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Thursday, 10 April 2008

More than the patentee deserves? No problem ...

Back in May 2007 Mr Justice Kitchin gave a ruling in H Lundbeck A/S v Generics (UK) Ltd and others, noted here by the IPKat with reference to the facts -- which will not be repeated here. That decision was based on the so-called ‘Biogen insufficiency’ principles, set down by Lord Hoffmann in Biogen v Medeva and neatly noted on the Jenkins website here. The Court of Appeal ruling has just been handed down today (you can read it here in full on BAILII).

Right: getting valid patent claims will soon be child's play if the courts carry on like this

Remarkably the court is spearheaded by a Law Lord, the redoubtable Lord Hoffmann, with Lady Justice Smith and Lord Justice Jacob making up the panel.

At paragraphs 26 to 36 Lord Hoffmann got to grips with the insufficiency issue:

"26. The judge held that claim 1 and claim 3 (which is dependent on claim 1) were insufficient. His reasoning was that claim 1 ... was a claim to a monopoly of that product however made: see section 60(1)(a) of the 1977 Act. But Lundbeck's inventive idea was not to discover that the enantiomer existed and had a medicinal effect. Everyone knew that the two enantiomers existed and that one or other or both had a medicinal effect. What Lundbeck discovered was one way of making it. But that did not entitle them to a monopoly of every way of making it.

27. ... In an ordinary product claim, the product is the invention. It is sufficiently enabled if the specification and common general knowledge enables the skilled person to make it. One method is enough.

28. The statutory basis for a claim for revocation on the grounds of insufficiency is section 72(1)(c):

"[T]he court…may… revoke a patent [on the ground that] the specification of the patent does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art".

29. In order to decide whether the specification is sufficient, it is therefore first necessary to decide what the invention is. That must be found by reading and construing the claims, in which the inventor identifies what he claims to be his invention. ...

30. Section 60(1) of the Act makes it clear that a claim may be either to a product or a process. In the case of a product claim, performing the invention for the purposes of section 72(1)(c) means making or otherwise obtaining the product. In the case of a process claim, it means working the process. A product claim is therefore sufficiently enabled if the specification discloses how to make it. There is nothing to say that it must disclose more than one way.

31. The judge founded his decision entirely upon the decision of the House of Lords in Biogen v Medeva [1997] RPC 1, which he subjected to a careful and detailed analysis. I shall try, with suitable diffidence ... to explain why I do not think that case yields so broad a principle.

32. In Biogen the inventor ... was the first to succeed in producing by recombinant genetic technology a DNA molecule which could express the antigens of the hepatitis B virus in a host cell. He wanted to patent his invention. But what had he invented? He could not claim to have invented the relevant DNA molecule, because it existed naturally in people suffering from hepatitis B. Nor could he claim to have invented the molecule isolated and outside the human body, because that had been done by purification of samples of the infective agent: .... What he had invented was a process for making it. But he obviously thought that simply to patent his process would not give him much of a monopoly, because the science was rapidly advancing and scientists would find other methods of making the antigens, outside the scope of any process claim he could justify. That was in fact what happened.

33. What [he] tried to do, with a view to claiming the widest possible monopoly, was to make a product claim to a DNA molecule which defined the product partly by the way it had been made and partly by what it did, namely to express the antigens. It was a hybrid or "product-by-process" claim,... It was not a simple product claim because, as I have said, that would have failed for lack of novelty. ...

34. ... as a matter of construction, the House of Lords interpreted the claim as being to a class of products which satisfied the specified conditions, one of which was that the molecule had been made by recombinant technology. That expression obviously includes a wide variety of possible processes. But the law of sufficiency, both in the United Kingdom and in the EPO, is that a class of products is enabled only if the skilled man can work the invention in respect of all members of the class. The specification might show that this has been empirically demonstrated or it might disclose a principle which can reasonably be expected to apply across the class: .... But the specification in Biogen described only one method of making the molecule by recombinant technology and disclosed no general principle. It was easy to contemplate other methods about which the specification said nothing and which would owe nothing to the matter disclosed.

35. In my opinion, therefore, the decision in Biogen is limited to the form of claim which the House of Lords was there considering and cannot be extended to an ordinary product claim in which the product is not defined by a class of processes of manufacture. It is true that the House in Biogen indorsed the general principle ... that—

"the extent of the patent monopoly, as defined by the claims, should correspond to the technical contribution to the art in order for it to be supported or justified."

