Patents - Evalve Inc. and Others v Edwards Lifesciences Ltd. #1

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Jane Lambert

Patents Court (Mr Justice Birss) Evalve Inc and others v Edwards Lifesciences Ltd [2020] EWHC 514 (Pat) (12 March 2020)

This was a patent infringement action. The patents alleged to have been infringed were EP (UK) 1 408 850 entitled "Devices for capturing and fixing leaflets in valve repair" ("850") and EP (UK) 1 624 810 entitled "Fixation devices and systems for engaging tissue" ("810")  The claimants, who were the patentee, exclusive licensee and exclusive licensee respectively, complained that the defendant company had infringed those patents.  The defendant denied infringement and contended that the patents were invalid.  The 850 on grounds of obviousness and added matter.  The 810 on the basis of anticipation and obviousness. The action came on for trial before Mr Jusiice Birss between 9 and 13 and 17 and 18 Dec 2019. His lordship gave judgment in favour of the claimants on 12 March 2020 (see Evalve Inc and others v Edwards Lifesciences Ltd #1 [2020] EWHC 514 (Pat) (12 March 2020)).

The MitraClip
The patents relate to a product known as the MitraClip which is used to treat mitral valve regurgitation by a transcatheter technique. The judge explained that

"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%."

He described the MitraClip as "a truly transformative advance in the treatment of this disorder" as there had been no effective transcatheter treatment before the device became available.  The only available treatment was open heart surgery which not every patient could undergo.

The defendant company has developed its own device to treat mitral valve regurgitation called the Edwards PASCAL transcatheter valve repair system.  The claimants alleged that PASCAL infringed 850 and 810.

One of the conditions for the grant of a patent is that "it involves an inventive step" (see s.1 (1) (b) of the Patents Act 1977).  S.3 of the Act provides that

"An invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part of the state of the art by virtue only of section 2 (2) above (and disregarding section 2 (3) above)."

The reason for this requirement is that a 20-year monopoly should not be granted for the banal or trivial.  Unlike anticipation where the question is the objective one of whether the invention has already been invented, the test of obviousness is subjective.   It is whether a person with the appropriate skill and knowledge ("the person skilled in the art") would regard the invention as obvious taking account of matter already in existence.  Matter already in existence is usually referred to as "prior art".  The reason for involving a notional person skilled in the art is that he or she has the skill and knowledge required to judge whether an invention is obvious when compared to the prior art.  The matter is of course decided by a judge but he or she tries to put him or herself in the position of that skilled person. In some cases and commentaries, the judge is said to "don the mantle" of the skilled addressee.

The first step is for the parties to agree or for the judge to profile the person skilled in the art.  In the case of some inventions, that person may be a team.   Next, it is necessary to determine what would be within the knowledge of such a person or persons.  Such knowledge is often referred to as "common general knowledge."  The skilled addressee is not expected to know everything.  In particular, he or she is not expected to know about unpublished patent applications because s.2 (3) of the Act is specifically excluded from the definition of "the state of the art"  For the purpose of determining obviousness, the state of the art is limited to:

"all matter (whether a product, a process, information about either, or anything else) which has at any time before the priority date of that invention been made available to the public (whether in the United Kingdom or elsewhere) by written or oral description, by use or in any other way."

The Prior Art
The prior art relied on by the defendant were two patent applications by the first-named claimant company
His lordship remarked at paragraph [5]:

"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."

The Person Skilled in the Art
The learned judge held at paragraph [18] of his judgment that

"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."

Common General Knowledge
Mr Justice Birss considered the skilled team's common general knowledge between paragraphs [19] and [43] of his judgment.

Long Felt Want
At paragraph [44] the judge said:

"Patent law has identified the concept of a "long felt want" or "long felt need". Based on the technical evidence about the common general knowledge, I am sure that there was a need for an effective interventional cardiology based technique to treat mitral regurgitation, and it was felt by real skilled teams including interventional cardiologists. In other words real teams had identified the problem and knew that they wanted to solve it. How long was it? The Alfieri technique had been in the literature since 1995. The best way to characterise the point in my judgment is that real teams were looking to solve this problem for at least a few years before the priority date. In other words, based on the evidence about common general knowledge in this case, I find there was a reasonably long felt want at the first priority date (June 2001) and a longer one at the second priority date (May 2003)."

Patent 850
The abstract of the corresponding US patent describes the invention as follows:

"The present invention provides methods and devices for grasping, and optional repositioning and fixation of the valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. Such grasping will typically be atraumatic providing a number of benefits. For example, atraumatic grasping may allow repositioning of the devices relative to the leaflets and repositioning of the leaflets themselves without damage to the leaflets. However, in some cases, it may be necessary or desired to include grasping which pierces or otherwise permanently affects the leaflets. In some of these cases, the grasping step includes fixation."

His lordship read the specification between paragraphs [54] and [67].

