A NAFTA Challenge to Canada’s Patent Utility Doctrine is Necessary

Canada is not the first country that comes to mind as a threat to U.S. trade. After all, Canada is our largest goods trading partner, with $632 billion in total goods traded bilaterally during 2013. Canada was one of America’s first free trade agreement partners, and the importance of the North American Free Trade Agreement (NAFTA) is demonstrated by the continuing economic integration between the two countries. Most recently, the U.S. and Canada have undertaken bilateral dialogues on border security issues (Beyond the Border) and regulatory cooperation (the U.S.-Canada Regulatory Cooperation Council).

While the good news of U.S.-Canada trade cooperation is well-recognized, this doesn’t mean the trading relationship is always smooth sailing. A trade dispute over Canada’s subsidies for softwood lumber has been an irritant for over two decades and Canada has voiced strong concerns over U.S. government procurement practices. Over the last decade U.S. pharmaceutical companies have faced trade challenges in the form of a narrow interpretation of patent eligibility in Canada. Canada’s patent utility provisions are a serious threat to U.S. innovative industries, and therefore are legitimately being raised in NAFTA’s dispute settlement system.

Concerns about Canada’s intellectual property rights (IPR) protections are neither recent nor unique to the pharmaceutical sector. In fact, Canada has been cited in the United States Trade Representative’s (USTR) “Special 301” report – which identifies countries that have serious IPR deficiencies – every year since 1989. On April 10, 2014, 32 members of Congress, including 19 members of the powerful House Ways and Means Committee, sent a letter to USTR urging it to further downgrade Canada in the 2014 Special 301 report due to Canada’s treatment of pharmaceutical patents. In the 2014 Special 301 report, USTR noted that Canada has made improvements in some areas but, “with respect to pharmaceuticals, the United States continues to have serious concerns” with Canada’s IPR protections. USTR also highlighted Canada’s “amorphous and evolving [patent utility] standard,” known as the promise doctrine, as a serious concern because it leads “to uncertainty for patent holders and applicants and undermines incentives for investment in the pharmaceutical sector”.

The established international standard under the WTO’s Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement, and the standard in the United States, is that an invention must be novel, not obvious, and “useful or capable of industrial application” to be awarded a patent. However, Canadian courts, through the promise doctrine, are holding innovators to an entirely different standard. The promise doctrine makes Canada the only developed country in the world with a patent utility standard that is inconsistent with both NAFTA and TRIPS.

This promise doctrine has three aspects: a process where the judge subjectively interprets the “promise of the patent” from the patent application; a requirement that the promised utility either be demonstrated or be based on a “sound prediction” of utility on the date of the patent application; and a requirement that evidence establishing a “factual basis” and “sound line of reasoning” for the predicted utility be disclosed in the original patent application.

The promise doctrine causes significant uncertainty for innovators because it not only requires the innovator to “soundly predict” how its invention will be used but also provide enough information in the patent application to prove the invention will successfully fulfill its promise. This doctrine presents innovators with a Catch-22. To “soundly predict” how a new medicine would be used, innovators must complete extensive human clinical trials before filing a patent application. However, for a patent to be granted, inventions must be new and useful. If an invention has undergone Phase II human clinical trials, which are consistently published in medical journals, the innovator risks the validity of the patent because the invention will no longer be new. Fulfilling the terms of Canada’s patent promise doctrine could therefore lead innovators to invalidate the novelty of their invention.

Canada’s requirements pose a severe risk to innovative U.S. biopharmaceutical companies, which are major contributors to American jobs and economic growth. The promise doctrine has already resulted in 19 revoked patents for innovative medicines over the past nine years despite the Canadian health regulatory agency’s approval of all 19 drugs as safe and effective. In the 25 years before Canadian courts created the promise doctrine only two patents were invalidated due to lack of utility. This doctrine puts both high-quality American jobs and future industry spending on healthcare research at risk by causing innovative U.S. firms to lose billions of dollars.

