Thursday 13 December, 2007

Alza setteled with Johnson & Johnson over Venlafaxine controlled release patent

Alza Corp. (Johnson & Johnson unit) and rival pharmaceutical company Wyeth have settled a patent dispute over a drug-delivery system used in Wyeth’s popular antidepressant Effexor (Venlafaxine HCl).The parties asked Judge Ron Clark, of the U.S. District Court for the Eastern District of Texas, to dismiss the case with prejudice on Tuesday. The judge granted their request on Wednesday.In the complaint, which was filed on July 26, 2006, Alza accused Wyeth of willfully infringing its patent covering controlled-release dosage technology for Effexor’s specific chemical compound. The technology allows a drug like Effexor to be released steadily into a user’s bloodstream.Effexor has been a source of both revenue and legal action for Wyeth. During the first quarter of 2007, Wyeth sold about $891 million worth of Effexor. In both 2006 and 2005, Effexor accounted for 18% of Wyeth's net revenue, according to Wyeth's 2006 financial report.Alza alleged that Wyeth knew and intended that users of Effexor would use the product in ways that infringed the dosage technology patent.The patent in the case i.e. U.S. Patent No. 6,440,457., titled “Method of administering antidepressant dosage form,” assigned to Alza, was issued in August 2002 . It expires in August 2019.Alza sought treble damages and attorneys’ fees.Wyeth has been to court multiple times to protect its patents for venlafaxine, the active ingredient in Effexor. The patents were granted to Wyeth in 2001 and 2002.In July, the company sued Mylan Pharmaceuticals Inc., after receiving a letter from Mylan giving notice that it had filed an abbreviated new drug application with the U.S. Food and Drug Administration to market a generic version of the drug.Wyeth now wants the court to declare that the filing of the ANDA was an act of infringement with respect to each asserted patent and that the commercial manufacture, sale or importation of Mylan's venlafaxine hydrochloride extended-release capsules would infringe the patents.Wyeth's complaint also asked that the effective date of any FDA approval not come before the expiration of each of the three patents and that the court enjoin Mylan from seeking approval of the ANDA in dispute, or making, selling or importing its proposed venlafaxine product until all three patents have expired.Wyeth already filed similar lawsuits against several other generic drug makers, including Lupin Ltd., Anchen Pharmaceuticals, Osmotica Pharmaceutial Corp. and Impax Laboratories.In 2005, it settled a lawsuit with Israeli generic drug company Teva Pharmaceuticals, which had also filed an ANDA to sell a generic version of Effexor.The case is Alza Corp. v. Wyeth and Wyeth Pharmaceuticals Inc., case number 9:06-cv-00156, in the U.S. District Court for the Eastern District of Texas, in Lufkin.

No comments:

web page statistics
Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
eXTReMe Tracker