Second medical use patent series: Understanding infringement and enforcement

John:               Alright. It looks like we're pretty stable there right now so I'll get started. There will be some people, I suspect, joining but I think we're pretty much leveling off right now. Good morning. Good afternoon. Good evening. Welcome everyone to our latest webinar in the Life Sciences series. Today we're going to talk about second medical use patents and this is part one of a two part series and this is focused on infringement and enforcement. As you can imagine this topic is a large topic. We decided to break it up into two sessions. So, everybody here probably understands that even after a medication has been discovered and a use is found, innovation still happens. Research still happens and companies still look for new uses for that medication. Patents try and recognize that you can have a new unknown use for previously known medication. Perhaps one of the most famous examples is thalidomide. Back in the 50's it was used for morning sickness during pregnancy and, unfortunately, it led to a lot of birth defects and side effects that were undesirable and led to the termination of that approval. But then research into the product continued and over the years they found that it was actually useful in multimeloma and in skin lesions and leprosy. Again, you can see how initially there was one indication that was patented and approved and then a second indication later on came about, and for a while that drug had a new life based upon the new use. But one of the challenges that new use for known medications creates is what happens if a generic decides to come to market claiming the old use, as an indication, but not the new use. Is that infringement? And it creates a lot of interesting discussion about whether that new use is still being used even though the second entrant is not actually indicative of that second use. So that's what our panel's going to be looking at today is how do you enforce the second medical use patents.

With that stage set, a couple of small little housekeeping matters. This session will be recorded and we'll make it available afterwards. If you want to go back and look at anything that we've said. We also have a Q&A button on the bottom. Feel free to use that. We'll answer questions at the end but that's how we'll deal with questions.

So, who are we? My name is John Norman. I'll be your moderator today. I head up the life sciences group in Canada and Russia. I'm a patent litigator and I work in Canada out of the Ottawa office. Our first panelist, Alex Gloor. Good partner of mine. We work closely together. He is a partner in our Ottawa office as well and he is a patent litigator. Our second panelist, Jenny Davies. Jenny is a legal director in London and she is a specialist in life sciences. Next we have Vlad Ugryumov. He is also a partner in our Moscow office. He is a specialist in patent litigation and patent prosecution. Last but not least, Dr. Jian Xu. He is in our Beijing office. Jian is qualified both as a lawyer and as a patent agent/patent attorney. So what's going to happen today is I'm going to pose a number of questions to the panelists and they will answer that question based upon how the law is set up in their jurisdiction.

Before we get there I thought it would be helpful just to set out some of the claim types that we'll be talking about today. I don't want to get too far into this but just to let everybody know what we're talking about and most people will probably be familiar with these claim types. But there are four claim types that we'll be talking about and different jurisdictions approach and deal with them differently. So the first one, EPC 2000. Most people will know this as the type or the style it is is substance X for use in a method for treating disease Y. The next claim type we will be discussing is the Swiss style claim and basically the form of this is the use of compound X in the manufacture of a medicament for the treatment of disease Y. As you will notice it's got the manufacturer component in there and that can be particularly important when the use itself has to be tied back to commercial activity. The third type that you will hear our panelists discuss is the German or the Bare Use. Very straightforward. Very simple. Use of compound X for the treatment of disease Y. The last type, which is a little more challenging in certain jurisdictions, is a Method of Treatment claim and this style is essentially method of treating disease Y in a patient comprising and administering to patient compound X. So with that sort of rough outline of claim types I'd now like to turn it over to our panelists and ask them some questions and have them answer them based upon their jurisdiction.

So the first question is, what claim style or claim type for second medical use patents is available and appropriate in your jurisdiction? Let's start off with Russia. Vlad, can you give us an answer to that question?

Vlad:                Thank you, John. In Russia almost all types of second medical use claims are allowed except for EPC 2000 claims that are the main second medical use claims in Europe and in some other jurisdictions. Those claims are not allowed in Russia because under the local practice a substance itself must be novel while the new use of an old substance can't impart novelty and inventiveness for such claim. Among three remaining claim formats that are allowed in Russia, German type claims are the strongest form the enforcement prospective while the Method of Treatment claims are the weakest and I'll speak about this in a minute.

John:               Thanks, Vlad. Jian, how about China?

Jian:                Compared with Russia, China is much less flexible for the style of claim types. China, as many people know, like many countries do not allow patents to be granted for Method of Treatment of disease or diagnosis. But China does allow the need to protect novel medical use of non-compounds which is medical use. In practice, China basically only adopts those three type claims that John had mentioned which is absence of ... claim types for Europe and which is about the use of compound X for the manufacture of a former compilation for treating disease Y. Just to give an example, suppose compound X is found to be effective to treat the Coronavirus, in China you cannot draft a claim like use of compound X for treating Coronavirus disease like with German types. Instead use is drafted in first form like use of compound X for the manufacture of a former compilation for the treatment of Coronavirus disease. So that's the style that's allowed in China.

