kerr agrees that, upon Meijer’s request, Kerr shall execute an assignment of claims containing language substantially similar to the language contained in Paragraph 2 above as further evidence of such assignment.
Pis.’ Opp’n at 42 n. 63; Pls.’ Opp’n, Ex. 47 (10/4/02 Assignment). Therefore, Meijer and Meijer Distribution had standing at the time they filed their claims. In Reply, Barr argues that a party cannot assign claims that it does not possess at the time of an assignment,
see
Def.’s Reply at 34, but that argument is legally deficient.
See, e.g., King & King v. Harbert Int’l, Inc.,
Finally, Barr argues that one or more wholesalers may lack standing because possible “overcharges” were “passed on” through the use of “cost plus” contracts, and therefore, the assignees of the wholesalers would also lack standing. Def.’s Mot. at 43-44. Barr’s five-sentence argument is based on
Hanover Shoe, Inc. v. United Shoe Machinery Corporation,
a case where the Supreme Court held that, in general, only direct purchasers (as opposed to indirect purchasers) have standing to assert antitrust injury.
the purchaser is insulated from any decrease in its sales as a result of attempting to pass on the overcharge[ ] because its customer is committed to buying a fixed quantity regardless of price. The effect of the overcharge is essentially determined in advance, without reference to the interaction of supply and demand that complicates the determination in the general case.
Barr fails to cite to a single decision where this exception has ever been satisfied, and the Third Circuit has characterized its vitality as “doubtful.”
McCarthy v. Recordex Svc., Inc.,
IV. CONCLUSION
For the reasons set forth above, the Court shall DENY Plaintiffs’ Motion for Partial Summary Judgment, and shall GRANT-IN-PART and DENY-IN-PART Defendant’s Motion for Summary Judgment. The Court holds that the agreement between Barr and Warner Chilcott must be evaluated under the rule of reason and cannot be condemned as a per se unlawful restraint of trade. The Court further holds that genuine issues of material fact exist with respect to the proper definition of the relevant product market in this case, and that these factual issues preclude entry of summary judgment. An appropriate Order accompanies this Memorandum Opinion.
Notes
. "Warner Chilcott” refers to Warner Chilcott Holdings Company III, Ltd., Warner Chilcott Corporation, Warner Chilcott (US) Inc., Warner Chilcott Company, Inc., and Galen (Chemicals), Ltd.
. On July 10, 2008, the Court approved a settlement between Plaintiffs and Warner Chilcott that dismissed Warner Chilcott as a Defendant in the above-captioned cases.
See Meijer, Inc. v. Warner Chilcott Holdings Co. III, Ltd.,
.As the Court previously informed the parties,
see, e.g.,
No. 05-2195, Order at 1 (Dec. 9, 2005), the Court strictly adheres to the text of Local Civil Rule 56.1 when resolving motions for summary judgment.
See Burke v. Gould,
. Plaintiffs deny that BMS was obligated to supply Warner Chilcott with "line extension” products, citing section 2. 10.1 of the agreement. See Pis.’ Resp. Stmt. ¶ 7; Pis.' Stmt. ¶ 52; Def.’s Mot., Ex. 42 (1/26/00 Agreement). Plaintiffs’ argument and citation are puzzling given that the very next section of the agreement states that "[o]nce [Warner Chilcott] has obtained any regulatory approvals that may be required, if any, to market a Line Extension Product in any country, such Line Extension Product shall be included as a Product under this Agreement....” Def.’s Mot, Ex. 42 § 2.10.02. Plaintiffs’ meritless objection is, in any event, irrelevant to the disposition of the instant motions.
. A company seeking to market a new drug in the United States must first obtain approval by filing a New Drug Application ("NDA”) with the United States Food and Drug Administration (“FDA”). Pis.’ Stmt. ¶ 48; 21 U.S.C. § 355. The NDA must include reports and other materials showing that the drug is safe and effective for use. Pis.’ Stmt. ¶ 48; 21 U.S.C. § 355(b)(1). A company seeking approval to market a generic drug may file an Abbreviated New Drug Application ("ANDA”) with the FDA, which allows the company to rely on the FDA's prior determinations, made in the course of approving a new drug pursuant to an NDA, that the active ingredients of the proposed new generic drug are safe and effective. Pis.’ Stmt. ¶ 48; 21 U.S.C. § 355(j)(2)(A).
. Barr disputes the magnitude of Warner Chilcott's lost sales projections. See Def.'s Resp. Stmt. ¶ 6. For example, Barr contests the forecasts described by Mr. Poll, apparently on the basis that Mr. Poll was unsure of his projections. Id. The fact remains, however, that Warner Chilcott projected substantial lost sales and profits due to the entry of a generic version of Ovcon.
. The FTC also submitted a statement to the Court to "correct misrepresentations” concerning how Defendants Barr and (at the time) Warner Chilcott were characterizing their interactions with the FTC during this period. See State of Colorado v. Warner Chilcott Holdings Co. III, Ltd., No. 05-2182 (June 21, 2006), Docket No. [49], According to the FTC, "more than a month before [Defendants] entered into the final agreement, they were aware that Commission staff had significant concerns about the defendants’ agreement and was investigating the transaction.” Id. at 1. The FTC characterizes "Defendants' efforts to make relevant to this litigation their interactions in 2003 with some FTC staff members — along with what they deem the Commission’s lack of dispatch in issuing its complaint” as a "sideshow” that is "misleading.” Id. at 2.
