Once you decide to file a patent, you must determine what it will cover. Obviously, you need to protect your invention, but to reduce the risk of others designing around your patent, you need to ensure that your patent captures the entire inventive space and not just your specific activity.

To ensure your patent catches potential infringements in the future, you must plan carefully and pay close attention to patent drafting. How is the patent's scope defined? Does the level of protection differ across jurisdictions?

Watch our on-demand webinar to explore the scope of patent protection across jurisdictions and learn how to draft patents with an eye to the future. We will highlight key issues in patent scope that arise from the Doctrine of Equivalence. We will also discuss how the doctrine applies across jurisdictions and offer tips on how to use the doctrine to your advantage.

Transcript

John Norman: Good morning / Good afternoon / Good evening

Thanks everyone for joining us to day for our third instalment of the Lifecycle of a Smart Idea series.

Today's webinar is patent strategy, optimising your life science patents.

Over the discussions here we are going to highlight some of the issues that surround patent scope and adoption of equivalents. And as you will see the doctrine is applied differently across different jurisdictions and we will offer you a few tips on how to maximise the doctrine in different jurisdictions.

As a housekeeping matter, this seminar will be recorded and it will be available after the session has finished. We also encourage you to ask questions; you can just type it into the chat menu and as the time comes at the end of the seminar, we will actually answer those.

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My name is John Norman and I will be moderator today. I am co-leader of the life sciences group at Gowling WLG. I have a PhD in Biochemistry and I am a patent litigator in Canada.

And without further ado, I would like to introduce our panellists for today. Our first panellist, Ruben Dzermakyan, he is a patent attorney in Gowling WLG Moscow office and he focusses on patent prosecution and litigation. Our next panellist is Paul Inman. Paul is no stranger and Paul has been a partner with Gowling WLG in the London office for over 20 years. He has a degree is molecular biology and litigates intellectual property disputes in the UK internationally. Our next panellist is Thomas Mayer. Thomas is a partner in Gowling WLG's Munich office with more than 20 years of experience in patent litigation including a number of cases in life sciences. He has also been involved in a number of the key landmark German Federal Supreme Court cases. He is also a certified business mediator. Our next panellist is Dr Jian Xu. Jian has a PhD in biochemistry. He is dually qualified as a Chinese lawyer and a patent and trademark attorney. Jian heads up our IP group in our Beijing office. And last but not least, Dr Sonia Zieshce. Sonia is a principal and patent agent and she heads up our Vancouver Life Sciences group and Sonia's focus on the prosecution of biotechnology and pharmaceutical inventions.

So how this panel will work today is, I'll pose a number of questions to our panellists and our panellists will answer it based on upon the information and the practice in their jurisdiction. But just to set the stage, what we are going to talk about patent claim scope and in particular in respect of life sciences patents and we will talk about a number of the key strategies, how the doctrine of equivalents can be adopted in the various jurisdictions that we talk about.

So as many of your know, when you review and understand a patent, the first place to go is to the claims and you read the claims to get an understanding of what the invention is and what is covered. But the words of the claims themselves are not sufficient to understand the scope of the protection. So you to resort to the disclosure to understand the meaning and words of the claims. And that is how courts and the patent office construes the claims. They look at the disclosure to determine the breadth and scope of the claim. And as everyone here probably knows that a purely literal reading of the claim is not the full answer to understanding claim scope. For example a claim with specific drug formulation would protect that specific formulation and nothing more. However that is not how you are supposed to read a patent. And in fact the literal reading of patent claims allows people to design around and avoid infringement. Small trivial changes can be made that do not fall strictly within the words of the claim that would not be infringing. That is not how you are supposed to read a patent and the doctrine of equivalents helps understand how the principle in many jurisdictions can allow one to include minor trivial variations that infringers come up with that do not affect the invention.

So exactly what it is, is the court and the patent office looks for equivalents for the exact wording of the claim. For example, just a simple example, a literal construction of a claim to a bike with a bell would not be infringed by a bike with a whistle. Even if the purpose of the whistle was the same as the bell, namely to warn pedestrians that the bicycle is approaching. However the doctrine of equivalents allows for flexibility. It allows the patentee to catch infringers who try and avoid infringement by minor changes. It allows the words of the claim to be given life, breadth and not restrict reading.

So how does this affect the life sciences? Well, there are two major things that have changed the doctrine of equivalents and why it has become more important in recent years. The first is an advance in technology. Infringers are developing new and interesting ways of trying to avoid patent infringement. And in my view the second thing is increased regulatory flexibility. And as you will hear right now, a lot of small molecules are facing a new type of challenge. In particular, there is a thing called "salts" which the innovator may have a patent for a compound with a specified salt. The generics will try and avoid that patent by coming up with a new salt and regulatory flexibility has seen more and more generics switching salts to try and avoid patents.

