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You are here: BAILII >> Databases >> England and Wales High Court (Patents Court) Decisions >> Evalve Inc & Ors Edwards Lifesciences Ltd [2020] EWHC 513 (Pat) (12 March 2020) URL: https://www.bailii.org/ew/cases/EWHC/Patents/2020/513.html Cite as: [2020] EWHC 513 (Pat), [2020] RPC 13 |
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BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY LIST (ChD)
PATENTS COURT
The Rolls Building 7 Rolls Buildings Fetter Lane London EC4A 1NL |
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B e f o r e :
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(1) EVALVE INC. (2) ABBOTT CARDIOVASCULAR SYSTEMS INC. (3) ABBOTT MEDICAL U.K. LIMITED |
Claimants |
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- and - |
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EDWARDS LIFESCIENCES LIMITED |
Defendant |
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Piers Acland QC and Kathryn Pickard (instructed by Powell Gilbert) for the Defendant
Hearing dates: 15th, 16th, 17th, 21st and 22nd January 2020
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Crown Copyright ©
Mr Justice Birss :
The witnesses
The law
The Statutory Framework
"(a) for an injunction or interdict restraining the defendant or defender from any apprehended act of infringement;
(b) for an order for him to deliver up or destroy any patented product in relation to which the patent is infringed or any article in which that product is inextricably comprised;
(c) for damages in respect of the infringement;
(d) for an account of the profits derived by him from the infringement;
(e) for a declaration or declarator that the patent is valid and has been infringed by him."
"Medical and veterinary practitioners should be free to use their skills and knowledge of the best available treatments to achieve the utmost benefit for their patients uninhibited by any worry that some treatment might be covered by a patent."
i) extemporaneous preparation of a medicine for an individual (section 60(5)(c));
ii) use in clinical trials (section 60(5)(i)); and
iii) activity for the purpose of obtaining medicinal product marketing authorisations (sections 60(6D) and (6E)).
"(a) where the patented invention is a product, that a demand in the United Kingdom for that product is not being met on reasonable terms;
(b) that by reason of the refusal of the proprietor of the patent concerned to grant a licence or licences on reasonable terms–
(i) the exploitation in the United Kingdom of any other patented invention which involves an important technical advance of considerable economic significance in relation to the invention for which the patent concerned was granted is prevented of hindered, or
(ii) the establishment or development of commercial or industrial activities in the United Kingdom is unfairly prejudiced;
(c) that by reason of conditions imposed by the proprietor of the patent concerned on the grant of licences under the patent, or on the disposal or use of the patented product or on the use of the patented process, the manufacture, use or disposal of materials not protected by the patent, or the establishment or development of commercial or industrial activities in the United Kingdom, is unfairly prejudiced."
Enforcement Directive
"General obligation
Member States shall provide for the measures, procedures and remedies necessary to ensure the enforcement of the intellectual property rights covered by this Directive. Those measures, procedures and remedies shall be fair and equitable and shall not be unnecessarily complicated or costly, or entail unreasonable time-limits or unwarranted delays.
Those measures, procedures and remedies shall also be effective, proportionate and dissuasive and shall be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse."
The TRIPS Agreement
"1. A patent shall confer on its owner the following exclusive rights:
where the subject matter of a patent is a product, to prevent third parties not having the owner's consent from the acts of: making, using, offering for sale, selling, or importing for these purposes that product;
where the subject matter of a patent is a process, to prevent third parties not having the owner's consent from the act of using the process, and from the acts of: using, offering for sale, selling, or importing for these purposes at least the product obtained directly by that process."
"Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties."
Availability of Damages in Lieu of an Injunction
"… the injury to the plaintiff's legal rights is small;
And is one which is capable of being estimated in money;
And is one which can be adequately compensated by a small money payment; and
The case is one in which it would be oppressive to the defendant to grant an injunction."
"First, the application of the four tests [in Shelfer] must not be such as to be a fetter on the exercise of the court's discretion.
Secondly, it would, in the absence of additional relevant circumstances pointing the other way, normally be right to refuse an injunction if those four tests were satisfied.
Thirdly, the fact that those tests are not all satisfied does not mean that an injunction should be granted."
The application of Coventry v Lawrence to patent cases
"A patent system, for what the Statute of Monopolies called new manufacturers, has been adopted by nearly every country in the world, because it is generally accepted that the opportunity of acquiring monopoly rights in an invention stimulates technical progress in at least four ways. First it encourages research and invention; secondly, it induces an inventor to disclose his discoveries instead of keeping them a secret; thirdly, it offers a reward for the expense of developing inventions to the state at which they are commercially practical and, fourthly, it provides an inducement to invest capital in new lines of production which might not appear profitable if many competing producers embarked on them simultaneously. Those are particularly relevant to the development of medicinal products.
It is inherent in any patent system that a patentee will acquire a monopoly giving to him a right to restrict competition and also enabling him to put up or at least maintain prices. That affects the public and is contrary to the public interest, but it is the recognised price that has been accepted to be necessary to secure the advantages to which I have referred.
Ever since the Statute of Monopolies certain safeguards have been recognised to be necessary to protect the interests of the public against abuse by a patentee of his monopoly rights. Such safeguards, as are considered necessary to safeguard the public, are now contained in the Patents Act 1977."
