On April 30, 2006 Judge Richard W. Roberts of U.S. District Court for the District of Columbia, in his memorandum opinion, has ruled in the favor of Ranbaxy & Ivax (acquired by Teva) by granting them summary judgment and contending that the FDA has acted contrary to the clear intent of Congress in its decision to deny Ranbaxy and Ivax’s citizen petitions. This ruling means that Ranbaxy and Ivax are likely to be the sole generic competitors to sell generic version of Merck’s Zocor after the basic patent (U.S. Patent No. 4,444,784) covering simvastatin get expired on June 23, 2006.

Delisting Orange Book Patents

Earlier, at the time when Ranbaxy and Ivax submitted their abbreviated new drug applications (ANDAs) with US FDA, Merck had three listed patents for simvastatin in the Orange BookU.S. Patent No. 4,444,784 (‘784 patent’), U.S. Patent No. RE36481 (‘481 patent’), and U.S. Patent No. RE36520 (‘520 patent’). However, Ranbaxy and Ivax filed Para III certifications with respect to ‘784 patent but both filed Para IV certifications in respect of other two listed patents contending that the ‘481 and ‘520 patents were invalid or unenforceable, or that their drugs would not infringe those patents. Following the submission of Para IV certifications by Ranbaxy & Ivax, Merck, instead of suing them within 45 days, submitted a letter to the FDA requesting that the ‘481 and ‘520 patents to be delisted from the Orange Book. Learning that FDA has delisted the ‘481 and ‘520 patents from the Orange Book, both Ranbaxy and Ivax submitted citizen petitions, requesting FDA to confirm that it would not approve subsequent ANDAs until after the 180-day period and to relist the patents in the Orange Book.

On October 24, 2005 FDA denied both the petitions deciding that it would not relist the disputed patents, that no applicant will be entitled for 180-day exclusivity for delisted patents, and that it will approve all subsequent ANDAs for simvastatin. As a result, Ranbaxy and Ivax separately sued the FDA under 5 USC § 706 claiming that the FDA improperly nullified Ranbaxy and Ivax’s rights to a 180-day period of exclusive marketing of generic Zocor. These civil actions were consolidated and all three parties moved for summary judgment, contending that there are no genuine issues of material fact and that each is entitled to judgment as a matter of law.

The Last Laugh

The District Court Judge in his opinion ruled that the FDA should have granted the petition by Ranbaxy & Ivax and also that the FDA’s decision “contravened the plain and undisputed intent of Congress.” The issue is now sent back to the FDA by the District Court for a decision, giving Ranbaxy & Teva the last laugh. However, FDA may file an appeal against the ruling in the U.S. Court of Appeals for the District Court of Columbia Circuit, which may delay the sale of a generic Zocor beyond June 23, 2006.

Today’s post comes from Varun Chhonkar, Senior Officer – Patents with J.B. Chemicals & Pharmaceuticals Ltd., Mumbai, India (varun.chhonkar[at]jbcpl.com). © Varun Chhonkar.

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