## United States Court of Appeals for the Federal Circuit

2009-1071

ELI LILLY AND COMPANY, Plaintiff-Appellee,

v. TEVA PHARMACEUTICALS USA, INC., Defendant-Appellant.

Charles E. Lipsey , Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., of Reston, Virginia, argued for plaintiff- appellee. With him on the brief were David S. Forman , Howard W. Levine , Laura P. Masurovsky , Jennifer A. Johnson , and J. Derek McCorquindale , of Washington, DC. Of counsel on the brief were James P. Leeds and Gilbert T. Voy , Eli Lilly and Company, of Indianapolis, Indiana. Jordan A. Sigale , Loeb & Loeb LLP, of Chicago, Illinois, argued for defendantappellant. With him on the brief were Edward H. Rice and Marina N. Saito

. Appealed from: United States District C ourt for the Southern District of Indiana Judge Sarah Evans Barker

## United States Court of Appeals for the Federal Circuit

2009-1071 ELI LILLY AND COMPANY, Plaintiff-Appellee, v. TEVA PHARMACEUTICALS USA, INC., Defendant-Appellant.

Appeal from the United States District Court for the Southern District of Indiana in case no. 1:06-CV-1017, Judge Sarah Evans Barker.

__________________ _________ DECIDED: February 24, 2009

__________________ _________ Before MICHEL, Chief Judge , RADER and PROST, Circuit Judges

. Opinion for the court filed by Circuit Judge RADER. Dissenting opi nion filed by Circuit Judge PROST. RADER, Circuit Judge

. Finding that Teva Pharmaceuticals USA, Inc., (“Teva”) “recast its product more than eighteen months after it provided the orig inal sample to Lilly and only eight months before trial is set to comm ence,” the United States Distr ict Court for the Southern District of Indiana ext ended the statutory thirty-m onth stay of 21 U.S.C. § 355(j)(5)(B)(iii) (2003), preventing the U.S. Food and Drug Administration (“F DA”) from finally approving Teva’s Abbreviated New Drug Application (“ANDA”). Eli Li lly & Co. v. Teva Pharms. USA, Inc. , No. 1:06-cv-1017, 2008 WL 4809963, at *4-5 (S.D. Ind. Dec. 29, 2008)(“Extension Order ”). Because the trial court did not abuse its discretion, this court affirms.
I This case arises under the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98- 417, 98 Stat. 1585 (1984) (codifi ed at 21 U.S.C. §§ 355, 360cc (2003); 35 U.S.C. §§ 156 (2002), 271 (2003) (collectively, the “Hatch-Waxman Act”). Plaintiff-Appellee El i Lilly & Company (“Lilly”) sued Teva for patent infringement under 35 U.S.C. § 1 et. seq. and 28 U.S.C. §§ 2201-02. The Hatch-Waxman Act strikes a balan ce between the sometimes-competing policy interests of inducing pioneering re search and development of new drugs and enabling production of low-cost, generic copies of those dr ugs. A manufacturer that seeks to market a generic drug may submit an ANDA for approval by the United States Food and Drug Administration (“FDA”), ra ther than submitting a full New Drug Application (“NDA”) showing the safety and efficacy of the generic drug. Thus, the generic manufacturer may rely on safety and efficacy studies of the pioneer manufacturer upon showing t he generic drug’s bioequivalence with the previously approved drug product. 21 U.S. C. § 355(j)(2)(A) (2003). The Hatch-Waxman Act also requires a pioneer drug manufactu rer to notify the FDA of all patents that “claim [ ] the drug for which the [NDA] applicant submitted the application.” 21 U.S.C. §§ 355(b )(1) & (c)(2) (2003). The FDA lists such patents in its Approved Drug Products With Therapeutic Equivalence Evaluations, known as the “Orange Book”. Under 35 U.S.C. § 271(e)(2), a generic manufacturer infringes a patent