The other theory where we are starting to see doctrine of equivalents play out a great deal is in the biologic sphere. You tend to have a lot of antibodies, proteins that claim a protein that has a particular action. Infringers try and avoid those claims by specifically changing a very immaterial minor amino acid and then alleging that the claim does not cover their variant because they have changed an immaterial minor amino acid. So that is an area where we are starting to see equivalents come into play.

And with that background setting the stage, I would like to open it up and ask my panellists some questions and get their take on the doctrine of equivalents claim scope throughout the world. So my first question is, what are the rules for the doctrine of equivalents in your country and are there any rules specific to the life sciences sector? Thomas, let us start off with Germany.

Thomas Mayer: Yes, thank you John, I am happy to do so. According to the basic rule on the scope of protection of a patent in Germany which is for both German patents and European patents. Frankly for Germany, the extent of protection conferred by a patent shall be determined by patent claims but nevertheless, the description of the drawing shall be used to interpret the patent claims. This seems to be a general approach which is followed across many countries.

The German Federal Supreme Court held in its famous Formstein decision, Formstein is a molded kerbstone that a scope of protection of a patent generally encompasses equivalents to the patent's claim. Another important milestone that should be mentioned was a set of five decisions rendered in 2003 which generated the so called Schneidmesser questions – Schneidmesser is a cutting plate. These questions established a three step testing order to determine whether a patent is infringed under the doctrine of equivalents. The questions are: first, is the problem underlying the invention solved with modified means with objectively the same effect which means the first requirement is about the same effect. The second questions is, the person skilled in the art, able by means of his specialist knowledge to identify the modified means as having the same effect. So the second requirement is about obviousness. And the third question is, are the considerations to be applied by the persons giving the art focussed on the semantic content of the technical teaching protected in the patent claim such that the skilled person takes into consideration the deviating embodiment with its modified means as an equivalent solution. So the third requirement is about parity.

These questions have since then been applied by the Germany Federal and Supreme Court and the Federal and Supreme Court has advanced and further developed its guidelines for the application of the doctrine of equivalents in numerous judgments over the years.

As regards specific rules for the life science sector, it should be noted that these questions are generally applied in patents across all sectors which means irrespective of whether a case is located in the sphere of life science or any other particular sphere.

John: Thanks Thomas. So Germany does have a long established principle for finding equivalents to be within the scope of patent. Paul, what about the United Kingdom?

Paul Inman: Yes, thanks John. So, like Germany, we also have a doctrine of equivalents in the UK. But unlike Germany, I think the concept has had a very chequered history and has existed in various forms or not over the years.

To start with a basic point, patentees have been alleging that their patents should be treated as having a broad scope for years, well decades probably, if not centuries. As long ago as 1904 in a case called Osram and Pope the English Supreme Court was debating whether the alleged infringement was superficially different but in substance the same and even then, over 100 years ago, the Supreme Court was saying that this was a question of much difficulty and that judgment ended up in a 3 to 2 finding in favour of the patentee.

But it was towards the end of the 20th Century in the '60s and '70s that the UK got its fairly established form of a doctrine of equivalents (it was not called that yet) the Court would consider whether the alleged infringement took what they called "the pith and marrow" of the invention, effectively the clever bit of the invention while trying to avoid the particular specific wording of the claims and they called this a "colourable evasion of patents". And they said that the pith and marrow approach to infringement was necessary to prevent such sharp practice as they said.

But it all changed in the UK in 1990 in the Improver and Remington case which was in a number of European countries when Lord Hoffmann as he was then in the Supreme Court took the UK away from the most of the rest of Europe basically saying, there is no need for and therefore there is no doctrine of equivalents in the UK. Now Hoffmann was a very literal person, he took a very literalist view and he effectively said, look it's the language of the claim that matters. Now you have to interpret that language using the purpose of the inventor but it is the language that matters and it was this case, Improver and Remingon that he came up with what are called the three Improver questions which are how to interpret the claim not how to determine whether something is equivalent although these have gone on and I will come back to them later. But basically he said the questions you ask are, does the variant, does the allegedly infringing item work in the same way as the invention? If it does, then you say, well would it have been obvious at the priority date to the person skilled in the art that it worked in the same way? And again if it was, you then ask yourself the question, nevertheless, does the language of the claim suggest strict compliance with the words. Now that was UK purpose of construction but it went round in circles a little bit because it started with the wording of the claim and came back to it at the end.

