Methylphenidate hydrochloride extended-release 18 mg, 27 mg, 36 mg and 54 mg tablets (Concerta): disputed patent declared invalid

In a major victory to generic player Watson Pharma, the United States District Court for the District of Delaware has ruled that Watson's generic version of Concerta (methylphenidate hydrochloride extended-release tablets) does not infringe following Orange Book listed patent:

US6919373 (Expiry: Jan 31, 2018): the patent covers a method for treating ADD or ADHD comprising administering a dosage form comprising methylphenidate that provides a release of methylphenidate at an ascending release rate over an extended period of time.

Court opined that the '373 Patent is invalid. The opinion, dated March 30, 2009, was issued by Judge Joseph Farnan, Jr., and applies to Watson's generic versions of Concerta(R) in the 18 mg, 27 mg, 36 mg and 54 mg strengths.

Also, following patent is listed for this product in Orange Book:

US6930129 (Expiry: Jan 31, 2018): Which covers a method for treating Attention-Deficit Disorder or Attention-Deficit Hyperactivity Disorder in a patient, wherein the method comprises administering a pharmaceutically acceptable composition comprising methylphenidate and a pharmaceutically acceptable carrier to said patient in a manner that achieves a substantially ascending methylphenidate plasma drug concentration over a time period of about 8 hours following said administration.

Prior to the commencement of the trial, the plaintiffs offered Watson a ‘covenant not to sue’ on ‘129 patent, however, Watson declined to accept the covenant and asked the court to declare that the '129 Patent is invalid and not infringed. A decision on Watson's Declaratory Judgment claim on the '129 Patent is subject to further proceedings by the parties. However, Watson believes that the '129 Patent is invalid for the same reasons that the court held the '373 Patent is invalid.
Earlier In 2005, innovators AlzaCorp and McNeil, sued Impax and Andrx Corporation for patent infringement related to the generic version of Concerta. Watson acquired Andrx Corporation in 2006.
Methylphenidate is a mild central nervous system stimulant thought to exert its effect by enhancing dopaminergic transmission in the brain. Methylphenidate is used to treat attention-deficit hyperactivity disorder (ADHD).

Source: Watson press release Here