At the end of each patent specification, there is a set of numbered paragraphs known as "the claims",  The claims of a patent are important.  That is because s.125 (1) of the Patents Act 1977 provides: that for the purposes of the Act an invention for a patent for which an application has been made or for which a patent has been granted shall, unless the context otherwise requires, be taken to be that specified in a claim of the specification of the application or patent, as the case may be.

Claims in 850
The claims upon which the claimants relied were 1, 8, 11 and 17 of 850.  Those claims are broken down into integers in Annex 1 to the judgment (paragraphs [331] to [334]).  Mr Justice Birss construed them between paragraphs [68] and [81].

Obviousness in 850 
In Patents - Geofabrics Ltd v Fiberweb Geosynthetics Ltd, 12 March 2020, I wrote:

"The law on obviousness was not in dispute. Mr Stone was referred to paragraphs [52] to [73] of Lord Hodge's judgment in Actavis Group PTC EHF and others v ICOS Corporation and another [2019] Bus LR 1318, [2019] UKSC 15 and paragraph [23] of Lord Justice Jacob's in Pozzoli SpA v BDMO SA [2007] EWCA Civ 558:

'(1) (a) Identify the notional [skilled addressee]; (b) Identify the relevant common general knowledge of that person;
(2) Identify the inventive concept of the claim in question or if that cannot readily be done, construe it;
(3) Identify what, if any, differences exist between the matter cited as forming part of the "state of the art" and the inventive concept of the claim or the claim as construed;
(4) Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?'

He noted that the fourth Pozzoli question is the statutory test – the first three tasks are means of disciplining the court's approach to the fourth question. He was reminded that hindsight must be avoided: per Oliver LJ in Windsurfing International Inc v Tabur Marine (Great Britain) Limited [1985] RPC 59 and that Non-Drip v Strangers [1943] 60 RPC 135 and British Westinghouse v Braulik (1910) 27 RPC 209 remain good law (per Technip France SA's Patent [2004] RPC 46)."

Mr Justice Birss did not refer to the Supreme Court's decision in Actavis, the Court of Appeal's judgments in Pozzoli and Windsurfing which the Supreme Court approved or even Lord Justice Jacob's four-point test, but it is clear from paragraph [101] of his judgment that he had it in mind and had applied it:

"In terms of Pozzoli, I have identified the skilled team and the common general knowledge above. The various things disclosed in Deem differ from claim 1 of the 850 patent in different ways. The grasper tool shown in fig 87 and described in detail in the atrial-ventricular sub-section of the embodiments section is a capture device which is detachably connected to the catheter (feature C) but the detachable bit of that device has no extendable proximal elements. There are distal elements but they grip against the teeth on the central shaft. The difference between the fig 44 embodiment and claim 1 is different. It has proximal and distal elements but as described it is not detachable. It is a temporary leaflet capture device. The fixation is to be done in a different way."

He them directed himself at [103] that the question was whether it would be obvious to the skilled person to make a detachable capture device as shown in one of the patent drawings.  He answered that question at [108] that it is only with hindsight that it might be obvious to set about trying to convert the device in Deem into a detachable fixation implant.   He considered each of the claims and decided that none of them was obvious over Deem.

Added Matter in relation to 850
At paragraph [111] of his judgement, Mr Justice Birss said that the law on added matter is familiar and not in dispute.  There may not have been any dispute but I am not convinced that the law on added matter is familiar.   Many years ago, I tried to explain the basic principles in simple terms in a fictitious dialogue with an imaginary solicitor called Samuel Pepys entitled Educating Samuel: No. 1 Added Matter 4 Nov 2008 IP Northwest:

"Anyway! Sam, we're straying again. The point is that a claim is supposed to:
'(a) define the matter for which the applicant
seeks protection;
(b) be clear and concise;
(c) be supported by the description; and
(d) relate to one invention or to a group of inventions which are so linked as to form a single inventive concept.'
Of these, the most important paragraph is probably (c). The claim must be supported by the description. If it doesn't the inventor is claiming a monopoly for more than he or she is actually disclosing to the public."
"And that's a no-no?"
"Yes, that's a no-no, because the patent or monopoly is supposed to be an incentive for the disclosure of the invention. And that is why one of the grounds upon which the court or IP Office can revoke a patent is that
'the matter disclosed in the specification of the patent extends beyond that disclosed in the application for the patent, as filed, or, if the patent was granted on a new application filed under section 8 (3), 12 or 37 (4) above or as mentioned in section 15(9) above, in the earlier application, as filed.'
and another is that
'the protection conferred by the patent has been extended by an amendment which should not have been allowed.'
'Oh!' said Samuel clearly impressed, his mouth opening and shutting like a goldfish." 

A recent case in which added matter came up is Mr Justice Arnold's decision in  Conversant Wireless Licensing SARL v Huawei Technologies Co., Ltd and others [2019] EWHC 1687 (Pat) (4 July 2019) which I blogged in The Trial - Conversant v Huawei Technologies and Others  7 Aug 2019.

