Federal Court Ruling Addresses Patent Issue: When is a Combination Drug Obvious?

Therapies using combinations of two or more drugs have become more common in recent years. Often these combinations are produced from already known and FDA approved products. Not only do the combination drugs provide a health benefit, it is also desired that they produce a patent benefit as well. While patent protection may have already run out for the individual ingredients, the new combination product may be able to get its own patent protection. In fact, it is this “combo” protection that can help offset the development costs for researching and moving the combination product through the regulatory process. In Ortho-McNeil Pharmaceutical Inc. v. Teva Pharmaceuticals Industries Ltd. Slip Opinion 2008-1549, -1550 (Fed. Cir. 2009) the Federal Circuit looked at the patentability of a well known combination formulation, and in so doing provided some direction as to the value of patents and applications on combination drug products.

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