Million Dollar Mistake? The Cost of Limiting or Canceling IP Rights

Guest post by  Cynthia M. Ho, Clifford E. Vickrey Research Professor, Loyola University of Chicago School of Law.

Philip Morris and Eli Lilly think that they are entitled to millions in compensation from countries that limit or deny desired intellectual property rights.  These companies are the first to challenge IP issues pursuant to international agreements protecting investments of foreign companies. However, they join a trend of companies increasingly suing states before a panel of private arbitrators pursuant to investor-dispute settlement (ISDS).  The substantial financial stakes may have a chilling effect on traditional domestic laws and policies.

Although there are only two IP related ISDS disputes so far, IP policy makers should be concerned and oppose pending fast-track legislation that would permit President Obama to easily conclude more agreements with these problematic provisions.  Indeed, pending agreements have been criticized by a diverse group of individuals and countries including Nobel Prize winner Joseph Stiglitz, Elizabeth Warren, the Cato Institute and countries such as France and Germany.  The USTR recently issued a fact sheet, which was promptly debunked.

What is ISDS?

ISDS is a mechanism in over 3000 international agreements that permit foreign investors to seek compensation against countries.  The agreements guarantee freedom from discriminatory measures, a guarantee of being treated no less favorably than domestic companies, compensation for expropriation of investments, and “fair and equitable treatment.”  If these rights are allegedly violated, investors can bring a dispute before a tribunal of private (usually commercial) lawyers chosen by the parties to the dispute. There is not only no independent judiciary, but also no binding precedent and no appellate review, such that there can be inconsistent and unpredictable results.

Historically, these provisions were first added to international agreements promoting investments after World War II when newly independent nations wanted to encourage foreign investment.  ISDS was intended to provide protection to companies that lacked any legal recourse against unlawful state action.  ISDS was conceived as an improvement over “gunboat diplomacy” that nations used to protect their companies.

Why is ISDS relevant to IP?

Although ISDS was not originally designed to protect IP, companies are trying to use it for this purpose.

Most agreements providing ISDS do so only for investments of foreign companies.  These investments can include not only tangible, but also intangible property, which would seem to include IP.

Is a Canceled IP Right an “Investment” Subject to ISDS?

Even if IP is within the scope of covered investments, a critical question is whether this should include canceled IP.  IP lawyers and even students know that IP is at most presumptively valid, such that it can and often is canceled when found to not meet basic requirements.  Although canceled IP has never been considered to provide rights, Eli Lilly assumes it has rights.  In particular, it is seeking $500 million from Canada after failing to convince both a trial and appellate court that two of its patents were valid.

Highlights of Existing ISDS Claims Regarding IP

Eli Lilly’s case involves a challenge to Canada’s “promise doctrine” for assessing utility of patents and applications that make certain promises.  The promise doctrine is unusual as a utility requirement, but similar to disclosure and other patentability  requirements of other countries.  Eli Lilly claims that because this doctrine developed after its patents were granted (a point that is contested, even by some lawyers), it is improper to retroactively apply it to invalidate its patents, such that its patents have been improperly “expropriated,” which is roughly similar, but broader than US takings.  However, patents are routinely invalidated after common law modifications to laws, such as the scope of patentable subject matter with no claims of takings.

Eli Lilly seems to assume both that an issued patent is a state representation that it will remain forever valid and also that a nation can not modify its laws without violating legitimate expectations.  The supposed violation of its legitimate expectations figures prominently in a claim for denial of the amorphous condition of “fair and equitable treatment.”

Problematically, although a patent lawyer would readily reject the idea that patents are always valid and untouchable by subsequent law, they will not be deciding Eli Lilly’s case. Notably, when I presented a forthcoming article about this case to an international law colloquium, I was surprised that the audience resisted the basic principle that patent rights can and should be invalidated when found not to satisfy fundamental requirements.

