The decision in Biogen v Medeva was handed down by the House of Lords on the night of Halloween , more than 20 years ago. The case is a landmark. That decision was based on the so-called ‘Biogen insufficiency’ principles, set down by Lord Hoffmann in Biogen v Medeva and neatly noted. Honble Shri S. Chandrasekaran, Technical Member This is an original application for revocation filed under section 64 read with section D of the Patents Act.
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Please contact customerservices lexology. The drug sold under this patent called Cipralex is boasted as biogn the top selling antidepressant in terms of volume in the world. Citalopram is sold in the United Kingdom under the brand name Cipramil; other serotonin inhibitors are fluoxetine sold as Prozac and paroxetine Seroxat. Since the expiry of the Citalopram patent, the drug has been sold by a number of manufacturers in its generic form.
Citalopram is a racemate, consisting of equal numbers of two molecules called enantiomers. In brief, an enantiomer is a molecule that cannot be mapped to its mirror image by rotations and translations alone. The only physical difference between enantiomers is their effect on polarised light, causing rotation of the plane of light either to the left or right. A racemate is an equal mix of left and right-handed enantiomers that has no effect on polarised light.
Sufficiency: when is a product a product – Biogen v Medeva revisited?
It has been well known for many years that, despite their similarities, two enantiomers may bind to different proteins and produce different biological effects. It is now known as one of the best treatments for leprosy. Separating a racemate into its constituent enantiomers is not a straightforward matter. Because they have the same boiling point, they cannot be separated by conventional means such as fractional distillation or fractional crystallisation.
There are indirect methods of coming at the problem and Lundbeck set out to try to find one of them in This involved a good deal of trial and error and Lundbeck was not successful until They contended that Lundbeck was simply repatenting its previous invention of citalopram, or the active ingredient in that product, to extend its monopoly for another decade.
They claimed revocation of the patent on three grounds:. Claims 1 and 3 are invalid for insufficiency because they claim the enantiomer made by any method, but the specification discloses only two ways of making it. Kitchin J at first instance rejected the first two grounds of attack, but accepted the arguments regarding the lack of sufficiency thereby revoking claims 1 and 3.
He upheld claim 6. The parties appealed and cross appealed. A patentable invention must be new Patents ActSection 1 1 a and an invention is not new if it forms part of the state of the art Section 2 1.
The state of the art comprises all matter made available to the public before the priority date Section 2 2. In order to anticipate a patent, the prior art must disclose the claimed invention and together with common general knowledge enable the ordinary skilled person to perform it. It is agreed that the prior art did not anticipate the isolated enantiomer. It is settled jurisprudence in the European Patent Office EPO that disclosure of a racemate does not in itself amount to disclosure of each of its enantiomers.
Therefore, Lord Hoffman was satisfied that the subject patent was novel. Diastereomic salts of the amino diol the last intermediate in the synthesis of citalopram were resolved it into its enantiomers and then converted into the enantiomers of citalopram by a reaction that preserved their distinctive threedimensional structures. This method was specified in claim 6 of the patent. The specification also disclosed another method which had not been said to be obvious and therefore need not be considered.
Kitchin J found that the amino diol route was not obvious. The judge heard a good deal of evidence on how the skilled person might set about trying to resolve citalopram.
The parties agreed that he would initially try to resolve the molecules of the final product. Initially, 13 different possible techniques described in the literature were unearthed at trial and, although Kitchin J found that the skilled person would not have known about all of them, that still left several that he could and might try.
In no case was the outcome predictable. Experts for the Claimants were not deemed particularly helpful and their evidence was largely rejected. Once their evidence was dismissed, any issue regarding the obviousness of the patent faded away. The Court of Appeal then addressed the issue of sufficiency and, in particular, the decision of Biogen v Medeva.
In Biogen v Medevathe House of Lords considered the sufficiency of a product claim to a DNA molecule that defined the product partly by the way it had been made and partly by its function.
The patent claim was held to be a class of products that satisfied the specified conditions, which could have been made by a wide variety of possible processes. The House of Lords held that the law of sufficiency in both the United Kingdom and the EPO, was that a class of products was enabled only if the skilled man could work the invention in respect of ALL members of the class.
As the claim under dispute only described one method of making DNA and the patent specification disclosed no general principle, it was insufficient and therefore invalid. 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 bigen a monopoly over every way of making it. 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.
Sufficiency: when is a product a product – Biogen v Medeva revisited? – Lexology
One method is enough. The statutory basis for a claim for revocation on the grounds of insufficiency is Section 72 1 c:. In order to decide whether the specification is sufficient, it is therefore first necessary to decide what the invention is by reading and construing the claims, in which the inventor identifies what he claims as his invention.
Section 60 1 of the Patents 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.
Kitchin J clearly reached his judgment entirely upon the decision of the House of Lords in Biogen v Medeva. Lord Hoffman reviewed the House of Lords decision and ultimately concluded:. What the judge has done is to make the requirements for sufficiency under section 72 1 c differ according to the nature of the inventive step.
But the case is otherwise if the inventive step is to find blogen way of making an obvious compound. In my opinion, however, there is nothing in section 72 1 c which connects the medeca of sufficiency to the inventive step. What needs to be disclosed sufficiently to enable it to be performed is the invention as defined in the claim. That remains the same, whatever may have been the inventive step. Lastly, Lord Hoffman stated: Jacob LJ, however, wanted to provide his own spin on the main points under appeal and meceva particular on the issue of sufficiency.
That is novel and nonobvious. It is easy to see why Kitchin J was tempted to follow the Biogen decision straight down the line, especially as this area of law and the subject matter of the Lundbeck patent would not have made it any easier for the judge to see some of the subtleties of the case. He essentially saw one product claim as being very much the same as any other product claim but, that clearly was not the case and was expressly spelled out by Lord Hoffman niogen his judgment.
Ordinary product claims will not be affected by the Biogen decision. However, in order to avoid Biogen insufficiency, applicants for products defined by either the process of their manufacture or by their properties must be very aware that sufficiency of the specification will be very much at the heart of the case.
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United Hiogen May 31 They claimed revocation of the patent on three grounds: Claims 1, 3 and 6 are invalid for obviousness 3.
Claims 1 and 3 are invalid for insufficiency because they claim the enantiomer made by any method, but the specification discloses only two ways of making it Kitchin J at first instance rejected the first two grounds of attack, but accepted the arguments regarding the lack of sufficiency thereby revoking claims 1 and 3. Lord Hoffman biogeh sympathetic with this analysis but could not concur and stated: Lord Hoffman reviewed the House of Lords decision mmedeva ultimately concluded: A view of the bridge: United Kingdom Litigation Intellectual Property.
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