Opinion ID: 184499
Heading Depth: 2
Heading Rank: 2

Heading: Upjohn's Motion to Intervene

Text: We now turn to Upjohn's appeal of the district court'sdenial of its motion to intervene. The district court deniedUpjohn's motion on two grounds: first, that Upjohn's motionwas mooted by the grant of the preliminary injunction, andsecond, that s 355(j)(5)(B)(iv) does not provide a cognizableinterest upon which a pioneer patent owner or an NDA ownercan challenge the approval of an ANDA. We find that thedistrict court was in error on both grounds. A motion to intervene as of right turns on four factors: (1)the timeliness of the motion; (2) whether the applicantclaims an interest relating to the property or transactionwhich is the subject of the action, Fed. R. Civ. P. 24(a); (3)whether the applicant is so situated that the disposition of __________ in such a case that the patent-holder's failure to enforce its patent isattributable to a mistake. Moreover, the Federal Circuit has had no occasion to decidewhether there is a controversy of sufficient immediacy and realityto support a declaratory judgment action, Federal Express Corp., 67F.3d at 964, when the plaintiff requires a judgment under section355(j)(5)(B) in order to bring its product to market. It is possiblethat such a statutorily-created bottleneck, coupled with the statute'sexpress reference to declaratory judgment actions as a means ofrelieving that bottleneck, might suffice to allow a plaintiff to showthe existence of a case or controversy without demonstrating animmediate risk of being sued. the action may as a practical matter impair or impede theapplicant's ability to protect that interest, id.; and (4) whether the applicant's interest is adequately represented byexisting parties. Id. To the extent that a district court'sruling on a motion to intervene as of right is based onquestions of law, it is reviewed de novo; to the extent that itis based on questions of fact, it is ordinarily reviewed forabuse of discretion. See Massachusetts School of Law atAndover, Inc. v. United States, 118 F.3d 776, 779-80 (D.C.Cir. 1997) (noting, however, that application of the abuse-ofdiscretion standard seems anomalous in some circumstances). The issues that Upjohn raises on its appeal are all purequestions of law, so we apply de novo review. The district court erred in finding that Upjohn's motion tointervene was moot. The district court had entered only apreliminary injunction, not a permanent injunction. Thedistrict court presumably would have considered new evidence or new arguments in future proceedings, had Upjohn(or some other party) wished to present them. And intervening even after the injunction had been issued would haveallowed Upjohn to participate in the appeal of the injunction. See Massachusetts School of Law at Andover, 118 F.3d at 779(discussing intervention before the district court for purposesof appeal). The district court was also in error in finding that Upjohndid not claim[ ] an interest relating to the property or thetransaction which is the subject of the action, as is requiredby Federal Rule of Civil Procedure 24(a)(2). Rule 24(a)impliedly refers not to any interest the applicant can putforward, but only to a legally protectable one. SouthernChristian Leadership Conference v. Kelley, 747 F.2d 777, 779(D.C. Cir. 1984). Thus, a party that seeks to intervene as ofright must demonstrate that it has standing to participate inthe action. See id. There is no dispute that Upjohn hasconstitutional standing; numerous cases have found that afirm has constitutional standing to challenge a competitor'sentry into its market. See, e.g., Association of Data Processing Serv. Orgs., Inc. v. Camp, 397 U.S. 150, 152 (1970) (DataProcessing ). Mylan argues, however, that Upjohn is not within the zoneof interests of section 355(j)(5)(B)(iv), and that it thereforelacks prudential standing. We do not agree. The first stepin the prudential standing analysis is to identify the interestsprotected by the statute. To do so, we consider the purposesof the specific statutory provision that is at issue (here,section 355(j)(5)(B)(iv)), read in the context of the statutoryscheme as a whole. See Bennett v. Spear, 117 S. Ct. 1154,1167 (1997); Clarke v. Securities Industry Assoc., 479 U.S.388, 401 (1987) (stating that a court is not limited to considering the statute under which respondents sued, but mayconsider any provision that helps us to understandCongress's overall purposes....). The purpose of section355(j)(5)(B)(iv) is to provide a reward, in the form of anexclusivity period, to generic drug companies that are thefirst to file paragraph IV ANDAs. Section 355(j)(5)(B)(iv) isnot intended to benefit pioneer drug companies directly. Indeed, quite the opposite is true: the provision is intendedto reward generic drug manufacturers who challenge pioneerdrug companies' patents. Thus, in the nomenclature of thiscircuit's caselaw, Upjohn cannot show that it is an intendedbeneficiary of section 355(j)(5)(B)(iv). Scheduled AirlinesTraffic Offices, Inc. v. Dept. of Defense, 87 F.3d 1356, 1359(D.C. Cir. 1996) (Scheduled Airlines). But a plaintiff can be within the zone of interests of astatute even in the absence of an indication of congressionalpurpose to benefit the would-be plaintiff. Clarke, 479 U.S.at 399-400. As the Court recently made clear in NationalCredit Union Administration v. First National Bank &Trust Co., 118 S. Ct. 927 (1998) (NCUA ), a plaintiff onlyneeds to show that its interest is among those arguably ...to be protected by the statute. Id. at 935 (quoting DataProcessing, 397 U.S. at 153) (emphasis added). This analysisfocuses, not on those who