Philip Morris also claims its legitimate expectations were violated, but in a different way.  Philip Morris asserts that it had a legitimate expectation that Australia would uphold its obligation to comply with TRIPS requirements for trademarks.   This suit fundamentally challenges the process for resolving alleged TRIPS violations.  Only countries, not companies, have standing to adjudicate alleged violations under TRIPS.  Thus far, countries have been cautious in doing so since there are often political implications for their actions. Moreover, permitting violations of TRIPS to be litigated outside of the WTO forum would seem wholly inconsistent with the WTO dispute settlement process that is intended to be the only forum for litigating such disputes.  In addition, there could be conflicting results; indeed, there is a pending WTO case.

ISDS for IP Threatens Flexibilities Under TRIPS

Eli Lilly’s case poses a serious threat to the minimum standard approach of TRIPS (and NAFTA).  Although these agreements have been widely understood to permit nations flexibility to define key terms, such as what is “new” or what counts as “useful,” Eli Lilly falsely claims that Canada’s definition is impermissible.

Ironically, these cases are arising at a time when many academics and policy makers (Eastern Europe, South Africa) have been encouraging countries to take greater advantage of their already limited flexibilities under TRIPS.  The present disputes may have chilling effects at a time when countries such as South Africa and Brazil have been considering modifying patent laws.

Future Problems

In the near future, companies may use ISDS to challenge patent provisions, such as compulsory licensing and India’s patent law designed to prevent “evergreening” of drugs that have attracted criticism, but no WTO dispute.  Moreover, regulatory provisions are also ripe for challenge.  For example, countries that fail to provide data exclusivity desired by the pharmaceutical industry could be subject to challenge.  In addition, a pending EU law hailed by public health advocates for increasing transparency concerning data of approved drugs is also at risk.

Given the wide range of issues at the intersection of intellectual property and public health that are potentially threatened by ISDS, this should be an issue of major concern.  Those who want to preserve policy space for countries should oppose pending agreements that permit ISDS, such as the pending Trans Pacific Partnership Act, especially because there is no public access to draft text of pending agreements except through sources such as Wikileaks, which just released the secret investment chapter of the TPP, that permits ISDS.   Public opposition is important; the EU has now delayed consideration of ISDS in its pending Transatlantic Trade and Investment Partnership (TTIP) agreement with the US.  In addition, although “fast-track” legislation is presently stalled, it should be opposed if re-introduced mid-April.  In the meantime, you can join  a petition to Congress, or directly contact your Congressman to oppose fast track bills.

Cynthia is a Law Professor at Loyola University of Chicago School of Law.

About Dennis Crouch

Law Professor at the University of Missouri School of Law. Co-director of the Center for Intellectual Property and Entrepreneurship.

75 thoughts on “Million Dollar Mistake? The Cost of Limiting or Canceling IP Rights

  1. Cynthia Ho: although a patent lawyer would readily reject the idea that patents are always valid and untouchable by subsequent law, they will not be deciding Eli Lilly’s case. Notably, when I presented a forthcoming article about this case to an international law colloquium, I was surprised that the audience resisted the basic principle that patent rights can and should be invalidated when found not to satisfy fundamental requirements.

    I would love to hear more details about this. Frankly, given what some supposedly profssional patent lawyers believe about certain patents and the people who oppose those patents, nothing surprises me anymore.

  2. Great article. The links were very useful.

    There’s little doubt that investor-dispute settlement is being increasingly abused by multinational companies (and national companies that become multinational for the purpose of sueing a country). As has always been the case, when some “clever” lawyers discover a hammer, the greedy ultra-deep pockets who can afford to play will invariably dive in to grab some cash for themselves. Underlying all of that is the relentless desire of these corporations to bend the laws of every country in the world to serve their interests (= profit).

    Whatever you think of ISDS in the abstract, it was surely never intended as a means for recovering “lost profits” from a country after a patent in that country was invalidated as improvidently granted or otherwise “devalued” by some legal decision or a change in the law. That’s ridiculous.

