Strand, London, WC2A 2LL
B e f o r e :
| (1) Smithkline Beecham plc|
(2) Glaxosmithkline UK Limited
|- and -|
|(1) Apotex Europe Limited|
(2) Neolab Limited
(3) Waymade Healthcare plc
(instructed by Simmons & Simmons) for the claimants
Antony Watson QC and Thomas Mitcheson
(instructed by Taylor Wessing) for the defendants
Hearing dates : 21/22 November 2002
Crown Copyright ©
Mr Justice Jacob:
Infringement Construction of "solvate"
"A process for the preparation of paroxetine hydrochloride anhydrate substantially free of bound organic solvent which comprises displacing the solvated solvent or solvents from a paroxetine hydrochloride solvate using a displacing agent".
"Paroxetine hydrochloride anhydrate is also purported to be disclosed in [an identified publication]. The anhydrate is said to be produced by crystallizing paroxetine hydrochloride from anhydrous propan-2-ol. Subsequent repetition of this process has resulted in propan-2-ol solvate, a paroxetine hydrochloride. That is to say that there is bound propan-2-ol in the product. This bound propan-2-ol cannot be removed by conventional drying techniques such as vacuum oven drying.
Paroxetine hydrochloride anhydrate substantially free of bound propan-2-ol has not been described in the literature, nor has any method been disclosed which would yield such a product as an inevitable result. The method of preparing paroxetine hydrochloride anhydrates substantially free of bound propan-2-ol has now been found."
"Substantially free of bound organic solvent is to be interpreted to be less than the amount of propan-2-ol which would remain solvated, ie., bound within the crystal lattice of the product under conventional vacuum oven drying techniques".
There are other passages to like effect.
"A solvate is a single crystalline phase of a given compound of specific chemical structure in which a solvent molecule or molecules have been incorporated into the crystal lattice. In a solvate each solvent molecule will occupy a specific lattice point within the crystalline lattice, and a solvent is thus a discrete crystalline form that can be characterized as such on the basis of unique analytical data."
"The acetone content was 1.7% and the unchallenged analytical evidence was that this produced paroxetine hydrochloride anhydrate form A in the form of needles. There is more than a trace of acetone, and it is bound, but it is not solvate."
"Claim 11 is a method of converting a solvate into an anhydrate. For that purpose you must start with a solvate".
"It should be understood that the present invention comprising paroxetine hydrochloric anhydrate substantially free of bound propan-2-ol may contain unbound water, that is to say water which is other than water of crystallization.
Typically, the amount of bound organic solvent on a weight for weight basis would be less than 2% "
The non-exploitation point
"I am bound to say that the two cases on this point, seem inconsistent one with the another so far as the grant of interlocutory injunctions is concerned. In Polaroid the supposed inability to recover for loss sales of unpatented items was a reason for refusing an interlocutory injunction, yet in Corruplast it was a reason for grant. They can only be reconciled if one can draw a rational distinction between taking sales of unpatented items during the life of the patent and establishing a better position to take such sales after expiry. Yet both are foreseeably caused by infringement".
"(i) That the overriding principle is that the victim should be restored to the position he would have been in if no wrong had been done;
(ii) That the victim can recover loss which was (1) foreseeable and (2) caused by the wrong and (3) not excluded from recovery by public or social policy".
"That was an appeal against the grant of an interlocutory injunction. It was set aside, apparently on the grounds that damages would be a sufficient remedy. The plaintiffs relied on loss which they would suffer, not only to their business in the integral system of instant photography (which was patented), but also to their business in the peel apart system (which for the most part was not). That as it seems to me was not a case of convoyed goods; a photographer would buy one system or the other but not both. Infringing the patents relating to the integral system might, in the event, damage the business in the peel apart system but such loss would surely feel the test of causation or else (as Goff LJ had said page 397), be too remote".
"Subject to sub-sections 48(a) and 48 below, if he is satisfied that any of the relevant grounds are established, the Comptroller may order the grant of a licence".
"It is a question of looking to see which plaintiff has a cause of action and what economic loss it has really suffered."
He was concerned with a case in which one subsidiary was claiming that damage to a sister subsidiary was damage which had been caused to it simply because both companies had a common parent. That is miles from this case.
Do the amendment proceedings preclude the grant of an interim injunction?
"I may add that even if Claims 1 and 2 are so wide that the probability is that they are invalid, nevertheless it is plain that Claim 3 is valid. This brings me to section 62 of the Patent Act 1949 which provides in sub-section 1:
"If in proceedings for infringement of an patent it is found that any claim of the specification, being a claim in respect of which infringement is alleged, is valid but that any other claim is invalid, the court may grant relief in respect of any valid claim which is infringed".