Eli Lilly is one American company that has been significantly injured by Canada’s IPR practices. A Canadian generic drug company challenged Eli Lilly’s patents on two medicines based on lack of utility under the promise doctrine. The Canadian courts ruled in the generic company’s favor and invalidated the patents despite the fact that the two medicines were being used by hundreds of thousands of Canadian citizens. In both cases the Canadian generic drug company immediately began producing and selling generic versions of the Eli Lilly-developed medicines following the ruling.

In instances like this – where U.S. companies have significant trade and investments at stake – local courts are not always the best forum to challenge a damaging policy. U.S. and Canadian trade agreements, including NAFTA, contain provisions to address situations just like this one. These provisions establish the procedures for both states and investors to challenge a law that violates a country’s responsibilities under the agreement. Dispute settlement procedures are an important mechanism for safeguarding trade and investment and have been one of the principal elements of NAFTA for the last 30 years. In fact, there have been more than 70 state-state and investor-state arbitration cases heard under NAFTA alone. Mexico has been sued over barriers to the trade of high-fructose corn syrup. The U.S. has been challenged multiple times by Canadian generic drug company Apotex. Canada has been taken to arbitration over its treatment of wind energy projects. As the Canadian government has noted, “in such a large trading area, disputes are bound to emerge.” The point is, when disputes happen, it is not unusual for parties to utilize the agreement’s dispute settlement procedures.

Corporations generally prefer to avoid dispute settlement procedures due to the legal costs involved. But it should not be a surprise – and it isn’t a unique occurrence – that traders and investors will avail themselves of legal protections under trade agreements when necessary. In the case of Canada’s patent utility definition, it is perfectly reasonable for U.S. entities to make their case that Canada’s policy fails to meet the IPR obligations that Canada agreed to in NAFTA. Countries must be held accountable for meeting their agreed-to responsibilities to maintain a fair and equal playing field where discovery and growth can thrive.


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Join the Discussion

17 comments so far.

  • [Avatar for Gene Quinn]
    Gene Quinn
    June 13, 2014 11:49 am

    Friend of Richard-

    First, you ARE Richard. You are attempting to comment from the same computer as Richard previously commented from, so let’s not pretend. If you try and comment from a different computer that computer will be blocked as well, and so on and so on. Your brand of deceit is not tolerated and gets in the way of a meaningful discussion.

    Second, Richard and any of his imaginary friends are banned, so you can stop trying to get in the last word.

    Finally, everything I have said has been backed up with citations. You are completely wrong. You said there is no such thing as the “promise of the patent doctrine” in Canada, which is FALSE! You said no Canadian court has ever spoken of such a doctrine, which is FALSE! Not only is it false, not only did I provide citations, but there is a case on appeal to the Canadian Supreme Court currently that will require the Court to address the doctrine that you say doesn’t exist.

    You say there is no right of action under TRIPS, but the author never said there was an action under TRIPS. The article clearly says that the promise of the patent doctrine (which is a very real thing — SEE ABOVE) is inconsistent with TRIPS, which it is.

    One thing I didn’t address is your asinine constant demand for a cite that the Canadian standard is subjective. It shouldn’t have to be said, but since you are so intellectually challenged I will explain… not that you will ever get it. Courts can say a test is an objective standard all they want, but when the test allows the decision maker to do whatever they are already inclined to do the test is a subjective one. That is true, for example in the U.S. with respect to obviousness. Courts can say all they want that things are objective, but when at the end of the day the outcome is dependent on the view of a particular decision maker there is no intellectually honest way to describe the test as objective, not that you know anything about intellectual honesty.

    I don’t know why you are lying, but you are. Liars are not tolerated on IPWatchdog.com. There are plenty of place you and your imaginary friends can go online and tell all the lies you want. IPWatchdog.com is not one of those places.


  • [Avatar for Friend of Richard]
    Friend of Richard
    June 13, 2014 09:57 am

    As a Richard has been ‘banned’ I post this on his behalf:


    I take your inability to back up any of the statements made in the original posting that I said were in error to be an admission that the posting was wrong. I accept your apology an wish you a good day.