But that ended up being the case for about 30 years in the UK. Hoffmann in that case found that there was no infringement which was unlike most of the rest of Europe where they found there was infringement. But just three years ago, this question went back to the Supreme Court and from where Lord Hoffmann was long gone and Lord Neuberger said, no, Hoffmann was wrong, there is a doctrine of equivalents. And effectively what he said was, that variants that are outside the normal meaning of the claim can fall within its scope of protection. And he said really there are two questions to ask: firstly does this product fall within the normal meaning of the claims. Now if so, there is regular infringement. But even if it does not, he said you have to ask the question, does the variant nonetheless infringe because it varies from the invention in a way which is immaterial. And he said if so, then it will fall within the scope of protection under the doctrine of equivalents. But what is different is that Lord Neuberger said you have to focus very much on the inventive concept of the patent. So, is that material difference relevant to the inventive concept?

So now in the UK we have this very young doctrine of equivalents and there have been so few cases that it is still developing. As far as specifically to life sciences there have only been two or three so there is no clear pattern emerging for the life sciences point of view and we are going to have to watch the judgments as they come out. But we very much have a doctrine of equivalents now in the UK.

John: Thanks Paul, it was really interesting. Sonia, how has the doctrine of equivalents developed in Canada?

Sonia Ziesche: Thanks John. So doctrine of equivalents in Canada has actually a rich history that borrows heavily from the UK Improver case that Paul just discussed. So in short, where the substitute element such for example ingredients or device performs substantially the same function in substantially the same way to obtain the same result, then the element will be within the scope of a claim.

So according to Canadian patent law, the first pass of the courts in an infringement suit is to construe the claims. So the question basically that is asked during construction is what does the claim mean and purposely construction of the claim will show that some of the elements of the claim invention are essential while others are non-essential. So non-essential elements then can be substituted with equivalents within the claim and this could still be infringed.

So the Supreme Court of Canada found that it would be unfair to allow a patent will not be believed to have been breached by just a copycat device that simply basically switches bells and whistles to escape the literal claims of the patent. So therefore in Canada the proper process that only differs from the patent by the non-essential element that I just discussed, that is not a void infringement. So Paul mentioned earlier that the UK courts did not consider the Improver question to be a doctrine of equivalents. However here in Canada, the three Improver questions have been adopted by the Canadian courts as a basis for assessing whether the variant element in an accused product as a process constitutes an equivalent to what is claimed. I do not repeat the three questions but it is basically the Improver question that the Canadian court will ask.

Interestingly in the Free World Trust decision by the Supreme Court of Canada warned against using the doctrine of equivalents as it is borrowed from the US law in construing a claim based on the spirit of the invention to expand the language of the claims. So the Canadian doctrine of equivalents only really exists as an infringement doctrine and considers that whether the infringer has substituted or omitted an element that had been construed as being non-essential.

John: Thanks Sonia, so it is interesting that Canada seems to be borrow from the UK and in some ways dismisses the US.

Sonia: Yes.

John: Ruben, what about Russia?

Ruben Dzhermakyan: Thank you John. In the USSR was where a doctrine of equivalents was used both for processing patent ability and in determining cases of infringement.

In modern Russian law the doctrine of equivalents can be applied in cases of infringement only. Until 2014, the time for opponents to assess the equivalents is the time before infringement taking place. Since 2014, the equivalents is assessed before the invention's priority date. In general under the view it is less likely that something will be equivalent because equivalence is being assessed further in the past when the skilled person would have had more relevant knowledge. Despite the absence of legal regulations and guidance, the courts determining whether something is equivalent, consider at least the following: the technical aspect of the replacement must be the same. An equivalent feature and a feature being replaced in the claim must belong in the same technical field. In terms of the life sciences sector specifically, when doctrine of equivalents is applied predominantly in the mechanical field in Russia as is the case in China. It appears this all that Russia takes a quiet street approach for assessing equivalents.

John: Thanks Ruben so interesting that it has not found its way into the life sciences as it has in the UK and in Germany. Jian, what about China?

Jian Xu: Thanks John. So comparably speaking, China is heavily influenced by German practice. So as some of the audience might know, in 1985 experts from ETO patent office came to China to help set up the China patent system. So as we were saying, China is very heavily guided by the European / German practice. So I think all the principles that Thomas has outlined is also applicable here in China so I will not repeat. However from a practical point of view, I will summarise five key scenarios where doctrine of equivalents can apply in China.

So those are five key scenarios. For the first scenario is a simple of exchange of common technical elements. So they can apply to what John said about exchange of sodium salt to maybe a different salt. So it is a change of common technical elements.

