Appeal of rejection by USPTO board for lack of utility and obviousness. The invention related to chemical compounds, therapeutic compositions containing the compounds, and methods for using the compounds in treating mental depression in humans. After the applicant submitted an affidavit describing clinical tests of the compound, the examiner initially withdrew his utility rejection. The applicant then received approval from the FDA to introduce the compound commercially as an anti-depressant drug. However, the applicant subsequently removed the druf from the market and requested suspension of its FDA approval, because of suspicions that the drug was implicated in a small number of cases of agranulocytosis. The examiner seized on this to reinstate a utility rejection, finding that the applicant “had failed to prove the compositions are ‘safe in treating human beings.’†Id. at 1391. The examiner also stated that utility “requires that a therapeutic be both safe and effective for its indented use.†Id. at 1392. The board affirmed the examiners utility rejection.
The court reversed the utility rejection. First, the court noted that “§ 101 says nothing about safety.†Id. at 1392. The court went on to state that, as a matter of policy, a composition that would cause immediate death should not be considered useful, but noted that safety is “a relative matter.†Id. at 1394. The court next noted that Congress gave the FDA, and not the Patent Office, the duty of determining drug safety. Further, the court stated that a requirement of further research for commercial marketing purposes is not material to a utility determination. Finally, the court found that the record showed that the composition could be used safely by a practicing physician who had knowledge of the composition’s possible side effects.
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Thursday 16 of October, 2008 13:29:22 GMT by Unknown
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Thursday 16 of October, 2008 13:29:22 GMT by Unknown