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“Commercial Success” in Pharmaceutical Patent Litigation, and Cross-Examination of the Patent Owner’s Economist

By James J. Kozuch, JD, MBA of Caesar, Rivise, Bernstein, Cohen & Pokotilow, Ltd.

James Kozuch is a trial attorney who handles patent infringement cases and other intellectual property (IP) matters.  He also counsels clients on IP law issues, prosecutes U.S. and international patent applications, and provides patent opinions.  He may be reached at 215-567- 2010 or

A defendant accused of infringing a patent may challenge the validity of the patent, among other ways, on the grounds of obviousness of the claimed invention. Obviousness must be proven by clear and convincing evidence. 

Obviousness of an invention is established if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the pertinent art.  An obviousness analysis includes the following factual determinations:  (1) the scope and content of the prior art; (2) the differences between the prior art and the claimed invention; (3) the level of ordinary skill in the pertinent art; and (4) any secondary considerations of nonobviousness, such as commercial success of the invention, satisfaction of a long-felt but unsolved need by the invention, and failures of others attempting to solve the problem addressed by the invention.  KSR Intern. Co. v. Teleflex Inc., 127 S.Ct. 1727, 173...

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