Accord Healthcare Ltd v Research Corporation Technologies, Inc.
| Jurisdiction | England & Wales |
| Judge | Mr Justice Birss |
| Judgment Date | 07 November 2017 |
| Neutral Citation | [2017] EWHC 2711 (Pat) |
| Docket Number | Case No: HP-2016-000038 |
| Court | Chancery Division (Patents Court) |
| Date | 07 November 2017 |
[2017] EWHC 2711 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice, Rolls Building
Fetter Lane, London, EC4A 1NL
THE HON. Mr Justice Birss
Case No: HP-2016-000038
Piers Acland QC and Will Duncan (instructed by HGF Law) for the Claimant
Tom Mitcheson QC and Stuart Baran (instructed by Powell Gilbert) for the Defendant
Hearing dates: 19th – 22nd, 27th-28th September 2017
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
THE HONOURABLE Mr Justice Birss
| Topic | Paragraphs |
| Introduction | 1 |
| The witnesses | 8 |
| The skilled team and the common general knowledge | 32 |
| The lacosamide patent | 42 |
| Priority | 53 |
| Assessment – priority | 79 |
| The evidence | 86 |
| Inferences | 107 |
| Obviousness | 125 |
| Le Gall | 126 |
| What to do with Le Gall | 146 |
| Bardel | 209 |
| Conclusion | 212 |
Introduction
This is a patent action. It relates to EP (UK) 0 888 289. The patent covers an anti-epileptic drug called lacosamide. The lacosamide compound is (R) -N-benzyl-2-acetoamido-3-methoxypropionamide. Lacosamide is a successful medicine, with annual worldwide sales projected for next year to reach €1 billion. The patent application was filed on 17 th March 1997 claiming priority from a US filing on 15 th March 1996. The patent expired on 18 th March 2017. There is a supplementary protection certificate (SPC/GB09/007) which means that protection for lacosamide in this jurisdiction continues until 2022.
The claimant (Accord) is a generic pharmaceutical company. It contends that the patent is invalid. If it is right then the SPC will be revoked, clearing the way for generic competition. The defendant (RCT) is a technology investment and management company based in the USA. In effect the defendant works as a technology transfer office for a number of universities. This case concerns work done at the University of Houston by Professor Harold Kohn and his group. Prof Kohn and his group had been working on anticonvulsant compounds since the 1980s. The patent came out of that work. It is exclusively licensed to the pharmaceutical company UCB, who sell lacosamide to treat epilepsy under the brand name VIMPAT. A share of the licence fees paid to RCT under the licence goes back to the university and to Prof Kohn and the other relevant workers in the group.
Accord contend the patent is invalid on two grounds. Accord challenges the patentee's legal entitlement to claim priority from the 1996 priority document. If that challenge is successful then a paper by Choi becomes relevant prior art since it was published after the priority date but before the filing date. That paper makes lacosamide available to the public and there is no dispute that if priority is lost, the patent is invalid.
Accord's second challenge is obviousness. This is based on the state of the art before the priority date, which included a number of papers and other publications from Prof Kohn's group relating to their work on anticonvulsant compounds. Accord relies on two starting points for the obviousness analysis. One is a master's thesis by a student called Philipe Le Gall. It is entitled 2-Substituted-2-acetamido-N-benzylacetamides Synthesis. Spectroscopic and Anticonvulsant Properties. It was made available to the public in December 1987. Le Gall was a student of Prof Kohn. The other attack is based on a paper referred to as "Bardel" the full citation of which is given below. That also came from the work of Prof Kohn's group.
The attack based on Le Gall was originally put in two ways but by the closing Accord had narrowed its case over Le Gall to a single approach. Accord submits that it would be obvious for the skilled team given Le Gall at the priority date in 1996 to do a literature search to find what had come out of Prof Kohn's group in the nine years since the thesis. They would find a number of publications from the group. Accord contends that lacosamide is obvious over Le Gall taking that supplementary information into account. The other approach to Le Gall which had been part of Accord's case until closing was to rely on the thesis alone and not the supplementary information. That case was abandoned.
RCT denies the allegation of lack of entitlement to priority and denies that the invention is obvious.
