Ron Dimock: Hello. I'm Ron Dimock, an intellectual property litigation lawyer in the Gowling WLG office in Toronto. It is my pleasure today to have Andrew Waugh, one of the top intellectual property barristers in the United Kingdom as my guest for the next half hour. He and I will discuss IP litigation, and particularly, patent ligation. Welcome, Andrew, and thank you for doing this.
Andrew Waugh: My pleasure.
Ron: You and I met several years ago during the Palmaz coronary stent litigation. You and David Kitchin, now Lord Kitchin of the Supreme Court, won both the trial and the appeal. The trial went in front of Sir Nicholas Pumfrey and the appeal in front of Lord Aldous and had the patents declared invalid. A decade later you came to Canada and testified as an expert witness on UK patent law regarding the corresponding Canadian patents to the Palmaz patents in the United Kingdom and won the case on behalf of our common client Boston Scientific and now you are head of Chambers at 3 New Square very near Lincolns Inn Fields. You are one of the editors of Terrell on the Law of Patents and as we all know the leading textbook on patent law in the United Kingdom. As I understand it you have a degree from City University in London in chemical studies where you played Rugby at second row as I understand the game and when you weren't winning lineouts you wrote a major paper on pharmaceutical research and development; so quite a varied beginning. You were called to the Bar in 1982 and have been doing IP litigation ever since and in 1998 you became Queens Counsel and took silk as they say, no longer a mere stuff. Although you have litigated scores of patent cases in your 48 years of practice in diverse subject areas from A, antibodies, to Z zoledronic acid, to garden variety patents such as patented garden hoses. You are renowned today for your pharmaceutical and biotechnology patent work in the High Court, Court of Appeal, and the Supreme Court. We'll get to some of your cases in a moment Andrew, in particular the Actavis case, but first I have this question for you.
Andrew: Ron before you crack on. Thanks for that generous introduction. I am impressed you know about my playing second row at City University because I lost a very large Australian client because we were in a very noisy restaurant after a trial and he said, did you ever play rugby, and I said yes I play for City University and this Australian, in a broad city accent said oh you must have played with David Campese then and I said well no I have never played with David Campese. Oh what about Nick Farr Jones he was captain of the team you must have been there with Nick Farr Jones and I said no I don't remember Nick Farr Jones at all and it obviously became very apparent I had never played rugby for Sydney University which is exactly where most of the Australian rugby team came from and he thought I was a complete fraud and you know I never had a conversation with him after that so City and Sydney were just too close on that occasion.
Ron: Yes, well we play rugby in a few universities here in Canada but I must admit we tend to play other types of football and…
Andrew: Well I hope you don't do it through the winter because what I do recall about the case for Palmaz the stent case in Toronto was it was either in January or February and was just extraordinarily cold and although you put me in a hotel that was just one block from the Courthouse I had a roll-along bag which required having my hand out of my pocket for more than 30 seconds at about minus 30 degrees was a very, very painful event so I was lucky not to come away with frostbite but that's my recollection of Toronto being a very, very cold and windy place.
Ron: Yes, I have a recollection of your testifying in the court I'll come to later in our conversation. I'll try not to embarrass you much about it but yes getting back to the question that I always get asked a lot and I would like to ask you Andrew, what made you decide to go into intellectual property law in the early 1980s when in fact IP wasn't even an acronym at that time and patents and trademarks and copyright were really marginal areas of the law?
Andrew: Pure accident. It was just an accident in history because I did my first six months pupillage with no guarantee in fact that I was told I would not get a tenancy, I was Martin Moore-Bick's pupil who's now doing the Grenville Tower inquiry and the pupil before me was Nick Hamlyn who is now Lord Hamlyn who has just taken his seat in the Supreme Court alongside David Kitchin which dates it and I never ever used to have lunch in Middle Temple Hall but there was no internet. There was no social media so a postcard on a post board was really how you got your news and I went to lunch at Middle Temple Hall and what had happened was there was a very good set of IP chambers at 6 Pump Court as we then were and there was a postcard saying second six month pupil required, science degree required, 6 Pump Court and still I knew nothing about patents, I knew nothing about IP but it said science degree required so I though oh I've got nowhere else to go, I'll give them a call and I duly did so and I took an interview and I the only way I found out about who they were as I asked the senior clerk where I was doing my pupillage, what's this all about 6 Pump Court. He said well they're a very famous set of IP chambers. I said, IP fine you know I'll take it. You know so the rest is history as they say. I went and did pupillage with Simon Thorley.
