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Combination Drug Patents in the Post-KSR World

By Yong Chen and Sandra Lee
September 29, 2009

Combination drug therapies play an important role in today's pharmaceutical marketplace because they can provide additional protection on therapies developed by a company and access to significant revenue streams. As an example, Advair' (GlaxoSmithKline), a combination drug containing fluticasone and salmeterol, which was covered by U.S. Patent Nos. 4,992,474, 5,126,375, and 5,225,445, earned $5.3 billion in sales in 2007.

Combination drug therapies can present unique patent issues, particularly when they employ individual drug compounds that are known in the art. In such situations, the patentee must demonstrate that the combination is not obvious over the prior art. In KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727 (2007), the U.S. Supreme Court clarified the paradigm for analyzing a claim's obviousness. Since KSR, the courts have had limited review of cases involving combination drug therapies. However, the Board of Patent Appeals and Interferences (“BPAI”) of the U.S. Patent and Trademark Office (“USPTO”) has reviewed a number of such cases. In this article, we survey post-KSR decisions in an effort to assess what impact, if any, that Supreme Court decision may have had on the patentability/validity of combination drug therapies.

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