Monday, 22 June 2009

House of Lords addresses ‘Biogen insufficiency’

Authors: Paul Inman and Simon Spink (Howrey LLP)

Citation: Journal of Intellectual Property Law & Practice 2009 4(7):459-461; doi:10.1093/jiplp/jpp075



Generics (UK) Limited & Ors v H. Lundbeck A/S [2009] UKHL 12, 25 February 2009

In this decision, the House of Lords addressed its own earlier decision in Biogen v Medeva where the oft-cited principle of ‘Biogen insufficiency’ arose. As stated by Lord Walker in his opinion, ‘The distinction between product claims and process claims, especially in relation to the appropriate test for sufficiency, is at the heart of this appeal’.

Facts

Lundbeck's patent for escitalopram, a single enantiomer drug for the treatment of depression, claimed both the product itself and the method for its manufacture. Generics challenged the patent on grounds of novelty, obviousness, and insufficiency. At first instance ([2007] EWHC 1040 (Pat)), Kitchin J found that the enantiomer was both novel and inventive but that, by the priority date, enantiomers of known racemates were ‘obviously desirable goals’. He therefore followed the principle apparently laid down by Lord Hoffmann in the House of Lords in Biogen v Medeva, namely that ‘the first person to find a way of achieving an obviously desirable goal is not permitted to monopolise every other way of doing so’. To do so would exceed the ‘technical contribution’ to the art. On that basis, he found the claims to the enantiomer invalid for so-called ‘Biogen insufficiency’.

On appeal ([2008] EWCA Civ 311), Lord Hoffmann (unusually sitting in the Court of Appeal) held that Kitchin J had misinterpreted his judgment in Biogen which, he said, applied only to ‘product-by-process’ type claims and not to ‘simple product claims’ such as Lundbeck's claim. With Jacob LJ in agreement, the Court of Appeal overturned the finding of insufficiency.

In October last year, the Lords gave permission to Generics to appeal further. The Lords heard the appeal in January and gave their decision less than 6 weeks later.

Analysis

The Lords' decision (lead judgment by Lord Neuberger) was unanimous in dismissing Generics' appeal and upholding the claims to the enantiomer.

The Lords agreed that when seeking to revoke a patent for ‘sufficiency’, in addition to considering the clarity and completeness of the specification (under the Patents Act 1977, section 14(3)), consideration must also be given to the ‘support’ given by that description for the claims (under section 14(5)(c)). As Lord Walker pointed out:

Section 14(3) and (5)(c) operate together, as EPC Articles 83 and 84 operate together, to spell out the need for an ‘enabling disclosure’, which is central to the law of patents.
Though section 14(5)(c) had been thought to be more relevant to the examination process than revocation proceedings, this judgment confirms the position in Asahi Kasei Kogyo KK's Application [1991] RPC 485, that section 14(5)(c) has a place in the assessment of sufficiency.

The Lords agreed (following the recent trend of the UK Patents Courts) that clear principles arising from the EPO and its boards of appeal should be adhered to in the UK. In this case, the principle laid down in the EPO's decision T409/91 EXXON/Fuel Oils [1994] (OJEPO 653) that ‘the monopoly to be granted to the patentee is to be assessed by reference to the ‘technical contribution’ made by the teaching of the patent', was key.

In the Court of Appeal, Lord Hoffmann had said that Kitchin J was mistaken in equating the ‘inventive concept’ of Lundbeck's patent (ie the process), with the ‘technical contribution’. What he should have found was that the novel and non-obvious enantiomer was itself the technical contribution.

The Lords' analysis of this section of Lord Hoffmann's speech, particularly on the part of Lord Walker, went somewhat further. Lord Walker considered how the two concepts, ‘inventive step’ and ‘technical contribution’, should be defined and distinguished. He suggested that the ‘inventive concept’ is concerned with the identification of the core of the invention, whereas the ‘technical contribution’ to the art is concerned with the evaluation of its inventive concept: how far forward has it carried the state of the art?

In assessing the technical contribution, Lord Walker indicated that regard should be to the ‘lasting strategic importance’ of the invention to the art. How this will be interpreted in future cases relating to sufficiency remains to be seen.

