Appeal from interference proceeding where priority was awarded to senior party. The invention at issue involved androstene steroid compounds. The junior party’s specification claimed that the compounds had improved solubility properties, as well as anti-fertility, anti-androgenic, and anti-estrogenic properties, and were useful in the treatment of antherosclerosis. The specification also stated that the compound could “be prepared and administered to mammals, birds, humans, and animals, in a wide variety of oral or parenteral dosage forms.†Id. at 644.
The board found that biological evaluation tests performed by the junior party’s witnesses on laboratory animals “‘were insufficient to establish an actual reduction to practice of the invention of the counts.’†Id. at 644. In so deciding, the board stated that screening test data presented by the junior party represented “no more than an initial test to determine (along with other tests and toxicity data) whether or not additional work should be done, leading to a reduction to practice.†Id. at 646. The board further noted that the tests performed by the junior party included “‘no toxicity dat {sic} at all, nor the presence of controls,’ and that ‘meager amounts’ of the four compounds were employed.†Id. at 646.
The court reversed the board. First, the court noted that “clinical testing in humans, approval by the Food and Drug Administration, {and} commercial usefulness†are not necessary to establish a reduction to practice. Id. at 646. The court also noted that since the interference counts did not state an intended use, “evidence establishing substantial utility for any purpose is sufficient to show reduction to practice.†Id. Thus, addressing the board’s finding that the tests performed by the junior party were too preliminary and tentative to be considered a reduction to practice, the court found no evidence to support the board’s finding that further tests were necessary. The court noted that the junior party was satisfied that the compounds had anti-fertility properties. Finding that each compound was both effective and safe (“at least to the point of not producing death by reason of acute toxicity in the test animalsâ€), the court found that the junior party had “demonstrated by a preponderance of the evidence that the compounds, when administered to a standard experimental animal, possess the significant property of preventing pregnancy-the intended purpose-and were tolerated by the animals during the test periods. We think that is enough.†Id. at 647. In so holding, the court noted the public policy that “it is our firm conviction that one who has taught the public that a compound exhibits some desirable pharmaceutical property in a standard experimental animal has made a significant and useful contribution to the art, even though it may eventually appear that the compound is without value in the treatment of humans.†Id. at 647.
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Thursday 25 of September, 2008 13:29:53 GMT by Unknown
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Thursday 25 of September, 2008 13:29:53 GMT by Unknown