John: So, this is Part 2 of our series on Second Medical Use Patents and this one is primarily devoted to validity. As many of you know continuing innovation leads to new uses for non-compounds and this can be very beneficial because new uses can be found for compounds that are not used, even in addition to not used, there's an new, even better use for some of these compounds. But because it's a second medical use there are certain validity challenges that crop up. As you can imagine the first one is there's a lot more prior art. If there's already been research on the compound and it's shown to be effective in ..., that prior art can be cited in subsequent challenges to the patent for second medical use. The other thing is there's this philosophical debate. Once a drug has been patented once should it be patented a second time for a different use? That's a philosophical debate but quite often it infuses the litigation. So today our panelists will talk about some of the validity concerns around second medical use patents.
Just a couple of housekeeping matters. Today's session will be recorded and if you look on the bottom of your screen there's a Q&A button. Feel free to use the Q&A button and we'll answer questions at the end.
So to get started, my name is John Norman and I'll be your moderator today. I'm a partner and head of the Life Sciences Group in our Canada division and our Canada division includes Moscow, which Vlad is a part of. It's kind of a strange definition for Canada but that's where we are. I'm a patent litigator in Ottawa. Our first panelist, Paul Inman, he's a partner in our London office and he does patent litigation as well. Our next panelist, Alex Gloor. He is a patent litigator and he is based in our Ottawa office. Our next panelist, Vlad Ugryumov. He's a partner in our Russia office. Vlad does patent litigation as well as patent prosecution. Last, but not least, Jian Xu, who's a legal director in our Beijing office. He is a qualified lawyer as well as a patent and trademark agent. So what we'll do today is I'll pose a series of questions to our panelists and they will give their answers to those questions for their own jurisdiction. At the end of each question, or close to the end of each question, we'll put up a slide that summarizes the different ideas or requirements in the various jurisdictions. Please have a look at that as well and I'll just quickly recap that. So that's kind of how we're going to set it up today.
So, without further ado, our first question. What validity challenges to second medical use patents exist in your jurisdiction? Jian, let's start off with China.
Jian: Yeah, sure. Thanks, John. There are mainly two types of challenges for second medical use patents in China. The first type is novelty and inventiveness. The second type is the sufficiency of support. When it comes to novelty or inventiveness a ... may be controversial issue in China is whether or not medication features, such as the dosage or the dosage regiment or even the patient group for the medicine and the like, can they be considered to be used as a distinguishing feature to argue novelty or inventiveness of the patent. So, ... that China is more cautious and restrictive to allow medication features such as dosage or dosage regiment to act as a distinguishing feature which I will explain later in more detail. The way it comes to a second type, sufficiency of support, as some of the audience may know China has historically been one of the most strict telling countries regarding data. Basically, if you only describe the technical fact without ... experimental data then you are in trouble of sufficiency. To make it even worse, China has also been known to be very strict with post-filing data. A few years ago it was almost impossible to overcome sufficiency problem by providing post-filing data, data that was filed after the filing date of the patent. However, the good news is that China is becoming more and more relaxed with sufficiency and the post-filing data in the last 3 years and I will explain what has happened, again, later on. So, John.
John: Thanks, Jian, that was very interesting and as the panel will probably discuss throughout this seminar, the four letter word for this seminar, is data. With that, Paul, let me turn it over to you and you can tell us about the UK.
Paul: Sure. So, second medical use patents similar to any patent in the UK and, indeed, Europe subject to the statute in the UK, section 72. The Patents Act in Europe, article 100 of the European Patent Convention. Patents can be revoked in the event they're not patentable which incorporates novelty, inventive step, industrial applicability and some statutory exemptions including methods of treatment of humans, which of course is why our second medical use claims are drafted as they are in Swiss form or in the more recent EPC 2000 form. So, effectively novelty and inventive step, or insufficiency, and in the case of second medical use patents the principle challenge is, certainly in the UK, come in the form of either lack of inventive step or obviousness or insufficiency. Often these attacks are pleaded as a squeeze argument. The argument going either the patent does not provide information or data to demonstrate the new medical use works, so it's insufficient, or if there is enough data and, particularly in the case where clinical trials have been published or considered, that may well have been known to the skilled person so the new use is obvious. In recent years this sort of squeeze mentality in relation to second medical use patents is really crystallized around this new concept of plausibility and I'll address that further when we get to it.