Ron: Way back in the 80s I think patent lawyers were considered to be geeks and nerds and of course now they're fashionable geeks and nerds in your practice.
Andrew: There were certainly even fewer of them than there are now. Even now there are only what say 20 silks at the Patent Bar who are regular attendees in Court, I don't know what, 40, 50, 60 juniors. It's not a lot for a Bar to have.
Ron: Here in Canada the Bar has expanded greatly over the last several years so perhaps it's reaching a certain level but over the years in patents and trademarks, what have you enjoyed most about the practice. Is it the people, is it the law, is it the Courts? What is it you?
Andrew: It's all of the above Ron but being at the patent Bar has got negatives and positives. The positives are nobody goes to jail if you fail to defend successfully. No one loses custody of their children if you fail to represent them properly and there are no tears generally at the end of the day. At the end of the day, we may be a footnote in some company's accounts at the end of the year, but we don't have the grief that the practitioners at the Family Court or the Criminal Court have, but more than that we are confronted every day with intellectual challenges which the legal framework stays the same pretty much. Into that legal framework every case is different. The technology is different and that's what's really been a privilege at the Patent Bar is that you get to encounter technology when it's not quite at the cutting edge because you're always litigating a patent about ten years after the priority date but you still get to meet people, experts who are the top of their field and where I've been incredibly lucky is to be instructed by larger multi-national firms for whom I wouldn't say money is not object but they invest very substantially in products that are worth a fortune. Take a product like Humira which peaked in 2018 at five billion dollars a year of the world's best-selling drug. OK I was on the other side but my clients wanted a slice of that action which we may talk about later.
Ron: Your fees are a mere pittance of what they make every day.
Andrew: Indeed. Small beer by comparison but the point of this is that they invest to retain the very best experts and it's not just that experts will want to appear for innovated companies like Eli Lilly, like Glaxo. Generally, these companies make a difference to people's lives. Drugs save lives and we may come on to talk about COVID vaccines and I generally do feel that being a patent practitioner you are promoting innovation. If people don't get rewarded for their inventions, they're not going to invest in them. It is a fundamental tenant that's existed since the Statute of Monopolies. You should reward innovation and development and that's what patents are fundamentally all about and what that does, it's not just the money but the reputation of the companies for whom I act does mean that they can attract the best experts, Nobel prize winners, people at the top of their field who are prepared, generally be on the scientific board of these companies anyway, but they're prepared to give us their time because genuinely drugs, ethical drugs are a good thing.
Ron: Well, I know from talking to others and reading your cases that you're best at cross examining experts in the pharmaceutical field or whatever scientific field the patent is dealing with, but as I understand it one of your worst moments in trial was not in cross-examining an expert but was actually leading an expert witness. Tell me about that Andrew.
Andrew: This is something that junior barristers don't understand. The criminal barristers have to lead the evidence of the witnesses from a proof of evidence in the way that we used to 20, 30 years where you basically had a piece of paper that written on what the witness was going to say or you anticipated that they were going to say and I think it was my first trial ever. I was being led by Willy Aldous and it was between Mars Corporation and Cadbury's Limited and both, Forrest E Mars was at the helm of Mars Corporation and the Cadbury clan were at the head of a Cadbury firm, but they were always litigating and money was again no expense in these wars. Hugh Laddie was on the other side for Cadbury leading David Kitchin which rather dates it, but they were a very popular double act.
Ron: A formidable opposition.