2009-1071 2by filing an ANDA to obtai n approval for a generic drug pr oduct claimed by a valid and unexpired patent. 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. 21 U.S.C. § 355(j)(2)(A)(vii). The Hatch-Waxman Act specif ies the certification alternatives, (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 new gener ic drug for which the ANDA is submitted. 21 U.S.C. § 355(j)(2)(A)(vii)(I -IV) (2003). These are commonly referred to as paragraph I, II, III, and IV certifications. When an ANDA certifies under paragraph IV , the applicant must provide the patentee a detailed basis for its belief that the patent is not infr inged, that it is invalid, or that it is unenforceable. 21 U.S.C. § 355(j)(2)(B) (2003). The patentee then has fortyfive days to sue the ANDA applicant for patent infringement. 21 U.S.C. § 355(j)(5)(B)(iii). If the patent ee does not sue, the FDA ma y proceed to approve the ANDA. If the patentee does file suit, the FDA may not approve the ANDA until expiration of the patent, resolu tion of the suit, or thirty months after the patentee’s receipt of notice, whichever is earlier. Id. The court entertaining the suit has discretion under the statute to order a shor ter or longer stay if “either party to the action fail[s] to reasonably cooperate in exped iting the action.” Id. In this case, Lilly holds the approved NDA for raloxifene hydrochloride (“raloxifene”) tablets. This product is marketed under the brand name Evista ® for the

2009-1071 3treatment and prevention of pos tmenopausal osteoporosis. Lilly lists twelve patents that claim Evista ® in the Orange Book. Teva filed an ANDA with the FDA in early 2006, seeki ng approval to manufacture and market generic raloxifene. As part of its ANDA, Teva filed paragraph IV certifications. On May 16, 2006, Teva notified Lilly of its paragraph IV certifications. Lilly sued Teva on June 29, 2006, alleging that Teva ’s ANDA infringed four method patents of its twelve lis ted Orange Book patents for using raloxifene to prevent or treat postmenopausal osteopor osis: U.S. Patent Nos. RE 38,968 (“the ‘968 patent”), RE39,049 (“the ‘049 patent”), RE39,050 (“the ‘050 patent”), and 6,906,086 (“the ‘086 patent”). The FDA then stayed approval of Teva’s ANDA fo r thirty months, from the date that Lilly received Teva’s paragraph IV notifications, expiring on November 16, 2008. Extension Order , 2008 WL 4809963 at *1. On September 25, 2006, the district c ourt entered a scheduling order, setting a trial date of March 9, 2009—four months after expiration of the th irty-month statutory stay. In February 2007, Lilly amended its compla int to assert that Teva infringed three additional Evista ® patents—U.S. Patent Nos. 6,458, 811 (“the ‘811 patent”), 6,797,719 (“the ‘719 patent”), and 6,894,0 64 (“the ‘064 patent”)—covering raloxifene particle size and formulation. On July 8, 2008, Teva amended its A NDA to include a new particle-size measuring methodology for the active pharma ceutical ingredient in its proposed raloxifene tablets. Extension Order , 2008 WL 4809963 at *2. Teva disclosed this amendment to Lilly on July 10, 2008, and prov ided it three batch samples on July 28, August 19, and September 17, 2008. The dist rict court, however, previously set a