The second scenario is a sinkhole moving of the provision of the product feature. So this mainly happens in the mechanical field if you move some accessories with higher up to lower that may be for under doctrine of equivalents. So the third scenario is a simple breakdown or combination of technical details. For example, for a bike you might combine a whistle with a light whether this can fall under doctrine of equivalents on art. So the fourth scenario is, if you have a massive claim, sometimes a simple change of steps in a massive claim can also fall under a doctrine of equivalents. And lastly, this really applies to numerical ranges for simple or minor increase or decrease of quantity that can also apply with a doctrine of equivalents.

So these are the major five scenarios in China for doctrine of equivalents and lastly I also want to point out that in China a doctrine of equivalents can be limited by two other principles. So the first principle is so called a "donation" principle. That is you disclose embodiment in the title of notification but you do not claim it in the claims. So that it is assumed to the public and you cannot delete or protect those unclaimed technical solutions or embodiments through doctrine of equivalents. Secondly, China also acknowledges the prosecution history estoppel. So what you said in the patent prosecution can be used against you. Yes, that is all for China.

John: Thanks Jian. So let us look at question 2. Is there anything unique about the doctrine of equivalents in your country? Jian, let us start with China again.

Jian: OK. Yes, for China, as I said China is very much influenced by German and now US case law so I would not say unique but I can highlight three trends. So overall, China is much stricter in applying doctrine of equivalents compared with other countries. That is as many as three aspects. So firstly, about functional features. So many patent adjusters, they like to use function features because the language is broad but in China the court very much dislikes functional features and the way it comes to interpretation of the scope of a functional feature. So very often you will find that the judges will interpret a functional feature to be equal or equivalent to the embodiment in the patent notification so it basically becomes a doctrine of equivalents based on embodiments in terms of functional feature. So that is more limited than other countries.

Secondly I mentioned about numerical ranges. So in the past five years, the Chinese court were trained. Basically they will say doctrine of equivalents do not apply to numerical ranges, so what you have put down in numbers in your claims basically you are linked to the numbers that you put down. It is very hard to pick through the numbers.

Lastly, equally for in the life science, we sometimes use close ended claims, which means we use language like, a composition consisting of A, B, C. If you use 'consisting of' which is a close ended claim in China in the past five years, basically the court is very clear doctrine of equivalents do not apply with close ending claims.

John: Thanks Jian, that's really interesting, so even though China has adopted the EPO and the German model, it still has a certain limit that you do not find in Germany. Thomas, along those lines, what can you say about Germany?

Thomas: Thank you John. Jian, discuss for China, we have a specific defence against the allegation of an infringement under the doctrine of equivalents. In Germany the so-called 'Formstein defence' which the German Federal Supreme Court has together in the decision which I mentioned before.

First of all, I should emphasise that this defence only applies if infringement under the doctrine of equivalents is asserted, but not with respect to literal infringement. So, what is this defence about?

This defence brings considerations of validity and patented with subject matter into determining the scope of the claim. According to the Federal Supreme Court, the defence that the embodiment claims to be an equivalent does not represent a patented invention in view of the prior art, is inadmissible defence. This is due to the consideration that the scope of protection must not be extended to embodiments which are covered by the prior art.

The defendant in a patent infringement litigation can therefore not only defend himself with the fact that the alleged infringing embodiment is known from the prior art but also by effect that it is obvious in view of the prior art.

It is important to note that when this objection is raised, the German infringement court has to assess whether the embodiments to the equivalent is indeed not patented in light of the prior art. Accordingly, the Formstein defence is an exception to the principle of bifurcation which is the rule that the German infringement courts usually do not have jurisdiction to assess the patentability.

John: Thanks Thomas that is interesting. So essentially what we have got now is a defence for infringement is the patent is invalid so it has come both ways. Paul, how does that approach develop in the U.K. and does it exist?

Paul: As I mentioned earlier, it is a new doctrine of equivalents. We do not have much case law but the approach is fairly settled.

First of all, you look at the normal interpretation, then you ask if there is any – if the variants differs only immaterially. As I said, this brings in the old three improver questions, but upgraded to new questions and they are very much focussed on the inventive concept of the patent.

The way the courts assess equivalents is to ask the following questions. The first one is, does the variant achieve substantially the same effect in substantially the same way? That is the same as the old improver question but in this case, it is with respect to the inventive concept of the patent.

The court is having an eye to 'what is the inventive concept'. Is the variant doing things in the same way as the inventive concept?

The second question, as before, was 'would it have been obvious to the skilled person that it would be doing it in the same way' but what has changed here is now the Supreme Court says you have to assess that at the time of the infringement. It is interesting to hear that in Russia they had gone the other way as Reuben said that equivalents is now assessed from the priority date.

