Appeal from interference proceeding in which priority was awarded to senior party. The subject matter at issue was a chemical compound, nortriptyline (NTL), which is an antidepressant compound at moderate dosage levels and a tranquilizer at higher dosage levels. There were two issues in the case; first, when and whether the junior party established a practical utility for the compound, and thus established an actual reduction to practice, and second, whether the junior party conceived of the compound before the senior party and was diligent until a subsequent constructive reduction to practice. With regard to the utility issue, the junior party argued that the results of three laboratory tests carried out on laboratory animals established substantial utility for the compounds. These tests included 1) a Mental Health General Screening Test, in which physical responses of animals to a drug are observed, which may indicate desired pharmological properties of the drug; 2) a Tetrabenazine Antagonism test, which operates to screen candidate drugs for antidepressant activity; and 3) a Sidman Avoidance Test, used to screen drugs for tranquilizing activity by measuring the before and after performance of animals in avoiding an electronic shock.
Despite positive indications from the tests that NTL did possess “pharmological activity, the board was of the opinion that the results of the tests did not establish a reduction to practice for the reason that they failed to prove that the compound had any particular utility. Specifically, the board felt that the tests did not demonstrate that NTL would exhibit antidepressant or tranquilizing activity in man.†Id. at 1383.
The court first noted that since the count involved in the interference did not identify any specific utility, that substantial utility established for any purpose was enough to show a reduction to practice. The court then noted two categories of cases involving tests on laboratory animals which were sufficient to show utility, and thus reduction to practice. The first category involved cases in which the tests were considered to prove utility in human therapy. The second category involved cases in which the tests proved utility for the treatment of animals. Having established these categories, the court found that the tests at issue failed to establish utility under either category. The court then proceeded to discuss the allegations of utility which regard to each test.
First, with regard to the Mental Health General Screening Test, the allegation was that the test proved that NTL had anticholinergic activity because its administration caused the pupils of the eyes of the test animals to dilate. The court rejected this contention, noting that drugs other than those having anticholinergic activity can cause pupil dilation and thus finding the test not specific for this property.
Next, with regard to the Tetrabenazine Antagonism test, the court noted that the test was newly developed, and thus stated that “the test cannot be regarded as having been an adequate predicator of antidepressant activity in human beings because at the time the test was run there was insufficient experience with it to show the necessary correlation between tetrabenazine antagonism in mice and antidepressant activity in man.†Id. at 1384. The court also found that the test established a utility in animal therapy, stating that “{i}n the first place it has not been established that the property of tetrabenazine antagonism is per se useful. Secondly, the record established that mice are not depressed, hence the need for chemical simulation of depression using a tranquilizer. Therefore, NTL cannot be regarded as being useful for alleviating depression in animals.†Id. at 1384-85.
Finally, with regard to the Sidman Avoidance test, the court first noted that NTL demonstrated a weak tranquilizing activity in squirrel monkeys, and stated that this test “cannot be regarded as proof that tranquilizing activity would be observed in man.†Id. at 1385. The court also noted that very large doses of NTL were required to cause a tranquilizing effect, and hypothesized that “{a}t such doses the possibility that harmful side effects would occur, which would negate any tranquilizing properties, becomes very much enhanced.†Id. Finally, the court stated with regard to animal therapy utility that “the record is devoid of any indication that the ability to tranquilize monkeys, particularly the very slight ability shown for NTL, is a property having substantial utility.†Id.
Having not found a substantial utility sufficient to establish a reduction to practice, the court nevertheless reversed, finding that the junior party had established conception and diligence until a constructive reduction to practice. It should be noted that, with regard to conception, the court stated that “{i}n the board's view . . . even when the invention is a chemical compound which has been made and is defined by a count reciting no limitation related to its use, conception of that invention is not complete absent a conception of its utility. {The junior party} does not challenge this interpretation of the law. Accordingly, we will treat it as the law of this case although in our minds its applicability remains very much an open question. However, any resolution of this issue should be deferred until squarely presented and briefed by the parties to an appeal.†Id.
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Friday 19 of September, 2008 18:39:03 GMT by Unknown
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Monday 22 of September, 2008 15:46:28 GMT by Unknown