2009-1071 4discovery deadline of August 18, 2008. Id. at *4 n.2. By Septem ber 5, 2008, Teva also provided Lilly with 27,000 pages of related documentation. Mo reover, the district court ordered Teva to produce additional raloxifene samples to Lilly by December 15, 2008, in response to Lilly’s motion to compel discovery. On September 17, 2008, Lilly moved the district c ourt under 21 U.S.C. § 355(j)(5)(B)(iii) to extend the statutory thirty-month st ay due to Teva’s alleged discovery violations, prejudicing Lilly’s pr eparations for trial. Extension Order , 2008 WL 4809963 at *1. Lilly alleged that Teva “fa il[ed] to ‘reasonably co operate in expediting the action’ . . . as evidenced by Teva’s last-minute alteration of its proposed drug product and its ‘multiple delays in producing critical discovery . . . [which have] adversely affected Lilly’s infringement case and trial preparation.’” Extension Order , 2008 WL 4809963 at *2 (citing Lilly Mot. for Ext. of Stat. Stay at I-2) (second alteration in the original). Lilly also alleged that Teva prejudi ced its preparations for trial by not timely disclosing its plans to alter the particle-size measuri ng methodology of its proposed raloxifene tablets. Id. Teva allegedly began ch anging its particle-size measuring methodology as early as Nove mber 2007 with the goal of avoiding infringement of Lilly’s asserted patents. On October 6, 2008, Lilly moved the dist rict court for a temporary restraining order (“TRO”) and preliminary injunction to pr event Teva from launching its product on November 16, 2008, after expiration of the statutory thirty-month stay. The court granted Lilly’s motion on October 29, 2008, to extend the statutory thirty-month stay until the beginning of trial on March 9, 2009. Extension Order , 2008 WL 4809963 at *6.

2009-1071 5Lilly’s motions for a TRO and preliminary in junction were thus denied as moot. Id. at *6
n.5. Given the urgency of Teva’s si tuation, just weeks before tr ial, it filed a motion in this court for an expedited appeal from the di strict court’s order. Because the district court continued the injunction against the FD A, preventing it from finally approving Teva’s ANDA until March 9, 2009, this court has jurisdiction over this appeal under 28 U.S.C. § 1292(a)(1).
II The standard of review in this case is abuse of discretion in both the United States Courts of Appeals for the Federal and Sevent h Circuits. See Rick’s Mushroom Serv., Inc. v. United States , 521 F.3d 1338, 1342 (Fed. Cir. 2008) (“We review a denial of a request for additional discovery for abuse of discretion.”); Gile v. United Airlines , 95 F.3d 492, 495 (7th Cir. 1996) (“[ W]e review a district cour t’s discovery determinations for an abuse of discretion.”). Therefore, this court need not decide the question of which jurisdiction’s law ap plies and will apply an abuse of discretion standard to its analysis. “A district court would necessarily abuse its discretion if it based its ruling on an erroneous view of the law or on a clearly erroneous assessment of the evidence.” Cooter & Gell v. Hartmarx Corp. , 496 U.S. 384, 405 (1990). Wh ile extending the thirtymonth statutory st ay, the district court found, In light of the fact that Teva has recast its product more than eighteen months after it provided the original sample to Lilly and only eight months before trial is set to commence, we find that, in preparation for trial, Lilly is entitled to have sufficient opportuni ty to identify the nature and composition of the raloxi fene product as Teva intends for it to be sold.

2009-1071 6Extension Order , 2008 WL 4809963 at *4-5. In making this determination, the record contained sufficient evidence, not based on clearly erroneous factual findings, upon which the district court rational ly based its decision. The cour t relied on the evidence in the record that Teva altered its proposed generic ra loxifene hydrochlori de tablets late in the litigation. Specif ically, Teva changed the particle size manufacturing specification of its active pharmaceutical ingr edient and the method of measur ing the particle size. Id. at *2. Teva then delivered its changed samp les to Lilly past the court’s August 18, 2008, discovery deadline. In making these findings, the district court acted within its discretion in this area. 21 U.S.C. § 355(j)(5)(B)(iii) grants district courts the di scretion to adjust the statutory thirty-month stay of ANDAs if “either party to the action failed to reasonably cooperate in expediting the action. ” Trial courts, thus, may shor ten or extend the thirty-month statutory period based on t he parties’ uncooperative disco very practices before the court. Allergan, Inc. v. Alcon Labs., Inc. , 324 F.3d 1322, 1337 n.5 (Fed. Cir. 2003) (Schall, J., concurring). In explaining the statutory language, t he House Committee report specified, “[f]ailure by either party to cooperate in a reasonable manner may be used by the court to reduce or lengthen the time, as appropriate, before an ANDA approval becomes effective.” H.R. Rep. No. 98-857 , at 16 (1984), as reprinted in 1984 U.S.C.C.A.N. 2686, 2700. Because Teva provided Li lly with its altered raloxifene samples just eight months before trial, the district c ourt extended the stay “to prov ide Lilly with a reasonable amount of time to allow its expert to test and report on the altered raloxifene samples

