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The legalities and overall effect of special out-of-court settlements that result in lengthening the period of exclusivity for a brand drug by stalling generic entry are up for debate on Capitol Hill as members of the Senate Judiciary Committee plan to hold a hearing scheduled for Jan. 17, congressional sources say.
The Supreme Court’s recent ruling upholding the right of a patent licensee to sue the patent holder may ease market entry for generic drug manufacturers who rely on abbreviated new drug applications to challenge the enforceability and validity of brand drug patents.
A company’s right to challenge a patent that it is licensed to use is not restricted by the licensing agreement between it and the patent holder, the U.S. Supreme Court said in a Jan. 9 ruling.
Armed with several production and method-of-use patents to cover its cancer drug Thalomid, Celgene said it is preparing a legal challenge to head off Barr Laboratories’ move to market thalidomide, a generic version of the drug, company executives said.
The production, sale and distribution of Pravachol and generic pravastatin sodium by Bristol-Myers Squibb (BMS) and Watson
Pharmaceuticals are being challenged in federal court.
A federal court has upheld a preliminary injunction preventing Watson subsidiary Andrx Pharmaceuticals from marketing clarithromycinn, a generic version of Abbott Laboratories’ extended-released antibiotic Biaxin XL.
The production, sale and distribution of Pravachol and generic pravastatin sodium by Bristol-Myers Squibb (BMS) and Watson Pharmaceuticals are being challenged in federal court.
Australian biotechnology company Giaconda said that the European Patent Office has granted it a patent for Ibaconda, its combination therapy for irritable bowel syndrome (IBS).
The U.S. District Court for the District of Delaware officially dropped the patent infringement litigation concerning a generic version of GlaxoSmithKline’s migraine and cluster headache drug Imitrex (sumatriptan succinate), Spectrum Pharmaceuticals announced last week.
Plaintiffs are asking the Supreme Court to review the dismissal of a case to determine the legality of reverse payment agreements, where brand drugmakers pay generic rivals to keep their low-cost versions of prescription products off the market.