John:               That's very interesting, Jian. Thanks very much. Jenny, how about the UK?

Jenny:             The UK is in some ways similar to China. Method of Treatment claims are not allowed in the European Patent Office. So, stealing Jian's example, the use of substance X for the treatment of Coronavirus would be regarded as Method of Treatment and excluded from patentability. So what is allowed in the European Patent Office? Historically the Patent Office allows patent applications for the second medical use in the Swiss form claim. That's use of substance X for the manufacture of a medicament for treating disease Y. That was the kind of accepted approach for some time. There was a rule change in the Patent Office on the 28^th of January, 2011. So prior to date, if you've got a filed patent application you're allowed to continue to obtain Swiss form claims from that application, as long as the priority date predates 28^th of January, 2011. After that date your only allowed, in Europe, to have claims in the EPC 2000 format. But because of the transition period we will continue to see Swiss form claims in patents until 2031 and what we're seeing coming through the course is patents with a combination of Swiss form and EPC 2000 claims. So people can hedge their bets. So the main claim today, as I just mentioned is EPC 2000 claims. Those are substance X for use in the treatment of disease Y, and those claims are treated in Europe in the same way as other claims. So you still have the kind of typical requirements having to show novelty and inventive step and we'll talk about that more in the next webinar. The last thing I'll just mention is that you can also have First Medical Use claims in Europe so you can have substance X for use of a medicament in the more kind of general sense.

John:               Interesting. So it sounds like you've got a system in which you'll have some claims being litigated before 2011 and then afterwards. That creates almost a dichotomy system.

Jenny:             That's right.

John:               Okay. Alex, how about Canada?

Alex:                Thanks, John. So, in Canada Swiss form, Bare Use, EPC 2000 claims are all permissible though, as we will discuss, there are some differences in terms of how these claim types are treated in litigation. Just to give a preview, the contrast with Russia and what Vlad was mentioning, in many ways the Bare Use claims or German claims in Canada can afford sometimes the weakest protection here for reasons that we'll get into. Method claims, per se, are permissible in Canada but there's a broad exception to this and it's that claims to a method of using the substance for curing or preventing a disease are not patentable. In that situation these claims are set to relate to methods of medical treatment which the Canadian courts and Patent Office treat as constituting unpatentable subject matter. I don't want to give too much away because we'll get into this in the next webinar, but the foundations of this prohibition are a bit shaky under Canada's current Patent Act, which has resulted in some judges in Canada to call on appellate courts to revisit the propriety of this prohibition. But in any event, as it stands right now, if the method of use is securing or preventing a disease is not patentable if you have a method of claim to, for instance, a diagnostic method or a method of use produces only cosmetic results and do not impart therapeutic benefit, that is patentable.

John:               Great. Thanks, Alex. So let's move on to question two. One of the big questions in second medical use patents is how do you prove infringement? This is always a hot button topic especially in trials and judges are always looking for evidence that the generic is actually infringing the second use. The big question is, is intent required to prove infringement? To start off this discussion, Alex, let's turn to Canada and you can give us the perspective from Canada.

