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May 1, 2014
Eli Lilly vs. Canada
Eli Lilly has been complaining the U. S. Government for a while about the Canadian regulatory authorities, after they invalidated the company's patents for Strattera and Zyprexa a few years ago. Unfortunately for them, as Ed Silverman reports, the U. S. Trade Representative has refused to put Canada on the list of countries that don't respect intellectual property treaties (and this despite several members of Congress joining in the request). The office has mentioned that the Canadian law is a bit fuzzy, and that the mechanisms to appeal it are not clear, but they're not going anywhere near as far as Lilly wanted. The company is suing the Canadian government under NAFTA provisions, but that's going to take a while to bear results, if it ever does.
So why were the patents invalidated in the first place? They're holding up everywhere else. The Canadian generic drug industry challenged them under what may be a unique provision of Canadian patent law: the "promise" doctrine. If a company files a selection patent, the basis for which is that a particular form of the invention is in fact preferable, then under Canadian law the patent can be invalidated if that "promise" is not borne out by data:
In the mid 2000s one could start to see Canadian patent cases “turning” somewhat. Before this, the general sense was that a mere scintilla of utility was enough to obtain a patent. However, if the patentee made an explicit and unequivocal “Promise” of a certain use or result, recent cases have held the patentee to this result. Eli Lilly’s selection patent for an antipsychotic agent (olanzapine) was first held invalid in 2007 (in preliminary type proceedings) (2007 FC 596). Eli Lilly’s patent promised that its compound was better than the rest. However Eli Lilly had not actually determined its Promise, nor was their Promise soundly predictable (ie. it was a guess).
I'm definitely not a patent attorney, but I don't know of any other jurisdiction that puts the bar up quite that high. My impression is that if a company has demonstrated that it's willing to go to the trouble of filing a selection patent, that this is enough of an indication that it feels that there's something special about its claims. You have to show real advantages versus the prior art (things that are presumably already known), but not against your own initial filing. We'll see how far this gets (and if any other countries are tempted to put in a promise clause of their own, as a handy tool for patent invalidation). India, with its large generic industry, might be a candidate, if they don't have something like this.
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