John: Thanks, Paul. That's really interesting. Vlad, how about Russia?
Vlad: Thank you, John. In principle second medical use claims can be, and are challenged, on the basis of all patentability requirements including novelty, inventive step and industrial applicability. Industrial applicability in Russia covers, to some extent, sufficiency and so I'll speak about this in a minute. In principle those patents can be challenged on the edit matter basis too provided that the elements of the granted claims are not accurately supported by their original specification. However, like inventiveness, and sometimes novelty, are the main threads for validity of the second medical use of patents in Russia.
John: Thanks, Vlad. Alex, how about Canada?
Alex: Thanks, John. Canada's Patent Act has no specific mention of second medical use patents. So there's no specific ground of invalidity that is particularly second medical use patents. But like in Russia and the UK, at the end of the day you do see all of the typical grounds of invalidity in these case. Novelty, obviousness, insufficiency, utility and method of medical treatment really being the principle ones, and more recently overbreadth as well. But like Paul alluded to in the UK, a common theme in these cases is attention on the squeeze between what was disclosed and known of the art and thus relevant for obviousness and anticipation versus the grounds of utility or overbreadth where that same knowledge is sometimes used as part of the basis on which the claim invention is supported. That squeeze is often especially apparent in second medical use cases because the work required to put an invention into practice, to recognize that a proposed use is actually an effective use is often, especially in recent years, a clinical trial that is by necessity disclosed to the public on a clinical trial registry. So navigating these issues is one point that I will talk about in our future questions this morning. Back to you, John.
John: Thanks, Alex. It was clear to me listening to the various summaries of the jurisdictions there's probably three main challenges for second medical use patents. It's novelty, inventiveness and sufficiency. So even though certain countries will have different peculiarities of challenges those seem to be the three throughout the world. The other thing that's interesting is the squeeze as Alex and Paul referred to. It's essentially the idea that arguments in respect of inventiveness can help you support your inventiveness of a patent but they may undermine your sufficiency arguments. So it's an interesting squeeze where you have to tailor your argument such that your fully defending inventiveness but you're not inflicting a self-inflicted wound on sufficiency, for example. This slide just overviews some of the points that the panelists talked about.
Let's go to question two. So what approaches to novelty and inventiveness challenges to second medical use patents exist in your jurisdiction? To start off with, Vlad, why don't you tell us about novelty and inventiveness challenges in Russia.
Vlad: Thanks, John. So the formal approach for novelty and inventiveness over second medical use claims is the same as for all types of claims. The invention should not be anticipated by the prior art and the invention should not be obvious for a person's skill and art. Until recently the approach of the Patent Office was quite propensity and second medical use claims were granted in the regular course of events. However, most recently we have been observing the campaigns going forward with the innovators, have been accused of evergreening the innovations by obtaining a series of secondary patents to artificial extent monopoly for their drugs. Those campaigns had a certain effect on the approach of the Patent Office towards secondary inventions including second medical use claims. In other words, it's getting more and more difficult to get patents for second medical use claims and to defend the granted ones before the Russian Revocation Tribunal. In order to challenge novelty of the second medical use patent a single prior art must teach the technical solution that has all the features recited in an independent claim of the challenged patent. The feature directed towards a new purpose is assessed equally along with the other features of the invention, and if the prior art does not teach the possibility of this product to be used for this very purpose, then the invention is deemed valid. So the hot topic that we currently see, that is used mainly to anticipate the invention, is whether the clinical protocol where the intention is shown that can be covered for the second medical use patent, and provided that those protocol other prior art, whether they can anticipate the invention. Until recently it was not possible as the intention could not qualify for a technical solution to kill novelty of the patent, however, this approach can change soon or maybe not soon. So when the clinical protocols for the future trials can be used as a novelty destroying prior art. However, the most serious threat for validity of a second medical use patent would be like an inventive step. For example, if an invention is directed to treatment of the new disease with an old compound but it can be proven that the compounds underlying mechanism of action for both diseases are similar. For example, the receptive types of which the compound is interacted is similar then the invention could be recognized as not involving an inventive step and the patent can be rejected. It is even more difficult to prove inventive step of the dosage regime patents but we can speak about it a bit later, if we have time for this. Thanks, John.
