Argument Recap

Last week the Federal Circuit heard oral arguments during its September sitting in Washington DC. Here is a short recap of Sanofi-Aventis Deutschland v. Mylan Pharmaceuticals Inc., one of the argued cases we’re following.

As previewed on this blog, Adam Banks argued on behalf of Sanofi-Aventis Deutschland that the Patent Trial and Appeal Board failed to find any specific reasons that would have motivated a person of ordinary skill in the art to make the insulin glargine claimed in Sanofi’s patent—an argument that the Board failed to meet its burden to prove that the claimed invention did not meet patent law’s non-obviousness requirement. Judges Newman, Taranto, and Chen presided over the oral argument. In response to a question about prior art that discloses insulins with an acidic nature (one of the claimed characteristics of insulin glargine), Banks explained that those insulins and their acidic nature were naturally occurring, while the inventors used their own knowledge to modify insulin glargine to make it acidic to solve particular problems related to insulin aggregation.

In opposition to Sanofi, Douglas Carsten argued on behalf of Mylan Pharmaceuticals that the Board appropriately made a factual determination of whether insulin glargine was “special or different” compared to the prior art and reached the proper conclusion that it was not. For example, according to Carsten the Board relied on ample evidence in the record to support its position that a person of ordinary skill would not have expected insulin glargine to behave differently than other prior art insulins. According to Carsten, “this notion that the Board didn’t even consider this idea or this factual presentation by Sanofi that insulin glargine is special is just incorrect; [Sanofi] just disagree[s] with what the Board did.”

Absent a summary affirmance, the court should resolve the case within the next few months. Given the oral argument, the case may be decided on the basis of its facts; it may be too much to expect any grand pronouncements on the law of non-obviousness.