Patent Infringement Litigation galantamine

Analysis This case is an example of an issued patent being invalidated at trial and the decision being upheld upon appeal. The mechanisms used to defeat the patent were (1) lack of enablement and (2) lack of utility. 

Teaching how to make and use an invention, also known as enablement, is a requirement for obtaining a patent. Establishing an invention s usefulness, also known as utility, is a separate requirement for patentability. An application can meet the utility requirement but still fail to demonstrate enablement. During the trial phase, the district court conducted a two-pronged analysis of the application and concluded that the application lacked both utility and enablement. However, on appeal, the Federal Circuit focused only on the utility requirement. 

The courts, however, are not bound by the decision of the Patent Office to issue the patent. In considering whether the application had utility, the Federal Circuit approvingly quoted the district court s determination that the application did not provide analysis or insight connecting the [summaries of the six references]. .. to galantamine s potential to treat Alzheimer s disease [4]. In conjunction with this analysis, witness testimony given at trial was also considered. For example, the sole inventor testified that when I submitted this patent, I certainly wasn t sure, and a lot of other people weren t sure, that cholinesterase inhibitors [such as galantamine] would ever work [to treat Alzheimer s disease] [5]. (Emphasis added). 

The Federal Circuit then briefly summarized the utility requirement. To have utility, inventions must have substantial utility and specific benefit existing in currently available form [6]. The utility requirement prevents mere ideas from being patented and also prevents the patenting of a mere research proposal. .. [6]. Quoting a famous Supreme Court patent case, the court emphasized that a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion [7].  

The court concluded that the application was a mere research proposal, lacked utility, and therefore was not enabled at the end of the day, the [application]. .. does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis [8].  

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