"… it is necessary, when exercising the discretion, to take into account the basic nature of patent monopolies and the steps that the legislature has taken to protect the public from the effect of the grant of such monopolies. Thus the mere fact that the grant of an injunction to restrain infringement of a patent will restrict competition and tend to maintain prices, does not suggest that the injunction is contrary to the public interest. It is in the public interest that patent monopolies be enforced with the resulting restrictions upon competition that are inherent in the patent system. It is also necessary to bear in mind that the legislature envisaged that in certain situations the public interest required a fetter upon patent rights and took appropriate steps to safeguard the interest of the public. For instance, the Crown can authorise the use of the patent in certain circumstances. That suggests that the interests of the public will normally be protected by the provisions of the Patents Act 1977 and an injunction should normally be granted restraining infringement unless the contrary is indicated in the Act. Thus it is a good working rule that an injunction will be granted to prevent continued infringement of a patent, even though that would have the effect of enforcing a monopoly, thereby restricting competition and maintain prices. Something more should be established before the Court will depart from the good working rule suggested in the Shelfer case."
"32. Conclusion. Drawing these threads together, I consider that Article 3(2) of the Enforcement Directive permits and requires the court to refuse to grant an injunction where it would be disproportionate to grant one even having regard to the requirements of efficacy and dissuasiveness. Where the right sought to be enforced by the injunction is a patent, however, the court must be very cautious before making an order which is tantamount to a compulsory licence in circumstances where no compulsory licence would be available. It follows that, where no other countervailing right is in play, the burden on the party seeking to show that the injunction would be disproportionate is a heavy one. I suspect that the practical effect of this approach is little different to Pumfrey J's test [in Navitaire v EasyJet [2005] EWHC 282 (Ch)] of "grossly disproportionate"."
[reference to Navitaire added]
Assessment of Damages in Lieu of an Injunction
" … the court must have sufficient information before it to be able to estimate the compensation and decide whether the defendant can pay it. The suggestion that the court should refuse the injunction and order that there be an inquiry as to the amount of compensation should not be accepted. To do so, would mean that the court would refuse the injunction without being able to conclude that the compensation was adequate and small. Further at the inquiry, which might not take place for many months, the court might conclude that the compensation could not be properly estimated or that the amount was not adequate or was large. Determination of the amount and sufficiency of the compensation is part of the decision whether to refuse the injunction and needs to be undertaken at the same time."
"As in the case of any other tort (leaving aside cases where exemplary damages can be given) the object of damages is to compensate for loss or injury. The general rule at any rate in relation to "economic" torts is that the measure of damages is to be, so far as possible, that sum of money which will put the injured party in the same position as he would have been in if he had not sustained the wrong (Livingstone v Rawyards Coal Co (1880) 5 App Cas 25, per Lord Blackburn, at p. 39)."
"Cases where 'the benefit of the invention in such cases is realised through the sale of the article or product… [where] the measure of damages will then normally be the profit which would have been realised by the owner of the patent if the sales had been made by him.'
Cases where the patent is 'exploited through the granting of licences for royalty payments…[where] the measure of the damages he must pay will be the sums which he would have paid by way of royalty if, instead of acting illegally, he had acted legally.'
Cases not falling into the above categories, where the Court should 'consider what would have been the price which – although no price was actually quoted – could have reasonably been charged for [permission to use the invention], and estimate the damage in that way'."
Comparative Law
Summary of general principles
i) A general injunction to restrain future infringements is the normal remedy for the patentee.
ii) The burden is on the defendant to give reasons why such an injunction should not be granted.
iii) All the circumstances should be considered. The public interest, such as the impact on third parties, is a relevant consideration. This applies under domestic law (Coventry v Lawrence) and under Art 3 of the Enforcement Directive.
iv) In a proper case the public interest may justify refusal of or carve out from injunction, and an award of damages in lieu. Smallness of the damages in lieu is not determinative. Even if the damages were a large sum of money and/or one which was difficult to calculate, it might still be in the public interest to refuse an injunction or carve scope out of it.
v) The starting point of any consideration of the public interest in relation to a remedy after a patent trial is that the patent system as a whole is already criss-crossed with provisions which strike balances between different public interests.
vi) The availability of an exclusionary injunction is an important manifestation of the monopolistic nature of a patent right. While monopolies in general are against the public interest, once a patent has been found valid and infringed, the patent monopoly is something which it is in the public interest to protect by an injunction in order to further the purposes of the system as a whole, such as to promote investment in innovation.
vii) Therefore when, as here, various public interests are engaged and pull in different directions, one should have in mind that the legislator is better equipped than the courts to examine these issues and draw the appropriate broad balance. The jurisdiction to refuse or qualify a patent injunction on public interest grounds is not there to redraw the broad balance of public interests set by Parliament in the patent system. The power should be used sparingly and in limited circumstances.
The application of these principles to the clinical setting
The facts
MitraClip
PASCAL
"The PASCAL system provides several unique technical and procedural advantages that may allow the treatment of patients not well addressed by other therapies. For example, regurgitation is addressed by a combination of the central spacer that fills the regurgitant orifice area and broad contoured paddles that maximise coaptation around the spacer, thereby limiting the stress on the leaflets from the device…the independent clasp control allows leaflet capture in complex anatomies".
Comparative Data
The state of clinical trial data overall
Design Features of the PASCAL
Distal Elements
Existence of the central spacer
Independent grasping
Use of nitinol as a construction material
Reposition/Removal configuration
Frictional elements
The medical criteria
Wide coaptation gaps
Severe prolapse or flail
Short posterior leaflets
Tethered, flimsy, fragile or calcified leaflets
Significant disruption of the sub-valvular apparatus, such as broken, thickened, or damaged chordae
Leaflet clefts
Small valves
Commissural mitral regurgitation
SLDA - single leaflet device attachment
Combinations
The facts – findings overall
Conclusion
Annex 1
Current MitraClip NTR (left) and XTR (right)
MitraClip: the various positions:
Annex 2
PASCAL (taken from Edwards' website Mr Estay's exhibit RE-14)