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MYLAN v. FDA

Executive Summary

PRAZOSIN GENERIC EXCLUSIVITY WILL NOT BE GRANTED to the firm following Mylan's defeat in Clarksburg, West Virginia federal court on May 5. Judge William Kidd ruled that FDA's interpretation of the generic exclusivity law was "rational" and added: "since Mylan was not the first ANDA to file a complete application containing a paragraph IV certification, it is not entitled to clause (iv) [generic] exclusivity." Pfizer markets the antihypertensive drug under the brand name Minipress. Other companies with approved ANDAs for prazosin -- including Zenith, Danbury, Lederle, American Therapeutics and Cord Labs -- are expected to launch the product May 16 when Pfizer's patent expires. Danbury and American Therapeutics filed motions to intervene in support of FDA's position. Danbury has been promoting the upcoming launch for prazosin in trade journals for roughly six weeks. The Schein subsidiary plans to price the drug at approximately 20% below the Pfizer average wholesale price. Mylan was the third company to file an ANDA for prazosin, following Zenith and Danbury. After Mylan gave notice to Pfizer regarding the ANDA submission, Pfizer sued the generic company for patent infringement. In a complaint filed last year in Clarksburg, West Virginia federal court, Pfizer asserted: "Mylan has failed and refused to provide Pfizer with information necessary to establish Mylan's claim of noninfringement." The suit was dropped when Mylan later provided Pfizer with samples of its drug which confirmed noninfringement. However, when Mylan asked FDA for exclusive marketing rights to prazosin, the agency denied exclusivity based on the fact that the company was not the first to file an ANDA for the drug. The key issue in the Mylan v. FDA suit was whether FDA "rationally" interpreted the generic exclusivity provision of the 1984 ANDA/patent act. The law denies approval to other ANDA applicants for 180 days if a "previous application" was submitted with a paragraph IV certification that the reference product's patent is not infringed by the drug subject of the ANDA. The term "previous application" was considered ambiguous by the court because it could refer to "the first ANDA" or, as Mylan argued, "the first ANDA subjected to lawsuit," among other possibilities. Mylan claimed it merited the 180-day exclusivity period on the grounds that it was the first company to be sued and subsequently cleared of patent infringement because "there has been no commercial marketing by any previous ANDA with a paragraph IV certification," the opinion notes. In determining FDA's reading of the law, the court looked to the agency's two-pronged "bright-line" test, which determines if an applicant is entitled to generic exclusivity. First of all, FDA requires that the ANDA be the first complete application with a paragraph IV certification. Secondly, the applicant must have been sued for patent infringement. The judge determined that FDA's interpretation is "rational" and that the exclusivity provision "is not implicated unless and until a clause (iii) [patent infringement] lawsuit is instituted and then, only if instituted against the first ANDA." The court also stated that the FDA interpretation "certainly furthers the congressional intent to provide and encourage generic competition but also provides a reward to the first applicant who initiates competition if subjected to a suit" for patent infringement.
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