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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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May 1, 2014

Eli Lilly vs. Canada

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Posted by Derek

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.

Comments (4) + TrackBacks (0) | Category: Patents and IP


COMMENTS

1. PorkPieHat on May 1, 2014 8:03 AM writes...

Im no patent attorney (although I did just sleep at a Holiday Inn), but this passes the sniff test to me. A selection patent claims as an invention the selection of specific compounds, chosen from a larger class or range of compounds (genus), which have certain benefits or desirable features. Those benefits should be relative to the genus, not to prior art, otherwise, it does not really represent 'selection'. So, if you dont ever show that benefit or promise (which means to demonstrate a true preference, meaning you have to show the other members of the genus dont have the same 'promise' or benefit), it seems to me that you dont really have a case.

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2. NoDrugsNoJobs on May 1, 2014 8:44 AM writes...

Its just a question of when you make the case, at the time of the filing (as in all of the data demonstrating your selection was not obvious over the prior art genus because you have unexpectedly good results, etc). Now that we are all under a first to file system, the fear is that somebody else will "scoop" you with their filing first. Its a challenge, especially when your waiting on clinical data to prove your selection at the time of filing - there are just to many ways for mischief, loss of confidentiality, etc to occur. The reality is that many drugs do not single themselves out as unexpected until they actually become drugs (that's truly unexpected). The answer is to typically file your selection invention, if you have one, at the time you identify it as a compound that you are going to commit significant resources to. If you make a company wait to file until it has a drug, then you are asking the company to take on all the financial risk without at least letting them put their foot in the doorway to patentability at the time they make the investment - that is the problem with the Canadian system (and others such as Brazil, China). The incredibly long development time and expense and risk of drug development really have to be thought through from the exclusivity standpoint and from the mile high view, we need more certainty of the requisite exclusivity and not less.

Simply extending the exclusivity period for any new drug, patent or not would help the industry a hell of a lot - its a shame to see a good compound get dropped due to poor or uncertain IP potential, it just doesn't make sense from a policy standpoint. Patents and drugs are a volatile mixture!

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3. a. nonymaus on May 1, 2014 10:49 AM writes...

Either the selection is or isn't better than the genus. If it's not, then what is the invention that is being taught in exchange for the temporary monopoly? Indeed, the entire reason for patents is to get these teachings out and usable to the public on expiration of the patent. Patents that do not teach the preferred implementation should be invalidated, otherwise what incentive is there to do so? Patents that are full of guesses are doubly dangerous since they act as a lottery where you get a monopoly in return for guessing correctly and they pollute the patent literature with incorrect guesses. These incorrect guesses will then lead the public astray when they consult expired patents to determine how to utilize existing art for their own purposes. If I pick up an expired patent that claims to solve my problem and there is a high chance that it is full of incorrect guesses, then I am in no better of a position than if I had to reinvent a process that had been kept secret, thus defeating the purpose of patents.

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4. DensityDuck on May 1, 2014 12:42 PM writes...

#1 and #3: The issue is that the stuff that would go into a "promise" clause is either undefinably subjective or so specific as to be meaningless.

Company: "Well, we have to have an objective we can meet, otherwise you'll invalidate the patent. So how about we say 'administration of this drug will cause blood levels of the drug to rise'?"
Government: "No, that's meaningless. You have to describe a specific therapeutic benefit."
Company: "Okay, well, this is an anti-cancer drug, so we'll say that it, um, cures cancer."

(twelve years later)

Government: "You didn't define what 'cure' or 'cancer' meant, so you didn't meet your patent promise!"
Company: "We spent twelve billion dollars making a drug that dissolves cancerous tumors!"
Government: "Sure, but you didn't show that they won't come *back*, and you can't really say that cancer is *cured* if the tumors come back. Patent invalidated!"

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