  • [Avatar for Gene Quinn]
    Gene Quinn
    June 12, 2014 11:48 pm


    Your intellectual dishonest is breathtaking.

    You are banned. More is expected from those who participate in comments on IPWatchdog.


  • [Avatar for Richard Gold]
    Richard Gold
    June 12, 2014 11:37 pm


    As I have read every case dealing with promises, I am well aware of Sanofi. I am particularly aware of the fact that the Court in that case and in the subsequent case of Bell Helicopter held that the determination of a promise was nothing more than a factual finding of the asserted utility. The holding was clearly contrary to the argument that there is a doctrine. A finding of fact is not a doctrine. In addition to reading every case, I also did a search on all federal court cases dealing with patent law. Not a singe one speaks of a promise doctrine.

    I do agree that certain practitioners who have not read all the cases do sometimes use the term “promise doctrine” while others hold that it does not exist. The former lawyers are in error, but it is common enough that if it had been the only error in the posting, I would have let it slide.

    I notice, however, that you have failed to even acknowledge, let alone respond to the other errors I raised which are more serious than whether there is or is not a doctrine.

    I will make a deal with you. If you can provide a case (not a lawfirm blog) that says the following, I will happily apologize to the author:

    1. Other than the two Eli Lilly cases, a decision of the federal courts in which a pharma patent was invalidated (i.e., not an NOC action) solely on the basis of utility between 2005 and spring 2013 (the relevant period put forward by Eli Lilly).
    2. A court that used a ‘subjective’ test to determine the asserted utility that was upheld on appeal, if any. I take subjective here to mean something else than a finding of fact based on the understanding of the POSITA armed with the patent and general knowledge.

    I will leave the other errors alone.

    If you are unable to come up with both of the above, I expect a full apology from you and a correction of the posting. Fair is fair.


  • [Avatar for Gene Quinn]
    Gene Quinn
    June 12, 2014 08:02 pm


    Obviously you are not reading my comments, so let me try once more. I said earlier:

    “I provided a link above from a federal court in Canada that spoke at length about the promise doctrine. See Sanofi-Aventis v. Apotex Inc., 2013 FCA 186 (CanLII). This case uses the term “promise” no less than 60 times. It talks about the “promise of the patent” and the “promise of the invention” and “patent promise” and “promise of a specific result” and “explicit promise” and “invention promise.” So for you to say that there is never been a court in Canada that has discussed the “promise doctrine” is simply false. At best you are being extremely disingenuous to the point of intentionally misleading. Perhaps that specific term “promise doctrine” is not used, but ALL fair minded observers would clearly acknowledge that there is a promise doctrine in Canada and one that is talked about at great length in cases and in virtually every explanation of Canadian cases written by Canadian law firms.”

    CLEARLY there is something referred to as the promise of the patent doctrine and there is NOTHING incorrect about shortening up what everyone familiar with the law knows as the promise of the patent doctrine as “promise doctrine.” Everyone other than you seems to know that Canada follows the promise of the patent doctrine relative to what is said in the specification relating to utility.

    Furthermore, I cited several law firms, and could site dozens more and mention other Canadian lawyers who have contacted me to thank me for the article because they have difficult explaining this to clients. I cited those firms because you said that I should have run this article by experts prior to posting, as if to suggest that Canadian attorneys would believe it to be incorrect. The truth is Canadian attorneys disagree with your self serving, incorrect, intellectually dishonest assertions! Canadian law firm after law firm writes about the promise of the patent doctrine, as do Canadian Courts. I know you don’t like this reality, but it is the truth, which you would understand if you read the cases I cited, or if you were familiar with Canadian and U.S. patent law.

    With respect to TRIPS, you most certainly did claim that the author was suggesting a right of action under TRIPS, which he never did. As your 5th point of criticism you said: “neither NAFTA nor TRIPs support a trade action.” Why say that when the author never implied there was a right of action under TRIPS?