In the U.K. we have gone the other way. It is worth pointing out that a number of judges have said that if you have a yes to question one, it is doing a substantially the same thing in substantially the same way, it will be unlikely that the skilled person does not know that.

So, questions one and two are tending to go together. If yes for both one and two, nevertheless would the skilled person think that strict compliance is essential but again, with respect to the inventive concept. So, the court is saying you have got to keep the inventive concept of the patent in mind and in making the assessment the court will, of course, consider the patent specification and the wording of the claims, but there is still a reluctance in the UK for the Court to look at the prosecution history. Some judges may, some judges may not, but as a result of this if the alleged infringement has differences from the patent but differences which do not relate to the inventive concept, then the patent claims may reach significantly further than the literal drafting, but we really need more case law to see how far they will go.

It is just worth saying another unique aspect in the UK is we do not have any of these established defences yet, so as Thomas mentioned, the Formstein defence in Germany where if something infringed is under the doctrine of equivalents, if it was in the prior art then you would have a defence in Germany, but we do not have that defence yet. It has been talked about in a couple of cases but it is not yet established, and similarly we do not have the if it is "a selection patent" and you mention a load of items but then only claim one then you are deemed to have disclaimed the rest, again we do not have that yet.

Again these have been discussed and just a very recent case in akibian fibrinogen that came out last month, these were discussed but they were sort of incorporated into the assessment of question three – would the skilled person think that strict compliance with the claims as required. So, again, it is difficult to give any clear ways that the Court is going. I suspect we may move towards Germany, but we need more case law at the moment.

John: Jolly interesting Paul, thanks. So it sounds like you do not have a defence for the doctrine equivalents but that may be short-lived.

Paul: I think that is right, yeah.

John: Ruben, how about Russia?

Ruben: As a rule, variation of the technical ethic which will be achieved by the product if one feature is replaced by another. But there is a key rule in the demanding equivalents. If they are replacing feature exhibits that gives the product a new technical property it cannot be considered equivalent. In cases of equivalent there is a defence when an alleged infringer if they are able at first to indicate the documents from the prior art in which the equivalent feature is disclosed and second to show that the technical skills in which the equivalent feature is disclosed that is the response the technical field in which the patented invention belongs. So we have a defence in Russia which is a little like in Germany. It is enough to provide information about the design, functions, structure and other characteristics of the found technical features supporting the possibility of by using such a feature as equivalent of a specific patented object.

John: Thanks Ruben. Really interesting that Russia has a form of defence. Let's move on to question three. So I will ask the panel to give an example of a case where the court found infringement by reliance upon the doctrine equivalents. Paul the UK has a fairly recent case – the Actavis case dealing with this. I know it is also in Germany. So Paul let's let you lead the discussion off for the UK. What happened in the UK?

Paul: Sure, okay, so you are back to me pretty quickly there John. Okay. Thanks. Right. Yeah the Actavis case. So this was the case that brought the doctrine of equivalents back into UK case law. So this was a case, I will not go into the facts too much, but the patent claimed effectively use of a sodium salt of the active ingredient, it was a pharmaceutical case. The question was whether the potassium salt, which was what the alleged infringer was using, was also within the scope of the patent. Now with this new approach, Lord Neuberger said right well the inventive concept of the patent was actually a combination of the an iron of the active ingredient with another ingredient – which was vitamin B12. So he said the sodium moiety of that salt was not actually relevant to the invented concept. It was just the drug part once it has disassociated from its salt. So he therefore held that a potassium salt fell within the claim scope because the skilled person would have known that the active ingredient would be doing the same thing in the same way and it would have been obvious to any skilled person at the time of that infringement that that would have been the case.

I think, as you said John, Thomas will talk about this case a bit more because a different approach was taken in Germany, but that is a case where there is quite an extreme finding of infringement outside the literal scope of the claim.

It is probably worth just mentioning one more case, again in the life sciences field, this was a case called Regen and Estar and the patent claim, again boiling it down to the relevant bits, was to a process for preparing platelet-rich plasma but part of the claim was you had to centrifuge whole blood in, amongst other things, a buffered sodium citrate solution at 0.10 molar sodium citrate, and the question was whether the allegedly infringing sodium citrate was at a molarity of 0.13 whether that was within the scope of protection.

Now I think before Actavis and Lilly the specified claim integer of 0.10 would not have incorporated 0.13 it is plainly not the same thing. But importantly in this case, the judge said that the doctrine of equivalents, our new doctrine of equivalents in the UK, applied equally to claims containing numerical limits. So again, unlike Ruben who said in, I think, Russia that, or maybe it was Jian, sorry I apologise, but it will not extend to numerical limits. Here they said it would.

