In Merck, the Federal Circuit found a patent to be obvious where the claims merely comprised conventional manufacturing steps.
Merck was the owner of a patent directed to a stabilized formulation of an antibiotic. The stabilized formulation was obtained by filling a reaction vessel with CO2, adding the compound and a base to the vessel at a temperature near freezing, and freeze drying the resulting product.
Hospira filed an abbreviated new drug application seeking approval to make a generic version of Merck’s patented antibiotic, alleging that Merck’s patents to the product were invalid. Merck sued Hospira for infringement. The district court found the patent the compound to be valid and infringed by Hospira’s proposed generic product, but held that the patent directed to the process for making the stabilized formulation was invalid as being obvious. Merck appealed.
The Federal Circuit affirmed the district court’s finding of obviousness. While no prior art reference disclosed the specific method steps claimed, it taught that the antibiotic could be stabilized with the addition of carbon dioxide, and a person of ordinary skill in the art would have understood that degradation could be minimized keeping the reaction at low temperatures. Each of the three steps comprised nothing more than routine, general manufacturing steps that a person of skill in the art would have used to obtain the compound disclosed by the prior art.
Key Takeaway: Claims to a method for manufacturing a known compound may be obvious where the steps comprise nothing more than routine, conventional manufacturing steps and common sense solutions.