Alex:                Sure. Thanks, John. This is a big question as you mentioned. I'm going to answer this in a few parts and it will still be somewhat incomplete but I'll do my best here. So first I'll set out the general rule in Canada as to what constitutes infringement and whether intent matters, and I'll get into infringement via direct infringement versus via inducement and the implications that this has with respect to the issue of intent, and finally I'll try and tie things together with respect to these issues and second medical use claims in particular. To start with, patent infringement in Canada, like in most jurisdictions is strict liability. If you own a patent, if you prove infringement of a claim of that patent, that is enough. To prove infringement you must simply show that a defendant has acted in a manner that has deprived you, the patentee, of the full enjoyment of your monopoly, as defined by the patent claims. Now, unlike what we've seen in the UK through the Water Lambert decision and in some other national courts in Europe, Canadian courts have not really considered the notion of having a specific infringement test or a specific infringement criteria for second medical use claims. We have no legislation in Canada's Patent Act that relates specifically to second medical use claims. So with that we just revert to the general principal, which is that intent is irrelevant when considering issues of infringement. Our Supreme Court in the Monstant Pfizer case held that the issue was what the defendant does, not what the defendant intends. Now, things are not always so straightforward when we talk about second medical use patents because the concept of infringement via inducement often arises. So, just as a quick prior of this, so this will be known to some of our participants but for others I think it's worthwhile to go over this. Direct infringement occurs when a defendant makes, constructs, uses or sells the patented subject matter themselves. Whereas a patentee can also establish infringement via the concept of inducement, which occurs when the defendant is not itself commit an act of direct infringement, but they cause a different party to directly infringe. But to establish inducement the patent owner must prove that the third party, that did commit the act of direct infringement, was influenced by the acts of the patent owner to the point that without that influence direct infringement would not take place. But the patent owner must also prove that the defendant's influence was knowingly exercised. So this is where that question of intent comes into play again. Now at this point we have a recent holding from our Court of Appeal which states that the knowledge required here, the knowledge required of the defendant, is only knowledge that the influence is being exercised. It does not require knowledge that the resulting activity of the third party will constitute infringement of the patent claim. To close the loop on intent the general rule is that intent is irrelevant but when we're looking at infringement via inducement, which I'll get into a bit more in a second, the patent owner must prove that the defendant knowingly exercised influence that resulted in a third party committing an act of direct infringement. Okay. So, tie all this into second medical use claims and why am I getting into this difference between direct infringement and inducement. Under the assumption that the defendant in any litigation that we're talking about today is the generic or the biosimilar manufacturer seeking to come to market with their product, courts in Canada have basically taken the position that Bare Use claims are to be assessed via inducement whereas Swiss form and EPC 2000 claims are typically viewed through the lens of direct infringement. Courts are taking the position that the Bare Use claims are directly infringed only by a doctor or a patient and thus that's why patent owners must prove that the generic manufacturer induced that infringement. Not sure this is entirely correct. In a lot of situations it's the generic manufacturer selling it's product for use in the treatment of the disease that also, in my mind, appears to meet the activity aspect of the claim and this could constitute a direct infringement. I believe that, for instance in Russia, you do have direct infringement of Bare Use claims by the generic manufacturer. In any event, because of this additional criteria for inducement that I mentioned, Bare Use claims are more difficult to successfully assert in Canada than Swiss type claims and Method of Use claims. So when patenting it's important to include Swiss type claims and EPC 2000 claims. If you do get to litigation and if you have a patent with multiple types of claims, you want to be clear and consistent, at least that the latter claims are directed to the activities of the generic manufacturer or to the substance itself, and not to any downstream user of the medicine, in order to benefit from the recent decisions which are held that the EPC 2000 and Swiss type claims can be infringed directly by a generic manufacturer. I'll leave it there for now and turn things back to John and our other panelists.

John:               Thank you, Alex. So, essentially one of the things that you see in Canada is that these use patents have multiple claim sets. Like they'll have a claim set to EPC 2000. They'll have a claim set to Swiss. They'll have a claim set to Use and that explains why that happens.

Alex:                Exactly. Very briefly there was a recent decision on the drug paliperidone. It had each of the three, Swiss, EPC 2000 and Bare Use. The Bare Use claims were found not infringed by the generic because they couldn't overcome the inducement hurdles. Whereas the EPC 2000 and the Swiss claims were both found to be direct infringement without really too much analysis or thought on that.

John:               Excellent. Jenny, I suspect the situation is not quite as complex in Europe but please do tell us if you disagree.

