In just the last few weeks Canada has once again taken steps to invalidate yet another medicine (Zymar®) by applying the “promise doctrine.” See Allergan Inc. v. Apotex Inc., 2016 FC 344 (April 1, 2016). This is just the most recent in a litany of important medicines and cures that have been subjected to invalidation because of a novel legal theory used nowhere else in the world. Coming on top of a similar case earlier this year, these court decisions are aimed almost entirely at biopharmaceutical innovators and confounds the time-tested way that basic research is turned into new treatments and cures.
Outside of Canada, the development process for new treatments is built around the core concept of the creator showing that the approach is new, useful and involves an inventive step. If that is the case, a patent is granted and the firm then proceeds through a series of clinical trials necessary to show the active ingredient is safe and effective for the treatment of a particular disease or condition.
However, in Canada the courts have upended this practical and proven process and changed the rules in the middle of the game. The “promise doctrine” arbitrarily requires information at the time a patent is filed that is typically shown much later through clinical trials. As a result, biopharmaceutical innovators have to take extraordinary risk without any early protection for their potentially breakthrough ideas.
Canada’s application of the “promise doctrine” hurts innovative growth and ultimately is a disincentive to the creation of tomorrow’s treatments. In fact, over two dozen biopharmaceutical patents have been revoked in Canada because of the “promise doctrine.” As we noted during Prime Minister Trudeau’s visit to the United States in February, there is an opportunity to reform Canada’s system so that it aligns with peers like the United States and the United Kingdom and encourages an innovative economy and the creation of new medicines.
To learn more about the “promise doctrine” and what Canada can do to reform its approach to IP, check out patentsprotect.org.
Mark Grayson Mark Grayson is deputy vice president of public affairs at PhRMA focusing on intellectual property, trade and international issues. Mark has been at PhRMA for more than 30 years joining PhRMA after a career with large public affairs firms focusing on FDA and financial issues. In his spare time Mark plays squash, bridge and takes long walks with his squirrel-chasing dog Teddy.