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: Paragraph IV Cases
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Bayer Schering v. Barr Labs, No. 2008-1282 (Fed. Cir. 2009) A divided panel of the Federal Circuit today affirmed a district court decision holding Bayer's U.S. Patent No. 6,787,531 invalid due to obviousness. The '531 patent, which claims pharmaceutical compositions of drospirenone and ethinyl estradiol, protects Bayer's popular birth-control pill Yasmin. In today's decision, the…
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Eli Lilly & Co. v. Teva Pharms. USA, Inc., No. 2009–1071 (Fed. Cir. 2009) Under the Hatch-Waxman Act, final FDA approval of an ANDA is automatically stayed for thirty months when a patent owner files suit for patent infringement within 45 days of receiving a Paragraph IV notice letter. The purpose of the stay is…
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Sanofi-Synthelabo et al. v. Apotex, No. 2007-1438 (Fed. Cir. 2008) In an opinion released last Friday, the Federal Circuit affirmed the decision of the U.S. District Court for the Southern District of New York, following a 2007 bench trial, that Sanofi's U.S. Patent No. 4,847,265 is not invalid for anticipation or obviousness. The '265 patent covers…
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Takeda v. Mylan and Alphapharm, Nos. 2007-1269, -1270 (Fed. Cir. 2008) In an opinion released Monday, the Federal Circuit affirmed a district court decision granting $16.8 million for attorney fees, expenses and expert fees to Takeda for baseless paragraph IV certification letters and litigation misconduct by Mylan and Alphapharm in ANDA litigation involving Actos (pioglitazone). …
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Merck & Co. v. Apotex, No. 2008-1133 (Fed. Cir. 2008) In 2005, Hi-Tech Pharmacal became the first company to file a paragraph IV certification relating to Merck's glaucoma drugs Trusopt and Cosopt. Hi-Tech filed paragraph IV certifications with respect to all three of the Orange Book-listed patents for these drugs: U.S. Patent Nos. 4,797,413; 6,248,735;…
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Celgene and Novartis v. KV Pharm., No. 07-4819 (D.N.J. 2008) KV Pharmaceutical filed an ANDA for a generic version of Ritalin LA (methylphenidate HCl extended-release capsules) with paragraph IV certifications to Celgene’s U.S. Patent Nos. 5,837,284 and 6,635,284. Apparently KV made an offer of confidential access to its ANDA, but Celgene and Novartis (which markets…
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Eisai v. Dr. Reddy’s and Teva, Nos. 2007-1397, -1398 (Fed. Cir. 2008) Patents on chemical compounds are holding up well to obviousness arguments in the Federal Circuit, even after KSR. In an opinion released today, the Federal Circuit affirmed the nonobviousness of rabeprazole, the active ingredient in Aciphex. This follows a decision last year affirming the nonobviousness…
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Teva announced Friday that it is acquiring Barr Pharmaceuticals for $7.5 billion plus $1.5 billion in debt. For more: AP; Reuters; WSJ. Zentiva, the Czech generic drug maker, announced Friday that it rejected a takeover bid from Sanofi-Aventis. Sanofi already owns 25% of the company. Meanwhile, the WSJ Health Blog recently reported that the CEOs…
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Merck & Co. v. Apotex, No. 2007-1362 (Fed. Cir. 2008) Fosamax (alendronate sodium) is one of the all-time best-selling drugs for the treatment and prevention of osteoporosis, with over $3 billion in U.S. sales last year. Merck listed ten patents in the Orange Book for Fosamax: U.S. Patent No. 4,621,077, which claims a method of inhibiting bone resorption…
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AstraZeneca v. Teva Pharms. USA and Sandoz, No. 05-5333 (D.N.J. 2008) On July 1st, the U.S. District Court for the District of New Jersey granted AstraZeneca’s motion for summary judgment that its patent on quetiapine fumarate, the active ingredient in Seroquel, is not unenforceable for inequitable conduct. The decision disposed of the last remaining issue in…
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