Jenny:             I disagree. I think the situation in Europe, in some respects, is quite straightforward and in other respects is equally complex. Because we're moving towards EPC 2000 claims, and just having those claims in the future, the system should become more simplified over time but during this transition period it does still remain quite complex unfortunately. So focusing on the UK requirements for intention and knowledge, there's kind of two ways that intention and knowledge come into play from different perspectives which kind of lay on top of each other. They come from the two main sources which are depending on whether the alleged infringement is direct or indirect infringement. There may be a statutory requirement for intention which would apply to any type of claim. So it sounds like this is slightly different to Canada. We have in the UK direct infringement of a product claim, which is strict liability, but direct infringement of a process claim would require a knowledge element. Similarly indirect infringement, which in the UK is supplying means essential for putting an invention into effect, so rather than supplying the entire invention you're supplying a key part of the invention and to another party. The indirect infringement, that also requires a knowledge element. Direct infringement of processes, and indirect infringement by supplying means essential, come both bringing kind of knowledge and intention requirements into any type of claim but then lay it on top of that there's a second requirement for knowledge, or potential requirement for knowledge, that comes from the specific language of a second medical use claim. So because the second medical use claims are purpose bound claims limited to use for a particular disease indication, that incorporates a separate knowledge requirement, layered on top of the statutory requirement. Although the details of how that works is an area of debate in the UK which I'll come back to in a minute. So there are these two key areas where the knowledge or intention requirement comes in and the extra complexity on top of that, sorry John, is that there are currently two different, because of the EPC 2000 and the Swiss form claims, be two different claim forms. They're treated differently in the courts. The Swiss form claim is treated as a purpose bound process claim because it's about the manufacture of a drug for a particular purpose. Whereas, the EPC claims are use of a product for a particular purpose of they're treated as a purpose bound product claim and because of this difference, I mentioned before about statutory and infringement and the way that the two claims are drafted, a product claim and a process claim have different knowledge and intention requirements. So that just adds a little bit more confusion into the mix. The area where there's been most interest in the UK has been around the language of the claim. In a second medical use claim and the wording for and how that may or may not introduce a knowledge requirement. That was considered by the Supreme Court in the Water Lambert case a couple of years ago. Two warnings, or maybe three warnings, the reasoning in that case on this point was overturned so it wasn't part of the ratio of the judgment. The reasoning has received a lot of scrutiny in the UK. Not all that positive. Not much of it positive actually. So it's likely that this will be revisited in the future and it has been the case in recent years that the Supreme Court has revisited some of its previous case law. So this is an area where we might see that happening. But, essentially, what did the Supreme Court say about this for language and what it incorporated into the claim? They looked at whether the for language requires the manufacturer to have a specific subjective intention. Whether it requires the manufacturer to have an objective kind of intention or whether it's more about the outward presentation of the product and how it's placed on and presented to the market. The court was divided, not even clearly divided, kind of two and a half people voted one way, two another way and then half a vote when in a different direction. But it seems the court preferred the outward presentation test, which is about this presentation of the product to the market, rather than looking at exactly what the manufacturer was intending and what it was intending to do. So the interesting thing is that this is limited to Swiss form claims because these are claims about manufacture so that's why it's talking about manufacturer's intention. But it does seem that, based on the current reasoning at least in the Supreme Court, what matters when it comes to infringement of Swiss form claims is how the product is presented to the market. We'll come back to this a little bit later, but just as a kind of tidbit, when you're thinking about Skinny label products where the marketing authorization has been limited to a non-patented indication but there's a risk of the product going into a patented indication, the court is potentially saying, in relation to Swiss form claims, you're only interested in what the marketing authorization says and not how it's in fact used and how the manufacturer intend it to be used by the end user. So that's why the decision has created quite a lot of discussion and is likely to be revisited because it's quite a generic friendly approach in some ways. The other thing to note on that is that the Supreme Court didn't consider EPC 2000 claims and whether the similar kind of mental element would apply there. Sorry, the similar kind of presentation test would apply there. EPC 2000 claims being about the product rather than about the process, may well have a different approach because it's the way that the claim is worded and formed is kind of accepted as creating a broader scope of protection, but that remains to be seen. There's been a few UK cases where this has arise in relation to EPC 2000 claims and the courts have very skillfully dodged dealing with the question so we'll have to wait and see when that really does need to be decided, and of course will be, but I think in the meantime the courts are happy to just let things lie as they are and wait and see. Just briefly, I mentioned statutory intention as well, and the difference between direct infringement of a product claim which is strict liability, direct infringement of a process claim which has a knowledge and intention requirement and the indirect infringement which has the knowledge and intention requirement. So as I said, that's kind of layered on top of the language of the second medical use claim as introducing a potential other requirement. The other point I was going to add there is that if you allege infringement of a Swiss form claim there's a question around what you're alleging and who that's targeted to. So the Supreme Court in Water Lambert considered this as well. In that case the drugs were imported into the UK, sold in the patented indication and the patentee argued that the pharmacist was part of the process of manufacture because, again, it was a Swiss form claim so it's about manufacture and they said the pharmacist is labelling and dispensing the drug so technically that's part of the manufacture. So they are providing the drug, by the means essential, as kind of being involved in that manufacturing process. But the court said, "No. Manufacture is just the actual manufacture of the drug. That all happens outside the UK." So indirect infringement, where you're contributing essential means to that manufacture, would all be the steps prior to the manufacture and since that was outside the UK there was no infringement found in that case. But again that reasoning is likely to be revisited in future cases so we'll have to wait to see how that unfolds.

John:               Well, it sounds like facts really do matter in these cases. It's a complex web. Vlad, how about Russia? I think the complexity is not quite as great but you can correct me if I'm wrong.