    You are wrong on there not being a promise of the patent doctrine in Canada, which is easy for anyone to verify. You are wrong on implying the author suggested a right of action under TRIPS, the article suggests Canadian law is inconsistent with TRIPS, which is correct. You are wrong on your understanding of utility law in the U.S. So why would anyone believe anything you’ve written when the foundation of your argument is based on clearly erroneous facts and understandings?

    You said in your last comment you were taking one last attempt. Allow me to take my own last attempt. Either you apologize and admit you are wrong or go away! I’m not going to tolerate this asinine ignorance any longer.


  • [Avatar for Richard Gold]
    Richard Gold
    June 12, 2014 07:52 pm


    One last attempt. Please find a SINGLE case (not a lawyer or firm — particularly Gowlings which represents Lilly) in which the term “promise doctrine” is to be found. I actually did the search for my article (which i suggest you read since it was actually reviewed by Canadian patent practitioners) and found NO such case.

    I did not claim the action was under TRIPs. It is under NAFTA. As you well know, the NAFTA text is based on the TRIPs text and is virtually identical. To bring the action (investor state under NAFTA chapter 11), Eli Lilly must show that there is a doctrine that came into being after its patent was granted. Unless it label discussions of promises (i.e., assertions) as a doctrine, then there has been no introduction of a new legal rule. Without this, its case fails.

    As the author discussed TRIPs and suggested it set a standard, it was appropriate to cite the international authorities on TRIPs who state that this is an error.


  • [Avatar for Gene Quinn]
    Gene Quinn
    June 12, 2014 07:41 pm


    Please. Grow up! You said: ““There is no case, anywhere in Canada, in which a court has spoken of a ‘promise doctrine’.”

    That is wrong and you know it. Why you wont’ admit that what you said is erroneous is becoming ridiculous, as are your attempts to back pedal and say you didn’t say what you clearly said above.

    You say: “I take offence when someone makes blatantly false and vexatious accusations of Canadian patent law without knowing anything about it.”

    A rather remarkable statement from someone who started this by proclaiming that there is no such thing as a promise of the patent doctrine and continue with that clearly erroneous assertion even after I cited multiple Canadian cases that talked at great length about a doctrine that you say no Canadian Court had ever spoken of.

    As far as shooting the messenger, I’m not. I’m just pointing out that you are wrong about your statement that no such thing as “promise of the patent doctrine” in Canada, which is patently false.

    You have a tremendous amount of gall to expect the author to correct anything when your criticism is provably false and you won’t acknowledge it.

    Further, the articles does not say or suggest there is a private right of action under TRIPS. The only time TRIPS is mentioned is in this paragraph:

    “The established international standard under the WTO’s Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement, and the standard in the United States, is that an invention must be novel, not obvious, and “useful or capable of industrial application” to be awarded a patent. However, Canadian courts, through the promise doctrine, are holding innovators to an entirely different standard. The promise doctrine makes Canada the only developed country in the world with a patent utility standard that is inconsistent with both NAFTA and TRIPS.”

    So your complaining that the author is wrong to suggest a private right of action under TRIPS is wholly incorrect and a figment of your own very wild imagination. Quite clearly, given the promise of the patent doctrine and how that differs from international norms, the author is correct with what was written above.

    You really need to look in a mirror. You are the one who is making stuff up and you are the one who is completely and total wrong. There isn’t even a debate to be had. Your criticisms reach fallacious conclusions and your factual assertions about utility and the promise doctrine are easily shown to be clearly erroneous. You are the one who needs to apologize for blatant errors.

    Your failure to recognize the clear truth of the matter despite citations proving you wrong is comically amusing, but growing very old. If you cannot accept truth and must continue to profess things that are clearly wrong from a factual standpoint you really need to go elsewhere. This forum is intended for meaningful debate, not grandstanding lies.