2009-1071 7provided by Teva and for Lilly to assess and utilize that information and analysis in preparation for trial. ” Extension Order , 2008 WL 4809963 at *6. Teva argues that this court’s opinion in Andrx Pharmaceuticals, Inc. v. Biovail Corporation , 276 F.3d 1368 (Fed. Cir. 2002), shows that the district court erred in extending the thirty-month stay. In Andrx , Biovail and Andrx were embroiled in patent litigation over both infringement and validity. Id. at 1372. The filing of the action triggered an automatic thirty-month stay of A ndrx’s ANDA from the date Biovail received Andrx’s paragraph IV ce rtifications on February 20, 2001. Id. Before the expiration of the thirty-month stay, Biovail acquired an exclusive license to a second patent in January 2001 that allegedly claimed t he subject matter of its NDA. Id. Biovail changed its manufacturing process to fall within t he claims of the second patent, which it submitted to the FDA on January 8, 2001, for listing in the Orange Book. Id. at 1372-73. In a February 2, 2001, letter to Andrx, t he FDA stated that becaus e of the listing of Biovail’s second patent, it no longer in tended to approve Andrx’s ANDA upon the expiration of the thir ty-month stay. Id. at 1372. Andrx filed paragraph IV certif ications with the FDA on February 16, 2001, that it did not infringe the second patent and t hat the patent was invalid. Andrx , 276 F.3d at 1373. On April 5, 2001, fort y-four days after it received the paragraph IV certifications on February 20, 2001, Biovail filed a second suit against Andrx under 35 U.S.C. § 271(e)(2) for infringement of the second patent. Id. The second suit triggered a second thirty-month statutory st ay ending August 8, 2003. * Id.

* In June 2003, the FDA amended its regulations so that an NDA holder could not obtain additional thirty-month stays based on patents added to the Orange Book after a generic manufactu rer filed its ANDA. See Apotex, Inc. v. Thompson , 347

2009-1071 8Andrx moved for summary judgment under 21 U.S.C. § 355(j)(5)(B)(iii) that the district court shorten the se cond thirty-month stay. Id. at 1374. In granting the motion, the district court found Biov ail had intentionally impeded and delayed the expeditious resolution of the patent actions between it and Andrx. Id. at 1374-75. The district court, thus, shortened the second statutory thirty-m onth stay to September 27, 2001. Id. at 1375. On appeal, this court held t hat the district court exc eeded its authority under 21 U.S.C. § 355(j)(5)(B)(iii), vaca ted the district court’s order, and remanded for further proceedings. Andrx , 276 F.3d at 1370. This court found the district court’s reading of the statute was overly broad. The district court concluded it could shorten the thirtymonth stay due to the alleged delay in the resolution of both patent disputes between the parties. Id. at 1376. The district court, howev er, erred by basing its decision on Biovail’s positions before the FDA. Id. Unlike Andrx , in this case, the district cour t extended the stat utory thirty-month stay based on its findi ngs of Teva’s lack of cooperation in expediting the patent litigation in its court. The court’s findings were not based on Teva’s filing with the FDA. Moreover, as discussed, the district court’ s decision was support ed by the record, its factual findings, and proper application of the law.

F.3d 1335, 1341 (Fed. Cir. 2003); Robert A. Ma tthews, Jr., Annotated Patent Digest § 10:154 (2007). In late 2003, Congress am ended 21 U.S.C. § 355(j)(5)(B)(iii) to eliminate the thirty-month stay for any pat ent the NDA holder acqu ired after the generic manufacturer filed its ANDA. Pub. L. No . 108-173, § 1101(a)(2)(A)(ii), 117 Stat. 2448 (2003).

