Alzo457 patent.jpgJohnson & Johnson’s Alza drug unit sued Wyeth (Alza Corporation v. Wyeth, Wyeth Pharmaceuticals, Inc. Case No. 9:06-cv-00156-RHC), saying that Effexor XR infringes a patent for a method of administering antidepressants.

Effexor is Wyeth’s biggest product and the world’s best-selling antidepressant. Global sales of the drug were $918 million in the second quarter and $3.5 billion for all of 2005. Effexor XR® (venlafaxine HCl), is a once-a-day extended-release version of the antidepressant, approved for the treatment of major depressive disorder, generalized anxiety disorder, social anxiety disorder and panic disorder.

Alza owns a patent 6,440,457, issued August 27, 2002, for a controlled release version of antidepressants. The ‘457 patent contains a single claim to:

1. A method for administering a drug to the gastrointestinal tract of a human, wherein the method comprises: (a) admitting orally into the human a dosage form comprising a drug of the formula: [1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol] which drug possess antidepressant therapy and the dosage form comprises a member selected from the group consisting of a sustained-release dosage form and a controlled-release dosage form; and, (b) administering the drug from the dosage form over an extended period of time in a therapeutically responsive dose to produce the antidepressant therapy.

In the lawsuit was filed July 26 in federal disctrict court in the Eastern District of Texas, Alza says the Wyeth drug is administered in that patented method. Wyeth says the ‘457 patent doesn’t cover its drug.

The patent suit is not the reason Wyeth had “homicidal ideation” added to the drug’s label as one of its rare adverse events.

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