Evalve Inc. v Edwards Lifesciences Ltd
| Jurisdiction | England & Wales |
| Judge | Mr Justice Birss |
| Judgment Date | 12 March 2020 |
| Neutral Citation | [2020] EWHC 514 (Pat) |
| Court | Chancery Division (Patents Court) |
| Docket Number | Case No: HP-2019-000003 |
| Date | 12 March 2020 |
[2020] EWHC 514 (Pat)
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY LIST (ChD)
PATENTS COURT
Royal Courts of Justice
The Rolls Building
7 Rolls Buildings
Fetter Lane
London EC4A 1NL
Mr Justice Birss
Case No: HP-2019-000003
Richard Meade QC, James Abrahams QC, Michael Conway and Jennifer Dixon (instructed by Taylor Wessing) for the Claimants
Iain Purvis QC, Piers Acland QC, and Kathryn Pickard (instructed by Powell Gilbert) for the Defendant
Hearing dates: 9th – 13th, 17th and 18th December 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.
This action is about two patents, EP (UK) 1 408 850 entitled “Devices for capturing and fixing leaflets in valve repair” and EP (UK) 1 624 810 entitled “Fixation devices and systems for engaging tissue”. Each patent is owned by the first claimant (Evalve), exclusively licensed to the second claimant (Abbott Cardiovascular Systems Inc) and the third claimant (Abbott Medical UK Ltd) is the UK exclusive sub-licensee. All three companies are part of the Abbott Laboratories group and can be referred to compendiously as Abbott. Both Abbott and the defendant (Edwards Lifesciences Ltd) are major international life sciences technology businesses.
The 850 patent was filed on 27 th June 2002 claiming priority from a US filing dated 27 th June 2001. It was granted on 23 rd September 2009. The 810 patent was filed on 18 th May 2004 claiming priority from 3 simultaneous US filings made on 19 th May 2003. It was granted on 5 th July 2017. The 810 is still in opposition in the EPO. On 4 th November 2019 the Opposition Division upheld the patent in an amended form.
The patents relate to medical devices used to treat mitral valve regurgitation by a transcatheter technique. The patents protect a successful Abbott product called MitraClip which has been on the market since 2008. In the human heart the mitral valve is the valve from the left atrium leading into the left ventricle. Mitral valve regurgitation is a disorder characterised by the inability of the valve to close fully and stop blood flowing back from the left ventricle into the left atrium instead of flowing where it ought to go – onto the aorta. It is a common disorder prevalent in 1.7% of the population, with the prevalence rising sharply with age. One estimate for the prevalence in the over-75s is up to 10%. The MitraClip has been a truly transformative advance in the treatment of this disorder. Before the MitraClip there was no effective transcatheter treatment available. The only effective treatments involved open heart surgery. One surgical approach was annuloplasty and another more recent one was called the Alfieri stitch. They will be described in more detail below. Those patients with progressive mitral valve regurgitation have a poor prognosis and without treatment many will die within a year of diagnosis. However a significant number of the elderly patients with mitral valve regurgitation are not strong enough to be able to have open heart surgery. That is why the ability to treat the disorder by a transcatheter technique, which does not involve open heart surgery, is so significant.
Starting from before the earliest priority date of the patents, Edwards sought to develop a transcatheter treatment for the disorder. The product was called MOBIUS and was based on trying to translate the Alfieri stitch approach into a transcatheter technique. It worked in a different way from the MitraClip. The MOBIUS was taken into clinical trials but did not lead to an approved product and the MOBIUS project was stopped. Now Edwards have produced a new product called PASCAL. PASCAL achieved CE mark approval in 2019. Abbott contends PASCAL infringes both patents. Edwards denies infringement and contends both patents are invalid.
The prior art publications relied on are International Patent Application PCT/US00/09290 published as WO 00/60995 on 19 th October 2000 (Deem) and US patent application US2002/0013571 A1 published on 31 st January 2002 (Goldfarb). Both Deem and Goldfarb are Evalve patent applications which were part of the development work which led to Mitraclip. Goldfarb is a publication of the US application in the same family which produced the 850 patent in Europe. Deem is relied on as full prior art to the 850 patent and Goldfarb as full prior art to the 810 patent. In fact the disclosures within these documents on which Edwards builds its case are the same figures which appear in both (and in 850) although there is a difference in the text between Deem and Goldfarb which needs to be addressed.