    At the very least, countries looking to enter into international trade arguments should remove IP disputes from the ambit of the ISDS paradigm. Companies like Eli Lilly and Philip Morris should feel free to obtain insurance if they are uncomfortable with the risks associated with IP, or they should simply get out of the IP business entirely.

    1. MM, check the John Olive video linked below.

      In one example, a tobacco company sent a letter to a very small impoverished African country that wished to regulate tobacco packaging. The letter threatened a virtual avalanche of litigation should the regulation be implemented. The letter cited an Australian case as support for the proposition that the African country could not win. But the Australian case in point ruled 6 to 1 against the tobacco company, with the majority essentially saying that the cause of action for trademark expropriation was “delusional.” One judge however thought that the trademark misappropriation case had merit. This is what letter to the African country cited without letting the African country know about the majority opinion.

      All told, this kind of letter, containing misrepresentations, containing threats of massive litigation, is an abuse of process in my opinion. It seems to me that rather than tolerate this, the United States should actively pursue litigation against these companies for abuse of process – and should join the defense of these lawsuits wherever they are filed.

      Talk about Trolls!

        1. I was wondering the same thing. The chances that the local PM affiliate acted in sending that letter, without U.S. corp oversight, is probably pretty slim. Sure, local affiliates act without authorization from the U.S. “home” office all the time, but not too often in legal matters.

          Adding to my imagined daisy chain, assuming the U.S. home office vetted the letter, it’s likely that both in-house and out-house U.S. counsel vetted the letter.

          Knowing it was spouting lies.

      1. The funniest thing about the Oliver video is how very much it reminded me of Ned Heller’s highly selective parsing of history and Supreme Court (and other much lower court) writings to make it as if current law is somehow different than what it actually is.

        Ned symbolizes the threat that Big Tobacco makes to Togo, because to Ned, his “End” justifies the means.

  3. It is rare that I ever read comments on these articles because they always seem to take the direction of the commentator – kinda like what some of the commentators here are arguing about the author’s article that it is not balanced enough or objective enough and therefore should implicitly be ignored or degraded. That’s too bad because Professor Ho does a fine job of identifying the very concerning international law issues and concerns applicable to ALL IP rights – not just patent owners and their unique aspects identified in the comments. In my experience, very few US patent attorneys are aware of these international law issues and how they are actually (ab)used in the real world. If the article is imbalanced, it is because it doesn’t provide enough examples of what ISDS is really intended to do.

    Every person who is interested enough to subscribe to PatentlyO, after reading this informative article, ought to be interested enough to further understand the workings and the affects of the ISDS and how it is being (ab)used by very large multinationals to attempt to overcome a country’s ability to legitimately regulate and police products for the health, safety and welfare of its citizens because of alleged IP takings!

    For another “one-sided” view of the issue, consider HBO’s John Oliver’s take down of the issue – link to youtube.com

    1. I agree this is a very interesting topic and I will learn more about it. You should consider that it is difficult to spend a lot of time reading about a topic when the author does not clearly identify their biases and does not clearly present both sides in the best light. We should expect a fair presentation of the issues from scholars. That is not what we get from people like Lemley who have a clear bias and have a intent to change the laws through judicial activism.

      It makes it very hard to spend time reading articles when often they are so biased that one cannot trust anything they say. For example, I do not trust cites in Lemley’s articles. I have spent some time with his functional paper to see if the cites actually supported his propositions. I do not think they do. Law journals are particularly bad as they seem to be forums for law professors to advocate for judicial activism or their favorite causes without peer review and seemingly with no consequence for anything they may say in the article.

      Consider that maybe the reason they don’t get read is that they are not scholarship but advocacy.

      1. You should consider that it is difficult to spend a lot of time reading about a topic when the author does not clearly identify their biases and does not clearly present both sides in the best light.

        Please feel free to jump in and present Philip Morris in the best light.