John: Thanks, Vlad. So the concept of evergreening, again, it comes up to that philosophical debate. Whether you should be entitled to two patents for the same drug. Alex, how about Canada?
Alex: Yes. It's interesting listening to Vlad. What I'm about to speak to and the Canadian jurisprudence recently seems to have some real parallels to what's happening in Russia. Anyway, the basic novelty and obviousness questions are well understood in Canada and apply to all different types of claims. There are two hot topics, I guess, that have frequently arisen recently in the context of medical use claims that I'll really focus on in response to this question. So the first issue, it's a construction type issue that greatly impacts what must be disclosed in the prior art to render a claim anticipated or obviousness. The second issue that I'll get to is the impact the public conducting of a clinical trial or the public disclosure of a clinical trial protocol, the impacts of that on anticipation and obviousness. So to start the basic novelty question is whether the claim subject matter was disclosed and enabled by a single public disclosure prior to the relevant date. While the obviousness question in Canada is framed as whether the claim subject matter would have been obvious to the skilled person, as of the relevant date based on the prior art as a whole, and the skilled person's knowledge. It's typically assessed by the four part test adopted by Canada's Supreme Court in the Sanofi decision which draws on the Windsurfing and Pozzoli approach by the UK. Now, both anticipation and obviousness are framed around a so called subject matter of the patent claims. The first issue that I'm going to talk about revolves around that. We've seen some Judges take an interest in view as to what that subject matter actually is when we're talking medical use claims. I think this is best understood if I start with a very simple hypothetical. If you have a simple second medical use claim to say the use of the compound AZT to treat the disease HIV. The question becomes, that the courts have been grappling with is, is the subject matter of that claim simply the idea of using AZT to treat HIV or does it include the knowledge that the application of this treatment imparts the desired result? That it actually treats the disease. The implication being, if it's the first articulation, then the idea of using AZT to treat HIV, the disclosure of that in the prior art, the disclosure of the idea to try to use AZT to treat HIV regardless of any attached expectation of success may anticipate or render the patent claim obvious. By contrast, if the claim subject matter includes the knowledge that the administration of the drug actually results in the treatment, then the prior art must teach this effect to anticipate or at least has to teach that the claim treatment is likely to be a success in order to render the patent as being obvious. So the traditional view in Canada, and it's still the correct view in my mind, comes from a 1982 Supreme Court decision, Shell Oil versus the Commissioner of Patents, which held that a new use for a known compound is only patentable subject matter in the first place because it conveys commercially valuable knowledge that the compound imparts a particular result. In other words you have no invention if no statutory subject matter, under Canada's Patent Act, from just a disembodied idea. You only have an invention after you show that the idea of one practice provides that result. But this is in stark contrast, in my view, the 2020 decision from last year, the Court of Appeal decision of Hospira and Kennedy Trust where the result of the treatment was not said to be relevant consideration for novelty or obviousness because in the court's view it was not part of the claim subject matter. So there's been commentary this. One of Canada's leading patent academics, Norman Siebrasse, criticized that Court of Appeal decision for potentially introducing an era of what he calls anticipation by speculation. For now, until it is revisited by Appellate Courts and maybe the Supreme Court, there is some uncertainty as to how exactly courts will treat this subject matter of a use claim.
So my second issue, which I'll hit a bit more briefly, is the impact of a patentee's own clinical trial being conducted in pubic before the patent's filing date. Of course there's a requirement for most modern clinical trials to be conducted in the public eye. Most notably the protocols are to published on public trial registry. Until the company has a positive result and may not have reduced it's invention to practice and it may be premature to file its patent application. So what we see in litigation these days is generic companies attempting to seize on this by creating the squeeze that we talked about in the introduction. If the patent owner waits to file its application until results are available we frequently see allegations of anticipation and obviousness by virtue of the public nature of the trial. By contrast, if the applications filed earlier, parties challenging often take the view that the claims are speculative and they're utility over breadth concerns. Which is the next question we'll discuss. So what Canadian courts have done is they apply what's known as the experimental use exemption to anticipation. It's a common law doctrine. It basically holds that a prior use will not be considered anticipatory if it was done for experimental purposes and if any disclosure is made in the course of conducting those experiments were necessary. It has broader applications than just medical use claims but it squarely applies in the context of second medical use claims. The only caution though is unnecessary disclosures by a patent owner of an ongoing clinical trial that relates solely to commercial purposes will not fall within that exemption. So far that exemption has only been applied in the context of novelty but I do think that a logical next step is to see this experimental use exemption also considered for the purpose of obviousness. So the bottom line is that for a patent owner there's a strong argument that disclosures made in the ordinary course of conducting research, via a clinical trial, do not impact patentability, at the very least anticipation, but making unnecessary associated disclosures for purely commercial purposes may put the validity of the future patent at risk. John?