2009-1071 92009-1071 10 III Because the district court did not abuse its discretion with it s discovery findings and extending the statutory thirty -month stay to March 9, 2009, this court affirms. Given the short timing of this appeal, under Federal Rule of Appellate Procedure 40, a petition for panel rehearing or rehearing en banc must be filed within seven days after entry of judgment.

AFFIRMED

## United States Court of Appeals for the Federal Circuit

2009-1071 ELI LILLY AND COMPANY, Plaintiff-Appellee,

v. TEVA PHARMACEUTICALS USA, INC., Defendant-Appellant. Appeal from the United St ates District Court for the Souther n District of Indiana in case no. 1:06-CV-1017, Judge Sarah Evans Barker. PROST, Circuit Judge , dissenting. The thirty-month stay described in 21 U.S.C. § 355(j)(5)(B)(iii) may be extended for one reason and one reason only: “because either party to the action failed to reasonably cooperate in expediti ng the action.” Because I believe that the majority misapplies the law and misapprehends the fact s in affirming the district court, I respectfully dissent.
I The question here is one of statutory construction, which we review de novo. Although the majority is correct in that a district court’s decision to issue a stay is generally reviewed for abuse of discretion, see, e.g. , Cherokee Nation v. United States , 124 F.3d 1413, 1416 (Fed. Cir. 1997), the power to issue a stay in most cases arises under district courts’ “broad discretionary powers to control their dockets,” Gould v. Control Laser Corp. , 705 F.2d 1340, 1341 (Fed. Cir. 1983). Where, as here, the stay is explicitly tied to a statut ory standard, that standard must be properly construed. See In re Princo Corp. , 478 F.3d 1345, 1353–55 (Fed. Cir. 2007) (construing a statute thatrequires a stay by reference to dictionaries and legislative history, among other things). In the past, we have recognized that interpre tation of the stay pr ovided in 21 U.S.C. § 355(j)(5)(B)(iii) is a question of law reviewed without deferenc e. Andrx Pharm., Inc. v. Biovail Corp. , 276 F.3d 1368, 1375 (Fed. Cir. 2002). In Andrx , Biovail appealed a district court’s decision to grant partial summary judgment, shortening the thirty-month stay and requiring the Food and Drug Admi nistration (“FDA”) to approve Andrx’s Abbreviated New Drug Application (“ANDA”). We stated that “[i]nterpretation of statutes governing the grant of summary judgment pres ents threshold questions of law that are reviewed without deference,” th en proceeded to do just that, ultimately vacating and remanding. Id. But even under an abuse of discretion standar d, the district court’s decision should not stand. Let us be clear about what the district court “found.” The district court never made any finding related to the statut ory standard, i.e., whether Teva reasonably cooperated in expediting the action. The c ourt briefly described the background of the case and the parties’ relative positions, and noted that the magistrate judge had ordered Teva to produce various documents prior to August 18, 2008. Although Teva did not complete production until September 5, 2008, the court did not purport to base any finding that Teva “failed to reasonably co operate in expediting the action” on this eighteen-day delay. Instead, the court’s fi ndings were limited to the following: As this Court observed in its or der granting a limit ed extension of the statutory stay in Eli Lill y & Co. v. Barr Laboratories, Inc. , it appears “important, perhaps essent ial, that the composit ion of the generic drug product for which FDA approval is being sought . . . and whic h Lilly alleges to be the infringing product should be definitively established.” That proposition similarly applies here. In li ght of the fact that Teva has recast its product more than eighteen months after it provi ded the origin al sample to Lilly and only eight mont hs before trial is set to commence, we find that,