      2. MM, you clearly don’t like Prof Lemley’s approach in his scholarly articles – that’s fine. But to conflate that issue with a “Guest Post” by Professor Ho on the Patently-O website seems to me your comment is intended to undermine the entire post as “non-scholarly”. I’ve never considered a “post” on Patently-O to be a “scholarly” work. The definition of a digital “post” is clearly and logically understood to NOT necessarily be “scholarly” even if it is posted by a Professor on another Professors blog (“post” (digital) is defined as “an online message that is submitted to a message board or electronic mailing list”).

        I respect your point and agree it is not necessarily “scholarly” but it does include many cites and I respectfully disagree that it is difficult to read Prof. Ho’s “post” merely because it isn’t “scholarly” enough because it doesn’t clearly and succinctly identify the author’s alleged bias. But that point causes me to ask, how do you know the author has such a bias and intent to change the law through judicial activism when you state the article doesn’t disclose it?

        I’m very glad the post achieved what I believe is one intended goal – to get others to be aware and get more information on the topic. It is a very important and topical international law issue involving IP rights that many are are not aware of.

    2. I don’t think patent holders should be compared to the tobacco companies. But, the John Steward video does do a good job of brining out the legal issues.

      And, interestingly, judicial activism (like Alice) can be compared to the new health law because both are making new law, which is effecting property rights.

      1. Maybe you want to think about the tobacco case a bit more too. Maybe the right thing to do is to punish companies for fraud and to compensate them when their property rights are taken. NAFTA was done to help the Mexicans. Gee, nice for them and nice good warm feeling for Billy Clinton. But what about the millions and millions of people that relied on the US manufacturing? They have been put into the street.

        Maybe we need to rethink what we should do when we pass new laws that affect people. Maybe if you want to help the Mexicans the cost should be born by everyone.

  4. Hey guys, I’m doing a bunch of PCT’s lately. 371’s actually. I keep getting CN PCTs. They tend to claim FP back to their CN applications. However, WIPO never seems to send us their FP documents (like they do for other countries). The MPEP seems to indicate that we in the office are supposed to attach the FP documents for them after getting them from WIPO (usually we just look it up on the wipo site).

    My question is, if the application has yet to publish at WIPO, how is the PTO supposed to get the FP papers?

    1. 6 – That original FP (Foreign Priority) document could be important b/c it provides for an additional year of priority. I think that there are several approaches here that you should pursue:

      1) Request the document from the applicant.
      2) If you don’t have the document, assume that it does not provide priority (unless shown otherwise).
      3) Inform your SPE about the problem.

      1. I think too that the applicant had to check off that it was OK for WIPO to send the FP, so maybe they didn’t check it off.

        But, in all cases, I am pretty sure that if you don’t have the FP that you are supposed to request it from the applicant.

        Of course, the problem here is the date to use on the prior art search.

        1. “I think too that the applicant had to check off that it was OK for WIPO to send the FP, so maybe they didn’t check it off.”

          Yes that might be what is happening. But this seems to be standard for CN PCTs. None of them have their FP documents. So either they’re all opting out, or something is broken.

          “But, in all cases, I am pretty sure that if you don’t have the FP that you are supposed to request it from the applicant.”

          Except in this specific circumstance which is special. You can check the MPEP re the subject, it’s in there, I forget where off hand though.

        2. “Of course, the problem here is the date to use on the prior art search.”

          Yeah would be sometimes, but in this case it isn’t that big of a deal, he only has a month of FP. Unlikely to amount to much.

      2. Thanks for your assistance D. I know how to do all the “slow ways”, I’m looking for a way that I can actually find the document like the MPEP says the office is supposed to for applicants in this situation.

        But it appears there aren’t any, I’ve got people working the problem though.

        Thanks again.

      1. Ned, the problem with that is then the examiner may have to redo their work with the new priority date and not get any extra points.

