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European IP Bulletin, Issue 5, October -
Patents
Patents
8. Celltech Appeal Allowed
Celltech Chiroscience v Medimmune Inc [2003] EWCA Civ 1008
The Court of Appeal, on appeal from the first instance decision of Mr Justice Jacob, were required to assess the doctrine of equivalents and file wrapper estoppel under post-Festo II US law. In doing so the Court of Appeal partially overturned first instance decision, finding both amendment‑based estoppel and argument‑based estoppel, albeit with one of the three judges dissenting.
The dispute centred around the alleged infringement of a British patent. However, because the Defendant was a licensee of the Claimant, and the licence was subject to US law, the relevant law to be applied was therefore US law. Consequently, the UK courts assessed the issue of patent infringement in line with US legal concepts, in particular the doctrine of equivalents and file wrapper estoppel.
There are two types of file wrapper estoppel, each of which aims to prevent a patent proprietor disclaiming an aspect of his monopoly in order to get a patent granted, but then reclaiming it during infringement proceedings via the doctrine of equivalents.
The first type is amendment estoppel, which prevents a proprietor who has narrowed his claims during prosecution in order to meet requirements of patentability from then asserting the patent against any equivalent technologies falling within the scope of a surrendered territory.
The second type is argument estoppel, which is similar, in that where a proprietor has made statements to the Patent Office during prosecution with regard to the scope of a claim, he cannot then assert the patent against equivalent technology in contradiction of that assertion.
The patent in question involved the synthesis of an antibody combining both human and mouse elements. This patent had initially claimed that there must be a mouse amino acid in at least one of three positions within the antibody, including possibly position 23. However, the claims were amended during prosecution to require mouse amino acids at each of four positions, including position 23.
The Defendant had also produced an antibody, which was identical to the Claimant's antibody, except that it had a human amino acid at position 23, rather than a murine one. This difference meant that the Claimant could not rely on literal infringement of its patent. Although expert evidence had stated that this difference was very slight, the Defendant argued that the Claimant could also not rely on any equivalents to the claim due to both the amendments made during prosecution and the supporting arguments giving rise to file wrapper estoppel.
At first instance, the judge held there was no amendment estoppel, because although the claim amendments had cut down the number of possibilities claimed, they did not exclude the possibility of equivalents to murine amino acids. However, the Court of Appeal judges disagreed, stating that by amending the claim so that the listed positions, including position 23, had to be murine amino acids, the claimants had denied the possibility of equivalents in which the amino acids were anything other than murine amino acids.
Additionally, during prosecution, the Claimant had argued that all successful antibodies had murine amino acids at position 23. At first instance, this was held to be an argument estoppel preventing equivalents, and the Court of Appeal agreed, upholding the judge's ruling.
Nevertheless, the position was not clear-cut, with Arden LJ dissenting. Arden LJ instead agreed with Jacob J's analysis of the amendment estoppel, and disagreed with both Jacob J and the other Court of Appeal judges with regard to argument estoppel, believing that there was not an unmistakable or unequivocal assertion by the Claimant that position 23 could never be anything other than a murine amino acid. He therefore believed that the patent was infringed. Nevertheless the majority opinion carried, and Celltech's assertion of patent infringement was dismissed.
9. BASF And SmithKline Appeals Dismissed
BASF AG v SmithKline Beecham [2003] EWCA Civ 872
This case concerned an appeal by SmithKline Beecham Plc against a judgment of Pumfrey J of 12 July 2002 and a cross appeal by BASF AG. Both appeals were dismissed on 25 June 2003.
In his judgment of 12 July 2002 ([2002] EWCH 1373 (CH)), Pumfrey J held that claims 1, 2, 3, 7, 10(ii), 12 and 13 of UK Patent GB 2,297,550 (the “Patent”) were invalid and claims 10(i) and 11 of the Patent were valid. SmithKline Beecham appealed against this order and BASF cross appealed, contending that the judge should also have held claims 10(i) and 11 of the Patent were valid.
SmithKline Beecham's appeal essentially turned on a question of construction, in particular the meaning of the phrase “substantially free of bound propan-2-ol” which appears in claim 3 of the Patent. If that phrase had the meaning for which SmithKline Beecham contended then, upon the findings of the judge, claim 3 and its dependent claims would be valid.
BASF supported Pumfrey J's conclusion on construction and also contended that claims 10(i) and 11 should have been held to be anticipated by the disclosure in UK patent application no. 8526407, referred to as 407, or was obvious in the light of that disclosure.
SmithKline Beecham’s Appeal
The importance of the phrase “substantially free of bound propan‑2‑ol” arises out of an allegation that claim 3 of the Patent and its dependent claims lacked novelty. BASF relied on an experiment in 407 in which the anhydrate Form A, was produced using acetone as the solvent. Propan-2-ol was never used. As that experiment did not use propan-2-ol, claim 3 was anticipated.
