Drug: pemetrexed ALIMTA®
The Federal Court has dismissed an application for prohibition concerning the drug ALIMTA®. Although the parties joined issue on a significant number of evidentiary and legal issues the Court declined to address them all and only addressed the issue of sound prediction of utility.
The 794 Patent was filed by Takeda in Canada on March 23, 1989 and issued more than a decade later on October 19, 1999. As an "Old Act" patent, it will expire on October 19, 2016. Lilly had previously obtained a license to sell pemetrexed covered under a different patent until it expired on December 10, 2010.
The Court asked whether the person of skill in 1989 could have soundly predicted the promised utility of the untested compounds falling within Claims 7 and 9 from the test data reported in the Patent and from what was known in the art.
The vast majority of the compounds covered by Claims 7 and 9 (including pemetrexed and said to be in the thousands) were not specifically disclosed nor were they made or tested by Takeda before the filing date. The Court did not allow Lilly to rely on in-house test data or upon a sound line of reasoning that cannot be found in the Patent.
The Court dismissed Lilly's arguments that there was no promise of utility in the compound claims. The Court held that when a compound claim is silent as to use, the person of skill must resort to the specification to determine the utility promise of the claim. The Court relied on statements such as, "This invention relates to the novel pyrrolopyrimidine derivatives which are useful as anti-tumor agents, the production and utilization thereof" in finding a promise of in vivo activity in relation to abnormal tissue.
In the result, the Court found that the patent was an overreaching attempt to monopolize a huge class of compounds on the strength of its highly discrete test data.