Vlad:                It's not as a creative in England and Europe and in Canada. It's much more straightforward for different reasons. So we come from the civil country over so that commonwealth countries that seem to be more complicated. So in Russia, intent is not relevant for patent infringement civil  proceedings at all. So as I mentioned before, German and Swiss form claims are better for enforcement than Method of Treatment claims. German and Swiss type claims deemed infringed if generic product is intended for use in accordance with the indications covered by a patent. In other words, German and Swiss type claims are interrupted as a purpose limited product claim. Infringement of those claims take place if the label of the competitive product includes the indication that is under protection of the patent. Comparing German and Swiss type claims, German or Bare claims, the term that is used in Canada, could be easy to enforce. If the Swiss claim is enforced, not against the drug manufacturer but against a distributor so the patentee may have the same problems as in Europe or in England, the distributor can allege that they do not infringe their Swiss type patent as they do not manufacture the medicament directly. But the only sell it. While the language in the manufacturer medicament would be one of the features of the Swiss but not of German type claims. A Method of Treatment claim doesn't have much value for enforcement in Russia, at all, currently. Russia recognizes direct infringements only but not inducement. This means that an infringer of a Method of Treatment claim can be amended to that directly applies that patented method. That can be hospital, a doctor or arguably a patient and it's highly unlikely that a patentee will enforce the patent against any of these entities for this or that reason. At the same time a generic manufacturer or distributor cannot be held liable for infringement of Method of Treatment claim because they don't have to apply directly this method. That makes Method of Treatment claims, arguably, useless for patent enforcement. So this is Russia.

John:               Interesting, Vlad. Thanks very much. Jian, so how about China? I think that this area is not quite as well developed as elsewhere in the world but do correct me if I'm wrong.

Jian:                Actually you are right. I think there are not many if not by the second medical use in many cases in China. So we are fortunately, or unfortunately, kind of even simpler when it comes to that point. To be fair, China doesn't acknowledge direct infringement and then use of infringement. Those concept exists but because China currently only allows Swiss type of claims and is common in Canada, UK and Russia, Swiss type claims are normally proven under direct infringement. So that also means intent is not relevant as well. So just let me elaborate a little more on the courts ... So the Chinese court generally will think Swiss type claims will have three major parts. For example, my earlier example, use of compound X for manufacture of a former compilation for the treatment of Coronavirus. So the court will think that there are three major parts. The first part is that the active ingredient is compound X affecting the part of the claim they said compound X can be used to manufacture a former compilation and that the third parties, the final compilation can be used to treat Coronavirus. So the court will then look at the evidence. The evidence is most likely to be the medical labels, instructions, packaging or the medical manual instructions. So if those descriptions in the medical label or instructions match the claim chart of Swiss type claims or if they covered on document of equivalence than we are direct infringement. So that's no difference to any other type of redeeming of infringement. Sometimes the defendant will try to argue intent. In China sometimes we will argue that the indicate of the medical use, the purpose is to provide safety instructions or alerts not for guidance for medical use. But that kind of argument will not be agreed by the court. The court will see that this is not a proper ...  and not an exemption to direct patent infringement. So I can elaborate on this point with case law later on so that's about China.

John:               Thanks, Jian, very much. Very interesting. It sounds like this is a pretty complex topic that jurisdiction by jurisdiction if you closely look at it. Let's go onto question number three. The question number three deals with issues within enforcing second medical use patents. In particular I'd like you to focus on the impact of skinny labelled or carved out labels and just to help set the stage there are lots of second entrants, generics, that will come to market and they will essentially indicate for an unpatented use and they will carve out the patented use which can be the second medical use. A lot of questions come up about whether or not that's infringement in jurisdiction by jurisdiction. I want you to give me some thoughts on how a carved out label would be dealt with in your country and, Jenny, maybe we can start off with you.