Andrew: They certainly were. They certain were but I was being led by Willy Aldous, it was a trademark case in the days when I used to do trademarks. It was all about the trademark 'Treat'. You would think of a treat as being something you give to someone as a treat but somehow Mars managed to get a registered trademark for Treat and Cadbury's wanted to bring out a chocolate in packs of small chocolates called Treat size chocolates. So that was one in the eye for Mars so they sued Cadbury's and we were instructed by Clifford Turner as they then were and we could not get anybody to support the notion that Treat was a proper trademark that would be seen as a brand or a secondary trademark is what it's called but anyway at the eleventh hour I remember David Perkins my instructing solicitor came along with a proof of evidence from a marketing brand expert whose name I have forgotten who were prepared to stand up in Court and say that Treat was a secondary trademark. So basically this guy is sworn in and Willy Aldous says, you take this witness. If it was one of 50 witnesses I would have forgiven the late Willy Aldous but it wasn't it was our only witness and I was conscious of the fact that I couldn't lead the witness so I just said to the witness after he'd been sworn in, "How would you perceive the trademark Treat?" He more or less said "well what do you mean?" He was supposed to say I would see it as a secondary trademark. So Willy Aldous turned round to me because I was in the row behind him and said what did he say? I said he didn't say anything really. So he said "ask him again". So I asked him again, how would you perceive the trademark Treat? I didn't get any answer, so I thought OK desperation I'll have to lead him here. I said "would you see it as a secondary trademark" or words to that effect? Before Hugh Laddie could interject to say "objection My Lord" the guy said "no". OK Willy turned round to me and said, did he say "no" and I said "yes" and Willy said well ask him again. I asked him again and he said "no" and I don't what had happened but what was on my piece of paper did not tally with what the witness was supposed to say. If there was a trap door that could have opened up your first case as a junior barrister for two multi-nationals fighting against each other, anyway I was never instructed by the Martians again, as they were called, but I was instructed by Clifford Turner for quite a while but that's history too.
Ron: I guess you didn't have any cross-examination of that witness.
Andrew: Oh well, that was the day we knew more of the story because I remember Hugh Laddie was a great, very theatrical in Court, he stood up and he got his robe but he put over his shoulders and with a great flourish he said to Jack Woodford, the judge "no cross examination My Lord" and sat down again and Jack Woodford, he was a bit of a crusty old judge but even he managed a very broad smile at this point.
Ron: Your story reminds me of the time when I was leading your evidence at the Canadian patent stent trial and when all of a sudden during the course of my asking you questions you decided that your testimony would go better if you gave all your remaining answers without any further question from me and you did and your evidence did go in faster and came out better.
Andrew: Well there's a terrific book, it's called Forensic Fables by "O" and if anybody ever sees it great. If they haven't seen it they should get a copy and there's a great fable about the expert barrister who thought he'd made a good job of giving evidence and it's all about a tram running down a lady down on the Strand and how he was going to give all this evidence in perfect style but of course the whole thing breaks down and the judge derides him as a wholly unreliable witness. It's very funny.
Ron: Let's turn our attention now to what many patent people consider to be the most important and yet controversial patent decision in the United Kingdom in recent memory and I'm talking of course about Actavis and Eli Lilly the landmark decision of the UK Supreme Court three years ago. And for those who are interested, no doubt, Actavis and Lilly 2017 UKSC 48. We talked about Lord Kitchin, but according to Lord Kitchin while still in the Court of Appeal in a case called Ice Scapes he wrote that Actavis "introduced a markedly different approach to deciding patent infringement had been applied in the United Kingdom for almost 40 years". Now, you were one of the counsel Andrew in this Supreme Court for Eli Lilly, the winning side. What is the new approach that is used to decide patent infringement that is so different than what was used before?