2009-1071 2in preparation for trial, Lilly is entitled to have a sufficient opportunity to identify the nature and composition of the raloxifene product as Teva intends for it to be sold. Teva argues that the circumstances in [Barr ] are distinguishable from the situation at hand bec ause the defendant in Barr had failed to provide Lilly with even one sample of its generic drug product, whereas here, on December 12, 2006, Teva provided Lilly wit h its original raloxifene sample, and has since produc ed to Lilly three samples of the altered product (the first on July 28, 2008, the second on August 19, 2008, and the third on September 17, 2008). Th erefore, Teva c ontends that an extension of the statut ory stay here is unnecessary because it has fully disclosed all the required information to Lilly in an expedi tious fashion. Although Teva correctly cites the fact ual differences between the case at bar and the situation in Barr , those differences are not viewed by us as determinative on this issue. In Barr , we did not simply extend the statutory stay through the date on which the defendant produced a sample of its product to Lilly. Instead, our order provided that, after the defendant produced the sample, the stay w ould extend through “a reasonably expeditious time period for preparing for trial.” A similar extension is warranted here in order to provide Lilly with a reasonable amount of time to allow it s expert to test and report on the altered raloxifene samples provided by Teva and for Lilly to assess and utilize that information and analysis in pr eparation for trial, which is set to commence on March 9, 2009. For the foregoing reasons, the Court hereby EXTENDS until March 9, 2009, in th is action the period under 21 U.S.C. § 355(j)(5)(B)(iii) during which the FDA is barred from approving ANDA No. 78-193. Eli Lilly & Co. v. Teva Pharm. USA, Inc. , No. 1:06-CV-1017, 2008 WL 4809963, at *2 (S.D. Ind. Oct. 29, 2008) (citations and f ootnotes omitted) (“O rder Extending Stay ”). Not once in this order did the court indicate, mu ch less unambiguously st ate, that it found Teva had failed to reasonably co operate in expedi ting the action. 1 The court provided at most two justifications fo r extending the stay: (1) to provide Lilly “a sufficient

1 If anything, statements by the district court suggest that the court agreed that Teva reasonably cooperated by expediti ously “disclosing all of the required information,” but extended the stay r egardless. Order Extending Stay , 2008 WL 4809963, at *2. Specifically, Teva clai med that an extension of the stay was unnecessary because it fully disclosed all of the required information in an expeditious fashion . The court stated that “[a]lthough Teva correctly cite[d] the factual differences between the case at bar and the situation in Barr , those differences are not . . . determinative on this issue.” Id. (emphasis added).

2009-1071 3opportunity to identify the nature and composit ion of the raloxif ene product as Teva intends for it to be sold,” and (2) to give Lill y “a reasonable amount of time to allow its expert to test and report on the altered ralo xifene samples provided by Teva and for Lilly to assess and utilize that information and anal ysis in preparation for trial.” Id. Neither of these reasons remotely resembles the statutorily required finding. It is clear from the record, in my view, that the district court never related Teva’s conduct to the statutory standard. But even if the court had made a conclusory statement regarding Teva’s coo peration, that alon e would not suffice. In Gechter v. Davidson , we clarified that althou gh “we review decisions, not opinions,” a district court opinion “must contain sufficient findings and reasoning to permit meaningful appellate scrutiny.” 116 F.3d 1454, 1458 (F ed. Cir. 1997). We went on to state the following: A district court therefore may not mere ly state its findings in conclusory terms, but must provide sufficient det ail to elucidate the reasoning by which the court reached its ultimate finding on an issue of fact or conclusion on an issue of law; otherwise, the appella te court is unable to carry out its appellate review function. Indeed, as to the facts it must also find subsidiary facts “specially,” and not just the ultimate fact, here of anticipation. If it fails to do so, its decision will or dinarily be vacated. Id. In fact, in Nazomi Communications, Inc. v. Arm Holdings, PLC , our court vacated a district court’s claim construction, an i ssue that we examine de novo, stating, This court’s review of a district court’s claim construction, albeit without deference, nonetheless is not an independent analysis in the first instance. Moreover, in order to perfo rm such a review, this court must be furnished “sufficient findings and reas oning to permit meaningful appellate scrutiny.” This requir ement for sufficient reas oning applies with equal force to issues of law, such as claim construction, and issues of fact, such as infringement. . . . Unlike Gechter and Graco , where the records were devoid of any claim construction analysis, the dist rict court in this case provided some claim construction analysis. No netheless this analysis is inadequate because it does not supply the basis for its reasoning sufficient for a meaningful review.

