Patent protection for pharmacogenomics innovations is facing significant challenges. U.S. patent law has undergone major changes recently due to a series of court rulings that will have significant impact on biotechnology innovations. Traps for the unwary are plentiful, and missteps can lead to failure to obtain the desired protection. This article explores some of the challenges to and practical approaches in pharmacogenomics patenting.
To be patentable, an invention must not be obvious to a person of ordinary skill in the art (a skilled artisan). The standard for determining obviousness underwent a momentous shift as a result of the Supreme Court decision in KSR v. Teleflex. In KSR, the Supreme Court found that the prior test for determining obviousness was too restrictive on the scope and use of prior art. A broader range of prior art is now available to the patent examiner.
For example, prior art that is directed at a different problem than what is solved by a patent applicant may be applied as long as it is within the area of prior art that a skilled artisan should have known and considered. The examiner may also apply common sense possessed by the skilled artisan and consider whether an invention is obvious to try.
In an April 2009 decision, In re Kubin, the Federal Circuit applied the KSR decision in the context of biotechnology patenting and overruled a long-standing obviousness standard for gene patenting. Patent applicants now face significant difficulties in patenting DNA sequences that encode known proteins. Those that discover new proteins may want to withhold public disclosure until the encoding DNAs are discovered and filed on.
On the flip side, a significant number of patents on DNAs that had been issued prior to the decision could be vulnerable to invalidity challenges. As a result, IP restrictions on certain diagnostic applications could potentially be lessened. Stakeholders should consult with counsel to devise approaches to identify and address these emerging risks and opportunities.