The judge decided that the invented concept was all to do with the centrifugation and dealing with the supernatant, and he said the evidence indicated that the molarity of the sodium citrate is not essential to the inventive concept, so would not have been regarded so by the skilled person. So in that case they have found that a claim to a specific molarity of 0.10 was found to cover 0.13. So that is where we are. I think there is, the UK is possibly a good place at the moment to enforce patents with numerical limitations if you are trying to enforce them against people outside those limitations.

John: Thanks Paul. You know I kind of, not that it matters much, but I kind of agree with the decision. A buffer of .1 versus a buffer of .13 is still doing the same thing.

Paul: Ah, but it is significant figures John, point one zero.

John: [Laughing] I know – we can debate this for a while. Thomas, as Paul mentioned, Germany has the Actavis case as well. How does it work out in that country?

Thomas: Yeah, to start with the Actavis case is called the Pemetrexed case in Germany, so we refer to this matter as the Pemetrexed case and as Paul said, this occurred between Eli Lilly and Actavis and concerned a European patent owned by Eli Lilly that is directive at the use of pemetrexed disodium which is the disodium salt off the anti-folate pemetrexed together with vitamin B12 for cancer treatment. In the patent apart from a general remark that all anti-folates are suitable for use in the patented invention, the specification only refers to pemetrexed disodium. The Actavis product comprised pemetrexed liquitassium which is a liquitassium salt and also together with vitamin B12.

First of all and quite clearly the German Federal Supreme Court found that there was no literal infringement by using the liquitassium salt instead of the disodium salt.

The Federal Supreme Court then used this case to further develop its case law and to mitigate the quite strict approach they had taken in earlier decisions. For example, in a case of 2010 which we call Okklusionsvorrichtung which is an occlusion device, the Federal Supreme Court had ruled that if an embodiment is only mentioned in the specification but not in the patent claim, the patent does not cover such embodiment. This is referred to as a selective invention. Essentially if the patentee has considered and disclosed an equivalent feature in the specification, but they have not claimed it, they cannot later say that the patent feature should be within the scope of the claim.

In the Pemetrexed case the Law Court, the Appeal Court in Dusseldorf was of the opinion that by referring to a class of compounds, the anti-folates, in the specification all members of that class were protectable. So it was a selective invention case where the patentee had disclosed more in the specification than it had claimed, therefore the Appeal Court said that the potassium salt was not in the scope of the claim based on the doctrine of equivalents.

In contrast to this, the Federal Supreme Court did not treat it as a selective invention and indicated that this principle is not to be supplied in a case where a class of chemical compounds is concerned. By mentioning a class of chemical compounds in the specification the patent does not automatically disclose all compounds that are members of this class. The reason is that the person skilled in the art usually needs additional information to individualise these compounds. Therefore the Federal Supreme Court came to the conclusion that the disodium and the liquitassium salts should be considered to be equal in the sense of the Schneidmesser method question. The case was then referred back to the Appeal Court as with the two other Schneidmesser method questions still needed to be answered. The Appeal Court had not dealt with them, but they had just focussed on the third question.

John: Thanks Thomas. We are getting a little short on time, so Sonia I am going to skip over the next section. Jian can you tell us about a life sciences case in China?

Jian: Yes. In the past ten years the most influential case in life science is a Chinese Supreme Court Case on a pain relief drug and the issue is about whether doctrine of equivalents applies in close-ended claims. So basically the claim said the product consisted of two ingredients, one is called Adenosine Disodium Triphosphate (ADT) the other ingredient is called Magnesium Chloride but the claim language is close-ended. Composition consists of ADT and MC. So the alleged infringing product not only had ADT and MC, they also have some accessories like sodium carbonate or adenine. So the patentee argued that those kind of accessories, like sodium carbonate or adenine, they are not relevant in the concept of the invention. So I assume in the UK now that kind of argument will fly with the court but not in China.

The Chinese court has two points. So firstly, the court said a close-ended claim is very clear that it only consists of the ingredients listed. So in view of the realistics it might contain some impurities, that is understandable, but in this case sodium carbonate and adenine are not impurities in the manufacturing. So certainly the court is of the view that by using a close-ended claim the patentee is very clear about the scope of protection, so the public trust that, but now you are coming back claiming that the innovative concept is similar and disregarded the language, so the court will disagree. So basically the court does not want to apply doctrine of equivalents for close-ended claim and the patent keeps being punished by using that kind of claim.

John: Thanks Jian. So if I read this correctly, in the UK we have a very broad, organic reading of the claim whereas in China it is very strict, almost literal and if you do not claim it, it may be a problem, right?

Jian: Yeah it is only the close-ended part which is a problem.

