Court Finds Two Celebrex Patents Valid, One Invalid

The U.S. Court of Appeals for the Federal Circuit has partially reversed a lower court’s ruling on Pfizer’s Celebrex patents, holding two patents valid and one patent invalid.

Last year, the U.S. District Court for the District of New Jersey ruled in favor of Pfizer that the ’823, ’165 and ’068 patents are valid and would be infringed on by Teva Pharmaceuticals’ proposed generic product. The appeals court agreed with the district court’s decision on the ’823 and ’165 patents but found the ’068 patent to be invalid for obviousness-type double patenting.

Pfizer brought suit in 2004 after Teva submitted an abbreviated new drug application for Celebrex (celecoxib) to the FDA with Paragraph IV certifications for multiple patents. Celebrex, a nonsteroidal anti-inflammatory drug, had U.S. sales of $1.7 billion in 2007, according to Pfizer.

The district court had rejected Teva’s argument that the ’068 patent is invalid due to double patenting. The court decided that the ’165 is not considered prior art for the ’068 patent under section 121 of patent law since both patent applications were filed in response to a U.S. Patent and Trademark Office requirement that the Cox-2 compound, composition and method-of-use claims not be submitted together in the single, broad patent application that Pfizer originally filed.

The appeals court’s opinion issued Friday describes the ’823 patent as covering several Cox-2 inhibiting compounds Pfizer discovered. The ’165 patent covers various Cox-2 chemical compositions, and the ’068 patent covers methods of use.

Even though the district court held that the ’165 patent couldn’t be used against the ’068 patent, it had found that the claims of the two patents were not patentably distinct, a finding with which the Federal Circuit court agreed. “The claims at issue of the ’068 patent merely recite methods of administering a ‘therapeutically effective amount’ of the compositions found in claim 5 of the ’165 patent,” the panel wrote.

Therefore, the court agreed with Teva that the ’068 patent, which expires in 2015, is invalid for obviousness-type double patenting.