The Court dismissed an application for prohibition. In doing so, the Court held that the applicant bears the legal burden of proving on a balance of probabilities that the allegations of invalidity are unjustified and that it had not done so.
The patents at issue related to two polymorphic forms of clarithromycin and processes by which they could be prepared. The Court found that one of the patents was invalid because the form of clarithromycin it claimed was already known. Thus, the innovator could not have a valid patent for that form even if it was produced by a novel process.
The second patent at issue was found invalid for obviousness. The innovator argued that although the form of clarithromycin was known, its use as an antibiotic was not known. The Court did not accept this argument. Instead, the Court found that the patent contained nothing to support the contention that the use of Form II clarithromycin was not known as an antibiotic. The Court found that the generic company had met its evidentiary burden showing that this use was obvious in light of the prior art, and as the innovator had not tendered evidence supporting its position, and as the innovator bears the onus of proof on the issues of validity, the innovator had not proven this allegation was unjustified.
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