John: Thanks, Alex. So I guess, really, one of the take home points is the facts of the case really do matter, right? Because it can be germane.
Alex: They certainly do. As always.
John: Yup. Alright, Paul, how about the UK?
Paul: Sure. I think a number of similar principles applies as Alex has just gone over in relation to Canada. Going back again, starting with the statute, novelty, section 2 of the UK's Patents Act, article 54 of the European Patent Convention, an invention shall be new if it does not form part of this state of the art. So how do we interpret that? Will in the UK there's a lot of case law on this. The Supreme Court, in the case of Synthon, said in relation to anticipation there are two requirements for a claim to be anticipated by a prior document. Firstly, disclosure but also enablement of the invention that is thought to be anticipated. There are many quotes from case law across the decades. One that comes up again and again is from General Tire in 1972, which is still pertinent, to anticipate to the patentee's claim a prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented. The went on to say a signpost, however clear upon the road to the patentee's invention will not suffice. So it's a strict test. You've got to really put down in the prior document precisely what's in the claim. Thinking about second medical use claims, in particular, the wording which is use of X for, or for use in, the treatment of disease Y, the words 'for, or for use in' had very much served to render second medical use claims as purpose directed claims. It's this purpose which of course confers novelty of the claim over the known existence of the actual product itself. So it's that purpose that is the important novelty conferring aspect. In the EPO the position is that the actual achievement of the therapeutic effect is a functional technical feature of the claim as opposed to a mere statement of purpose or intention. This is similar to the UK position where the claim is construed as requiring a therapeutic effect. So in order to decry the second medical use claim of novelty the prior art must not only show the idea of the new medical use but the prior art must also show that it is effective in such indication. For example, in the Court of Appeal in a recent Regeneron case, there was no finding of lack of novelty of the second medical use claim because, as the Court said, the prior art does not teach that the antibodies in that case have the therapeutic effect claimed in the patent nor does the prior art give clear and unmistakable directions to perform the claimed invention. So there's this dual requirement for anticipation of both the idea but also the effectiveness. In terms of inventive step, in the UK, the court follows the Windsurfing or Pozzoli test that Alex mentioned which is to identify the inventive concept. Identify the common general knowledge. Work out the differences between the prior art and the invention and then the question comes back to are those differences obvious? Always a question of fact in each case based on expert evidence but in pharmaceutical cases, second medical use cases, where it's very much an empirical art as to whether products work in particular situations. What it often comes down to is whether something was obvious to try from the prior art but with a reasonable prospect of success. In the recent case of Actavis and I-Cost the court pointed out that in many cases the consideration there is a likelihood of success which is, or has been, sufficient to warrant an actual trial is an important pointer to obviousness. So what they're saying there is if someone thought it worth putting this stuff into a clinical trial it may well have been obvious. This is where the squeeze problem arises with second medical use claims. Do you wait until you've got trial data to ensure that your specification is sufficient? In which case Actavis suggests that there was a likelihood of success so points to obviousness. Or do you file your patent before you've got clinical data to protect against obvious but risk falling foul of this clausability issue, which I mentioned earlier. But I'll turn to clausability when we get to insufficiency a bit later.
John: Thanks, Paul. It really seems a little unfair doesn't it? They've got you either way.
Paul: Yup.
John: Oh well. I guess it makes for an interesting time in court. Jian, how about China?