It seems to me that under that section an interlocutory injunction can be granted in respect of the valid claim. It is not necessary for the court at the interlocutory stage to consider whether an amendment should be made to the specification (under sub-section 3). That can be considered at the trial. It is sufficient for an interlocutory injunction that a prima facie case of validity is established in respect of Claim 3 in this letters patent and of the infringement of it".
"Even that leaves the third claim admittedly valid and admittedly infringed, and if the plaintiffs are driven to it they have recourse to Section 62. It is said that one ought not have regard to Section 62 for the purpose of an interlocutory injunction; I do not agree with that contention. You will not decide the matter upon Section 62 but you will look at its possible help to the plaintiffs only if one or more of the other claims is proved to be invalid. Prima facie, under Section 62 the plaintiffs will get relief, unless they had been dishonest in some way."
"A patentee can obtain relief in respect of a patent which is partially valid: Patents Act 1977 Section 63. Further, in appropriate cases an interlocutory injunction will be granted where a patent contains a claim which is invalid but another claim is valid and infringed".
"I have already referred to the option to stay the proceedings in this country which, in my view must be the preferred option when opposition proceedings are before the EPO. Unfortunately the judge did not consider whether in this case a stay would cause injustice. He referred to lengthy periods during which good and valuable patent rights would be unenforceable, but did not consider the possibility that interlocutory relief could be granted in the meantime."
The Section 62(3) point
"Where an amendment of the specification of a patent has been allowed under any of the provisions of this Act, no damages shall be awarded in proceedings for an infringement of the patent committed before the decision to allow the amendment unless the court or the Comptroller is satisfied that the specification of the patent as published was framed in good faith and with reasonable skill and knowledge."
"An amendment of a specification of a patent under this section shall have effect and be deemed always to have had effect from the grant of the patent".
"The High Court may by order (whether interlocutory or final) grant an injunction in all cases in which it appears to the court to be just and convenient to do so."
"The object of the interlocutory injunction is to protect the plaintiff against injury by violation of his right for which he could not be adequately compensated and damages recoverable in the action if the uncertainty were resolved in his favour at the trial".
He also referred me to what was said by Lord Wilberforce in Garden Cottage Foods  1 AC 130 at p.153:
"The evidence makes, to my mind, a clear case of what is called 'irreparable' damage. Of the many cases in which this has been held, I will cite only the well-known judgment of Kay LJ in J Lyons & Sons v Wilkins  1 Ch 811 at 827, where he said:
' in all these cases of interlocutory injunctions where a man's trade is affected one sees the enormous importance that there may be in interfering at once before the action can be brought on for trial because during the interval, which may be long or short a man's trade might be absolutely destroyed or ruined by a course of proceedings which may be determined to be utterly illegal and yet nothing can compensate the man for the utter loss of his business by what has been done in that interval".
"But Mr Platts-Mills has other arguments. First, he advances a discrete point of law. It is that, upon the premise that RPR could not maintain an action for damages either against MCA or against the importers, no injunction should go: an interlocutory injunction should not be granted to protect a plaintiff or applicant against potential losses which would themselves be irrecoverable at law. This argument involves, to my mind, the proposition that the very reason why damages are an inadequate (because unavailable) remedy to RPR amounts itself to a reason why they should not obtain an injunction. At first blush, the submission possesses an Alice in Wonderland, or perhaps Gilbertian, quality. However, Mr Platts-Mills cited authority: Peaudouce v Kimberley Clark  FSR 680. He referred to a passage at 692, where Robert Walker J (as he then was) said:
"But the important point for present purposes is the plaintiffs's claim for an injunction as a protection against, among other things, avowedly irrecoverable losses elsewhere in the Molnycke deivision of the Svenska group. It seems to me that that approach is wrong in principle. In general ... injunctions are granted in order to protect a plaintiff from loss which would sound in damages, not from loss which would not sound in damages. As Goff LJ said in Polaroid Corporation v Eastman Kodak Co  RPC 379, 397: " one is not entitled to an injunction to avoid damages which, if suffered, would be too remote"
However in Peaudouce the plaintiffs were seeking protection against losses which might potentially be suffered by a third party, a stranger to the proceedings: see, in particular, p 693 of the judgment.