  • [Avatar for Richard Gold]
    Richard Gold
    June 12, 2014 07:19 pm


    This is a new low for you. I never claimed (please read my comments above) that Canadian courts never discussed promises. I simply made two points with respect to this. First, the concept is analogous to what you call asserting utility. Are you saying that there is no such concept in US patent law? If so, I will accept your conclusion since I recognize your greater knowledge of US patent law. Perhaps I misunderstood US patent law and there is never any discussion of asserting utility. Second, the point about the word “doctrine” is critically important to the NAFTA case. Perhaps you have not read Eli Lilly’s claims and do not understand that if there is no separate “doctrine”, the case falls apart. Essentially, Lilly is claiming that this is a new invention of the courts (ignoring 200 years of history) and that it is a separate legal rule that caused it to lose its patent. If promises are simply part of a general utility analysis, then Lilly’s argument that there is a new, separate, legal rule falls apart. This would seriously undermine its claims. So before you say I am splitting hairs, perhaps you should inform yourself of the actual claims by Eli Lilly.

    My agenda is simple. I take offence when someone makes blatantly false and vexatious accusations of Canadian patent law without knowing anything about it. I have seen through your blogs that you too take offence when you believe someone is factually wrong in making an argument against something, be it Bayh-Dole or other aspects of US law. I have no problem with criticism and have no stake in the game, but I am proud of my country’s legal system and the integrity of our judges and do not appreciate it when they are falsely maligned. You too would be outraged if the reverse were to happen.

    Don’t shoot the messenger: the author of the blog made blatant errors that all comments so far have recognized. If the author is not willing to correct them, then you should. If you are unwilling to do so, this speaks more about the value of your blog than anything about me.


  • [Avatar for Gene Quinn]
    Gene Quinn
    June 12, 2014 07:09 pm


    Don’t lecture you? WOW. Apparently you can’t read my friend. You made a statement that was clearly erroneous and anyone who can read knows that to be true. You want to split a ridiculous hair saying it is disingenuous to say there is something called the promise of the patent doctrine, when Canadian Courts talk about that very thing all the time over and over.

    Your comments here are among the most intellectually dishonest that I’ve ever seen, so I will lecture you! Your understanding of U.S. utility law is completely lacking. I don’t know what your agenda is but you came out swinging and you are dead wrong. You really owe the author an apology. Based on how you are on your high horse I doubt you will man up and extend that apology, which speaks volumes about you.

    Finally, you are obviously no expert in Canadian law. I’ve cited case after case, and many lawyers in Canada disagree with you. So before you comment on a blog please inform yourself in the future. This type of inaccurate commentary is not what is expected, particularly after citations have been provided proving you wrong. I notice you haven’t taken issue with anything I’ve cited. I wonder why that is?


  • [Avatar for Richard Gold]
    Richard Gold
    June 12, 2014 06:41 pm


    With all due respect, unless I am unaware of your Canadian credentials, please do not lecture me on Canadian law. I never said courts have not talked about promises of utility; they do and they mean exactly the same thing as assertions of utility in the United States. If I were to do a search of US law in which the term “assert” and “utility” were in close proximity, I would have many, many, many hits. Do you therefore conclude that there is an “assertion of utility” doctrine in the US? Of course not. You would simply say that there is a general utility analysis, part of which involved determining the asserted utility. The exact same is true in Canada. So please respect the fact that you do not have expertise in Canadian law and accept that no court has ever spoken of the “promise” doctrine. If you find an explicit reference to the use of the word “doctrine” in conjunction with “promise” and “utility”, advise me.

    As for your assertions that it is known to judges and lawyers, this is false. Judges themselves reject this term as well as many lawyers. In fact, there was a Canadian patent litigator specializing in phrma patents at a policy briefing last week who categorically said there was no such thing and stated that it was a pure invention. Again, unless you have actually spoken to Canadian judges, please do not lecture me on Canadian law. If you actually read my article, you would have seen that it was vetted by Canadian judges and those practising in the field of patent law. I trust their views — as experts in the field — rather than someone who, I am guessing, knows little about Canadian law, let alone patent law.