Jian: Well, yes, let's move on. So as I mentioned earlier, art and when it comes to what's our copy about novelty in this is about where the medical features, such as dosage or dosage regiment, can be used as a distinguishing feature of novelty or inventiveness. So some background for the audience who has not attended our first webinar, in China, currently we only allow Swiss type claims for second medical use which is use of compound X for the manufacture of a medicament for the treatment of the disease Y. So here what's the key word? ... for the manufacturer of a medicament. So basically China has adopted the principle is that whether facts medicament features can affect the manufacture process of a drug. If they can they can be used as a distinguishing feature. But as we can imagine it's quite hard under that dosage or dosage regiment can affect the manufacture process of a drug. So here the case law which I will share briefly. A US pharma company who owns a patent about using an antibody for treating breast cancer. So the claim one, in Swiss type, is said use of a particular antibody for the manufacture of a medicament for the treatment of breast cancer. So the only difference between the claim one and the prior art is the dosage and the dosage regiment of antibody. So it was outlined in ... a company in South Korea filed an addition of US company's patent. Basically the end, over 5 years, this case had ... all the way from Patent Office to the China Supreme Court. In the end the China Supreme Court has declared patent invalid. So the ... is the court thinks the dosage and the dosage regiment they consent only the selection of treatment by doctors and they are not involved in the manufacture process of the drug. So fact features will not relate to, or have any restriction, on the drugs manufacture, per se. So these features will be not used as a distinguishing feature from prior art. So to summarize, in China currently, if the second medical use patent is different from prior art only in dosage or dosage regiment and the like it can have a hard time to argue novelty or inventiveness. John.
John: Thanks, Jian. So just a quick summary here of what the various panelists talked about. Though the one thing that I've captured from this is that really the battle ground is obviousness. Novelty can be a problem. Sufficiency can be a problem but really many of these cases come down to obviousness so that's where a lot of the fighting goes on in trials. The other thing is that every jurisdiction has its own peculiarities and so really you kind have to look at each jurisdiction and see what's important and what's not. For example, in Canada, critical trial protocols have now developed a new light. It sounds like in the UK there's some interest in what clinical trial protocols disclose. Even then if there's some disclosure via a clinical trial protocol then ... the defense such as experimental use and that sort of thing. Ultimately it's jurisdiction specific but it seems like obviousness is the battle ground.
Okay, let's go to the third question. So our third question is, what is required for sufficiency of a second medical use patent? Paul, can you start us off with this in the UK and the EU?
Paul: Yeah, sure. Sufficiency is probably the area, in the UK, where there is the most debate at the moment and an awful lot of case law, not all of which hangs together. It is a bit of a mess at the moment but we'll see where we can get to. Again, both in the UK and the EPC European Patent Convention, the requirement is the same. That the specification must disclose the invention clearly enough and completely enough for it to be performed by the skilled person. That as a sentence is fairly easy to understand. Effectively the skilled person must be given enough information in the specification to perform the invention. Over the last 15, 20 years this has developed into probably three types of insufficiency. There's classical insufficiency which is, as I've just said, but there's also now biogen insufficiency, or excessive claim breadth and also ambiguity or uncertainty insufficiency. But these all fall into the basic statutory structure. So excessive claim breadth is when the patent doesn't inform the skilled person how to make everything that's in it, or everything that's claimed, and uncertainty is where the claim is unclear in certain ways so the skilled person doesn't know if he's made what's in the claim or not. But historically that was insufficiency. In a nutshell, the patent doesn't include enough information for the skilled person to carry it out. But in 2006 the Boards of Appeal in the EPO came up with this new concept of appealability. That was a case in relation to Johns Hopkins patent for a class of polypeptides and the Board of Appeal said that in that case there was not enough evidence in the application to make it at least plausible that all of those polypeptides worked in the indication. That was the beginning of a snowball really. Since then, despite plausibility not being mentioned in any patent statute, this concept of plausibility has really pervaded many aspects in patent law. It tends to arise mainly in relation to insufficiency and most often in relation to second medical use patents. But now the established law, in the UK and the EPO, is that the patent must contain enough information to show that it is at least plausible that the claimed product, and if it's a wide class, that substantially all of those products work in the claimed indication. As I say, it's quite a significant change over the last 10 or 15 years. There's a famous quote from Mr. Justice Pumfrey in 2004 where he said, has to be remembered a perfectly valid patent may be written by a person who does not stir from his armchair and does no experiments to confirm his hunch. These days we have to show plausibility and the question that arises is, what is the test for plausibility? Or what level of proof satisfies the plausibility test? As I say, in the last 4 or 5 years, this has really been thrown into some doubt. Not least because two cases that have gone to the Supreme Court on this have ended up in front of panels with no specialist patent Judge. So, it's difficult. I think the best place that there is at the moment