Recent Posts
- Hikma v. Vanda: Oral Argument Recap
- Teva v. Lilly should not be read as creating a new 112 rule for method of use claims
- Should ANDA filers be using the PTAB to mount early challenges to OB patents?
- Switching to WordPress
- Judge Hughes concurrence highlights post grant review appeal standing issue for pharma cases
Category: Orange Book Issues
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Earlier this week, FDA Law Blog provided an update on Teva’s suit against the FDA, seeking relisting of Janssen’s patent on Risperdal (risperidone) and confirmation of Teva’s 180-day exclusivity on a generic version of the drug. Last week, FDA Law Blog reported on a recent FDA determination that Watson Labs forfeited its 180-day exclusivity on…
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Last Friday, Rep. Anna G. Eshoo (D-CA) announced that she and Rep. Joe Barton (R-TX) introduced H.R. 5629, the "Pathway for Biosimilars Act" (click here for summary; click here for text of bill). BIO immediately applauded the bill, while GPhA immediately denounced it. For more, visit FDA Law Blog; Pharmalot; or the WSJ Health Blog.…
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A reader recently e-mailed me about an interesting citizen petition that Teva filed last August. In the petition, Teva requests that FDA: (1) relist U.S. Patent No. 5,158,952 in the Orange Book for Risperdal (risperidone) tablets; (2) confirm Teva’s right to 180-day exclusivity for risperidone tablets; and (3) refrain from approving any other ANDAs for…
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Merck v. Apotex, No. 06-5789 (D.N.J. 2007) Merck has sold Cosopt (dorzolamide hydrochloride/timolol maleate), an opthalmic drug indicated for the treatment of ocular hypertension and open-angle glaucoma, since 1998. In October 2005, Hi-Tech Pharmacal filed the first ANDA for a generic version of Cosopt with paragraph IV certifications to the Orange Book-listed patents: U.S. Patent…
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The Supreme Court this morning denied Pfizer’s cert petition in the Norvasc case (AP story). Although the Federal Circuit’s March 22 decision is controversial, the denial of Pfizer’s cert petition is not surprising, given that the Court had previously denied Pfizer’s motions for an emergency stay and for an expedited appeal. Late last Friday the…
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The Federal Circuit reissued its July 11 opinion in Daiichi Sankyo v. Apotex as a precedential opinion, one day after denying Daiichi's petition for rehearing. According to Hal Wegner, a major reason for making the decision precedential was Prof. Joseph Scott Miller's Rule 47.6(c) filing. Biosimilars legislation is "off the table" for now. The FDA…
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Last week, the U.S. District Court for the District of Columbia denied Mylan’s emergency motion for a temporary restraining order that would have forced FDA to relist Pfizer’s Norvasc patent in the Orange Book. Until June 22, when FDA delisted Pfizer’s patent, Mylan and Apotex had the only approved ANDAs for generic Norvasc. Bloomberg reported…
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The Court of Appeals for the D.C. Circuit today affirmed a district court decision finding that the FDA wrongly delisted two Merck patents on Zocor (simvastatin), which in turn unlawfully denied Teva and Ranbaxy from 180 days of marketing exclusivity on generic simvastatin. FDA appealed the district court decision but did not request a stay. …
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KV Pharmaceutical Company recently filed a citizen petition asking the FDA to relist U.S. Patent No. 5,246,714 for 100 mg and 200 mg Toprol XL in the Orange Book. In the same petition, KV asked the FDA to refrain from approving any ANDA for 100 mg and 200 mg Toprol XL filed after KV's ANDA…
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