Globes bericht: "Teva Pharmaceutical Industries Ltd. has chalked up a victory in the UK against Mylan Inc., after losing a court case in the US. The Court of Appeal for England and Wales has found in favor of Teva, upholding the validity of the asserted claims of its Copaxone patent through May 2015. The court dismissed the appeal by Mylan subsidiary Generics [UK] Ltd.
Copaxone, for the treatment of multiple sclerosis, is Teva's flagship product, and is reportedly responsible for half of the company's profits. On Friday, the US Court of Appeals for the Federal Circuit ruled in favor of Mylan and Sandoz Inc. that Copaxone's patents were only valid until May 2014. That ruling will allow the launch of generic Copaxone in the US next year."
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England and Wales Court of Appeal, Chancery Division, Patents Court, 29 July 2013, Mylan v Teva.
Enkele overwegingen m.b.t. de problem-solution approach en post-published data:
51. The judge recorded at [343] that there was no dispute that if the patent, when read with the skilled person's common general knowledge, did not disclose enough to make it plausible that the invention solved the technical problem, then that was the end of the matter, and it was not permissible for the patentee to rely upon evidence which post-dated the patent to demonstrate the technical effect. He identified the dispute as being over a second proposition advanced by Mylan, namely whether, if the patent did make the invention plausible, it remained open to the other party to cast doubt on this by post-dated evidence. At [350], having reviewed some EPO cases and a decision of his own in Sandvik Intellectual Property AB v Kennametal [2011] EWHC 3311 (Pat), he concluded as follows:
"In my judgment, however, these decisions represent the limits to which post-dated evidence may properly be put. In short, post-dated evidence may be relied on to confirm that the disclosure in the patent either does or does not make it plausible that the invention solves the technical problem. Post-dated evidence may not be relied upon either to establish a technical effect which is not made plausible by the specification in order to rebut an allegation of obviousness or to contradict a technical effect which is made plausible by the specification in order to found an allegation of obviousness. In my view it would be bizarre if, as counsel for Mylan submitted, a patent which at the time it was applied for disclosed what everyone thought was a good invention could be revoked 20 years later because subsequent advances in science had revealed that in fact the invention did not solve the technical problem. "
52. I would start from the proposition that, in general, evidence may be deployed if it is relevant to a matter properly in issue between the parties. Evidence that the claimed invention does not in fact result in a particular technical advance will be admissible if, under Article 56 EPC, one of the issues which may properly and relevantly arise is whether the patentee has made the technical advance on which he relies. I think there are a number of reasons why, under Article 56, it is relevant to ask whether the alleged technical contribution has in fact been made.
53. Firstly, the problem and solution approach suggests, by its very name, that it is an approach which shows that the patentee has in fact provided a solution to a problem.
54. Secondly, and more importantly, the underlying principle which the problem and solution approach to Article 56 seeks to encapsulate and promote is that the patentee's monopoly must be justified by his contribution to the art. It would be a surprising result if the effect of applying this approach was that a monopoly could be justified by reference to an alleged contribution which could be demonstrated not to exist in fact.
55. Thirdly, if all that the patentee has contributed is a plausible but untrue prediction, this is the very antithesis of a contribution. What he would have contributed is a suggestion that something might plausibly work. But as Lord Hoffmann said in Conor at [28]:
"It is hard to see how the notion that something is worth trying or might have an effect can be described as an invention in respect of which anyone would be entitled to a monopoly"
[...] 59. The judge at [348] of his judgment in the present case supported his conclusion that evidence was not admissible to contradict a technical effect made plausible by the specification by reference to "the fundamental principle … that whether a claimed invention is obvious or not should be judged as at the priority or application date." He went on to say at [350]:
"it would be bizarre if, as counsel for Mylan submitted, a patent which at the time it was applied for disclosed what everyone thought was a good invention could be revoked 20 years later because subsequent advances in science had revealed that in fact the invention did not solve the technical problem."
60. I do not dispute for one moment the fundamental principle which the judge identified. The evidence which is relied on to show that the invention was an obvious step for the skilled person to take must, plainly, be evidence which would have been available to the skilled person at the time. But in order to determine whether an invention is obvious at the priority date one needs to decide an anterior, and purely factual question: what is the invention?
61. There is, of course, no general principle that all the evidence which is admitted on the issue of obviousness must be evidence which was available at the priority date. Thus, it is well settled that the reaction of those skilled in the art to the invention (something which occurs after the priority date) can be secondary evidence of inventiveness. So, in Schlumberger Holdings Limited v Electromagnetic Geoservices A/S [2010] EWCA (Civ) 819 Jacob LJ said at [81]:
"Another important matter to consider is the reaction of experts at the time of the invention, both before and after."
62. Equally it is common to admit evidence of subsequent commercial success, although it is necessary to make sure it is commercial success of the invention: see Schlumberger at [79] to [80] referring to Laddie J's lucid explanation of the principles in Haberman v Jackel [1999] FSR 683. Similarly, the fact that a defendant has later copied, or applied to patent the invention himself, may be factors of weight in appropriate cases: see as to patenting e.g. Unilever v Chefaro [1994] FSR 567. One of the matters often taken into account in assessing obviousness has always been whether the invention brings with it important practical benefits. Fletcher Moulton LJ made clear the importance of the practical consequences of the invention (which might only be demonstrated later) in British Westinghouse Electric & Manufacturing Co. v Braulik (1910) 27 RPC at 230:
"I confess I view with suspicion arguments to the effect that a new combination, bringing with it new and important consequences in the shape of practical machines, is not an invention, because, when it has once been established, it is easy to show how it might have been arrived at by starting from something known, and taking a series of apparently easy steps." (emphasis supplied)
63. The problem and solution approach to obviousness requires the court or tribunal to judge inventiveness by reference to what it is that the invention brings with it: its technical effect or advance. Like any other fact relevant to an issue, however, it must be open to being refuted. In doing so one is not judging the obviousness of the claimed invention by reference to later evidence: one is simply defining by evidence what it is that the invention is or brings with it.
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B912451