. The agreement actually consists of two separate agreements that were simultaneously executed — an Option and License Agreement and a Finished Product Supply Agreement. See Def.'s Mot., Ex. 85 (3/24/04 Finished Product Supply Agreement), Ex. 86 (3/24/04 Option and License Agreement). Following the convention of the parties and unless otherwise specified, the Court shall refer to both agreements as Barr and Warner Chilcott’s single “Agreement.”
. Barr did not begin purchasing Ovcon from Barr until May 2005 (approximately one year after execution of the licensing agreement) and continued to receive its supply from BMS until that time. Pis.' Stmt. ¶¶ 86-87. Barr explains that it was not in a position to immediately begin production of Ovcon once Warner Chilcott exercised its licensing option. Def.'s Resp. Stmt. ¶ 86.
. Plaintiffs object to the relevance and description of Barr's sampling explanation, but do not object to the underlying premise that companies such as Warner Chilcott engage in the practice of sampling for their brand-name products, and that such practices are generally terminated once a generic equivalent of the branded drug is introduced into the market. Pis.' Resp. Stmt. ¶¶ 25-27.
.Both parties include extensive "facts” related to market definition and competition in their factual statements that are far from undisputed. The Court shall address these areas in the context of the parties’ summary judgment arguments, where they are more appropriately considered.
. The captions on these briefs include State of Colorado v. Warner Chilcott Holdings Co. III., Ltd., No. 05-2182. The plaintiffs in that proceeding reached a settlement with Barr on February 25, 2008, after the above briefing had already been completed, and are therefore not parties to this opinion. See Civ. A. No. 05-2182, Docket No. [157] (Stipulated Final Order and Permanent Injunction).
. The Court granted the Parties’ requests for leave to file their pleadings and accompanying exhibits under seal, but required that they "file on the public docket a redacted copy of all documents filed under seal.” Min. Order dated Nov. 28, 2007.
. For this reason, the Court rejects as legally inaccurate Plaintiffs’ argument that "a decision to apply the
per se
rule does not depend on any inquiry into market definition or mar
. Plaintiffs attempt to dimmish the significance of Dr. Rnbinfeld’s concession by characterizing it as testimony relating to a “legal standard.” See Pis.' Reply at 5 n. 9. While Plaintiffs are correct that Dr. Rubinfeld’s testimony as to whether the Agreement should be analyzed under the rule of reason or the per se rule would have no bearing on the Court’s determination of the same, Dr. Rubin-feld’s analysis concerning the economic effects of delayed generic entry is an appropriate area for expert testimony and is a relevant consideration in the Court’s analysis.
. Plaintiffs argue that "there is ample evidence ... that the supply relationship [between Barr and Warner Chilcott] was merely a pretext to disguise the Agreement’s actual purpose....” Pis.’ Reply at 4. As Plaintiffs concede, however, whether the supply relationship was pretextual "must be determined by the trier of fact and cannot be resolved on summary judgment.” Pis.' Opp’n at 12 n. 11.
. Plaintiffs' reliance on
Engine Specialties, Inc. v. Bombardier Ltd.
is also unpersuasive.
. The Court notes that Barr raised two other arguments on which the Court expressly does
not
rely. First, Barr argues that the
per se
rule is inappropriate in instances where a party marshals evidence of procompetitive effects. The Court rejects this argument because the Supreme Court "has consistently rejected the notion that naked restraints of trade are to be tolerated because they are well intentioned or because they are allegedly developed to increase competition.”
United States v. Topco Assocs., Inc.,
. Plaintiffs argue that Barr’s counterclaim filed in
Celgene Corp. v. Barr Laboratories, Inc.,
No. 07-286,
. The parties do not appear to dispute that Ovcon and its generic equivalents are in the same market; they dispute whether the market also consists of other oral contraceptives.
See
Pis.’ Opp’n at 26 n. 39. Thus, the Court’s references to "Ovcon” (as opposed to "non-
. Plaintiffs counter that
Barr's
internal documents suggest that Barr considered the relevant market to be limited to Ovcon and its generic equivalents.
See
Rubinfeld Rebuttal Report ¶ 33 (“in its various sales forecasts for generic Ovcon, Barr identifies the price of generic Ovcon as a percentage of the branded Ovcon price. Barr then calculates the expect
. Plaintiffs seek to diminish the importance of promotional activities such as sampling by arguing that "Warner Chilcott did not react by increasing sampling during periods when entry of other branded and less expensive generic non-Ovcon oral contraceptives occurred.” Pis.' Opp’n at 28; Def’s Mot., Ex. 7 ¶ 27 (Rebuttal Report of Keith Leffler) ("the sampling of Ovcon 35 was relatively constant from April 2002 through 2005, a period of substantial entry of both branded and generic oral contraceptives”).
. Defendants also quote from a book that Dr. Rubinfeld co-authored that stated "[i]in the pharmaceutical industry ... [m]arkets are usually defined in terms of therapeutic classes of drugs.” Def.'s Mot. at 31 (quoting Pin-dyck, Robert S. and Rubinfeld, Daniel L., Microeconomics (6th ed.2005) at 10). The Court is unpersuaded that the general statements contained in this book have any application to the particular market at issue in this case.
. Although the Court does not reach the merits of Barr’s proffered procompetitive benefits, the Court notes that "benefits” are only procompetitive when they promote and protect competition, not competitors,
see Brooke Group Ltd. v. Brown & Williamson Tobacco Corp.,
. Barr cites to
In
re
Ditropan XL Antitrust Litigation
for support, but it has no relevance to the present matter.