John: Let's move on to question four and I am going to let Sonia lead the discussion on this and give us a fairly fulsome understanding and so the fourth question that we had is what is the impact of the doctrine of equivalents in your country and how do you draft patent applications to either avoid the doctrine of equivalents or to capture it. Sonia I'll hand it over to you.

Sonia: Thanks John. Yeah in terms of claim drafting the objective is really to capture a competitor and a direct infringement without really having to rely on the doctrine of equivalents, and why the doctrine of equivalents can be used to capture competitors through litigation, claims should really be concentrating on targeting direct infringement. They should really encompass readily known equivalents.

So there are several drafting techniques that can be used to cover the full scope of an invention, for example if you have a claim that recites feature x and is equivalents. So, to stay with the earlier example that John had with a bell on a bike, if feature x is a classic thumb activated bell, the drafter might also include an electric bell. So claims can also list feature x and all of the individual equivalents of x that the drafter could think of.

So with the bell example, the drafter might want to expand the equivalent to other acoustic signalling devices, for example, whistles or horn. They also can include a multitude of claims each individually citing feature x or the equivalents and, it is, of course, possible to include feature x described in generic language. For example, instead of reciting a bell on a bike the drafter might what to recite a signalling device on a bike. Another option would be to use functional claim language – so the client could recite a device for signalling or for making a sound, to say the bell example.

So while functional claim language is allowable under Canadian patent practice, it should be kept in mind that not all jurisdictions do allow it and there is also a risk of either claiming too broadly or including inoperable embodiments when using functional claim language.

Another problem with these techniques that I mentioned is that they may broaden the claims both forward and backwards. So for example the claim might feature an electric bell for a bike, but then the drafter decides to use the broader terms of signalling device in an attempt to broaden the claim to also capture maybe electric horns. So however, now by reciting the signalling device the claim is now so broad that some signalling device like a thumb operated bell, the classic bell, might also fall under this claim. So while the claim might capture equivalent technology it also increases the odds that the claim literally encompasses prior art. So it really, when claim drafting, is comprises a fine balance of drafting so the invention is fully defined to provide maximum protection but, at the same time, you have to avoid the prior art.

Then of course there is also consideration with drafting the disclosure. So the claim invention has to be enabled by the specification and the claims need to be supported in the specification. So it can be sometimes difficult to balance enablement in support against claims that are broad enough to fully encompass the invention. So drafters should really consider firstly determining the desired claim scope and then making every effort to make sure all disclosed alternatives in the specification literally infringe.

The specification should also be drafted to capture subject matter that can easily been foreseen during the application process but, as we discussed before, you need to keep in mind that under the specification dedication all subject matter that is disclosed in the specification but never claimed may be viewed as dedicated to the public.

So therefore, if you choose to disclose the alternative in question it should be really claimed as well. Disclosure dedication can be avoided by drafting broader independent claims, of course, or by incorporating all the close alternatives in more narrow dependent claims. So these are kind off, my takeaway and tips for drafting.

John: Thanks Sonia. Jian how about prosecution tips for China?

Jian: Yes so my suggestion is prevention is better than cure so doctrine of equivalents has to be considered as early as in the drafting stage. So I will offer three major tips about drafting in China.

Firstly, we are talking about anything you can claim. You should try to avoid any kind of limitation language in the claim one. So what I say for the drafter you should avoid phrases like "at least" or "not more than" or "not less than" – that kind of language. Also if you have a method claim you should consider maybe some steps are not sequenced one by one. If so, you should avoid using a sequenced list in a method claim, for example: step one, step two, firstly, secondly – that kind of language if the steps are not actually critical one by one.

Secondly, at the moment as China is very strict with numerical limitations and a close-ended claim. So if the life science sector we use numerical ranges and close-ended claims sometimes. So you should try to avoid such close-ended claims or numerical ranges in your claim one as much as possible. Also in the patent prosecution stage when you are replying to office actions you should try to avoid changing an open-ended claim to a close-ended claim as well.

So finally, as regards the patent specification, you should have as many embodiments as you can because many of the functional features in China will be interpreted as equivalent to the embodiments, and also you should try to describe the working principle, or the technical effect, of any embodiments or any imitative concept you must state them so at least you will have much more room to broaden your scope by adoption of equivalents. So that is the three major tips I will offer from a Chinese perspective.

John: Thanks Jian. That is really helpful. Ruben, how about Russia?

Ruben: In Russia some of the same considerations apply to specification and claim drafting as Jian has discussed for China. In particular, you should try to avoid limitation languages in your independent claims to permit broad interpretation. The problem with your independent claims should not be limited to technical fields or uses, to facilitate the application of the doctrine of equivalents the working principle and technical effects of each embodiment and of the distinguishing of each technical feature should be described in as much detail as possible, rather than skipped over or just touched upon.