In this case, an application to amend the grounds of invalidity to add added matter as a defence was raised at the pre-trial review. The judge granted the request but insisted on the defendant's setting out its amendment in a separate pleading.  His lordship found no added matter on any ground.

Infringement of 850
Having construed the claims upon which the claimants relied between paragraphs [68] and [81] of his judgment, the learned judge considered whether the PASCAL transcatheter repair system fell within any of them between paragraphs [136] and [144].  He found that it infringed 1 and 11 at paragraph [142] and 8 and 17 at paragraphs [143] and [144].

Patent 810
The abstract of the corresponding US patent described the invention for which 810 was granted as follows:

"The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues."

Mr Justice Birss reviewed the specification between paragraphs [145] and [164].  

Claims in 810
The claimants relied on claims 1, 2, 4, 14, 16, 18, and 19 which appear at Annex 2 (paragraphs [335] to [342]). The judge construed those claims between paragraphs [165] and [188].

Infringement of 810
In Eli Lilly v Actavis UK Ltd and others [2017] UKSC 48 (12 July 2017)  [2017] RPC 21, [2017] Bus LR 1731 at paragraph [54], Lord Neuberger introduced a new approach to patent infringement:

"In my view, notwithstanding what Lord Diplock said in Catnic [1982] RPC 183, 242, a problem of infringement is best approached by addressing two issues, each of which is to be considered through the eyes of the notional addressee of the patent in suit, ie the person skilled in the relevant art. Those issues are: (i) does the variant infringe any of the claims as a matter of normal interpretation; and, if not, (ii) does the variant nonetheless infringe because it varies from the invention in a way or ways which is or are immaterial? If the answer to either issue is “yes”, there is an infringement; otherwise, there is not. Such an approach complies with article 2 of the Protocol, as issue (ii) squarely raises the principle of equivalents, but limits its ambit to those variants which contain immaterial variations from the invention. It is also apparent that the two issues comply with article 1 of the Protocol in that they involve balancing the competing interests of the patentee and of clarity, just as much as they seek to balance the encouragement of inventions and their disclosure with the need for a competitive market. In my view, issue (i) self-evidently raises a question of interpretation, whereas issue (ii) raises a question which would normally have to be answered by reference to the facts and expert evidence."

Mr Justice Birss considered how PASCAL works between [192] and [206].  He decided at [219] that the defendant's product fell outside claim 1 of 810 on what Lord Neuberger called a "normal interpretation"  He then addressed the question of equivalents and asked himself the following questions:

"Question 1: does the variant achieve substantially the same result in substantially the same way as the invention?
Question 2: Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?
Question 3: Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?"

The patent had been challenged in opposition proceedings under art 99 of the European Patent Convention,  On 4 Nov 2019, the Opposition Division upheld 810 in an amended form.  Mr Justice Birss held at [326] that PASCAL would infringe amended claim 1 under the doctrine of equivalents, He added that if claim 1 was infringed under that doctrine so would the others on which the claimants relied.

Validity of 810
The defendant contended that Goldbfarb had anticipated 810 or that 819 was obvious over Goldfarb because figure 18 of Goldfarb was essentially the same  as figure 44 of 810,



The judge analysed each of the claims of 810 to determine whether Goldfarb fell within them from paragraph [244] to[249].  For different reasons, he decided that it did not.  His finding put paid to the defendant's lack of novelty contention.

Turning to whether 810 lacked an inventive step over Goldfarb, the judge referred once again to the Pozzoli test that I mentioned above. Reminding himself that he has already identified the persons skilled in the art and the common general knowledge, he considered the differences between Goldfarb and 810 at paragraph [251].  Lastly, he considered whether those differences were obvious or whether they would have required an inventive step.  He concluded at [308] that claim 1 was not obvious and at [309] that the remaining claims did not lack an inventive step.   

It followed that both 850 and 810 were valid and that both had been infringed by PASCAL. Although the parties did not know the result until 12 March 2020 there was another trial between the parties on whether or not the defendant should be injuncted if PASCAL was found to infringe a valid claim of either patent.  That trial took place between 15 and 22 Jan 2020 and judgment was also delivered on 12 March 2020 (Evalve Inc and others Edwards Lifesciences Ltd  #2 [2020] EWHC 513 (Pat) (12 March 2020).   In that judgment, Mr Justice Birss decided to grant an injunction in the terms sought by the claimants.   I shall discuss that decision in another post.

In the meantime, anyone wishing to discuss this case or patents generally should contact me through my contact form. In line with the government's directions, our clerks are working from home during the coronavirus emergency with the result that they are relying heavily on their mobiles to which calls to our landline are diverted.  I am therefore discouraging calls to that number for anything other than instructions,  I shall be glad to call anyone who wants a chat by phone or VoIP.


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