2009-1071 4403 F.3d. 1364, 1371 (Fed. Cir. 2005) (citing Gechter , 116 F.3d at 1458; Graco, Inc. v. Binks Mfg. , 60 F.3d 785, 791 (Fed. Cir. 1995)) (cit ations omitted). As in Nazomi , the district court here did not pr ovide sufficient findings and reasoning to permit meaningful appellate scrutiny. Thus, regardless of whether we review the distri ct court’s order de novo or for an abuse of discretion, the order should be vacated. II The consequences of the majority opinion are of particular importance here. Rarely have district courts had the opport unity to address the circumstances under which the thirty-month stay may be extended or shortened. 2 Those courts that have addressed the issue have recogn ized the statutory standard and strictly abided by it in determining whether to modify the stay. See Zeneca Ltd. v. Pharmachemie B.V. , 16 F. Supp. 2d 112 (D. Mass. 1998); In re Brimonidine Patent Litig. , No. 07-md-1866, 2008 WL 4809037 (D. Del. Oct. 31, 2008); Nova rtis Corp. v. Dr. Reddy’s Labs., Ltd. , No. 04- Civ-0757, 2004 WL 2368007 (S.D.N.Y. Oct. 21, 2004); Minn. Mini ng & Mfg. Co. v. Alphapharm Pty. Ltd. , No. CIV-99-13, 2002 WL 1299996 (D. Minn. Mar. 8, 2002); Eli Lilly & Co. v. Zenith Goldline Pharm., Inc. , No. IP99-0038-C-H/G, 2001 WL 238090 (S.D. Ind. Mar. 8, 2001). Appropriate findings by the district court are especially important where, as here, Congress set forth a clear statutory timefr ame and provided one narrow exception to the

2 Even commentators have noted that “[s ]tatutory stay adjustments have not been frequent.” Gerald Sobel et al., Hatch- Waxman Litigation from the Perspective of Pioneer Pharmaceutical Companies, in Patent Litigation Strategies Handbook 183, 196–97 (Barry L. Grossman & Gary M. Hoffman eds., 2d ed. 2005).

2009-1071 52009-1071 6 general rule. 3 Only once has this court exami ned the matter directly. In Andrx , we analyzed a single question: whet her the district court had t he authority to shorten the stay period based on one party’s conduct bef ore the FDA. 276 F.3d at 1376. We expressly limited our review, declining to r each the question “whether the district court’s authority to shorten the thirty -month statutory stay is limi ted to those cases in which there was a failure to expedite the infringement action once it is filed or whether the authority extends as well to situations in which the infringement action was not commenced expeditiously.” Id. In short, this court has not previously provided any guidance to the district courts as to what q ualifies as a “fail[ure] to reasonably cooperate in expediting the action.” To affirm in this case is to effectively e liminate the statutorily required finding, and to pr ematurely terminate the dev elopment of appropriate standards governing modification under 21 U.S.C. § 355(j)(5)(B)(iii). For the foregoing reasons, I respectfully dissent.

3 The legislative history indicates that the thirty-month stay was a hard-won compromise between brand-name manufacturers, generics manufacturers, and other stakeholders. The length of the stay was the subject of heated debate in the House. 130 Cong. Rec. H24426–31 (Sept. 6, 1984). Init ially, the House ve rsion of the bill provided for a stay of just eighteen months. H.R. 3605, 98th Co ng. § 101 (as reported by H. Comm. on the Judiciary, Aug. 1, 1984). The Senate version, which ultimately prevailed, described a thirty-mo nth stay. S. 2926, 98th Cong. § 101 (1984). In light of this fact, we should be especially careful w hen reviewing district courts’ decisions to modify the statutory period. That period ceases to have meaning when district courts are able to modify the stay without articula ting why the narrow circumstances described in the statute are present.