Pumfrey J's judgment held that the phrase “substantially free of bound propan-2-ol” as used in claim 3 meant what it said. It followed that claim 3 of the Patent was anticipated by paroxetine hydrochloride anhydrate (“PHA”) even though it was not substantially free of the solvent used in preparation, provided it was free of bound propan-2-ol which was not and could not have been present.
SB contended that in context “propan-2-ol” is a synecdoche (i.e. a figure of speech in which a more inclusive term is used for a less inclusive one or vice versa, as a whole for a part or a part for a whole). SmithKline Beecham argued that it is an example standing for whichever member of the class of solvents that was used in the process of production. Any other construction rendered the specification inconsistent.
CA held that section 125 Patents Act 1977 made it clear that the invention of a patent is to be taken to be that specified in the claims. The claims have to be interpreted with the aid of the description. However the Protocol on the Interpretation of Article 69 of the European Patent Convention also applies. CA held that, for the purposes of this case, it was sufficient to record that the proper approach is to seek the middle ground between literal construction and treating the claims as guidelines. The quest has to achieve reasonable certainty for the public and fair protection for the patentee.
CA held that the skilled addressee would interpret the specification taking into account the nature of the technical contribution, but would also realise that the patentee claimed his monopoly in words of his own choosing. To disregard the apparent intention of the patentee could lead to an unfair result. CA held in this case that the suggestion that the words “propan‑2‑ol” should not be given their ordinary meaning, but should be read as “organic solvent” would be a deviation from ordinary rules of construction and would do violence to the language which should be avoided unless no other reasonable construction is possible. CA could find nothing in the specification which would lead it to give the words “substantially free of bound propan-2-ol” used in claim 3 of the Patent a meaning different to their ordinary meaning and SmithKline Beecham's appeal was dismissed.
BASF’s cross appeal
BASF cross appealed, contending that claims 10(i) and 11 of the Patent had been anticipated and were obvious. The CA discussed the concepts of both novelty and obviousness in respect of the Patent.
The issue at trial was whether the skilled addressee would, when performing example 1 of 407, produce the anhydrate or the hemihydrate form of PHA. Both parties conducted various experiments to aid their respective cases in this regard. The same arguments were held to apply to both claim 110(i) and 11.
CA held that example 1 did not render claim 11 invalid as being obvious. The CA also held that even if claim 11 was obvious, the BASF experiments and the SmithKline Beecham experiment show that the process conditions of example 1 would still have to be altered. Therefore example 1 of 407 did not make the process of claim 11 available to the public. The alterations went further than replication by a skilled addressee of the disclosure in example 1 using his ordinary skills. CA stated that there must be clear and unmistakable directions to do something which will infringe a patent claim and that example 1 did not reach that standard in a number of ways. The specific details of claim 11 of the Patent cannot be read out of example 1 of 407 and to get claim 11 further information is needed. BASF's experiments did not seek to apply the directions in example 1, but demonstrated how Form A could be produced with alterations which did not prove anticipation. The CA also held that the same reasoning applied to experiment 3 of BASF.
The CA rejected the arguments of BASF's expert that the steps taken in the BASF experiments were those that would be carried out using the teaching of example 1 of 407, as the expert read 407 at the same time as the Patent and knew the answer to the difficulties of example 1 of 407. The expert then witnessed the repeat of the experiments and so his views were expressed after he know what to do. It was held that his evidence would have been more convincing if, before seeing the Patent, he had been given example 1 of 407 and been asked to carry it out.
The CA held that those that devised the BASF experiments must have known that they alone did not prove that example 1 made the claim 11 process available and that further evidence was needed. The best evidence would be that of a skilled addressee who, without knowledge of the Patent, carried out example 1 and produced Form A. BASF could not call evidence along those lines and relied on the opinion evidence of their expert which could have been coloured by hindsight.
CA, relying on the approach to deciding obviousness in Windsurfing International Inc. v Tabur Marine (Great Britain) Ltd, [1985] RPC 59, preferred the evidence of SmithKline Beecham's expert rather than BASF's in relation to the issue of obviousness. SmithKline Beecham's expert was of the view that the procedure carried out by SmithKline Beecham in their experiment was a realistic performance of example 1 of 407 and that the BASF experiments were not obvious ways of carrying out the example. In the SmithKline Beecham expert's view, it is only when you had read the patent that you would take the steps taken by BASF in the relevant experiments. CA held that Pumfrey J was entitled to come to the conclusion he did on obviousness and dismissed BASF's cross appeal.
10. Add A Hint Of Paroxetine Salt
The 25 June 2003 decision handed down by the Court of Appeal emboldens the position of patentees facing revocation orders for want of novelty. Synthon BV v. SmithKline Beecham [2003] EWCA Civ 861 provides the clarion statement of law with respect to when a prior unpublished application is novelty destroying: under General Tire and Asahi, it is not sufficient for the general information in applications to enable the product to be made, but in order to anticipate there must be clear and unmistakable directions, which if carried out would lead to the product in question.