As it happens Mr Hobbs took a similar point to that taken by Mr Platts-Mills in Timeload Ltd v BT (unreported, Court of Appeal, transcript 30 November 1993), which may not have been cited to Robert Walker J in Peaudouce. In Timeload the deputy judge at first instance had granted an interlocutory injunction to restrain BT from terminating the plaintiffs' use of a certain telephone number. It is not, I think, necessary to go into the facts. Sir Thomas Bingham MR (as he then was) said at 16C-D of the transcript, in the context of his discussion of the balance of convenience:
"I begin by touching briefly on the adequacy of damages for Timeload. Mr Hobbs took two main points. The first was that the relevant service was run by Free Pages Ltd and not by Timeload. Free Pages was not a plaintiff. He argued that Timeload could not recover damages suffered by a third party."
Then at 16F-G:
"It is not clear to me that Timeload will not suffer damage if the Free Pages business founders and I think it not improbable that it can recover damages directly, if not indirectly; but if it cannot, then damages are an obviously inadequate remedy for those who will suffer loss on the plaintiffs' side"".
"As to the inadequacy of damages for Monsanto, Mr Howe submitted that there are sound reasons of legal policy which preclude a claim by them for damages. It would be paradoxical if legal policy for refusing damages led to a greater readiness to grant injunctive relief: he sought support for this proposition from an observation by Goff LJ in Polaroid Corp v Eastman Kodak Co  RPC 379 at 397 and per Robert Walker J in Peaudouce SA v Kimberley Clark Ltd  FSR 680 at 692. He submitted that the same reasons of public policy which exclude recoverability of a head of loss in damages may also lead to that loss being disregarded when considering a claim for an injunction."
" 'Taking guidance from those statements, it is my view that section 63(2) imposes upon a plaintiff a duty to prove on the balance of probabilities two things: first that the specification was framed in good faith. That requires a plaintiff to prove that the specification was framed honestly with a view to obtaining a monopoly to which, on the material known to him, he believed he was entitled. Secondly, that the specification was framed with reasonable skill and knowledge. The words "skill and knowledge" are a composite phrase relating to the competence employed in framing the specification and require the specification as framed to be in the form in which a person, with reasonable skill in drafting patent specifications and a knowledge of the law and practice relating thereto, would produce'.
Neither the plaintiffs nor the defendants suggested that the observations that I made in that case were wrong. However, I did not have in mind the possibilility that the draftsman may not have been properly instructed on the details of the invention. In such a case, a patentee cannot be in a better position than a patentee who properly instructs the draftsman. Thus the words in the Act require the specification as framed to be in a form in which a person, with reasonable skill in drafting patent specifications and knowledge of the law and practice relating thereto, would produce with the patentee's knowledge of the invention."
Discretion on amendment
Are damages an adequate remedy?
"I turn to another factor which, to my mind, indicates that the injunction should be granted. It is this. The defendants have known for a long time about this patent. You would have to be very naοve in the pharmaceutical industry to think that the patentee, with a product as important as this, would not, if it had anything other than a frivolous chance of success, take action. So the defendants knew, when they set out upon this project in 1997 that if the patentees would cause trouble they would.
The defendants could, so soon as they settled upon the product they were intending to sell, have caused the litigation to start. They could have done a number of things: First, they could have launched a petition for the revocation of the patent and started a claim for a declaration of non-infringement. Or, since there are certain difficulties with the latter (for example onus of proof goes the other way round), they could simply have said to the patentees, "We intend (we are not saying when but it is a settled intention) to launch our product within the next five years. If you intend to sue us, sue us now". If they had taken such a course, having settled upon the product they intended to sell, the whole of this dispute would have been got out of the way before their date of intended launch.
Mr Arnold says, "That is quite unfair. It puts the burden upon the defendant. Why should there be any such burden to start litigation when they are firmly of the opinion they do not infringe and" as a back-up option "the patent is no good?" The answer, to my mind, is self-evident. They knew perfectly well the issue of infringement was likely to arise. If they wanted to be sure of their position they could and would have made sure that all their experimental data was properly in place and vouched for by an independent scientist. And they would have presented the evidence to the patentees.
This is not a case where they could say, on the material they had, it was certain not to fall within the claims. They had materials they could point to from their supplier and from the exerpiments conducted by their sister company in Australia which suggested that was so. They did not, in fact, have details of the experiments themselves no notebooks, no examples of the samples that were tested or anything of the kind. The commercial position was that they did not take the steps necessary to show exaclty what the product they were intending to sell was.
As for the validity of the patent, their case is that if you conduct what is described in 407 you will fall within the claims of this patent. Nothing would be simpler than to do just that and to show that was so. At the moment the case is constructed by way of interference and is no more than a possible case.
I see no question of principle involved here of any sort. It is purely commercial common sense. If there may be an obstacle in your way, clear it out. To my mind, this is a case where the retention of the status quo is a rational thing to do. It was something that could have been avoided by the defendants; they chose not do it."