Perhaps surprisingly, the Lords also drew support from a line of EPO case law starting with Kawasaki Steel Corp [1994] OJEPO 695, which dealt with the issue of obviousness. In this decision, the Board of Appeal had concluded that:
an otherwise obvious entity, may become nevertheless non-obvious and claimable as such if there is no known way or applicable (analogy) method in the art to make it and the claimed methods for its preparation are therefore the first to achieve this in an inventive manner.
Although in none of these decisions of the Board was any consideration given to insufficiency, Lord Neuberger noted that the argument based on obviousness considered by the Board was very similar to the insufficiency reason given by Kitchin J. He concluded that ‘it is fanciful to suggest that, if the reason had been arguable, it would not have been raised before or by the Board by now’.

With those principles in mind, Lord Neuberger considered whether (leaving aside Biogen) there was anything in the legislation (either UK or EPC) which meant that Lundbeck's claim to its enantiomer should be held invalid for insufficiency, and concluded:
... the product claim in the present case is valid. I appreciate that this means that, by finding one method of making a product, a person can obtain a monopoly for that product. However, that applies to any product claim.
The remaining question was whether Lord Hoffmann's Biogen speech should make any difference. Although they accepted that certain sections of Biogen, if read out of context, could be construed to support Kitchin J's first instance finding, the Lords ultimately agreed that Biogen was concerned with a very complicated claim that was certainly not comparable with Lundbeck's simple product claim.

Lord Walker said:
Statements of general principle relating to inventions with many embodiments may be irrelevant to an invention which consists of a single chemical compound. ... That is in my opinion the fundamental reason why Biogen does not provide a direct answer to this appeal.
Lord Mance's view was:
... perhaps even more relevant in my view is the fact that nowhere in Biogen Inc. v. Medeva plc do the speeches treat or discuss the claim as a simple claim in respect of a novel product. ... It seems to me therefore that the Court of Appeal was not in the present case bound by the reasoning or result in Biogen Inc. v Medeva plc to arrive at a conclusion that the present claims 1 and 3 were invalid.
And Lord Neuberger said:
the opinion of Lord Hoffmann in Biogen [1997] RPC 1, though a tour de force as Lord Walker says, is of no assistance to the appellants in this case. It applied in the light of the very unusual nature of the claim in that case.
Thus, each of the Lords dismissed the appeal and found Lundbeck's patent claims to its simple enantiomer product sufficient, and therefore valid.

Practical significance

In upholding the Court of Appeal judgment, the House of Lords have confirmed that:

* the principles arising in Biogen do not apply to a simple product claim;
* if a product is novel and non-obvious, the product itself is the ‘technical contribution’ to the art;
* a product which is an ‘obviously desirable goal’ (such as an enantiomer) should not be treated any differently to other product claims. On the contrary, Lord Neuberger went as far as saying:
... where (as here) the product is a known desideratum, it can be said (as Lord Walker pointed out) that the invention is all the more creditable, as it is likely that there has been more competition than where the product has not been thought of.
This decision is good for the research-based pharmaceutical industry, whose business is often reliant on patent claims to simple pharmaceutical products. Further, by removing the threat of ‘Biogen insufficiency’ against such patents, UK patent law has become better aligned to Europe, providing patentees with greater cross-border certainty.

However, it does not provide comprehensive guidance as to the scope of application of Biogen, which remains House of Lords authority, so to some extent the spectre of ‘Biogen insufficiency’ still hangs over patentees. In the Court of Appeal, Lord Hoffmann indicated that the principles in Biogen only apply to the sort of claims then in issue, ie ‘product-by-process’ type claims. Lord Neuberger, however, suggested that the claim in Biogen was ‘almost a process-by-product-by-process claim’. Thus, while the reach of ‘Biogen insufficiency’ has certainly been considerably curtailed by the Lundbeck speeches, where the limits lie remains to be decided.

What is also less clear is the extent to which the concept of ‘lasting strategic importance’ of the invention will play in assessing the ‘technical contribution’ in the future.

1 comment:

  1. I look forward to seeing some comments on this.

    ReplyDelete