Andrew: Well in a nutshell: a doctrine of equivalents but more than that it put right something that Lord Hoffman as Mr. Justice Hoffman as he then was in Remington v Improver I think got wrong but I would say that because I acted for Remington in that case. This was the epilator case where the claim was for a helical spring and the defendant's was a slitted rubber rod which turned and extracted hair in pretty much identical fashion. Lord Hoffman or Mr. Justice Hoffman as he then was formulated these three so-called Improver questions which was his analysis or reformulation of Lord Diplock in Catnic and the heresy that really followed from that decision was that it was a question of construction. Everything was a question of construction and once you decided what the construction was you could decide whether or not an equivalent fell in or with outside the wording of the claim. Well, if you actually look at the Catnic questions which for example are, does it have a material effect, does the infringement have a material effect on the way the invention works and would that have been obvious to the skilled person? It manifestly isn't a question of construction. It's a question of looking at the way the defendant's device operates and is it operating in the same way. Is it an obviously immaterial variant to put it another way and one of the big changes as a result of Improver is I had the misfortune to edit chapters 9 and 14 of Terrell and it was very difficult actually to separate out construction from infringement not because they weren't separate topics but they had been locked together like conjoined Siamese twins where it was rather difficult actually to pull them apart. But now they have a separate existence as a matter of intellectual rigor and approach from what Lord Neuberger said in Lilly and Actavis was absolutely spot on and in paragraph 55 of his judgment he lets Lord Hoffman down very lightly because not often after Improver went on to reformulate the so called Amgen approach which again I take issue having lost for Amgen but so having lost Improver, having lost Amgen, winning in Lilly and Actavis I think probably was the highlight of my career, not because it necessarily was the result it was but it put right so many wrongs so far as I was sort of concerned, it existed for over 30 years. Genuinely I think Lord Neuberger got it absolutely right, but I have to say that is not the mainstream view. The judges so far as I am aware, and I think Lord Kitchin may be among them, are very skeptical about the way that Lord Neuberger approached it. I am not sure why. I think Lord Justice Arnold is almost openly hostile to it or certainly he was at a meeting, a roundtable that was held at the University UCL but it's going to have to take another case on infringement to go to the Supreme Court but it is going to stay I think because intellectually and analytically it is correct.
Ron: Well, we now have David Kitchin in the UK Supreme Court, so who knows, but some say that he should have seen this coming especially when Lord Neuberger became President of the Supreme Court and in fact it was Lord Neuberger when he was a trial judge had decided infringement in the Kirin and Amgen case but was reversed by Lord Hoffman on appeal. Did you see it coming Andrew when you were there in the Supreme Court or preparing for the Supreme Court?
Andrew: I think I should have seen it coming and with hindsight in the Amgen case you're right David Neuberger, then Justice Neuberger as he then was, he decided because the issue there was whether DNA replicating in a host cell was in a host cell. It sounds odd because when you think of the early days of genetic engineering where you introduced genetic material into for example an e-coli cell or a CHO cell or some cell it's obviously an exogenous cell and it can produce this material and you harvest it like brewing in a brewery. You can see what a host cell is but what TKT had done and David Kitchin was for TKT, TKT had this concept of homologous recombination whereby they could target the DNA in a natural cell but a human cell and produced multiple copies without having to use an endogenous host cell. An exogenous host cell I should say. So the concept was exactly the same and it was a host cell. It was host to foreign material. It was host to multiple copies. The fact it was also a human cell was really neither here nor there so frankly David Neuberger, Lord Neuberger got it absolutely right in Amgen and he was then reversed by Willy Aldous in the Court of Appeal and that was upheld by Lord Hoffman in the TKT and Amgen case. I think actually people do say that it was Lord Neuberger basically putting right him being reversed in Amgen but I didn't get a flavour of that to be honest. I think he approached it de novo in Lilly and Actavis and just decided to come up with the right answer.
Ron: Well I suppose it's the current law until the UK Supreme Court decides otherwise so we'll see. But Lord Neuberger reduced the question of infringement in two questions: Is there an infringement with the ordinary traditional construction and then the second issue is the variant and in that case, I think it was pemetrexed di-potassium. Nonetheless it was an infringement because it varies from the invention in ways which are immaterial and the claim element. He sort of put it into a neat nutshell so we'll see what happens but most people when they win a great case at the Supreme Court might then decide to cease but apparently you have now developed a new area of the law based on an old case perhaps but called Arrow declarations. Tell me about that.