    In any event, this was the least important of the errors I pointed out. What about the claim that the determination of the asserted utility was “subjective” when exactly the same test is used in the US? What about the fact that only two cases actually found invalidity of a pharma patent based solely on utility between 2005 and 2013? What about the inaccurate claim that close to clinical trials are necessary to pass the utility requirement when the leading case stated that animal trials and an experiment in an in vitro human cell line was sufficient?

    I leave aside the fact that NAFTA says absolutely nothing about the substantive content of the utility requirement and that TRIPs explicitly leaves this to individual countries. In the joint report by the WTO, WIPO and WHO, it is stated that “[T]here is no agreed international understanding about the definition and interpretation of these criteria. This creates some policy space regarding their establishment under the applicable national law. Accordingly, patent offices and courts interpret and apply national patentability requirements on a case-by-case basis within the applicable legal framework.” These are the organizations that have the expertise in international trade and international patent law. Are you saying they are wrong?

    Please review submissions to your blog with experts from the country involved before publishing them. I have much criticism of the way Canadian law deals with utility and many other issues. No doubt, you have issues with the way US law deals with various issues, such as non-obviousness, patentable subject matter and more. These are helpful criticisms and through them we can hope to clarify and improve our law. But to have a blog that distorts the existing law only detracts from a constructive debate. I welcome criticism of the law as long as it is factually accurate.


  • [Avatar for Gene Quinn]
    Gene Quinn
    June 12, 2014 05:31 pm


    You say: “There is no case, anywhere in Canada, in which a court has spoken of a ‘promise doctrine’.”

    That is simply not true. I provided a link above from a federal court in Canada that spoke at length about the promise doctrine. See Sanofi-Aventis v. Apotex Inc., 2013 FCA 186 (CanLII). This case uses the term “promise” no less than 60 times. It talks about the “promise of the patent” and the “promise of the invention” and “patent promise” and “promise of a specific result” and “explicit promise” and “invention promise.” So for you to say that there is never been a court in Canada that has discussed the “promise doctrine” is simply false. At best you are being extremely disingenuous to the point of intentionally misleading. Perhaps that specific term “promise doctrine” is not used, but ALL fair minded observers would clearly acknowledge that there is a promise doctrine in Canada and one that is talked about at great length in cases and in virtually every explanation of Canadian cases written by Canadian law firms.

    Here is another case: http://decisions.fct-cf.gc.ca/fc-cf/decisions/en/item/57179/index.do

    If you Google “Canada promise doctrine”. You will find page after page after page of discussion of the promise doctrine in Canada, with citations to specific cases in addition to those I’ve provided. See, for example:

    http://www.gowlings.com/KnowledgeCentre/article.asp?pubID=2966 (discussing “the promise of the patent doctrine”)

    http://www.iposgoode.ca/2013/06/sitting-this-one-out-scc-refuses-to-clarify-promise-of-a-patent-doctrine/ (subtitled “The Promise of the Patent Doctrine and its Latest Interpretation”)

    So it is clear beyond any shadow of a doubt that it is completely erroneous to say that no court in Canada has ever discussed a doctrine that relates to the promise of a patent. There does exist a doctrine know as the promise of the patent doctrine in Canada. It is known to attorneys and Judges, and the use of the term here is perfectly consistent with case law. It is not made up by Eli Lilly as you suggest. It is a very real thing.


  • [Avatar for Richard Gold]
    Richard Gold
    June 12, 2014 04:52 pm


    Thank you for the thoughtful response.

    There is no case, anywhere in Canada, in which a court has spoken of a ‘promise doctrine’. Eli Lilly, in its trade complaint, made it up out of whole cloth. Following that, some pharma side litigators picked up the term, but it does not make it any more real. In fact, courts have consistently talked about identifying the utility explicitly asserted by the patentee in the context of a general utility analysis. There is not one case in which a court has invoked a promise as a separate legal doctrine. It means no more and no less than an assertion of utility based on the factual record and general knowledge of the POSITA. Calling it a doctrine does not change the fact that it is no different than finding an asserted utility.

    I agree that US patent law does not enforce utility at a high level. My reference to MPEP was only to show that the determination of the asserted utility in the US is basically the same as in Canada.