is from the Court of Appeal in the Warner-Lambert case, which was about pregabalin, where Lord Justice Floyd reviewed all of the UK and EPO law on plausibility. He said that both EPO and domestic cases do indicate that the requirement in plausibility is a low threshold test. He went on to find, in his view, it was a very low threshold saying that a predication based even on the slimmest evidence would satisfy the plausibility test. That seemed right to most patent practitioners. You simply have to show that there is some evidence to show that these things will work in this indication thereafter. I think Jian talked about post-published data. You can then rely on post-published data to support that. But you need that plausibility in the specification. The problem was when Warner-Lambert went to the Supreme Court. Lord Sumption, who's not a patents Judge, gave the leading judgment. He rejected this idea that this was a low threshold test. He said the principle is that the specification must disclose some reason for supposing that the implied assertion of efficacy in the claim is true. He then went on and talked about this plausibility principle being what he called mitigation of the principle in favour of patentability. So in fact he was saying as part of the patent bargain for being awarded a patent, the patentee must do more than just provide the slimmest evidence. But I'm not sure where he gets that from because this plausibility principle is not in the statute. Secondly, he's not that familiar with patent jurisprudence but anyway, that's what he said. He went on and laid down several principles. He said while the test is relatively undemanding it cannot be reduced to little more than the test of good faith. He said it's not made plausible by a bare assertion and he said that the specification requires some disclosure of how the product is expected to work. In that respect he suggested that this should be based on a direct effect on a metabolic mechanism specifically involved in the disease. So we've gone from sitting in an armchair saying this will probably work in this disease to having, really, a fairly hefty task of putting in data relating to metabolic mechanisms involved in the disease. He did go on and say you don't necessarily need data. You could rely on a prior reasoning from known properties of the product. But, of course, this then runs into the problem of the squeeze against an obviousness argument. This was plain from a recent case in Lilly and Genetic where patent claim second medical uses of a product both in rheumatoid arthritis and in psoriasis, two diseases in which many products are effective in both. The patent contained invitro data in rheumatoid arthritis but not on psoriasis. The result in that case was that the rheumatoid arthritis claims are held to be obvious and the psoriasis claims were held to be insufficient because they hadn't rendered the effect plausible in the specifications. So there is a problem here. Most recently the UK Court of Appeal have been trying to sidestep Lord Sumption's judgment, or reasoning, in Warner-Lambert, and it was in fact obiter, but it is the Supreme Court giving their opinion on what constitutes plausibility of the effect in the second medical use claim. Really it remains uncertain and I think we need, quickly, another Supreme Court judgment on this to straighten it out. But in summary I suppose for patentee it's really a balancing act. Do you wait for data to protect against obviousness and include that in the specification or do you file without data, in which case the effect may not be deemed plausible? What you do include, ideally, that should now be data on a metabolic mechanism specifically involved in the disease where there's more than one indication, explain the role in each pathology, and experimental evidence is going to be best either the presence in diseased tissue, invitro or roll in animal models, to avoid putting in clinical data. Bottom line though, John, is it's difficult at the moment and we really need more authority on it.
John: Fascinating what's happened in the UK. I'm sure you've heard the theory that many judges that take hold scotch important to a new bottle. Well it sounds like in the UK they've thrown the bottle and the scotch and come up with a new thing altogether. So fascinating. Thanks so much for that. Alright. Jian, how about China?
Jian: Yes. So its interesting how the thing work and interpreted differently and in China basically also adopts plausibility but China almost ... with ... from what it's seeing. So in practice basically you have to provide some efficacy data to meet the basic requirement. If you only describe the fact or the matter of the claim data without giving data then you are in trouble with sufficiency, in China, historically. The other topics I mentioned about post-filing data, so also China is very strict on post-filing data. Before 2017 it's almost impossible to overcome sufficiency by providing data after filing but this has been a bit relaxed in the last 3 years. So that being said, I think the good news that for the patentee is that we can expect China will become more flexible with experimental data and the post-finding data, sufficiency, from this year. So why? This is partly actually due to the US China Trade War. So as people must remember, before COVID, the hot news in the media is about US China Trade War and US and China have conducted a series of negotiations. Finally, we signed an agreement just before COVID, in January 2020. So in the agreement there's ... about pharma patents and China has made a commitment with, I quote here, China has committed to permit pharmaceutical patents to rely on supplemental data to satisfy relevant requirements for patentability, including sufficiency of disclosure and ... during all proceedings, including patent filing proceedings, patent review proceedings and court proceedings. So this commitment from China has also been confirmed in the latest amendment of China's Patent Examination Title Line, issued last month. So overall I think the method is that China has historically been very strict with sufficiency data and the post-filing data but we can expect China to be more flexible from this year on sufficiency requirements. John.
