Allegation of Double Patenting Justified

Merck v. Apotex Drug: dorzolamide

Merck applied for a patent containing a number of compounds including dorzolamide, which was named as an especially preferred compound. As a divisional from that patent, Merck applied for a second patent with a group of compounds that also included dorzolamide. The two patents will expire within 28 days of each other in 2011. Merck dedicated the first patent to the public.

The Court held that despite the dedication of the first patent, Merck is receiving a 28 day monopoly beyond the statutory 17 year period. The Court held that where a patentee obtains a divisional patent that does not conform to the Patent Act, remedy is provided by the prohibition against double-patenting. In the circumstances of this case, the Court held that the dedication of the first patent should not immunize the second patent from an allegation of double-patenting. Thus, the Court found that Apotex’ allegations of invalidity were justified.

Allegations of Anticipation and Obviousness Justified

Merck v. Apotex

Drug: dorzolamide and timolol

In this case, Apotex alleged that two patents were invalid. The first patent was the same as in the case listed above and the parties agreed that the outcome applies in this case as well.

With respect to the second patent, the Court found the allegations of anticipation justified with respect to the use claims, as a prior publication discussed administration of the two compounds 10 minutes apart. In discussing the co-formulation claims, the Court considered the test for obviousness and held that co-formulation would have been obvious as a result of this publication. The Court reviewed the patent and the evidence and found nothing in the patent and no evidence that there were any difficulties or arduous experimentation required to arrive at the co-formulation. Thus, it was more or less self-evident that co-formulation would work as well as co-administration.

Apotex’ allegations of material misrepresentation were held to be not justified.