Jenny:             Sure. So there's been a number of UK cases that have looked at enforcement of second medical use patents. As you say, infringement by skinny labels is a particular issue, so I'll cover that. I was also going to touch briefly on some of the kind evidential issues in enforcing second medical use patents. So one of those is the statutory knowledge requirement that I mentioned earlier and whether you can demonstrate that the knowledge of an intended use before a product ever comes to market. The third question is what are the evidential requirements brought into second medical use claim by the for language and what standard is required to show that the therapeutic effect in a claim is actually achieved. So starting with the main question about skinny label products, as I mentioned earlier, in the UK the Supreme Court considered Swiss form claims in the Water Lambert case, and they indicated that whether or not a claim brought in manufacture of medicament for a particular disease indication is satisfied, is based on the outward presentation of the manufactured drug to the market. Rather than the manufacturer's subjective intention. So, assuming that the Supreme Court kind of consensus is to be adopted then what would mean that products for the skinny label are unlikely to infringe a Swiss form claim, regardless of how the product is ultimately used. The label itself carves out the patented indication. But as I said earlier that reasoning was overturned and has been questioned so it may be revisited and is likely to be revisited in future cases. The lower courts have edged around the issue of EPC 2000 claims. There is no direct guidance but it seems likely that a different approach would be taken for EPC 2000 claims. As I mentioned before their product claims, which seem to have broader protection than process claims, and there's policy pressure to ensure that a patentee receives their protection and a generic with a skinny label doesn't encroach onto its market. So how all that will develop in relation to skinny labels and EPC 2000 claims is kind of a question still to be answered. It does create a real issue if these products with skinny labels aren't found to infringe. So for the old type of Swiss form claims this may be the case and that links into the UK prescribing system. In the UK prescriptions are written by doctors and are almost always written with a generic name of a drug. The prescriptions then taken to a pharmacist and the pharmacist will dispense a drug but will typically dispense the cheapest drug that fulfills the generic description. So that means that generics and skinny labels are often dispensed by pharmacists unwittingly for the patented indication. That came to light in Water Lambert in the lower courts. The NHS was ordered to issue guidance to doctors to prescribe the drug by its brand name to make sure that it would actually be prescribed rather than generics when the drug was being used for the patented indication. The NSH was ordered to give guidance to pharmacists so the prescription had a reference to the patented disease. The pharmacist would again prescribe the originator drug. But then that kind of creates another issue because once doctors and pharmacists are given this guidance to prescribe the branded product for that particular disease indication then when the patent expires it's likely the doctors and pharmacists will be so used to doing that they will carry on doing it and kind of artificially extending the patent life. So there's some complex questions that we still have in the UK around both the law and the interaction between the law and the NHS prescribing system and how that works. I think we had expected more development in the area by now by that's kind of moving slowly I guess with Brexit and COVID and lots of other things happening. So on to the second issue that I mentioned. So we talked earlier about indirect infringement of product claims and that's something that comes up quite often in the UK courts in relation to the EPC 2000 claims. Essentially, the knowledge requirement is that they must be showing that some ultimate users would put the invention into effect and that the alleged infringer would have know, or it would have been obvious, that the drug was suitable and intended to be used in that disease. So how do you prove that intention if there's no product on the market? That came up in the Akebia and FibroGen case and there is no innovative product on the market either in the claim disease indication. So the court had to consider whether the drug would be used off label in the claim disease and looked at the body of evidence around the disease mechanism and prescribing practices. The court said they basically had to try and predict the behaviour of prescribers and try and predict whether the prescribers would have undertaken this off label use. Essentially they looked at all types of evidence. The different phases of trial that had been undertaken and where they've gotten to. It's essentially said that there is no prospect of a marketing authorization on the horizon and it would be pure speculation whether or not this drug would be used in the off label patented use. So they couldn't find infringement in that case. Then just briefly, the evidential requirements from the for language in the second medical use claim and establishing the therapeutic effect. So it's quite well established that if you have a second medical use claim you have to actually demonstrate that the alleged infringement is efficacious in the target disease but the level of evidence that's required seems to be very fact and patent dependent. So just briefly, that's come up recently in two cases. In one case it was found that there needed to be a discernable therapeutic effect in the claim indication in some patients. In the next case it was found that there needed to be effects shown in an in vitro assay and an animal model which is definitely not discernable therapeutic effect in some patients. So it looks like the level of the evidential requirement will very much kind of continue to vary case by case in establishing an efficacy in the treatment.

John:               Wow, it's amazing. It sounds like when you take these cases to trial you really have to have your evidence lined up especially in all prescribing habits of doctors and the percentage of the market that's the new indication. It's fascinating how that come to play. Alex, how about Canada?

