INTERNATIONAL PHARMACEUTICAL's VINCRISTINE PRODUCT LAUNCH
INTERNATIONAL PHARMACEUTICAL's VINCRISTINE PRODUCT LAUNCH is underway. The firm maintained in a Feb. 6 press release that its liquid vincristine product does not infringe Lilly patents for Oncovin. International Pharmaceutical Products said it "has satisfied all applicable legal requirements, has a valid ANDA license and is legally entitled to market its vincristine product." The firm also noted that it informed Lilly "that it intended to market the vincristing product as not being violative of the Lilly patent." International Pharmaceutical Products' attorney Thomas Henteleff (D.C. firm Kleinfeld, Kaplan & Becker) told FDA in a Feb. 2 letter that as of that date, more than 45 days had passed since International Pharmaceutical Products informed Lilly of its intent to market vincristine. "Lilly has not brought any action against International for infringement of its vincristine patent. Accordingly, the agency is now in a position to immediately grant a new approval for International's vincristine product and thereby moot any issue as to whether the Nov. 26, 1986 approval contitutes a valid and currently effective approval," Henteleff stated. The firm's letter responded to an FDA reg letter which maintained that the generic firm's vincristine ANDA was not valid. FDA Office of Compliance Director Daniel Michels told Henteleff Jan. 14 that the agency does not consider International Pharmaceutical Products to have an approved NDA for vincristine and that if the company introduced the product into the market FDA "is prepared to invoke regulatory sanctions" ("The Pink Sheet" Feb. 2, T&G-5). Michels said FDA would be authorized to approve the firm's ANDA when International resubmitted certification regarding the patent status of Lilly's Oncovin liquid. International Pharmaceutical Products noted that its vincristine product is marketed in several other countries where Lilly also markets a vincristine formulation and that Lilly has never filed a patent infringement suit. FDA's Generic Drugs Division sent International an approval letter for its vincristine ANDA on Nov. 26. In a Dec. 2 letter to the firm, the division said "the approval dated Nov. 26, 1986 is null and void" because International's application contained an incorrect patent certification. FDA explained that at the time the Nov. 26 approval letter was signed "examination of agency files revealed no information that Lilly Research Labs . . . had filed patent information" with respect to Oncovin, the reference drug in International's ANDA. "In fact," the agency said, "by letter dated Nov. 26, 1986 and received by the agency on Nov. 28, 1986, Lilly Research Labs showed they had submitted such information to the agency on Oct. 28, 1986." FDA advised International Pharmaceutical Products to include an appropriate certification with respect to Lilly's patent, as otherwise its ANDA was approvable. In response to the agency, Henteleff wrote on Dec. 10 that "even if Lilly had made a timely filing which it could document by receipted copies, in conformity with accepted practice, International's certification would still be correct under [the Waxman/Hatch law] unless, in 'the opinion of the applicant and to the best of his knowledge,' the prior certification was no longer valid." Henteleff said that "FDA not only did not advise International that Lilly had filed patent information, but affirmatively advised International that it had not." In a Dec. 8 letter to Lilly Assistant Patent Counsel Charles Ashbrook, the generic firm's CEO Lionel Simon asserted that International Pharmaceutical Products' vincristine formulation "significantly differs" from the formulation claimed in Lilly's patent. "Based upon this fact and the fact that on Nov. 26, 1986, we obtained what we believe to be a valid and currently effective approval of an ANDA for our vincristine formulation, it is our intention to begin marketing our vincristine product."
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