Insufficiency of Product Claims

The UK Law Further Clarified*

By APLF Member Firm Kilburn & Strode, London U.K.

The UK Court of Appeal panel hearing this second-instance appeal included Lord Hoffmann, our most distinguished IP judge, which is unusual because he normally sits in the House of Lords, a court of third instance. It is assumed that he did so in order to explain and clarify his judgment in Biogen v Medeva**, until now the leading judgment on ‘insufficiency’ that he himself wrote.

Lundbeck owned a patent for the antidepressant drug Citalopram®. Citalopram is a racemate made up of two enantiomers. Lundbeck managed to separate the racemate into its enantiomers and found that the antidepressant effect was caused entirely by the (+) enantiomer. The patent in this case included Claim 1 to the (+) enantiomer itself, Claim 3 to a pharmaceutical composition comprising that compound, and Claim 6 to a method for the preparation of the compound. The issue was, Lundbeck had discovered one way of making the enantiomer, but did that entitle them to claims to every way of making it?

Lord Hoffmann commented:

“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.”

Lord Justice Jacob agreed and commented:

“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.”

Lord Hoffmann then reconciled his reasoning in Biogen in this way:

“Thus, [in Biogen], 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 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…

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 …. 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. [Lord Hoffmann then approved the EPO Technical Board decision in T595/90 Kawasaki Steel Corporation*** and said that English courts should give very great weight to such decisions, and continued:]

…Biogen should therefore not be read as casting any doubt upon the proposition that an inventor who finds a way to make a new product is entitled to make a product claim, even if its properties could have been fully specified in advance and the desirability of making it was obvious … In my opinion, however, there is nothing in section 72(1)(c) which connects the requirements 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. ….”

*H. Lundbeck v (1) Generics (uk) Limited & Ors; (2) Arrow Generics Limited and (3)T Teva UK Limited and Teva Pharmaceuticals Limited; Court of Appeal, Lord Hoffmann, Smith and Jacob LJJ; [2008] EWCA Civ 311; 10 April2008

**[1997] R.P.C. 1,

***[1994] OJ EPO 69

The information provided in this article is, of course, of a general nature and should not be considered as legal advice; if you have any specific questions, please contact Paul Chapman at in London, UK. E-mail: pchapman@kstrode.co.uk. Visit the website at www.kstrode.co.uk

The information contained in this alert is provided for informational purposes only and does not represent legal advice. Neither the APLF nor the author intends to create an attorney client relationship by providing this information to you through this message.

 

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