Alex:                Thanks, John. What I propose is I'll do the easy part first, very briefly, where there's no skinny label and then I'll get into the skinny label issue in more detail and I'll wrap things up by briefly discussing an issue that Jenny just hit on. The issue of proving infringement where the generic has not launched his product because that it is something that's a significant issue in Canada. So, typically establishing infringement and enforcing a use patent can be a relatively straightforward matter where the generic is not skinny label. Especially for Swiss and EPC 2000 claims. If the generic's product monograph continues the indications from the innovator's monograph that corresponds to the patent claim, the infringement will typically be found, so long as the patent claims that are being forced largely mirror the language of the indication in the monograph. With this finding of infringement courts will typically issue an injunction prohibiting the defendant, assuming they haven't already launched their product, for making, using or selling their product until the expiry of the patent term. But then, skinny labels, and it's a bit of a different story. In considering whether use claims are infringed Canadian courts typically, as with other jurisdictions, Canadian courts typically put significant weight on the product monograph of the proposed generic product. So the patent owner is behind the 8 ball from the get-go in these cases, often, because of the carve out in the indication section of the generic's monograph. So what is a patent owner to do and is there a prospect of success? There are some things that they can do and it's obviously going to be very fact dependent. But one thing that they can do right off the get-go is that you can look to the remainder of the generic's proposed monograph. Are there still references in there to clinical studies that relate to the claim use? Does the generic's monograph contain literature references that tells the reader that the generic's product can be used for the claimed use? Does the monograph still contain references to the innovators product monograph or even specific sections of the innovators product monograph that make reference to the claim use? All of this can be potentially helpful for a patent owner. But beyond the monograph itself Canadian courts are willing to look at the intrinsic to the label. That sort of evidence is not excluded outright and we have seen a trend in recent cases. Three cases in a row now actually where the court has looked to evidence intrinsic to the monograph and found it persuasive in considering infringement issues. So what sort of evidence am I talking about? What is a patent owner looking to marshal? The only thing to marshal evidence that the carved out indication is used with regularity. You want to show that the use of the product is synonymous with the carved out indication, at least in the significant percentage of the population. So to highlight this, the importance of the carved out label, the patentee can look to IRMS data for example, or its own sales data. Then, and perhaps a bit more difficult, the patent owner will also want evidence that the generic product will be used for the claim treatment despite the carve out. Here we're typically looking at expert evidence as a first form. The patentee would look for impartial experts who provide an opinion that the generic product would be substituted for the brand product independent of what the generic's label says. For instance, the expert might refer to prescribing guidelines which refer to the product by its generic or INN name rather than by the brand name. Recent cases have also relied on evidence from witnesses who discuss or testified that the generic product is likely to be considered interchangeable with the innovator's product for reimbursement purposes in respect of the claim use despite the carve out. Which is something that in Canada really is a Province by Province issue. In some instances the patent owner can also look to the actions of the generic itself which may suggest that they know or that they intend that their product will be used in an infringing matter despite the carve out. There was as recent decision involving claims to the adage of use of infliximab and methotrexate for the treatment of patients with RA, rheumatoid arthritis. It wasn't a skinny label case but it was a second medical use case. In that case the biosimilars own clinical trial utilized the very combination that was claimed by the patentee, and while not deterred the court did make note of this and found it to be one factor in favour of finding infringement, which they ultimately did. Similarly, it may be the case that the generic has marketing materials that suggest use of the carve out indication or, more likely, which just suggests that the generic product can be used as a substitute for the patented product or the innovators product, which obviously would encompass all indications. This has also been considered by Canadian courts in the past. So those are the sorts of things that a patent owner would look to, to seek evidence, they would  marshal to try and make a case where a generic has a skinny label. Even if you're able to marshal all that it's certainly still an uphill battle but with the right facts there is a chance of success. Now, as a last point here tying into what Jenny was saying, the question of timing and proving all of this where the generic has not even launched his product yet, or at the very least have not launched their product with the claimed indication. So historically in Canada there is kind of a two tiered pharmaceutical patent litigation system. There is an initial summary application which would occur before the generic launched but then regardless of the outcome of that the unsuccessful party could then commence a subsequent patent infringement or impeachment action. This was all over in 2017, Canada's linkage system, with one consequence being that pharmaceutical patent infringement actions in Canada will now predominantly occur before the generic biosimilar product is launched. So under the old system, along the skinny label jurisprudence, developing those summary applications where the generic has not launched yet but there's always going to be a later possibility for a patent owner to enforce their patent in an infringement action once the generic did launch or once real world evidence was available. This was something that courts routinely pointed to. They held patent owners to a very high bar in seeking to prove infringement of a second medical use claim. One reason that Canadian judges cited to justify this high bar was they said, "Well, patent owner, you can always start an infringement action later once we see whether the generic product, with its skinny label, once we can see what happens in the real world does the generic actually induce infringement or infringe directly despite the carve out when we look at real world evidence." Well now that possibility is gone. For the most part. Now the regime is of a nature that there's one patent action. You get one shot as a patent owner and that shot occurs before the generic launches. So the implications of this on infringement of second medical use claims, and skinny label claims in particular, and whether courts may revisit the high standard that they held patentees to is an open question. There have not been any second medical use/skinny label decisions under this new regime that have come out but it's something certainly to keep on an eye on. I'll turn it back over to you, John.

John:               Thanks, Alex. I'm conscious of the time and I want to save some time for questions. Vlad, how about Russia?

