Month: February 2007
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Pfizer v. Mylan Labs. et al., No. 02-1628 (W.D. Pa. 2007) For the third time, Pfizer’s patent on Norvasc has withstood a validity challenge from a generic rival. Following a week-long trial held last year, Judge Terrence F. McVerry of the U.S. District Court for the Western District of Pennsylvania ruled yesterday that Pfizer’s U.S.…
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Astellas Pharma et al. v. Ranbaxy et al., No. 05-2563 (D. N.J. 2007) A federal district court last week upheld Astellas Pharma’s patent on Flomax (tamsulosin HCl), preventing Ranbaxy from marketing a generic version of the drug until the patent expires in 2009. Flomax is a treatment for benign prostatic hypertrophy (BPH), with annual sales…
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We reported last month on a new declaratory judgment action that Apotex filed against GlaxoSmithKline in the Eastern District of Virginia. In its complaint, Apotex alleged that Glaxo’s listing of a patent on Zantac Syrup in the Orange Book gave rise to a justiciable controversy sufficient to support declaratory judgment jurisdiction. The Federal Circuit has…
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The new Thai government has been experimenting with the compulsory licensing provisions of Article 31 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). To date, Thailand has unilaterally declared compulsory licenses for three patented drugs: (i) Stocrin, a first-line anti-retroviral used in treating HIV/AIDS; (ii) Kaletra, a second-line anti-retroviral also used to…
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It has always been assumed the answer is "yes." Now the Federal Circuit will answer the question directly in Merck v. Hi-Tech Pharma., which concerns Hi-Tech’s ANDAs for generic versions of Merck’s Trusopt and Cosopt prescription eye drops. The case was argued in December and a decision could come at any time. Merck owns U.S.…
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A recent report published in the Journal of the American Medical Association found that the FDA’s Pediatric Exclusivity Provision (PEP) does not necessarily yield lucrative returns for innovator drug companies. The PEP authorizes the FDA to grant innovator drug companies a six-month extension of marketing exclusivity (beyond patent expiration) in exchange for conducting studies of…
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The Senate Judiciary Committee passed the "Preserve Access to Affordable Generics Act" (S. 316) today by unanimous consent. If enacted, the bill would prohibit "reverse payment" settlements of Hatch-Waxman litigation, in which an innovator drug company pays a generic drug company to delay marketing its generic drug product. Specifically, the bill would amend the Clayton…
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Most pharmaceuticals made using biotechnology are approved through a Biologic License Application (BLA) rather than a New Drug Application (NDA). The FDA requires essentially the same type of evidence for both biologics and conventional (i.e., small molecule) drugs; namely, results of adequate and well-controlled clinical trials demonstrating safety and effectiveness. However, currently there is no…
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Ortho-McNeil Pharma. v. Mylan Labs. et al., No. 04-1689 (D. N.J. 2007) Mylan Laboratories filed an ANDA in 2001 to market a generic version of Topamax (topiramate), Johnson & Johnson’s blockbuster anticonvulsant drug, and asserted that the patent on Topamax was invalid due to obviousness. As we previously reported, last October Judge Stanley R. Chesler…
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Watson Pharmaceuticals announced today that it has settled a patent infringement suit concerning GlaxoSmithKline’s popular antidepressant Wellbutrin XL (bupropion HCl extended release tablets) for $35 million. The suit was filed in the Southern District of Florida in December 2005 by Andrx Pharmaceuticals, which was acquired by Watson last year. Andrx asserted that Glaxo’s formulation for…
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