        1. Well, 6, do not acknowledge receipt of the priority documents and make a requirement that they be filed. (I am puzzled they are not available through WIPO. The record should reflect whether they were transmitted to WIPO from the receiving office, which, I presume is China.)

          Second, if the applicant ever wants to rely on their priority date, they have the burden of proof. They have to translate and demonstrate support for the claims in the priority document.

          1. “Well, 6, do not acknowledge receipt of the priority documents and make a requirement that they be filed. (I am puzzled they are not available through WIPO. The record should reflect whether they were transmitted to WIPO from the receiving office, which, I presume is China.)”

            Yep will do.

            They probably are “available through WIPO” somehow, it’s just that they’re not automatically sending the docs to us for some reason. My internal people can’t get them either. So I’m just going to make them submit or I’ll get them on the record when they come back.

    2. FYI – I contacted Andy Faile (Deputy Commissioner for Patent Operations) who got me in touch with folks in the USPTO International Patent Legal Administration. Their advice is that the examiner should call the PCT Help Desk (571-272-4300; M-F; 8:30 am – 5:00 pm (EST/EDT)) for assistance in obtaining the missing FP documents from WIPO.

      1. Thanks much D, that one is actually very helpful. I have people working the problem already, but if they fail I will call them myself.

  5. This reads a lot more like an Op-Ed piece than an article from an academic.

    Who’s got dogs in this fight?

    1. It is very interesting. I wasn’t aware of this. But, I agree that it lacks a certain objective distance from the subject. (But, Lemley publishes in the Stanford Law Journal, so I don’t think any law professor can ever call themselves an academic.)

      1. To be clear, I don’t know who does or does not have dogs in the fight. Perhaps no one does. I was only asking because this one seems very one-sided for a PatentlyO piece. Professors Gold (in comments) and Ho do seem to be quite aligned in their thinking, though.

        A few pieces here recently seem also to have similarly lacked “objective distance”, as you put it, so maybe I’m just being overly sensitive.

        1. I think it is the abysmal times we live in. There do not seem to be any (maybe one or two) academics that see it as their mission in life to objectively present the issues. Somehow we have lost our way. Everything seems to be a dog fight. This, by the way, was a stage in the downfall of Rome.

        2. this one seems very one-sided for a PatentlyO piece

          More “one sided” than this?

          link to patentlyo.com

          Of course not. Please keep blowing your referee whistle, though, when you detect “bias”. It tells us way more about you than Dennis.

          Or just learn to accept the fact that informed people occasionally have strong views about stuff.

          1. That article is hilarious by the way.

            I laughed out loud. He starts off by saying “let us assume for the moment that there are in fact such things as laws of nature.”

            What a generous concession! Also…

            “Second, individuals have differential responses to a given amount of the metabolites…This is exactly the same reason that one person can be drop dead drunk after five drinks and another can be stone cold sober at the same level.”

            …What…

          2. Please keep blowing your referee whistle, though, when you detect “bias”. It tells us way more about you than Dennis.

            Tweet, uhuh, tweet.

            Such a clairvoyant you are, Malc. Wrong, but oh-so-certain.

            Some say that’s all it takes – it has after all at times been a winning combination for the folks with the 1-900 numbers. You know, like Dionne and her Friends.

            But to answer your question – although I doubt I previously read the post you stretched back some 36 months to find – yes, indeed I do agree with you that it clearly fits in the same “one-sided” bucket (if not even more so).

            Almost as if the law firm lawyer who wrote that piece may possibly have had some clients with “a dog in that fight” (or, more likely, some fight very like it), wouldn’t you agree?

            In any event, I did not have a dog in that fight (nor do I in this one above).

            But just to be clear, I was rooting for ridding ourselves of the process claim asserted by Prometheus, and its similar ilk.

            So, also, your attempt to immediately answer for me the question you posed to me with, “Of course not”, is also not at all correct.