Andrew: Yes I had the good fortune to be instructed by one of your colleagues, Paul Inman in the London office of Gowling WLG who were acting for Fuji Film and Powell Gilbert were acting for Biogen Samsung joint entity and as I say I mentioned Humira, Adalimumab the antibody a little while ago, you're looking at what 20 billion dollars of sales and they came up with a generic or a biosimilar as they're termed in the biosimilar field and wanted to be able to market with legal certainty, clear the way as it's sometimes called, but I wouldn't call them quite a one product company but they are heavily dependent upon Adalimumab the Humira and they had literally carpeted the floor with divisional patent applications. Now I don't know whether you have divisionals in Canada or Australia but the problem with them in the European Patent Office is that you can apply for a divisional patent up to the time of the notice of allowance of a parent patent. So if a patent has taken 15 years in prosecution which I think probably was the case with Humira – I think there was 19 opponents and it was under opposition for 11 years – once that letter giving you grant of the parent patent up to then you can file as many divisional patent applications on that application and then you can file divisional on those divisionals up to the time they're granted so you can almost keep alive a patent filing prosecution strategy for decades and this is what Abbvie would do. They would get patents for various tweaks, various way of administering Adalimumab, various indications of Adalimumab and certainly no ingenuity was spared in getting dozens and dozens of divisionals and what Abbvie would do is once the division was ready for grant they would turn round and say well actually there's a typo on page 175 can you put it back into grant again please and then four months later they'd well it's ready for grant now and they'd say well actually I've spotted a typo on page 370 so they would never actually give consent to some of these applications and those patents that we did sue they withdrew straightaway because they knew they were on thin ice in the United Kingdom and the great thing about the Arrow Declaration which Mr Justice Kitchin as he then was had decided in the Maersk litigation was at least arguable at strike out level. That was Arrow against Maersk. He said that these Arrow declarations are a runner. Now an Arrow declaration is basically a declaration that you have a Gillette defence.
Ron: In Canada we have the Gillette defence but our divisional application process is far different than yours in the United Kingdom and Europe and don't think the Arrow declaration would be available or would be of any use but we do have the Gillette defence and it's very useful in the right circumstances.
Andrew: The great thing about a declaration if you've got a Gillette defence is you can take the prior art of whatever priority date happens to be to suit you and say look, I want a declaration that my product or my process is patently indistinct from the prior art at the priority date and what is uses almost like a Harry Potter invisibility cloak, it sort of shields you but you can go on forward as a businessmen knowing either I don't infringe or whatever rights they throw at me are invalid because I am patently indistinct so if I'm patently indistinct then so is the patent because to catch me it would have to be equally trivial or it doesn't catch me so you do get this very valuable right which is a protection.
Ron: It's like any declaration of a freedom to operate.
Andrew: Yes fundamentally it is. It has its limits and the Courts, the Abbvie case, the Fuji Film case was a truly exceptional case where the conduct of the patentee was truly egregious but there are other cases where divisionals are used as a marketing commercial strategy as opposed to a genuine intent to get valid IP rights but the Courts actually still handled them with a degree of scepticism. There's a case between Roche and Pfizer where and Mr Justice Birss refused to grant an Arrow declaration because he found that it was just to help the Belgian Court and he said that wasn't enough. We're not going to have forum shopping. We're not going to get decisions out of the UK Court and what's fundamental about getting an Arrow declaration right is you plead a useful purpose because under declaratory law says you can have a declaration provided it serves a useful purpose. It's pretty broad and all-embracing but in the Fuji Film case it would assist a settlement, it's a useful purpose. It would basically show that everything that Abbvie was saying about the value of their patent portfolio estate was a load of hogwash. It would actually interrupt European supply lines even though the declaration itself only concerned the UK patents because it gave that wide Gillette declaration, that's something that European parties would pay attention to and I think where we failed in the Pfizer Roche case was the fact that they just circumscribed their useful purpose too narrowly but I think going forward it will remain a useful tool in the armoury of clearing away.
Ron: So I said it is a pity not in Canada but our time is up. It's been a joy, a pleasure to talk to you again today Andrew, not in a courtroom setting but in an office and I want you to have continued good luck in the Courts, I'm sure you will and thank you Andrew for doing this today.
Andrew: Pleasure. Thank you for your time.