Relieving the Tension Between FDA’s PLAIR Program and Hatch-Waxman: A New Paper Suggests A Remedy

June 5, 2014

By Kurt R. Karst –      

FDA’s Pre-Launch Activities Importation Request (“PLAIR”) program got a lot of attention last July when the Agency finally announced the issuance of a draft guidance document (Docket No. FDA-2013-D-0836) describing the program.  Briefly, the PLAIR program allows, on a case-by-case basis and subject to FDA’s discretion, the importation and warehousing of finished drug and biological products where an application for approval (i.e., an NDA, ANDA, or BLA) is pending and where the import and warehousing will expedite the commercial launch of the product once FDA approves a marketing application.

We started talking about FDA’s PLAIR program years before the Agency issued formal guidance (see our previous post here).  In a later post (May 2012), we discussed a case – Sanofi-Synthelabo v. Apotex, Inc. – clearly showing some tension between FDA’s PLAIR program and Hatch-Waxman.  We won’t get into the specifics of the case here, as readers can refer to our previous post for the details.  However, in a nutshell, ANDA sponsor Apotex (the only company to have thus far commented on FDA’s draft PLAIR guidance) was, pursuant to an Order issued under 35 U.S.C. § 271(e)(4), permanently enjoined from “engaging in the commercial manufacture, use, offer to sell or sale within the United States, or importation into the United States” of its generic version of PLAVIX (clopidogrel bisulfate) Tablets until the expiration of a particular patent (and any associated pediatric exclusivity).  As Apotex was gearing up for ANDA approval, the company asked for an amended Order permitting importation of its drug product into the U.S. as a result of a PLAIR request submitted to FDA.  The request for an amended Order was denied by both a district court and the Federal Circuit. 

A new article published in the Hastings Science & Technology Law Journal authored by Alex Cheng and Matthew Avery, titled “The Conflict Between the FDA's Pre-Launch Activities Importation Request Program and the Hatch-Waxman Act,” further explores FDA’s PLAIR program.  It takes a close look at the tension between PLAIRs and the Hatch-Waxman Amendments, and, in particular, in the context of the Sanofi case.

Noting that “[i]f a district court issues a permanent injunction pursuant to section 271(e)(4) of the Patent Act to prohibit the generic company from importing its infringing drug product before the date that the patent expires, then the generic should not be able to take advantage of PLAIR to import its generic drug into the United States ahead of anticipated ANDA approval,” the authors suggest both an amendment to FDA’s PLAIR guidance and to 35 U.S.C. § 271(e)(4).  First, write the authors:

To ensure that the FDA does not approve PLAIR requests during the term of a patent injunction, the FDA should amend the PLAIR process so that an applicant is required to submit information identifying any injunctions that may prohibit importation of its product.  For example, the FDA could amend the PLAIR Draft Guidance to require the following be included with all PLAIR requests:

(j) A letter signed by an authorized representative of the applicant certifying under 18 U.S.C. § 1001 that the applicant is not a party to a court order subject to an injunction prohibiting importation of the drug product.

This requirement will save both the FDA and the courts resources. Such a requirement would allow the FDA to reject PLAIR requests that seek to illegally import products during the term of an injunction (or to summarily deny such requests if they fail to submit this required information). In turn, this would prevent courts from having to weigh in on whether importation under the PLAIR request is proper.

Although ANDA (and 505(b)(2)) applicants are currently required to notify FDA of court actions (see 21 C.F.R. § 314.107(e)), it seems unlikely that the FDA components to which these notifications are sent (i.e., the Office of Generic Drugs or a particular Division in the Office of New Drugs) would, as a matter of course, apprise the Agency’s PLAIR team in the event a PLAIR has been (or will be requested).  As such, this proposed additional element to a PLAIR request seems to make sense.

Second, the authors suggest a revision to 35 U.S.C. § 271(e)(4), as reflected in the bolded and italicized typeface below: 

For an act of infringement [caused by filing an ANDA with a Paragraph IV certification] – (A) the court shall order the effective date of any approval of the drug . . . to be a date which is not earlier than the date of the expiration of the patent which has been infringed, (B) injunctive relief may be granted against an infringer to prevent the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of an approved drug, veterinary biological product, or biological product, except importation into the United States shall be allowable to the extent that such importation is permitted by the Food and Drug Administration pursuant to a Pre-launch Activities Importation Request, . . . .

This amendment, say the authors, “would allow generic companies to import their products during the term of an injunction, while still prohibiting them from actually marketing their products until the brand-name manufacturer’s patent expires, thereby protecting the pioneer’s patent rights.”  In addition, the authors state that 35 U.S.C. § 271(e)(4) could be “further amended to only allow importation if the PLAIR applicant submits a letter signed by an authorized representative certifying under 18 U.S.C. § 1001 that it will not sell, offer to sell, or distribute its product prior to receiving final marketing approval from the FDA.”   Such amendments to the statute would appear to be a sufficient way to both protect patent rights and place all ANDA sponsors (both domestic and foreign) in a similar marketing position.