Until close to trial Edwards also relied on a published application called Kuehn (WO 00/03759, published 27 th January 2000). This came from a different group (St Jude Medical Inc, another well known cardiac device company). Much of the expert evidence was prepared starting from Kuehn but by the trial Edwards focussed their case on Deem and Goldfarb.
In addition, Edwards advances added matter arguments against the claims of the 810 patent.
Abbott relies on claims 1, 8, 11 and 17 of the 850 patent. Abbott argues that claim 1 is essentially the same as claim 11, and claim 8 similarly pairs with claim 17, although the added matter issues may differ.
Abbott relies on claims 1, 2, 4, 14, 16, 18, and 19 of the 810 patent. By closing only one set of claim amendments were in issue. The set is called Modified Conditional Amendment F. The Comptroller made observations about these amendments and those need to be addressed too if the amendments are relevant. Abbott asks the court to rule that the amendments would be allowable (even if they are not necessary to validate the existing claims) since that would avoid further proceedings if those claims are what emerged from the EPO.
The witnesses
Both Abbott and Edwards called expert evidence from a bio-engineer and a consultant interventional cardiologist. The experts' reports supported the case advanced by the party calling them.
Abbott's bio-engineer expert was Dr Bruce Murphy. Dr Murphy is an Associate Professor in Biomedical Engineering at Trinity College, Dublin. Dr Murphy's current research includes the development of minimally invasive medical devices to treat diseases in relation to transcatheter heart valve repair and replacement. He led the development of a new mitral valve replacement/repair device at Trinity College from 2009.
Abbott's cardiologist expert was Dr Christopher Baker. Since 2002, Dr Baker has held the position of a Consultant Cardiologist with a special interest in interventional cardiology at Imperial College Healthcare NHS Trust. He has used the MitraClip device, and was responsible for the development of the MitraClip program at his hospital.
Abbott also called evidence from Dr Stephen Kuehn, the inventor of the Kuehn patent application. From 1997 he led a project at St Jude to translate the Alfieri stitch procedure into a less invasive transcatheter system. The project was abandoned in 1999. Abbott relies on this as part of its answer to Edwards' obviousness case. He was not cross-examined.
Edwards' bio-engineer expert was Mr Jonathan Rourke. Mr Rourke is an engineer who began working in the field of cardiovascular medical devices in 1991. In 2012 he co-founded MitraSpan, Inc., which is a research incubator of mitral and cardiac structural techniques.
Edwards' cardiologist expert was Dr Nigel Buller. Dr Buller was the Head of Interventional Cardiology at the Queen Elizabeth Hospital, Birmingham and the Lead Clinician for its Cardiac Catheterization Laboratories until January 2008. Since then he has not carried out clinical work but has kept closely involved in developments in treatments. Dr Buller first appeared as an expert witness in a patent case in the Palmaz stent case in 1999 ( Boston Scientific v Palmaz). He has given evidence as an expert a number of times in patent cases in the UK and USA. Most of these appearances have been either for Cordis/Wyeth or for Edwards.
Edwards also made Mr Philip Corso available for cross-examination. Mr Corso is Vice President, Alliance Management of Edwards. He proved the Product and Process Description. He was not cross-examined.
Abbott contended that the evidence of both Dr Buller and Mr Rourke suffered from various problems. Edwards had concerns about Dr Baker's evidence and raised concerns about the way Dr Murphy was instructed. I was not convinced any of these matters were sufficient to justify taking a wholesale approach to their evidence, e.g. by preferring one witness to another other than by reference to the cogency of the reasons they gave. All four experts were qualified to give their evidence and did so trying to help the court understand the issues.
The person skilled in the art
The skilled person is a team consisting of an interventional cardiologist and a biomedical engineer. They would be interested in designing and developing products to treat cardiovascular conditions, in particular mitral regurgitation. The interventional cardiologist would take the lead in identifying clinical approaches and requirements and the engineer would take the lead in working out how to achieve those needs.
The common general knowledge
The common general knowledge can be treated as the same for both priority dates (June 2001 for 850 and May 2003 for 810). The only significant change was the first in man demonstration of a different cardiovascular transcatheter technique called TAVI (see below). The...
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