Regen Lab SA v Estar Medical Ltd
| Jurisdiction | England & Wales |
| Judge | Hacon |
| Judgment Date | 18 January 2019 |
| Neutral Citation | [2019] EWHC 63 (IPEC) |
| Court | Intellectual Property Enterprise Court |
| Docket Number | Case No: HP-2017-000018 |
| Date | 18 January 2019 |
[2019] EWHC 63 (IPEC)
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY LIST (Ch D)
PATENTS COURT
Royal Courts of Justice, Rolls Building
Fetter Lane, London, EC4A 1NL
HIS HONOUR JUDGE Hacon
(Sitting as a Deputy High Court Judge)
Case No: HP-2017-000018
At trial: Andrew Lykiardopoulos QC, Michael Conway and Tim Bamford (solicitor advocate) (instructed by Collyer Bristow LLP) for the Claimant
Richard Davis and David Sant (solicitor advocate) (instructed by Pearl Cohen Zedek Latzer Baratz UK LLP) for the Second to Fourth Defendants On 11 January 2019:
Andrew Lykiardopoulos QC and Tim Bamford (solicitor advocate) (instructed by Collyer Bristow LLP) for the Claimant
Piers Acland QC and Adam Gamsa (instructed by Cameron McKenna Nabarro Olswang LLP) for the Second to Fourth Defendants.
Hearing dates: 19–22, 25, 27–28 June 2018 and 11 January 2019
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.
HIS HONOUR JUDGE Hacon
Introduction
The Claimant (‘Regen’, pronounced as are the first two syllables of regenerate) is the proprietor of European Patent (UK) 2 073 862 (‘the Patent’). The Patent claims a method for the preparation of blood plasma enriched in platelets and other factors, known as platelet rich plasma, or PRP.
The First Defendant is not a legal entity and can be ignored. At the start of the action the Fifth Defendant (‘Mr Turzi’) was the owner of the Patent; Regen was his exclusive licensee. Mr Turzi was joined as a defendant only for that reason, although as CEO of Regen he gave evidence in support of his company.
The Second Defendant is a private company registered in Israel. It makes regenerative biomaterials. The Third and Fourth Defendants are private companies registered in the United Kingdom. Hereafter ‘the Defendants’ should be taken to mean the Second, Third and Fourth Defendants.
Regen alleges that the Defendants supply kits in the United Kingdom subsequently used to prepare PRP according to the method claimed in the Patent, infringing the Patent pursuant to sections 60(1)(b) and (2) of the Patents Act 1977.
The Defendants counterclaim for revocation of the Patent on the grounds of lack of novelty, lack of inventive step and insufficiency.
Regen has made a conditional application to amend claim 1 of the Patent. The amendment is opposed.
At the trial Andrew Lykiardopoulos QC, Timothy Bamford (solicitor advocate) and Michael Conway appeared for Regen, Richard Davis and David Sant (solicitor advocate) for the Defendants.
Technical background
Platelets are small unnucleated cells contained in blood plasma, responsible for blood clotting and tissue repair. PRP is plasma in which the platelet count is higher than would be found in the plasma of untreated blood. It is used by clinicians to promote the healing of wounds. There are also non-clinical diagnostic uses of PRP.
Where destined for clinical use, the PRP is prepared from the patient's own blood and is referred to as ‘autologous PRP’. The platelet content of the patient's plasma is enriched by exploiting the different densities of blood components. Red blood cells (erythrocytes) are the densest, plasma the least dense, with the white blood cells (leucocytes) and platelets being of middling density. If blood is centrifuged, red cells will move to the bottom of the tube, plasma to the top and in the centre will be what is known as the ‘buffy-coat’ or ‘buffy layer’ (after its buff colour) containing the leucocytes and platelets.
Machines for making PRP date from the 1960s. At the priority date various centrifugation techniques were known to separate the platelet fraction to obtain PRP. It was also known that before the blood was centrifuged it had to be treated with an anti-coagulant to prevent clotting. When the PRP is subsequently applied to the patient for wound healing or tissue regeneration the effect of the anti-coagulant is counteracted by an activator.
For some decades before the priority date PRP had another application, in vitro diagnostics (‘IVD’), checking or screening for conditions associated with blood. IVD was recognised to be a distinct field, self-evidently because its purpose was different but also because reagents that might harm a patient and/or the blood cells could be freely used in vitro.