Vlad:                So enforcement in Russia is relatively straightforward when generic label includes an indication that it's under protection of a German or Swiss form of claim. Pharmaceutical regulations do allow skinny label meaning that the generic maker can come out if he wants, the indication that is on the patent protection provided there are other indications that are of patent. Enforcement against skinny label is quite problematic. Mainly because Russia recognizes only direct infringement concept but not its inducement. As the claim feature regarding the use of the drug will be missing on the label of the generic drug. The likelihood that the court will find for the patentee is quite low. In other words, a skinny label can be effective defense against the second medical use patent, at the current stage of development of patent enforcement system in Russia. Over to you, John, again.

John:               Thanks, Vlad. Jian, how about China?

Jian:                So very, very briefly, so in China its as simple as Russia. Although we have no case law yet about second medical use against skinny labels but we can predict most likely that because China only allows Swiss type claims and they are proven to slow infringement so it will be very hard to enforce a second medical use claim in the first time for skinny label.

John:               Thanks. So you can definitely see the dichotomy between civil jurisdictions and common law. Common law in Canada and the UK are broader and accept more evidence and more leeway whereas China and Russia are more narrow. We've got a few minutes for questions. I'd like to turn it over, if you have any questions, please use the Q&A panel. We've got a question here. Can the panel comment on whether basis for a second medical use claim worded in the wrong wording can be reworded to correct the format? For Canada I can tell you that depending on the situation you're in you may be forced to reissue if you're within the 4 year mark. There's some challenges to that in Canada but it is possible. Vlad, how about Russia?

Vlad:                So it's not possible to change the format of the claims that proceeded to grant within their granted patent. But if the application is still pending, or there is a divisional pending, you can easily change the claim format without introducing other matter or other issues that could prevent issuing the patent or its challenge.

John:               How about China, Jian?

Jian:                I think because China currently only have one allowable Swiss type claims so you really cannot, for ... ..., you really can't change any other forms.

John:               Okay. The next question. Is it possible for a technology and its medical use field to then have a second medical use if it is used to cure disease or does second medical use only relate to biomaterials? That's an interesting question. Jenny, do you have any thoughts on that?

Jenny:             Sorry. I didn't quite catch the question there, John.

John:               I think what it's asking is can you have a new use for a known compound outside of the medical field? I know in Canada you can. For example, you can have it for herbicide in once instance and then a different use. Is that possible in the UK?

Jenny:             Yeah, outside the medical field, in theory, but it's quite restricted in the EPA. There was a case a few years back which established that you can have a known product in one particular use and then essentially have a second use for that product. I think, in a lot of cases, it's difficult to establish the other requirements of patentability so those patents are not to stand up.

John:               Another question. What is the current situation in Hong Kong SAR, China (hereinafter referred to as "Hong Kong")? Is Swiss form still the only allowed form in which case based upon Hong Kong and an EP? Medical use patent could be problematic.

Jian:                For Hong Kong, because Hong Kong is actually a different jurisdiction to China, so Hong Kong's system is actually based on UK system. So yeah, so it's different. So maybe Hong Kong, if following the UK approach, but I may have to do some research. Hong Kong does not conform to China's system.

John:               Are there any other questions? Alex, one question is can a patentee bring an infringement action against a generic post launch?

Alex:                So, I see the question there and the issue here is under the new PM NOC regulations regime, basically if the patent owner received a challenge under that linkage regime against a list of patent, if it does not commence a patent action in response to that challenge it is then precluded from asserting that patent in the future against the generic that issued the challenge, unless there were exceptional reasons why the patentee did not start the challenge in the first place. Now if we're talking about the situation where we're outside the linkage regime, if the patentee never received a challenge under the linkage regime, or we're talking about a patent that's not listed on Canada's Patent Register, Canada's Orange Book, then certainly you still have all of your typical rights. You can bring an infringement action against a generic for post launch activities. Basically you're just precluded if you receive a challenge under the linkage regime and decide not to commence under.

John:               Great. Thanks. Apologize. There's still some questions unanswered and we'll try and deal with those separately. But that pretty much sums up our webinar today. Thank you for joining. Thank you panelists for everyone for presenting today and giving us the overview from your jurisdiction. Couple of housekeeping points. Part two, the validity challenge, the second medical use patents will be coming up on January 26^th, if you're interested in that please sign up for that. Also, in February we're going to have a preliminary injunction webinar that may relate to COVID-19. That's kind of the idea right now. Again, if you have any questions please feel free to send them through, through email. Thank you. Good morning. Good afternoon and good evening. Take care. Bye bye.