First published: 14 October 2014. the progress of the disease at the time the earlier patent application was filed. In re Kaplan, 789 F.2d at 1566.
Tardive dyskinesia is a syndrome of involuntary, repetitive, irregular, and purposeless motor movements. Because of these involuntary movements, many patients with this disorder have a lack of facial expression and difficulty with chewing and swallowing. Id. at 1569.
The experts also identified three other diagnoses or sub-diagnoses, relevant to the analysis of the first to third Munroe clinical trial, as follows:
1) dopaminergic hyperfunction;
3) impulse control disorder.
C. The evidence with respect to the first Munroe clinical trial.
1) The record contains substantial evidence that bupropion hydrochloride has been shown to be effective for the treatment of major depressive disorder, in double-blind studies. This is not a novel phenomenon. Nonetheless, it would not be difficult to understand why depression was used as an example of a condition for which the effect of bupropion hydrochloride was determined to be established for purposes of the 1986 Act. The record contains no objective evidence of the persistence of the effect of bupropion hydrochloride beyond the time period for which a patent was filed. The presence of tardive dyskinesia was cited as a reason why the effect of the drug could be expected to "last for a period of time which would be sufficient for the drug to qualify as a useful treatment." However, the same expert who testified that bupropion hydrochloride is effective in treating depression also stated that it is one of the least effective of the treatments he had used for depression and that it takes five to six months to work. The record indicates that when the 1971 application was filed, the inventor, in his curriculum vitae, described his qualifications as a "mental health research psychologist," and was a past president of the American Psychological Association's section on applied behavior analysis. As to the second Munroe clinical trial, the record indicates that the disorder for which this double-blind study was conducted is "hyperactivity disorder" and that a second double-blind study was conducted for ADHD, for which an NDA was filed on July 25, 1992.
It is also relevant to note that the most recent double-blind, placebo-controlled trial of bupropion was conducted over the 0b46394aab