Partner Paul Stewart wrote the article “Lessons from Fed. Circ. Ruling on Lung Disease Patent,” the latest in an ongoing series spotlighting recent Federal Circuit cases, published by Law360. In the article, Stewart discusses the decision in Genentech Inc. v. Sandoz Inc., that includes two separate holdings involving patents claiming methods of varying doses of a specific medication due to adverse side effects.
“First, the court held that one set of patents was invalid for obviousness, in part because the practice of varying doses to avoid side effects was a well-established medical practice. Second, the court held that the remaining set of patents was not infringed by the defendant’s abbreviated new drug application filing even though the defendant’s proposed label encouraged performance of an infringing method,” said Stewart.
Stewart notes that the Federal Circuit’s noninfringement holding is significant because, “it shows that in ANDA litigation, the proposed label alone may not be dispositive on the issue of infringement.” Meanwhile, the obviousness holding should be of interest to those whose practice does not include ANDA litigation because it is an “important reminder of the role that a gut check or reality check can have in an obviousness analysis.”
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