John: Thanks Ruben. Thomas, what drafting considerations would apply for Germany?

Thomas: Yes – quite quickly the applicant should keep in mind that parity, you will remember this is, parity is referred to by the third Schneidmesser question, that parity is denied in the case of a so called selective invention. As I mentioned before, this means that certain embodiments are excluded from the scope of protection if they are disclosed or detectable in the specification but not included in the patent claim. Accordingly, if the specification discloses several embodiments of which all have been included the claim the scope of protection generally does not extend to the other non-included embodiments. Therefore make sure that all embodiments for which you seek protection are actually included in the patent claim to be on the safe side, do not mention other embodiments in the specification unless they are being claimed. However, as I also explained, people according to this recent Supreme Court case law are claiming by record of a specific chemical compound where the specification merely discloses the class of chemical compounds, it is not necessarily regarded as selective invention. This is due to the fact that the person skilled in the art would usually need further information to individualise the other members of the chemical class. Yes, I think that is quite quickly a lot.

John: Thanks. Paul, in one minute or less, what would you recommend for drafting in the UK?

Paul: Sure well it is easy. There is not a lot to say. I think the principle coming out of the UK court is that inventive concept of the patent is king. So if you get a broad inventive concept, even if your claims are narrow, you may well still find infringement by equivalents if the changes from the literal wording still deploy the inventive concept. So I think from a drafting point of view, try and keep your inventive concept wide and then if you are limited in claim scope, in prosecution well you may still have a chance.

John: Thanks Paul. Thanks to everyone for the presentations today. So just to sum this up very quickly, I guess the big takeaway message for me is, if you can avoid the doctrine of equivalents avoid it. Try and draft claims broadly but avoiding the prior art so that you catch potential infringers. Although in the biologic space we are seeing more and more chances where minor trivial changes can happen, so therefore it is a good idea to try and draft broadly, but if you need to rely on the doctrine of equivalents, try and focus on immateriality of the change and focus on how the invention is still the same.

Right now I would like to open it up for some questions. There is a chat function on the bottom if you want to use that, if you have any questions we can try and answer them, so please feel free to use the chat function for any questions you may have.

Sorry, Q&A, my mistake, it is the Q&A button if you want to answer, if you want to put any questions in the Q&A button.

While we are waiting for the questions to come in, I am going to direct this towards Jian, I guess. Why do you think the doctrine of equivalents has been so narrow in China?

Jian: Well I think that the principle is that China very much wants to balance between the public freedom and also the monopoly that patents conferred. So in the case I talk about this close-ended claim case, I think the argument is sound because the accessories are not really material but because the patentee has used a close-ended claim so that if the public trust that the close-ended claim means that the boundaries are very clear. So if now a patentee comes back trying to argue that the whole innovative concept is similar, so that can actually diminish the public trust on the boundaries. So I think China is, as in many areas, can be more balanced towards a public freedom or public trust and that is why I think China is trying to avoid people or patentee using doctrine of equivalents to broaden the scope maybe more excessively in my view.

John: Thanks Jian. So we have got a question online. Paul mentioned that the UK courts may consider file wrapper estoppel in cases of the doctrine of equivalents. What countries actually do consider the file wrapper for assessing doctrine of equivalents? Let's start with China.

Jian: Yeah so that is back in the beginning, China is very clear so the court is very clear, doctrine of equivalents should be limited by the prosecution history estoppel. So when a case is litigated in China the prosecution will be picked out and argued, so then even the case you know life sciences, also by the close-ended claim. So the patent is originally open-ended claim but in the prosecution stage in order for the patent to be granted, the patentee actually changed the claim from open-ended to close-ended so that had the dramatic effect on whether doctrine of equivalents can be applied. So in summary, China is very clear. The prosecution history will effect doctrine of equivalents.

John: Ruben, how about Russia?

Ruben: Actually we have no legal rules or regulations established using file wrapper, but actually I know that sometimes there are some cases where file wrapper was applied, but it is not a general, it is not established by law.

John: Thanks. That seems to be our time. Thanks everyone for attending today and thank you panellists for agreeing to do this. Our next seminar is Global Patenting Strategies in the world of Tech and Engineering and that is on June 24. Also this presentation was recorded and it will be found on the Gowling website and we have a new platform called "GoXL" so please feel free to peruse that and see what information we have.

Thanks everyone. Have a good day, have a good evening, have a good afternoon.

Read the original article on GowlingWLG.com

Originally published 24 June, 2020

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