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Executive Summary

IBUPROFEN ANDAs BASED ON DATA GENERATED PRIOR TO ANDA/PATENT LAW should not be approved, Boots counsel James Johnstone (Wiley and Rein) maintained in a May 13 petition to FDA. The firm petitioned FDA to "refrain from approving . . . ANDAs under 505(j) or paper NDAs under 505(b)(2) which rely on data generated as a result of the patent infringing use or manufacture of ibuprofen or ibuprofen containing products prior to the Sept. 24, 1984 effective date of the Drug Price Competition and Patent Term Restoration Act." Boots' petition notes that the firm is currently engaged in litigation over Mylan's alleged pre-September testing of ibuprofen for its pending ibuprofen ANDA. The petition requests that FDA not approve any ibuprofen generic applications until the Boots/Mylan litigation resolves the legal issue of whether pre-ANDA/patent law testing constitutes patent infringement under Roche v. Bolar. Johnstone stated the Boots' position is: "(1) that pre-Sept. 24, 1984 unauthorized manufacture and testing of ibuprofen was and is infringement, (2) that the 1984 act did not and could not retroactively change the law applicable to such pre-enactment infringement, and (3) that the patent holder is entitled to relief to prevent the infringer from benefiting from such infringement to the patent holder's detriment." Referring to the lawsuit, Johnstone stated that if Boots' "position is upheld, it would be wrong and wasteful for FDA to approve ANDAs or paper NDAs relying on data generated through patent infringement." The petition asserts that while patent holders could seek judicial "relief against the new NDA holders (and possibly FDA), such litigation would be wasteful and likely to adversely affect the public interest by creating more delay in generic drugs reaching the market than a clear policy of refusing to consider data generated through infringement." If FDA "believes it should not withhold approval of infringing applications," the petition requests that the agency "(1) immediately amend 21 CFR 314(b) to provide for 30 days prior notice to the patentee if FDA has decided to approve an application for which it appears that data was developed in derogation of patent rights and (2) give petitioner such notice with respect to any ANDAs or paper NDAs for ibuprofen."

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