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: Citizen Petitions
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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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SCOTUSblog reported on Wednesday that the Supreme Court has denied Pfizer’s emergency application for relief from the Federal Circuit’s ruling in the Norvasc case. TheStreet.com also has an article on the Supreme Court’s decision. On Tuesday, the Federal Circuit granted Mylan’s motion for summary reversal of the district court decision that had found Pfizer’s Norvasc…
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A dozen companies have submitted letters in response to FDA’s March 29 request for "comments from interested parties" on Norvasc (amlodipine besylate) exclusivity issues. Last week, as we reported here, FDA promised the U.S. District Court for the District of Columbia that by Wednesday, April 11, it will decide whether to approve any ANDAs for…
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Aventis Pharma v. Amphastar Pharms., No. 03-887 (C.D. Cal. 2007) In a ruling issued last Friday, Judge Mariana R. Pfaelzer of the U.S. District Court for the Central District of California held Aventis’s U.S. Patent No. 5,389,618 and its U.S. Reissue Patent No. 38,743 unenforceable due to inequitable conduct. The patents cover Lovenox (enoxaparin), a…
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The Antitrust & Competition Policy Blog reports on a new paper by Prof. Christopher Leslie of Chicago-Kent College of Law advocating the use of antitrust law to challenge the licensing of invalid patents. Richard Epstein, my law school Property professor, has a new book out entitled Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation. Judy…
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MedImmune Oncology v. Sun Pharm. Indus., No. 04-2612 (D. Md. 2007) MedImmune earns about $100 million annually from sales of Ethyol (amifostine), an injectable drug approved for the relief of certain side effects of chemotherapy and radiation therapy. Sun Pharmaceutical Industries filed an ANDA to market a generic version of Ethyol. In what appears to…
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In a dramatic turn of events in Savient Pharma’s patent litigation against Sandoz and Upsher-Smith, late this afternoon the Court of Appeals for the Federal Circuit granted Savient’s emergency appeal and temporarily enjoined Sandoz and Upsher-Smith from marketing their generic versions of Oxandrin (oxandrolone). The Federal Circuit’s order came just before a district court’s Temporary…
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Mylan and Impax were the first generic drug companies to file substantially complete ANDAs for generic versions of Ditropan XL (oxybutynin chloride, extended release), an incontinence treatment with annual sales of about $400 million. Mylan was the first to file for the 5 mg and 10 mg dosage strengths and Impax was the first to…
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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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Continuing their collaboration on new laws relating to pharmaceuticals, Senators Herbert Kohl (D-WI) and Patrick Leahy (D-VT) recently introduced legislation to stop perceived abuses of the FDA’s citizen petition procedure that result in delaying approval of generic drugs. The bill is entitled the Citizen Petition Fairness & Accuracy Act of 2006. According to Sen. Leahy’s…
Orange Book Blog 