Congress intended to benefit, buton those who in practice can be expected to police theinterests that the statute protects. In NCUA, the provisionbefore the Court imposed a rule called the common bondrequirement, which limits the membership of credit unionsto groups having a common bond of occupation or associa- tion. 12 U.S.C. s 1759 (1994). The question for the Courtwas whether a group of banks who had an interest in limitingthe markets that credit unions could serve were within thezone of interests of this provision. The Court found that thecommon bond requirement was intended to reinforce thecooperative nature of credit unions, which in turn was believed to promote their safety and soundness and allow accessto credit by persons otherwise unable to borrow. NCUA,118 S. Ct. at 935 n.6. The Court reasoned that by its verynature, a cooperative institution must serve a limited market, id., so that there is an unmistakable link between thestatute and a limitation on the markets that federal creditunions can serve. Id. at 935 & n.6. The Court concludedthat limiting the markets served by credit unions is thereforean interest arguably to be protected by the statute, so thatthe banks had prudential standing. The test applied by NCUA is not far removed from thiscircuit's suitable challenger test. See, e.g., Scheduled Airlines, 87 F.3d at 1359-61 (applying this test). Under thesuitable challenger test, a plaintiff must demonstrate thatits interests are sufficiently congruent with those of theintended beneficiaries that the litigants are not 'more likely tofrustrate than to further ... statutory objectives.'  Id. at1359 (quoting First Nat'l Bank & Trust Co. v. NationalCredit Union Admin., 988 F.2d 1272, 1275 (D.C. Cir. 1993)(quoting Clarke, 479 U.S. at 397 n.12)). NCUA allows aplaintiff to demonstrate that its interest and the interestserved by the statute have, by their very nature, an unmistakable link. NCUA, 118 S. Ct. at 935 & n.6; in otherwords, the plaintiff may show an inevitable congruence between the two interests. The two standards are thus verysimilar. It seems clear under NCUA that Upjohn has prudentialstanding. Here, Upjohn is seeking to enforce (its interpretation of) section 355(j)(5)(B)(iv), a statute by which Congresssought to regulate the timing of generic drug manufacturers'entry into the market. Although the statute speaks directlyonly to freeing the first generic drug company to file a paragraph IV ANDA from competition from other genericdrug manufacturers, this necessarily entails freeing the pioneer drug producer from such competition as well. Thus,Upjohn's interest in limiting competition for its product is,by its very nature, NCUA, 118 S. Ct. at 935 n.6, linked withthe statute's goal of limiting competition between genericmanufacturers. See also MD Pharmaceutical, Inc. v. DrugEnforcement Admin., 133 F.3d 8, 12-13 (D.C. Cir. 1998)(finding that a drug company was within the zone of interestsof an entry-restricting statute that regulated entry into itsmarket); Scheduled Aircraft, 87 F.3d at 1360-61 (finding thata party seeking to enforce a statutory demarcation is asuitable challenger) (quoting First Nat'l Bank & Trust, 988F.2d at 1278). Upjohn need not show anything more than that it hasstanding to sue in order to demonstrate the existence of alegally protected interest for purposes of Rule 24(a). SeeMausolf v. Babbitt, 85 F.3d 1295, 1299-1302 (8th Cir. 1996)(finding that a showing of standing suffices to demonstrate alegally protected interest for purposes of Rule 24(a)); but cf. United States v. 39.96 Acres of Land, 754 F.2d 855, 859 (7thCir. 1985) (finding, on the peculiar facts of that case, thatmore than a showing of standing was required). We therefore reject the district court's contrary conclusion that Upjohn did not have a sufficient interest in the action to intervene. The district court never reached the remaining elements ofthe Rule 24(a) analysis--timeliness, the risk that Upjohn'sinterests would be impaired, and whether Upjohn's interestswere already adequately represented in the litigation. Upjohn has included in its brief on this appeal a number ofarguments for the affirmance of the district court's injunction. In order to determine whether Upjohn is properly a party tothe appeal of the injunction question, we must reach theremaining Rule 24(a) issues. See Dimond v. District ofColumbia, 792 F.2d 179, 193 (D.C. Cir. 1986) (similarly addressing Rule 24(a) issues that the district court had, aftermaking an erroneous legal ruling, failed to reach); see also Mausolf v. Babbitt, 125 F.3d 661, 666-67 (8th Cir. 1997)(holding that if the court of appeals reverses the districtcourt's denial of a party's motion to intervene, that party mayparticipate in an appeal of a later ruling in the same litigation,if it has met the procedural requirements for doing so). Asto timeliness, Upjohn sought to intervene a few weeks afterMova initiated its action, and before the district court ruledon the preliminary injunction; this cannot be regarded asuntimely. Upjohn's interests were also at risk; Upjohn wasin danger of losing market share to Mylan if the district courtdenied the injunction and allowed Mylan's product on themarket. Finally, as to adequacy of representation, Mova is ageneric drug manufacturer, and therefore might have strategic reasons not to press certain arguments available to Upjohn in anticipation of (perhaps) finding itself in Mylan'ssituation in a future case. We thus conclude that Upjohn wasentitled to intervene as of right, and that Upjohn is thereforea proper party to the appeal of the injunction order and in allfurther proceedings in the district court.19