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

Heading: The Factual Scenario of This Case

Text: Glyburide is a drug used in treating diabetes, and micronized glyburide is one form of that drug. Upjohn holds apatent for a particular formulation of micronized glyburideentitled Spray-Dried Lactose Formulation of MicronizedGlyburide. In December, 1994, Mova filed an ANDA for a genericform of micronized glyburide, which included a paragraph IVcertification. Mova gave the required notice to the patentholder, Upjohn; within 45 days of receiving this notice, Upjohn filed a patent infringement suit against Mova in theDistrict of Puerto Rico. While this litigation was underway, in November, 1995,Mylan, too, filed an ANDA for a generic form of micronizedglyburide. Mylan's initial filing contained a paragraph IIIcertification; this meant that Mylan conceded patent infringement, so that its ANDA could not receive FDA approval untilUpjohn's patent expired. In August 1996, however, Mylanamended its ANDA to contain a paragraph IV certification. As Mova had, Mylan gave the required notice to Upjohn; but this time Upjohn, for reasons unclear, failed to sue withinthe prescribed 45-day period.5 The thirty-month suspensionof FDA approval provided for in section 355(j)(5)(B)(iii) onlyapplies if the patent-holder sues the ANDA applicant within45 days; thus, this waiting period did not apply to Mylan. And, because Mova had not yet successfully defendedagainst Upjohn's patent infringement suit, 21 C.F.R.s 314.107(c)(1), which incorporates the FDA's interpretationof section 355(j)(5)(B)(iv), did not require the FDA to delay itsapproval of Mylan's ANDA. Thus, the FDA approved Mylan's ANDA effective immediately, as of December 19, 1996. After learning of this approval, Mova, on December 26,1996, filed suit in the United States District Court for theDistrict of Columbia, seeking a temporary restraining ordercompelling the FDA to postpone the effective date of Mylan'sapproval. Although declining to issue a TRO, the districtcourt, on January 23, 1997, granted a preliminary injunctionrequiring that the FDA render its approval of Mylan's ANDAeffective no earlier than 180 days after the earlier of (1)Mova's first commercial marketing of its micronized glyburideproduct, or (2) the date of Mova's victory in the Puerto Ricolitigation. (This was precisely the relief Mova had sought.) In an accompanying memorandum, the district court explained that the successful-defense requirement in the FDA'sregulations was inconsistent with the plain language of section 355(j)(5)(B)(iv), and therefore unenforceable. The FDA __________ 5 Upjohn did eventually sue Mylan, on February 17, 1997. OnMarch 31, 1998, the court ruled that Upjohn's patent was invalidand not infringed. and Mylan (which had intervened in the proceedings) appealed. One further matter remained to be resolved. Before thepreliminary injunction was issued, Upjohn had filed a motionseeking to intervene in the proceedings before the districtcourt. The district court had not adverted to this motion ingranting the preliminary injunction. A few days later, however, on February 10, it denied Upjohn's motion to intervene,stating that the motion was moot (because the district courthad already issued the preliminary injunction), and also thatUpjohn did not have a cognizable interest in the litigation,and was therefore not entitled to intervene. Upjohn hasappealed this order, and argues that it should be allowed toparticipate in this appeal and in any further proceedings inthe district court. While these appeals were pending, there have been subsequent developments in Upjohn's patent infringement suitagainst Mova. On December 2, 1997, a jury found thatUpjohn's patent was invalid, unenforceable, and had not beeninfringed. Mova received final approval from the FDA tomarket its product on December 22, and began to sell itsproduct shortly afterwards. By its terms, the district court'spreliminary injunction will therefore expire 180 days afterDecember 2, 1997, on May 31, 1998.