    As to equivalents in US law, look to enablement rather than utility. To enable a second use or a selection (which were at issue in the cases Eli Lilly speaks of in its trade complaint), one would need to have a line of logic and some empirical basis at the time of filing that the second use or selection had a utility that went beyond that of the first use or utility of the genus.

    There are only two cases in Canada between 2005 and 2013 (based on Lilly’s list of cases) in which a Canadian court held a pharmaceutical patent invalid solely on the basis of lack of utility. Both of these cases involved Eli Lilly. All other cases cited either had multiple grounds of invalidation or did not even involve a determination of validity. Unlike the US, Canada has a system in which a pharmaceutical company can prevent the authorities from issuing permission to market a drug using a fast procedure based on affidavit evidence. Even if the patent holder loses, the patent holder can sue for infringement and fight out validity based on viva voce testimony.

    Two cases in 8 years does not a trend make.


  • [Avatar for Gene Quinn]
    Gene Quinn
    June 12, 2014 04:26 pm


    I’m not quite sure how you can say that there is no promise doctrine under Canadian patent law. As I understand it the Supreme Court of Canada is considering a case on the promise doctrine, with an anticipated decision date later this year. See:


    There are plenty of other places that mention the promise doctrine under Canadian law.

    As for your assertion that the promise doctrine is the same as utility in the U.S., that isn’t exactly true. In Canada if an inventor asserts a utility he will be held to the promise which he has made. In the U.S., utility can be express, inherent or implicit. The utility mentioned in the application, whether express, inherent or implicit, does not tie to the claims in the patent. Utility in the U.S. is an extremely low threshold. If the invention works at all for any purpose utility is satisfied in the U.S. This is explained in MPEP 2107.01(II), which explains that according to the Federal Circuit in order for a utility rejection to be appropriate “the claimed device must be totally incapable of achieving a useful result.” Thus, there does seem to be quite a difference between utility in the U.S. and the promise doctrine in Canada.

    As far as the MPEP section you cite, MPEP 2107.02(III)(B), that section deals with incredible utility. Examiners in the U.S. have for some time been instructed not to issue incredible utility rejections, but rather to instead simply issue utility rejections. Still, the type of utility that would provoke this type of rejection historically is a claim to something such as a perpetual motion machine, which science says simply cannot happen. Furthermore, as that section explains, rejections for lack of credible utility have been sustained by federal courts when the applicant failed to disclose any utility.


  • [Avatar for Gene Quinn]
    Gene Quinn
    June 12, 2014 04:07 pm


    You say: “There is nothing wrong with a sovereign deciding – within its borders – to treat applicants (and applications) the same regardless of national origin. That is a right of each sovereign. However, to demand that a different sovereign employ specific US law within that sovereign’s borders is a different topic.”

    Ordinarily I would agree with you, but what about NAFTA? I am no NAFTA expert, but it strikes me that when we entered into NAFTA laws in the U.S. changed to grant Mexican and Canadian citizens rights equivalent to those given within the U.S. Didn’t NAFTA also require the U.S. to recognize at least certain Mexican laws. It is my understand (perhaps incorrect) that the U.S. cannot impose safety standards on Mexican trucks, for example, if those trucks satisfy the safety standards of Mexico, which are quite relaxed (again, as I understand it).


  • [Avatar for Confused]
    June 11, 2014 01:26 pm

    Interesting post. There was a post on this issue I think several weeks ago on Patent Docs as well, but I remain confused. How is what the Canadian courts are doing with Canada’s patentability requirements any worse than what the US courts and patent office are doing, for example, with Myriad and the Myriad guidelines? Isn’t it basically the same thing with different labels? Also re sound prediction, we’re in basically the same place in the US (especially in biotech) due to the way the patent office applies the written description requirement. Is this whole thing just a ploy by the USTR and others to get Congress to roll back the Myriad guidelines? I would be in favor of rolling back the guidelines, but I don’t understand how the USTR can make these statements with Myriad looming over their shoulder.