John: Thank, Jian. Vlad, how about Russia?
Vlad: Thanks, John. So sufficiency has become a separate requirement for patentability quite recently. Historically, it was always there, but historically it was mainly a part of industrial applicability. In principle, sufficiency has never been a big issue for second medical use patents and they're rarely rejected or fall on this ground. The requirement for sufficiency has been quite lenient so far, although invitro data is usually not enough to support sufficiency, but even the specification has data on adequate animal models. In living models, not speaking about some basic clinical trials, then this information would be enough to support sufficiency of disclosure. Remarkably, in contrast to China, the Russian Patent Office has been historically quite generous, so far, in accepting post-filing data that can be filed at any time during prosecution of the application either in response to the office action or at the initiative of the applicant. However, it has been much more difficult to submit post-filing data in the course of ... proceedings. According to the Tribunal approach the applicant had enough chance to do this while his application was pending and it's too late to do this when the patent is being challenged. Another part of sufficiency relates to technical effect of the invention being a part of the test for inventive step. While until recently it was sufficient just to identify the technical effect and there was no need to prove it by submitting experimental data. Currently achievement of the technical effect must be proven by the examples. While the Patent Office would accept post-filing data during prosecution of the application to prove that the technical effect is achieved it's not possible to introduce a new technical effect that is not supported and has not been disclosed in their original specification. In other words you can provide approved experimental data, and provide experimental data during prosecution of the application proving that the technical effect is achieved, and this technical achieved must have been disclosed in the original specification. But it's not possible to submit additional data proving achievement of the technical effect that was not originally disclosed in this step. Thanks, John.
John: Thanks, Vlad. Very interesting. Alex, will give you 3 or 4 minutes to wrap up on Canada on sufficiency.
Alex: Thanks. The two primary requirements for a sufficient disclosure in Canada are that the patent specification describe the invention as contemplated by the inventor. Secondly, that the patent teach the skilled person how to put the invention into practice or enable the invention. But like in Russia, Canadian courts have not really used sufficiency as a ground of invalidating second medical use patents, by and large, although there was one notable exception in respect of the ... which really in my view was invalidated on some exception and fairly unique facts. What we do have in Canada is we do have quite a strong parallel between the UK plausibility requirement and the way that Canadian courts view the question of utility and utility is more frequently this battle ground in Canadian litigation, especially in the context of use patent. So that's what I'll talk about here briefly. In Canada for a long time, up until 2017 much of the discourse in Canadian patent law focused on something called the promise doctrine, the promise utility. This is a doctrine that required that any statement of a specific result, made anywhere in a patent specification, needed to have been demonstrated or soundly predicted as of the patent's filing date by the inventor, and if not, the consequence of making one such unsupported statement of the specification was that the entire patent was declared invalid. This was applied numerous times in Canada to invalidate what were otherwise valid patents. Now the Supreme Court did address the promise doctrine in 2017. In its place the Supreme Court put into a test which requires that utility be assessed claim by claim, and that the patent claim in question be possessed of at least a scintilla of some practical utility, based on a demonstration or a sound prediction on the part of the inventor. In terms of the date the relevant date for that consideration is the filing date. So typically in Canada only pre-filing data can be utilized in the analysis. In short, utility is now a low bar in Canada. More in line with the UK Court of Appeal Warner-Lambert plausibility judgment rather than the UK Supreme Court decision. But, there is the filing date restriction. Post-filing data only comes into question if the party challenging the patent questions utility, in fact, which is a more aware challenge given that typically the party challenging the patent wants to come to market with a product similar to what's claimed. In terms of the issue of what disclosure is necessary, Canada does not require disclosure of any data in the patent itself to meet the utility requirement, unless the utility is established not by demonstration but by prediction. In which case there are some decisions holding that there's a requirement to disclose the factual basis and the line of reason that form the basis of that prediction. But the general rule is very clear. The disclosure requirement for sufficiency is separate than the utility requirement. So where a patentee faces a utility challenge they can go to data from beyond the patent specification to defend themselves. Very briefly I will say that to some extent this issue has migrated to the doctrine of overbreadth in the last couple of years. There have been a couple of decision invalidating claims where a utility was not demonstrated across the full scope of the claim, as of the patent's filing date. Overbreadth doesn't have all the awards of the old promise doctrine as it's a claim centric inquiry rather than focusing on the entire patent specification. So if you've got a sufficiently narrow claim specific to an indicated treatment, as a patent owner you should be okay, and I'll also say that thus far those overbreadth decisions have been confined to the trial level. There is a case coming up in the Court of Appeal that should address this and it will be interesting to see what happens. So there we are, John, and I think we are 5 minutes left so I'll turn it over to you.
