Lord Hoffmann, sitting in the Court of Appeal, has explained and limited the scope of "Biogen insufficiency" with the result that an ordinary product claim in a patent will be sufficiently enabled even if the specification teaches only one method of making it.
Doubtless to avoid the risk that the action would not make it to the House of Lords, Lord Hoffmann took the unusual step of sitting in the Court of Appeal so that he could give judgment in the case of Lundbeck v Generics1 and thereby explain his earlier decision on sufficiency in Biogen v Medeva2. The claim in issue in Biogen was to a recombinant DNA molecule which could express the antigens of the hepatitis B virus in a host cell. It therefore defined the molecule partly by the way in which it was made (by recombinant technology) and partly by what it did (express antigens). As Lord Hoffmann explained, the form of the claim arose because the molecule itself was known (occurring naturally in hepatitis B sufferers and having already been isolated) and because a claim to the process for making the molecule would not give much of a monopoly. Alternative methods of making the molecule to that in the patent, which method was the real invention, would soon be found. The claim failed because effectively it was to a class of products made by recombinant technology, which covers a wide range of possible processes but only one of which was taught, or enabled, by the patent.
There was some similarity between this position and Lundbeck's patent - the product claimed was the (+) enantiomer of citalopram (an antidepressant sold by Lundbeck as Cipralex). It was known that citalopram was a racemic mixture so that the (-) and (+) enantiomers existed and that one or other or both had medicinal effects. There was no invention there. Instead Lundbeck's invention was a way of making the (+) enantiomer alone, which had not been done before. The first instance judge therefore applied Biogen to hold that, by claiming the (+) enantiomer, Lundbeck was effectively gaining a monopoly over all ways of making that molecule when it had only discovered one.
Lord Hoffmann sympathised with this reasoning but held it was contrary to the Patents Act 1977 and to the jurisprudence of the European Patent Office ("EPO") following both of which if a patentee finds a non-obvious way of making a product he is entitled to a product claim and the full width of the monopoly that confers. It was too late to have regrets over what could be seen as the unwarranted breadth of that monopoly. Further, the Biogen decision was limited to the specific form of claim under consideration in that case and could not be extended to ordinary product claims.
The clarification that the Lundbeck decision brings to the law of sufficiency is welcome for patentees and their IP advisors. What had become known as Biogen sufficiency was of uncertain scope and was routinely argued against biotech and other patents which disclosed limited ways of making a product. The prior position that, as long as a new and non-obvious product was claimed, only one method of making it need be taught had been lost sight of. It has now been reaffirmed as good law.
Footnotes
1. Aerotel Ltd v Telco Holdings Ltd & others and Macrossan's Patent Application [2007] RPC 7
2. [1997] RPC1
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