The non-profit Freedom to Operate (FTO) announced today that it has filed requests for reconsideration [PRG2022-00012 and PRG2022-00018] with the U.S. Patent Trial and Appeal Board (PTAB) in regard to its denials of FTO’s petitions for Post Grant Review of Compass Pathways’ Patents No. 10,947,257 and 10,954,259 directed to compositions and oral dosage forms containing its “Polymorph A” of psilocybin.
“We believe the PTAB has committed major errors in its decisions not to institute our petitions for Post Grant Review of Compass’s patents on its ‘Polymorph A’ of psilocybin,” “We maintain our belief that the specifics of PTAB’s decisions have rendered the Compass patents of little practical value as a tool to stifle competition. At the same time, an important policy function is advanced when bad patents are challenged and invalidated. On this basis, we are asking the PTAB to reconsider its decisions as is provided for under U.S. patent law.”
Carey Turnbull, founder and director of Freedom to Operate
In its requests for reconsideration of the decisions not to institute Post Grant Review of the Compass patents, FTO has identified two errors central to the PTAB’s rulings. First, the PTAB has incorrectly construed the Compass patents claims as permitting a mixture of crystalline polymorphic forms of psilocybin having x-ray powder diffraction peaks as identified in the patent claim. In doing so, the PTAB has ignored the inventor’s clear intention and acted contrary to how patents claiming polymorphs are interpreted by courts, which require that a form of a crystalline material be a single polymorphic phase of that material. Second, the PTAB has exceeded its statutory mandate by erroneously discounting the unrebutted testimony of FTO’s experts, the veracity of which should be subject to consideration at trial rather than the institution phase of the proceedings. Given the criticality of these two issues to the PTAB’s rulings, FTO is submitting that a review and reversal of the decisions not to institute the post grant reviews is required by U.S. patent law.
Irrespective of the outcome of these requests for reconsideration, FTO remains confident that the work undertaken to date in challenging the Compass patents will ensure that manufacturers and sellers of psilocybin will be able to bring treatments to market without risk of infringement.
About Freedom to Operate
Founded by Carey Turnbull in 2020, Freedom to Operate is a registered Section 501(c)(3) non-profit organization dedicated to advancing science and education, specifically research, in the public interest and for the public benefit.
“Freedom to operate” is a term of art in the field of intellectual property law, and refers to the ability to develop, manufacture, and market products without legal liabilities to third parties who claim intellectual property rights in those products. There is an important public policy interest in invalidating bad patents and promoting free competition that does not infringe on validly granted patents and other intellectual property rights. Issued patents are presumed valid and so operate to discourage investment by others into the same or similar subject matter. The public is benefited when potentially incorrectly issued patents are challenged or obviated.