GlaxoSmithKline Inc. v. Pharmascience Inc.

Drug: rosiglitazone

The Court granted an order prohibiting Pharmascience from coming to market with its product before the expiry of the patent at issue; finding Pharmascience’s allegations of obviousness, insufficiency, utility, and a lack of sound prediction not justified. The only claim at issue claimed the compound rosiglitazone.

Pharmascience alleged that a number of works by one company lead to the conclusion that GSK’s invention was obvious. However, the Court held that the invention was the result of patient research that was applauded by the scientific community. Furthermore, the Court held that the other company apparently never achieved the results that the inventor of the patent at issue did. The Court also rejected Pharmascience’s allegations of obviousness that were not raised in the NOA.

Pharmascience argued insufficiency, inutility and lack of sound prediction together. GSK argued that it was not running a case based on sound prediction. The Court tried to construe the patent by “taking an impartial approach being fair to both the patentee and the public, avoiding technicalities and undue harshness or benevolence”.

The Court held utility is to be determined on the basis of what had been performed by GSK prior to filing the patent as compared to the utility promised in the patent. In this case, the compound passed the primary screen upon which a skilled person could conclude it should proceed to further testing. The potential to work in humans had been established, and this was all that was promised in the patent.