  • [Avatar for Anon]
    June 11, 2014 10:58 am

    Three separate thoughts that coalesce into one conclusion:

    I am less sure that this is a “catch-22” as much as it is a general view that pharmaceuticals meet the patent requirements that all other inventions meet: that the application as filed has the utility claimed. While there is undoubtedly huge costs involved, and there are huge benefits, the patent system is not generally built to allow fishing expeditions of applications with claims filed prematurely (as in, before utility has actually been ascertained).

    I do understand that this particular art area has a utility that has closer scrutiny by other parts of the government (and rightfully so, given the direct human impact). But should that alone allow a lesser standard for patents? I do allow that the answer to this question may be a “yes,” but let’s not pretend that this would be an exception and a special treatment. I would also put forth that such special treatments should be miserly admitted, lest each and every different art unit clamor for its own special treatments and patent law – already complex – be hopelessly fragmented in exceptions.

    Patent law is and always has been a sovereign-specific law. Treaties that span borders thus need to be carefully looked at so as to not violate this type of sovereignty. There is nothing wrong with a sovereign deciding – within its borders – to treat applicants (and applications) the same regardless of national origin. That is a right of each sovereign. However, to demand that a different sovereign employ specific US law within that sovereign’s borders is a different topic. At the risk of appearing jingoist, I surely do not want to be held to another sovereign’s laws based strictly on a treaty that would allow that foreign sovereign to dictate the law withing this country’s borders. If in the present case we are demanding something of Canada – within Canada’s borders – that we ourselves would not want (and SHOULD not want) within our own borders, then we best pause and consider what it going on.

    (and related to the second point and previous posts of mine, I do NOT view large multinationals as directly being “citizens” of one country in the sense that Eli Lilly is being portrayed in this article. Large multi-nationals simply are not beholding to a single country’s rule of law, and a very real danger exists due to their trans-national existence. That very nature cannot be overlooked – especially in light of the fact that patent law is sovereign specific. Until (and if) we have a legitimate one-world government, we should be very wary of trans-national influence on sovereign specific law.

    I reject the takeaway of this article as it conflates the three items I list and projects a “national protection” argument to an entity that is neither “national” and to protection that is not rightfully under the proper scope of sovereign specific protection.

  • [Avatar for Richard Gold]
    Richard Gold
    June 11, 2014 10:27 am

    It is unfortunate that Mr. McDermid is so misinformed about Canadian patent law. There are at least five blatant errors in the text: 1) there is no ‘promise doctrine’ in Canadian law. No court has ever used this term nor claimed it was a doctrine. Rather, a ‘promise’ is nothing more than the asserted utility, a concept well known in US patent law; 2) the law is very clear that the determination of the asserted utility be based on an objective (not subjective) analysis of the patent through the eyes of the POSITA with a view to finding the patent valid; 3) no clinical studies or anything approaching them are required for predictions of utility (called sound prediction in Canada). The test is basically the same as set out in MEPEP 2.107.02(III)(B) in the US. In fact, in the leading case from the Supreme Court of Canada dealing with the second use patent for AZT, animal studies and an in vitro study using human cells were sufficient — a far cry from clinical studies — to show both the logic of the predicted asserted utility and a sufficient factual basis for it; 4) the evidence need not be in the patent if it comprises part of the general knowledge of the POSITA; 5) neither NAFTA nor TRIPs support a trade action. TRIPs is explicit about this, leaving the determination of the utility standard to individual countries. The one attempt to harmonize substantive patent law, through the WIPO’s Substantive Patent Law Treaty negotiations, was shelved due to disagreement on substantive law between the US and the EU.
    If you are interested in what the law actually is, rather than the opinion of someone who has no demonstrated knowledge of Canadian patent law or of international patent law, then read the following, recently published in the leading IP law journal run by practitioners and peer reviewed by practitioners: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2361146
    I am disappointed that IPWatchdog would publish a piece that is so factually and legally inaccurate. I trust that the posting above will be corrected to reflect the reality of Canadian patent law rather than the misinformation provided.