The invention in outline
The method claimed in the Patent employs a thixotropic gel. The relevant characteristic of such a gel is that when it is centrifuged it changes phase from solid to semi-liquid. The change means that the gel will migrate in the centrifuge tube to a position consonant with its density relative to the rest of the contents of the tube. At the end of the spin the gel re-solidifies and remains in position.
The patented method involves taking blood from a patient and transferring it to a tube containing a thixotropic gel and an anticoagulant. The blood and gel are centrifuged at a slow rate (there is a specified maximum). The gel is selected to have a density such that during the spin it moves to position above the denser red cells and below the less dense buffy layer. The plasma moves to the top of the tube, above the buffy layer. When centrifugation is complete the gel re-solidifies, forming a barrier isolating the buffy layer and plasma from the red cells. About half the plasma is removed from the top and discarded. The remainder of the plasma and the buffy layer are harvested. The platelets and other contents of the buffy layer are then resuspended in the plasma to give the PRP.
The witnesses
The experts
Each side provided expert reports from a clinician and a polymer chemist. Regen's clinician was Dr Robert Marx. He is Professor of Surgery and Chief of the Division of Oral and Maxillofacial Surgery at the University of Miami Miller School of Medicine. Dr Marx has been interested in developing devices for preparing PRP since 1992. Dr Marx has published several papers on the use of PRP, mostly for maxillofacial surgery and implant dentistry. In 2005 he published a book entitled ‘Dental and Craniofacial Applications of Platelet-Rich Plasma’. Since 1997 Dr Marx has worked with Harvest Technologies, manufacturers of medical devices including, from 1999, devices for making PRP. Dr Marx was a very good witness.
Dr Pawel Stepniak is polymer chemist who provided an expert report for Regen. He is a researcher at the Institute of Organic Chemistry, Polish Academy of Sciences in Warsaw. Dr Stepniak co-manages a research group of around 15 organic chemists and specialises in supramolecular chemistry (large structures of bound molecules). Dr Stepniak, who is Polish, had good English but occasionally struggled to find the correct words. Sometimes Dr Stepniak seemed less than rigorous in providing support for his propositions and this may have been part of the reason.
Dr Sean O'Connell, who gave evidence for the Defendants, is Assistant Professor in the Department of Vascular Surgery at Englewood Hospital and Medical Center, Mount Sinai School of Medicine, New York. His experience is in regenerative medicine, immunology, cell biology and tissue repair. Among Dr O'Connell's commercial advisor posts, from 2003 to 2014 he served as Chief Medical Officer at Cascade Medical Enterprises LLC, makers of ‘Fibrinet’, a device for preparing PRP. Dr O'Connell was an impressive witness.
Dr Stephen Daren also provided expert evidence on behalf of the Defendants. In 1998 Dr Daren founded Daren Labs, a consultancy based in Israel which supplies research and development services in the field of polymer chemistry. He was a careful and helpful witness.
The witnesses of fact
Mr Turzi was Regen's sole witness of fact. Mr Lykiardopoulos described Mr Turzi as a larger than life character. That he is. In the witness box he frequently took the chance to criticise the Defendants for one reason or another.
Mr Davis identified several occasions on which, he said, Mr Turzi had before the trial obstructed the emergence of relevant documents and other evidence. It is not necessary for me to go through each of these and I make no findings. However, it was my impression that Mr Turzi's first concern was to do all he could to advance Regen's case and that he made concessions in cross-examination only when he felt that he had no other credible choice.
The Defendants relied on four witnesses in support of their case on prior use: Jon Knight, Kama Levi, Morkel Otto and Arata Yamasaki. Mr Yamasaki's evidence was served under a Civil Evidence Act Notice. Ms Levi's evidence was not challenged. I found Mr Knight and Mr Otto to be honest witnesses.
There was also cross-examination of Aaron Esteron who did not provide a witness statement but had signed Regen's product and process description. Mr Esteron was a good witness.
The Patent
The Patent has a priority date of 21 August 2006.
The specification begins by setting out the background to the invention and the prior art, identifying known means of making PRP. It goes on to explain the invention. The section providing a detailed description of the invention gives a definition of PRP as used in the Patent:
“[0053] By the expression ‘PRP’ is intended to mean a platelet-rich plasma, preferably of human origin, more preferably autologous, prepared by the process of the invention in order to pellet and remove erythrocytes and concentrate the plasma in leucocytes, thrombocytes and adhesion proteins as compared to native whole blood.”
The PRP of the Patent thus...
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