            1. “… although I doubt I previously read the post you stretched back some 36 months to find…”

              But remember, he only spends about 2 hours a week drafting posts on this site.

              1. LOL – and let’s not forget that this is the same person that once boasted as to reading a fifty plus page Supreme Court decision and every post that I had ever written on the subject in a four hour span of time…

                The meaning of the word “credibility is just not associated with this person (which makes the Nedism of “you align with my Beleibs so you must be an Einstein” all the more jarring).

              2. Well, I don’t know how difficult it would be to find a particular post as long as you remembered some key information (and that was not the point I was trying to make in any event).

                But I was curious so I just did a quick check on google and found that using this website name, fenwick, and prometheus together puts Mr. Sachs’ post on the first page of hits.

                1. Fair enough. My point was that if you believe the nonsense Examiner Mooney posts about only spending 2 hours a week drafting his comments then I have some beach front property in Nebraska I think you might be interested in.

                2. Boats R Us and Mellow,

                  Given that Malcolm (I will not insult examiners by calling Malcolm that) spends zero actual time thinking and merely regurges the same small listed script items on every thread, the admitted “draft time” of two hours a week seems greatly exaggerated.

    2. Prof Ho definitely has her own perspectives on this issue. But, the article here is still primarily providing information on a topic that we have not covered on Patently-O.

    3. Prof. Ho is stridently pushing for a particular conclusion here.

      That being said, the links and the content here run deep and rich in information that can be assimilated in an objective manner.

      This will take some not insubstantial effort.

      This is not just your typical straight up IP laws (even of those in different sovereigns) at play here, and these “other laws” have huge ramifications.

      1. Yeah for sure. I have to say, I appreciate why people want ISDS, but that stuff appears near crazy to me. I guess a state would have to weight the potential benefits (in terms of increased investment, an ephemeral thing) against it’s potential loses.

        1. 6 it is not crazy.

          When someone takes your property, fundamental international law require compensation.

          Look that the reason the Palestinian controversy has so long festered.

            1. MM, the issue here is utility, not obviousness.

              Do you agree or disagree that if a claimed composition does in fact have utility it is patentable subject matter?

              1. Ned,

                It appears that you are playing the nominalist side of the coin now.

                Do you think that merely possessing the item (statutory category aspect of 101) at the time of filing suffices for possessing the other required aspect of possessing the utility at the time of filing?

                Can you possess that which you in truth do not know?

                Before you answer remember all of the items that fail the FDA process and that in fact do NOT have the required utility even years after filing.

              2. Ned: Do you agree or disagree that if a claimed composition does in fact have utility it is patentable subject matter?

                If the “claimed composition” is old (which is my understanding of the facts here) then the “claimed composition” is unpatentable.

                My understanding of the facts here (and I’m relying on Richard Gold’s summary) is that Lilly is trying to claim a new use for an old composition — a method claim, in other words. The court found that, as of their filing date, they didn’t have evidence showing that the method would in fact work to achieve the result stated. In other words, they weren’t in possession of the invention. They had a research plan, at best.

                Down below you wrote: as I understand it, one cannot even test drugs on humans until one proves them effective on animals. The question then becomes do animal test support a prediction about humans?

                The answer is “it depends.” But certainly data from mice and other “lab organisms” are used routinely to predict both the efficacy and toxicity (e.g., side effects) of potential therapeutic compounds (and dosages) for humans. On the other hand, all such data is not identically predictive for all purposes and certain predictions based on tests from lab rats are going to be far less reliable than others. Among other factors, the accuracy of the predictability will depends on the size and variation in the tested population and the controls, as well as on the quality/extent of any observed changes.

                Even microbes or plants could be considered test organisms for making predictions about the effect of a compound on a human (e.g., toxicity/mutagenicity).

                1. Ned you are (still) being a nominalist and exhibiting your bias against the statutory category of Process.

                  Utility applies at the time of filing for ALL of the statutory categories.

