patent law; pharmaceutical; biotechnology; obviousness


Patents incentivize innovation, but the face of innovation has changed over the past several decades. Patent law is adapting to the radical growth of the pharmaceutical and biotechnological industries, which produce drugs and biologics respectively. Research and development in these fields is largely incremental—new products are often derived from existing products. However, patents do not protect “obvious” improvements, those that anyone skilled in the relevant scientific field could have discovered through predictable, routine work. The line between incremental R&D and routine, obvious improvements is difficult to draw. The U.S. Court of Appeals for the Federal Circuit and the Patent Trial and Appeal Board have become critical of incremental R&D, in turn discouraging what they find to be “routine optimization.” This Note describes the modern obviousness standard as it applies to the improvement of drugs and biologics and examines arguments for and against protecting incremental innovation. In light of these considerations, this Note argues that modern expectations for innovation should be updated and advocates for a stricter, narrower definition of obviousness that reflects the value of incremental R&D to the continued growth of the pharmaceutical and biotechnological industries.