John: Thanks, Alex. Interesting. So, really the take home message is that sufficiency and data requirements are jurisdiction specific. For the most part it seems like post-filing data is not allowed. It can be considered. For example, in China they've allowed it recently. In the UK, Paul you confused me a little bit because I thought really you could rely on post-filing data, but then I think the Supreme Court has walked that back. The answer there really is wait and see and we'll find out in the future. With that, if you have any questions feel free to use the Q&A button.
First question is, could you comment on how common is the litigation on second medical use patents in each of the countries, total number of percentage of total patent litigation in health care? It's a good question. I'm not sure we can come up with total number of cases and percentages but perhaps we can just sort of give a quick snapshot. Alex, what do you think the answer would be in Canada?
Alex: Yeah, so, in terms of if we're just looking at pharmaceutical patent litigation I would say second medical use patents may be comprised, I would say maybe 20%-ish of the litigation. There's also formulation patents, patents to chemical compounds, patents to filing more quick forms, and I would say the litigation was roughly split between those different areas.
John: Paul, how about the UK?
Paul: Yeah, I was thinking about this. In terms of health care, or pharma patent litigation, there has been an increase in second medical use litigation recently. Which may well be because the amount of molecules is running out and more research is being done on second medical use. Off the top of my head I'd say probably more than 20%. Maybe 40% of pharma cases incorporate some form of second medical use claim and I think it's only increasing at the moment.
John: Okay. Jian, how about China?
Jian: China, for infringement, very little case for second medical patents in China for infringement. For validity techniques there are quite a few so ... case law and I think there at least five famous case laws I have in mind. But for infringement, only one case law, highly published.
John: Vlad, how about Russia?
Vlad: So as we have ... for invalidity and for infringement so if we're speaking about only invalidity and we take away all other secondary patents, then I think its about maybe 20%. The same for the second medical use claims as we ... treatment claims. For infringement, so the less gets to their trial, so maybe I was thinking about 10 - 15%, maybe less cases that I've heard in infringement proceedings.
John: Okay, thanks. One quick question, it says currently the EPO, the UK, the CNIPO accept disclosure method of medical treatment as a basis for second medical use claims. Is there a potential for this to change if added matter is assessed more strictly? Quickly, we're almost out of time, Jian, yes or no? What do you think?
Jian: I think still quite hard. China is also very strict on adding to the matters but the change in sufficiency ... has become particularly lax so we can expect maybe some elements are based on facts without much data can be accepted in the future.
John: Paul, what do you think?
Paul: One can never tell which way either the jurisprudence or, indeed, the sort of statutes going to change. I think it's too difficult to tell. Sorry. Sitting on the fence there.
John: Maybe yes. Maybe no. Alright. Thanks, everyone. We're almost out of time. I'd like to thank the panelists for a fascinating discussion. Thank you for attending. We truly appreciate it. We'll try and make these slides available in an email afterwards just so you can see the summary points. Just a note of an upcoming webinar. It hasn't been advertised. It should be in the next 2 or 3 days. February 23, we're going to have a preliminary injunctions webinar based on Life Sciences and questions related thereto. So, if you're interested in that, stay tuned. Thanks, everyone. Good evening, good morning, good afternoon. Thanks for joining and take care.