          1. “Look that the reason the Palestinian controversy has so long festered.”

            Didn’t they get they arses conquered upon? In a war they themselves started? I mean, “taking” people’s property is one thing, but conquering and redistributing is another.

            Also, ISDS doesn’t really address that situation does it? I mean, in ISDS we’re talking about governments legitimately governing the people. Yes, there will be costs, but thems the risks.

  6. “Eli Lilly seems to assume both that an issued patent is a state representation that it will remain forever valid and also that a nation can not modify its laws without violating legitimate expectations. The supposed violation of its legitimate expectations figures prominently in a claim for denial of the amorphous condition of “fair and equitable treatment.”

    Problematically, although a patent lawyer would readily reject the idea that patents are always valid and untouchable by subsequent law, they will not be deciding Eli Lilly’s case. Notably, when I presented a forthcoming article about this case to an international law colloquium, I was surprised that the audience resisted the basic principle that patent rights can and should be invalidated when found not to satisfy fundamental requirements.”

    In the US, patents are property. As such, their validity is judged under the statutes as they exist at the time of grant.

    Case law is a bit different. Case law is an interpretation of the law as its exists, and unless the statutes have changed, there should be no violation of fundamental rights.

    I don’t know where this promise doctrine came from, but if its origin is not in a change in statutory law, the I would think that Lilly is barking up the wrong tree.

    But this is the US, and Canada is Canada. If the courts operate differently there so that they can impose new legal requirements, then Lilly might have a case.

    1. The Eli Lilly NAFTA complaint relies on a claimed change in the interpretation of judicial precedent stretching back 200 years to English patent. Most observers do not believe there has been a change — me included — but at most the law on utility is part of the natural evolution of patent law. One may not like where that evolution has taken Canada — many in the brand name industry do not — but that is different from saying that it has no basis in law.
      The fact is, there are only 3 pharmaceutical patents invalidated in Canada since 2005 (the year that Lilly claims the change occurred at the court of appeal despite not being able to point to a single case that year) solely on the basis of the supposed ‘promise of the patent’ doctrine (which is actually a conflation of three patent law rules), 2 of which were held by Eli Lilly. Given that Lilly has lost 2 of the 3 cases, one may wish to examine Lilly’s patenting practices in Canada more than the caselaw. In fact, Lilly filed patents on just three known drugs claiming an amazing 96 different diseases they treated. It supplied (and the literature does not suggest) no factual basis for these claims. Lilly was filing speculative patents and is now complaining that it was caught.

        1. No, the courts did not overrule a prior case. Some claim that they stretched existing cases or did not do a good job summarizing prior cases and thus following the underlying rule. In my view, this is incorrect as this line of cases stretches back 60 years in Canada and beyond that in the UK. In addition, Australia, New Zealand and Israel — other common law jurisdictions — follow the same rule.

      1. Let me see.

        Lilly files on compound X, predicting utility Y based on Z tests that support the prediction. Years after the grant, Lilly proves utility Y. Generic, wanting to sell compound X for Y, challenges. Lilly’s patent is held invalid because at the time of prediction, it had not yet proven utility Y.

        Now if the prediction was of A-N utilities, does the patent get invalidated if any one of them does not prove out?

        Something seems wrong here.

        I do see the point about unsupported wild guesses though.

        1. Ned,

          You have hit upon a small slice of a tangent that has always bugged me about pharma patents. In all arts possession is a requirement at the time of filing. If I were to look then at the (rather high) rate of pharmaceuticals that fail to possess their desired utility – as shown in the FDA process, one has to wonder just how many patents for tho art actually have the possessed utility at the time of filing.

