New Rules, Different Risk: The Changing Freedom to Operate Analysis for Biotechnology

June 16, 2012

Patent protection has evolved since the inception of the Federal Circuit in 1982. Mandated to unify the fractured application of the patent laws, the Federal Circuit initially set out to reinforce the protections guaranteed to patented inventions. For the first couple of decades the Federal Circuit succeeded in strengthening the patent system. Recently however there has been a definite shift in this trend with efforts by the Supreme Court, Federal Circuit, and Congress to both raise the bars to patentability and limit some of the earlier protections granted, particularly to biotechnology patents. Patents are now more likely to be invalidated under the new stricter patenting standards, and the narrower patents that will survive these new standards will have less enforcement capabilities owing to the weakening of many of the patent remedies available to patentees. Overall, these efforts will change the freedom-to-operate calculus of both patentees and putative infringers. This Article reviews these recent changes.