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.

AstraZeneca initiated infringement suit against generic rosuvastatin calcium ANDAs

LONDON, Dec. 12, 2007-AstraZeneca today announced that it has filed patent infringement actions in United States District Court, District of Delaware, against seven generic drug manufacturers, which have submitted Abbreviated New Drug Applications (ANDAs) for Crestor™

On 1st November 2007, AstraZeneca announced its receipt of a notice-letter from Cobalt Pharmaceuticals, Inc., notifying AstraZeneca that Cobalt had submitted an ANDA to the U.S. Food and Drug Administration (FDA). Cobalt’s ANDA sought approval to market generic versions of Crestor™ tablets prior to the expiration of patents covering Crestor™ tablets. Cobalt’s ANDA contained a Paragraph IV certification alleging that the U.S. patents owned or licensed by AstraZeneca, and listed in the FDA’s Orange Book referencing Crestor™, were not infringed or that the patents were otherwise invalid or unenforceable.
Since receiving Cobalt’s notice-letter, AstraZeneca has received similar Paragraph IV Certification notice-letters from eight additional generic drug manufacturers. AstraZeneca received notice letters from (1) Teva Pharmaceuticals, USA (Teva) on October 31, 2007; (2) Aurobindo Pharma Limited (Aurobindo) on November 5, 2007; (3) Apotex, Inc. (Apotex) on November 6, 2007 and December 5, 2007; (4) Par Pharmaceutical (Par) on November 6, 2007; (5) Sandoz Inc. (Sandoz) on November 12, 2007; (6) Mylan Pharmaceuticals Inc. (Mylan) on November 15, 2007; (7) Glenmark Pharmaceuticals, Inc. USA (Glenmark) on November 15, 2007; and (8) Sun Pharmaceutical Industries Ltd. (Sun) on November 19, 2007.
Each of the eight additional generic drug companies has notified AstraZeneca that it has submitted an ANDA to the FDA seeking approval to market generic versions of Crestor™ tablets before the expiration of the U.S. Patents owned or licensed by AstraZeneca. Each notice-letter contained a Paragraph IV certification notice alleging that one or more of the three Orange Book listed US patents referencing Crestor in the FDA’s Orange Book was not infringed or otherwise invalid or unenforceable.
Based on these various ANDA filings and Paragraph IV certifications, on 11th December 2007 AstraZeneca filed individual patent infringement actions in United States District Court, District of Delaware, against Aurobindo, Apotex, Cobalt, Par, Sandoz, Mylan, and Sun, alleging infringement of U.S. No. RE 37,314 (the ‘314 patent). AstraZeneca licenses the ‘314 patent from Shionogi & Co. Ltd.

The Notice letter summary

Teva stated that its Paragraph IV certification alleges that the ‘460 patent and the ‘618 patent are invalid, unenforceable, and/or not infringed. AstraZeneca did not file patent infringement actions against Teva based on the ‘314 patent. Teva did not notify AstraZeneca that they intended to market generic rosuvastatin calcium tablets prior to the expiration of the ‘314 patent, which covers the active ingredient and expires in 2016.

Aurobindo stated that its ANDA includes a “Paragraph IV” certification, alleging that the claims of U.S. Patent Nos. 6,316,460 B1 (the ‘460 patent), 6,858,618 (the ‘618 patent), and the ‘314 patent are invalid, unenforceable, and/or not infringed.

Apotex stated that its Paragraph IV certifications alleges that the ’460 patent and the ‘314 patent are invalid, unenforceable, and/or not infringed.

Par stated that its Paragraph IV certification alleges that the ‘460 patent and the ‘314 patent are invalid, unenforceable, and/or not infringed.Sandoz stated that its Paragraph IV certification alleges that the ‘460 patent, the ‘618 patent, and the ‘314 patent are invalid, unenforceable, and/or not infringed.

Mylan stated that its Paragraph IV certification alleges that the ‘460 patent and the ‘314 patent are invalid, unenforceable, and/or not infringed.

Glenmark stated that its Paragraph IV certification alleges that the ‘460 patent is invalid, unenforceable, and/or not infringed. AstraZeneca did not file patent infringement actions againstGlenmark based on the ‘314 patent. Glenmark did not notify AstraZeneca that they intended to market generic rosuvastatin calcium tablets prior to the expiration of the ‘314 patent, which covers the active ingredient and expires in 2016.

Sun Pharma stated that its Paragraph IV certification alleges that the ‘460 patent, the ‘618 patent, and the ‘314 patent are invalid, unenforceable, and/or not infringed.