Species Claims Found Invalid Under 35 U.S.C. § 103(a)

In Prometheus Laboratories., Inc. v. Roxane Laboratories. Inc., Nos. 2014-1634, -1635 (Fed. Cir. Nov. 10, 2015), the Federal Circuit affirmed the district court's finding of invalidity for obviousness. It did not, however, address the district court's judgment of invalidity on the ground of obviousness-type double patenting.

The patent-in-suit was U.S. Patent No. 6,284,770 ("the '770 patent") owned by Prometheus. The '770 patent claims a method of treatment for a type of irritable bowel syndrome (IBS), i.e., diarrhea-predominant IBS (IBS-D), using alosetron. In 2009, Roxane submitted an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA), seeking approval to commercially market a generic version of alosetron before the '770 patent expired. A reexamination certificate for the '770 patent was issued on October 19, 2010. Following the Orange Book relisting of the re-examined '770 patent, Roxane submitted to the FDA a paragraph IV certification that the reexamined patent was noninfringed or invalid. Prometheus subsequently filed suit against Roxane, alleging infringement of reexamined claims 5, 6, 10, 13, and 14 of the '770 patent based on the filing of the ANDA. The reexamined claim 5, which is representative of the asserted claims, reads as follows (the underlined portions were added during reexamination of the '770 patent):

5. A method for treating a diarrhea-predominant female IBS patient, while excluding those with predominant constipation, said method comprising: assessing whether said diarrhea-predominant female IBS patient has experienced symptoms for at least six months; and administering an effective amount of alosetron or a pharmaceutically acceptable derivative thereof to said patient who has experienced symptoms for at least six months, wherein said effective amount is dependent on the condition of the patient and is at the discretion of the attendant physician.

Alosetron was initially approved by the FDA in 2000 for treatment of IDS. Due to severe side effects, alosetron was taken off the market in the same year of approval. Alosetron was relaunched in 2002 with indications corresponding to the limitations of the above reexamined claim 5.

The district court, relying on U.S. Patent No. 5,360,800 ("the '800 patent") as the primary prior art reference, found that the asserted claims would have been obvious in view of the prior art and secondary considerations of nonobviousness. The district court also...