Patent Obviousness: Prometheus Labs Inc. vs Roxane Labs Inc.

In the patent case between Prometheus Laboratories and Roxane Laboratories, the U.S. Court of Appeals for the Federal Circuit upheld the finding from the U.S. District Court for the District of New Jersey of patent invalidity on the basis of obviousness.

The contested patent, U.S. Patent No. 6,284,770, is in regards to Prometheus’ medication used to treat irritable bowel syndrome. The medication is called Lotronex. Prometheus sued Roxane on the basis of infringement of multiple claims of the patent. Roxane challenged the validity of the patent under theories of obviousness and obviousness-type double patenting in view of another patent owned by Prometheus and the state of the prior art of treating IBS. The claims in dispute are:

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.
6. The method for treating according to claim 5, further comprising assessing whether said female IBS patient has experienced at least moderate pain prior to administration of alosetron.
7. 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;
       assessing whether said nonconstipated female IBS patient experiences at least moderate base- line pain from IBS; 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 and who experiences at least moderate baseline pain from IBS, wherein said effective amount is dependent on the condition of the patient and is at the discretion of the attendant physician.

The court related this case to another case between AbbVie Inc. and Mathilda and Terrence Kennedy Institute of Technology. As a result, it held that

1. The patent was obvious
2. Secondary considerations did not support a conclusion that the patent was not obvious

Basically, the court did not find significant differences between the prior art and the limitations mentioned in the patent. As a result, the patent was deemed invalid.