The judge said that in holding claim 1 insufficient, he was applying this principle. But then he treated the relevant "technical contribution to the art" as being the inventive step, namely a way of making the enantiomer. That, I respectfully consider, was a mistake. When a product claim satisfies the requirements of section 1 of the 1977 Act, the technical contribution to the art is the product and not the process by which it was made, even if that process was the only inventive step".

Writing no doubt for a quotable posterity, Lord Justice Jacob came up (at paragraphs 52 to 57) with a pithy summary of the position as he saw it:
"52. I turn to sufficiency. ...The claim is to the (+) enantiomer. That is novel and non-obvious. If one asks the straightforward question "Does the patent enable the skilled man to make it?" the answer is an equally straightforward: "Yes." So, in the language of Art 83, the patent discloses "the invention in a manner sufficiently clear and complete for it to be carried out."

53. Where then, lay the Judge's error? He reasoned thus: that the (+) enantiomer existed was known. So all that Lundbeck "invented" - contributed to the art - was a particular way of making it. So its patent claim should be correspondingly limited. Were it otherwise, Lundbeck would effectively get a monopoly to any way of making the (+) enantiomer – ways which it had not invented. Hence the claim was insufficient.

54. But any product claim is apt to give the patentee "more than he has invented" – and in two ways. Firstly such a claim will have the effect of covering all ways of making the product including ways which may be inventive and quite different from the patentee's route. Secondly it will give him a monopoly over all uses of the patented compound, including uses he has never thought of.

55. I elaborate on the second point a little. A patent can only be granted for a novel substance if the patentee specifies a use for it (absent this he has simply not made an invention at all – has added nothing to human knowledge). But once he has specified a use, his claim to the substance will cover any use. For instance he may invent a new glue, specified in his claim by its chemical composition. If that glue turns out to be useful for some entirely different purpose, e.g. as a plasticiser, he has a monopoly over that too – more than he "invented".

56. It works the other way round too. If a substance is old, it may not be repatented as such just because the later inventor has found an entirely different use. ...

57. The fact that compound claims may give a patentee "more than he deserves" has not in practice proved to be much of a problem. Their certainty and pragmatic value has proved itself over the years. What matters for present purposes is that the concept "that the patentee should not have more than he deserves" does not form part of the statutory test for sufficiency".
The IPKat says, the courts do seem to be getting a lot kinder to patentees these days. Validity, infringement, damages: there does seem to have been a quantum shift in the pendulum's swing. Merpel says, so nothing has really changed, it seems. It's not what Biogen stands for but how you interpret and apply it -- or have I missed something? Tufty says, it's good to see Lord Hoffmann slumming with the Lords Justices of Appeal. Will this be a precedent? And does he fancy helping out at the Patents County Court too ...?

3 comments:

Anonymous said...

For me, the most significant part was the judgement that absolute protection of substances is not in practice a mischief. When X invents a drug to cure disease Y, he can have a patent for the drug molecule M, as such, because it just isn't very likely that another company will want to use molecule M for any unrelated purpose. Oh well. If anybody should know whether that's sound, it's Robin Jacob.

Anonymous said...

From par. 26:
"But Lundbeck's inventive idea was not to discover that the enantiomer existed and had a medicinal effect. Everyone knew that the two enantiomers existed and that one or other or both had a medicinal effect. What Lundbeck discovered was one way of making it."

My first reaction: if this is the case, then the product claim simply is obvious and (imho) it's not too useful to discuss sufficiency. Clearly, if you claim a product and disclose one way of making it over the whole claimed scope, then that should be sufficient disclosure.

But when I now look at the first instance decision I must admit things are more complicated. Par. 154 confirms the above par. 26 but points out that it was not known from the prior art how to make it. In that case the prior art is not enabling so can't be used for inventive step. So the product claim is allowable even though the invention resides really in the one disclosed way of making it. And that indeed is contrary to "the general legal principle that the extent of the patent monopoly, as defined by the claims, should correspond to the technical contribution to the art in order for it to be supported, or justified".

Interesting! Somehow Chemistry patents are clearly different from what I'm used to...

Anonymous said...

Also interesting is whether the Problem and Solution Approach gives the right answer, on obviousness. What's the technical field, for example? If the use is not recited in the claim then the field can only be "molecules". What's the objective problem? Can we invoke the "use" of molecule X that the court says must be stated in the patent application? Does the inventor need comparative data, to demonstrate the efficacy of that use? Is that a technical effect that Lord Hoffmann thinks is essential for validity? Take a claim to the other enantiomer, the one with the negative effect. Is that claim valid too? Can anybody offer a Problem and Solution analysis on the Lundbeck's claim 1, and to a claim on the other enantiomer?

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