SmithKline Beecham Plc were the proprietors of a patent in respect to an invention entitled “Paroxetine salt” which had a priority date of 6 October 1998. Synthon BV were the applicants for a patent dealing with 4-phenylpiperidine compounds. Jacobs J., in deciding whether the Synthon patent was anticipatory, dissected from General Tire that there were two ways of proving anticipation: the enabling disclosure and the inevitable result routes. He then reckoned that the more central concept was the enabling disclosure. He ultimately concluded that there is not a rule about inevitable result. It is about whether the two inventors in substance reached the same invention.
This type of reasoning formed the basis for Jacobs J.’s order for revocation. He held that both SmithKline Beecham & Synthon disclosed wide varieties of making the paroxetine salt (crystalline paroxetine mesylate), but Synthon got there first and all that could be said for SmithKline Beecham is that their disclosure is a readier way of making the crystals. In so doing, Jacobs J. was attempting to avoid the prospect of double patenting.
In the Court of Appeal Aldous LJ. held that such an approach was inconsistent with s.2(3) of the Patents Act 1977 and that while the purpose of s.2 (3) is to avoid double patenting, a different approach to novelty should not taken in s.2(3) cases when compared to s.2(1) cases.
While it would seem that the Synthon patent came so close to providing instructions to enable the person skilled in the art to make the said salt, it fell short of providing the clear and unmistakable directions required for the “inevitable result” test. As such, SmithKline Beecham’s patent was held to be valid. Interestingly, given the general nature of the two disclosures, it would seem that there would be some cause for considering SmithKline Beecham’s patent “obvious” in the light of the Synthon application. It is likely that the legislation foresaw such a result and as such, Aldous LJ reminds that “an application, deemed to form part of the state of the art under section 2(3), cannot be relied on to attack a patent on the ground of obviousness.”
4. Ajinomoto Sweetener Patent Upheld
Daesang Corporation v Ajinomoto Co Inc [2003] EWHC 973 (Ch)
The Patents Court upheld the validity of a patent under attack of the respondent whose revocation was sought by the claimants on grounds of obviousness, insufficiency and anticipation.
The trial related to the validity of Ajinomoto's European Patent (UK) for producing, on an industrial scale, a low calorie sweetener called Aspartame. Daesang sought revocation of the patent, on grounds of anticipation and obviousness over a published Japanese Patent specification, and insufficiency for ambiguity due to the terms used in the claims. Ajinomoto did not make any claim for infringement since this was pending before the Dutch court for the same Dutch patent.
The patent related to an invention of cooling a supersaturated solution of aspartame without stirring or any other movement so that a certain weight percentage of crystals formed, leaving a solution of water but in a pseudo-solid state. Then, this would be converted into slurry by stirring, from which crystals were extracted. The fact that the crystals could be extracted easily was the invention in the patent.
Daesang argued that the claims contained ambiguous terms such as 'sherbet-like pseudo-solid phase' and 'without effecting forced flow' and thus were insufficient. The Court however held that ambiguity in a claim is not a ground for invalidity.
Relating to prior art, the Court examined the Japanese patent, which described a method of removing impurities from aspartame by a combination of anion-exchange and an unspecified crystallisation step in an industrial method. The patent specification did not discuss the crystallisation technique in detail and did not specify the actual technique used by the patentee but mentioned two working examples on a laboratory scale. Expert witnesses disagreed whether this patent specification covered the patent in dispute or not. The Court held that since no particular method of crystallisation is mentioned, the described methods in the Japanese patent did not encompass the patent in dispute. Secondly, even assuming that the Japanese patent did teach the use of static crystallisation, it did so in the laboratory, which could not be equated to its application on an industrial scale. The Court stated that there were no clear and unmistakable directions in the Japanese patents to carry out the process taught by the respondent's patent and thus it was not anticipated.
As regards obviousness, the Court acknowledged the fact that the term 'industrial scale' and its boundaries are ambiguous but held them to suffice a skilled man to distinguish between processes carried out in the laboratory and commercial production. The Court held that the term included at least bulk production, speed, reduced cost and uniform and predictable quality. Furthermore, Daesang contended that a laboratory chemist was likely to make up an aspartame solution as part of his experiments and would find as a matter of course that without stirring, it settled into a pseudo-solid phase that would break down without leaving the residue, which he would then apply to industrial process. The Court disagreed with this contention for a number of reasons: the fact that too much 'hindsight' was used to arrive at such a conclusion; the fact that no one else had discovered this fact as there was common general knowledge that this would lead to a solid or pseudo-solid mass in the bottom of the crystalliser; and there was no reason to suspect that this mass could actually be removed more easily than the residue left by the conventional agitated crystallisation. Hence, the Patent Court upheld the validity of the patent.
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