Opinion ID: 184499
Heading Depth: 3
Heading Rank: 2

Heading: The Statute's Text and Structure

Text: Section 355(j)(5)(B)(iv) is far from a model of legislativedraftsmanship. The district court in this case called theprovision cumbersome; another district court described itas very confusing and ambiguous. Mylan Pharmaceuticals, Inc. v. Sullivan, No. 89-36-C(K), slip op. at 6 (N.D.W.V.May 5, 1989). But, to the extent that the statute is clearabout anything, it clearly forecloses the FDA's successfuldefense requirement.9 The successful-defense requirement is inconsistent with theliteral language of the statute. Section 355(j)(5)(B)(iv) saysthat, if an applicant has already filed a paragraph IV ANDA,later applications shall be approved not earlier than onehundred and eighty days after the commercial-marketingtrigger or the court-decision trigger is satisfied. The FDA'ssuccessful-defense requirement, by contrast, permits laterapplications to be approved even though neither trigger hasbeen satisfied, simply because the first applicant's litigationhas not yet come to a successful conclusion. The win-first rule also infringes on the statutory scheme ina second, subtler way: its practical effect is to write thecommercial-marketing trigger out of the statute. The commercial-marketing trigger seems intended to ensure that, if afirst ANDA applicant chooses to begin marketing its productbefore it has won its patent-infringement suit, the 180-dayexclusivity period will begin to run immediately. Under theFDA's regulation, however, the 180-day exclusivity period isonly available to an applicant who has already successfullydefended against a suit for patent infringement. Thus, if thefirst applicant begins marketing its product before it wins its __________ 9 We note that the Fourth Circuit recently came to the sameconclusion in an unpublished opinion. See Granutec, Inc. v. Shalala, Nos. 97-1873, 97-1874, slip op. at 13-14 (4th Cir. Apr. 3, 1998). Because the rules of the Fourth Circuit disfavor (but do notprohibit) citation of unpublished opinions, we will not discuss thereasoning of Granutec further. infringement suit, the 180 days of exclusivity do not begin torun; other applicants remain eligible for FDA approval tobegin marketing their products, at least up to the date thatthe first applicant wins the infringement action. If the first applicant eventually wins its lawsuit, the exclusivity period is counted as though it had begun to run whenthe applicant started commercial marketing. Thus, an applicant who begins commercial marketing 120 days before winning its lawsuit receives only 60 days of exclusivity; anapplicant who begins commercial marketing 180 days (ormore) before winning its suit receives no exclusivity period atall. The FDA thus construes the commercial-marketing trigger to potentially hurt, but never benefit, the first ANDAapplicant. There is no indication in the text or history of section355(j)(5)(B)(iv) that the commercial-marketing trigger is supposed to function in that one-sided manner. The FDA itselfprovided a more plausible explanation of how it should workin an initial notice of proposed rulemaking for the ANDAregulations. As the FDA then explained the statutoryscheme, Congress's decision to begin the 180-day period under section 505(j)(4)(B)(iv)(I) of the act from the first commercial marketing of the drug, rather than from the effective date of the ANDA, serves a rational policy only if Congress contemplated a situation in which an approval of an ANDA is in effect but the applicant's decision not to market the drug deserves to be protected because a delay in marketing serves the public interest. Such a situation occurs where, under the terms of section 505(j)(4)(B)(iii) of the act, an ANDA goes into effect 30 months after a lawsuit is filed, but the lawsuit is still pending. It serves the public interest to permit a prudent ANDA holder in that situation to stay off the market until the litigation is resolved, thereby minimizing potential damages. As drafted, sections 505(j)(4)(B)(iv)(I) and (II) of the act carefully avoid providing an incentive for immediate marketing; the 180-day reward of exclusive marketing begins when the applicant wins the lawsuit or when the applicant actually begins marketing, whichever is earlier. The applicant thus does not lose any of the 180-day period by electing to stay off the market until the lawsuit is over. Abbreviated New Drug Application Regulations, 54 Fed. Reg.28,872, 28,894 (1989). In other words, the 180-day exclusivityperiod should begin to run as soon as the first applicantbegins commercial marketing. In adopting the successfuldefense requirement in its final rulemaking, the FDA neitherrejected the foregoing analysis, nor explained how the successful-defense requirement would be consistent with it. SeeAbbreviated New Drug Application Regulations, 59 Fed. Reg.50,338, 50,353 (1994).10