          Now I get that Congress may want to make an exception, given the health benefits, but would it not be better if that exception was straight up as to not having utility (but still a solid development plan perhaps), instead of the wink-wink sure you “have” utility, but let’s give you X number of years extra so that you can “show” that you did (wink-wink) have that when you (ahem, too early) filed.

          btw, I have a fine gift of a white horse whom I have lovingly named “GrownUp-Arts” that tends to gallop about in this particular (art) field…

          1. Anon, the invention claimed is not utility Y, but compound X.

            If it proves out that compound X does have the utility predicted, the compound does have utility. It not only has utility now, it had utility then. It was predicted then. Where is the problem?

            1. “It was predicted then. ”

              ^I think that’s where anon’s problem arises. And I can see what he’s talking about. If you’re just predicting, you don’t really possess. Buuuuut, I see what you’re saying Ned, which is what the establishment says, that the invention is the compound, which was possessed. And I can agree with the later. Though I whole heartedly agree with anon if he’d like to change the law to where you need to know, with reasonable certainty, at least one substantial utility for your invention before you file.

              1. 6,

                Are you saying that the “thing” claimed does not have to have a known utility possessed at the time of filing?

                Really?

                That to have what I indicate would require a change in law?

                Really?

                Let me know if that’s what you understand of this utility thingie…

                1. (and maybe you missed the part about how bad those “predictions” have been)

                  Or does the “non-changed” law allow patents for things (just because they are things) that fall into a gee-maybe it might get lucky with this one…?

                  I have another white horse as a gift to go with the first. I’ve named it Lottery.

                2. I’m not going to sit and argue with ya bro. Da law is how it is today. If you’d like to change it then more power to you. Gl fighting multinational drug companies.

                3. I’m not asking you to “sit and argue,” “bro,” – but I am asking you to clarify what you think IS the current law as pertaining to actually possessing utility at the time of filing as opposed to an unripe “hey, I got a bunch of stuff here that I don’t know at the moment whether it works, but I want exclusivity now anyway.”

                  Da law is how it is today” is NOT being argued – but what that means – by you – IS being sought to be clarified.

                  Do you think that actually possessing the utility at the time of filing is required?

                  (and you should recognize that what I am saying is NOT a change in the law)

              2. Know? Why know? Why not predict based on evidence?

                The patent is invalid if it does not have utility. Utility is not a possession thing. It is not a prior art thing. It exists or it does not exist.

                1. It very much IS a possession thing as you are not permitted to file on speculation or mere “study plans.”

                  This is black letter stuff Ned. Don’t you hear the whinny of my gift horses?

        2. Actually, Lilly files on previously patented compound X (either as a selection from an existing genus or a second use on a known compound) claiming that what makes it patentable over the prior art is utility Y for which it did Z tests. The courts hold that Z tests do not support the prediction and that the PHOSITA would not have found the utility to be reasonably supported by the patent application. Years later, it turns out that compound X had utility Y.
          Of course, the patent holder also filed patents claiming utility A, B, C, D…. etc. on compound X. It only continued with the patent on utility Y because it turned out, years later, that that utility could be supported. This is rank speculation. The law of averages is that you will turn out to be correct once in a while. That is not grounds for getting a patent in Canada nor in any other jurisdiction of which I am aware (although, as stated in the article, the reason for invalidating the patent may differ by jurisdiction).

          1. Richard, if the compound X was known, but Y utility is new, then the patent is not on X, but on X for Y.

            Here, I would agree that in order to patent this utility, one should have at least one example that X is useful for Y.

            However, as I understand it, one cannot even test drugs on humans until one proves them effective on animals. The question then becomes do animal test support a prediction about humans?

            1. Under Canadian patent law, the patent is on X when it is a selection patent. Thus, for example, in the example of clopidogrel (the dextro-rotatory isomer of the racemate disclosed in the genus patent), the claim is on the compound. To be patentable, clopidogrel had to have superior qualities over the compounds in the genus. The patent promised increased efficacy and lower toxicity. The question before the courts was whether the POSITA would look for this increased efficacy and lower toxicity in animals or humans. The court ruled animals.
              No clinical trials are needed. What is required is a sound line of reasoning and some factual basis to support it.

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