There had been further points or squeezes on insufficiency and substantive priority concerning chronic toxicity but by the closing it was common ground they did not need to be addressed.
The witnesses
Accord called two technical experts: Professor Brian Cox, a medicinal chemist and Mr Reece Jones, a toxicologist.
Professor Cox is Professor of Pharmaceutical Chemistry at the School of Life Sciences, University of Sussex. Professor Cox received his PhD at the University of Manchester in 1986. He then had extensive experience in industry first at Schering-Plough and then at Glaxo Research Group from 1990. Whilst at Glaxo Research Group, Professor Cox worked on various of their medicinal chemistry programs, and was promoted to Research Leader in 1995. One of his projects was a study starting in September 1995 to look for analogues of the anticonvulsant sodium-channel blocker lamotrigine, seeking a treatment with improved tolerability. Around the same time, he was also lead chemist on a project to identify the molecular target of a competitor anticonvulsant product, retigabine and also worked on a project concerning calcium channel agonists as potential anticonvulsants. His Professorship at the University of Sussex started in 2014.
RCT levelled a number of criticisms of Professor Cox. The major ones were that: his positions were at odds with the textbooks, his views were influenced by hindsight, and he gave long answers which did not answer the questions put. I reject all of RCT's criticisms, for the following reasons. Professor Cox did not accept certain points in textbooks but that was an expression of his genuine views which he explained clearly. On hindsight, I do not accept Accord's case that Professor Cox's opinions on what is obvious over the prior art were fully formed without any reference to the patent. If it matters (and I believe it does not) the evidence did not establish that. However I also reject RCT's corollary that at some overall level the fact that his views were formed after he had read the patent means they are necessarily tainted with hindsight. Professor Cox understood that the court's task in trying an obviousness case is to work out what would be obvious, without hindsight. He sought to help the court by explaining his opinions about that. As for long answers not answering the question, Professor Cox did give quite long answers but that was borne of his desire to ensure that the court understood his full opinions on the topic. Also it was not helped by occasions on which a question was put by presenting a summary of what the Professor's report was said to say but which missed out relevant details.
Professor Cox was a good witness, seeking to help the court resolve the issues in this case.
Mr Reece-Jones is a consultant toxicologist who trained as a toxicologist following receiving his HND in Applied Biology from Manchester Polytechnic. He started training at Hazleton in 1979, and he has worked both in-house in industry and at consulting toxicology companies. He worked as a study director since 1988. He has worked on a wide variety of compounds antibiotics, antihistamines, and central nervous system (CNS) compounds. He is a highly experienced toxicologist and was well placed to give evidence as to toxicology in 1996.
Mr Reece-Jones was barely cross-examined. By closing the point to which his evidence went had been dropped. I thank him for his attendance at court.
RCT called two technical experts: Professor Wolfgang Löscher, a pharmacologist and Professor Simon Ward, a medicinal chemist.
Professor Löscher is Professor and Director of Pharmacology, Toxicology and Pharmacy at the University of Veterinary Medicine, Hannover. He is also the founder of the Centre of Systemic Neurosciences there. He has worked in the field of anticonvulsant drugs since the 1970s. He has worked primarily as an academic but his work has always involved close links with industry and drug development.
Accord submitted that Professor Löscher's experience with drug development was primarily as a consultant brought in only when the drugs were already at a stage of pre-clinical development or later. The contrast was between that and experience of an earlier stage of drug development. Part of Professor Löscher's extensive work in this field did involve the tasks referred to by Accord, but I reject the submission that this qualifies his expertise. He knew very well how the in vivo pharmacological assays such as the MES test (see below) were used in early stage drug development and was well qualified to express opinions about all the issues he covered in this case.
Accord submitted he was an ardent advocate of criticism of the MES test in particular especially for its tendency, as he saw it, to produce "me too" drugs. So he was. I was not satisfied that this view of the MES test represented the common general knowledge at the relevant time. He also had strong views about the need to address drug resistant epilepsy in particular as opposed to treating epilepsy in general and again I am not persuaded those views represented the common general knowledge of a drug development team in 1996. He also had worked with and visited the NIH and had personal...
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