UK: "Biogen Insufficiency" – The End Of The Road

Last Updated: 11 June 2008
Article by Paul Inman

On 10 April 2008 Lord Hoffman, unusually sitting in the English Court of Appeal, handed down judgment in the much anticipated appeal of H. Lundbeck A/S v Generics (UK) Ltd and Others. This was the first substantive appeal against a judgment based solely on the so called 'Biogen Insufficiency' principles, set down by Lord Hoffman in Biogen v Medeva.

This decision brings to an end the concept of Biogen Insufficiency, and brings the English Patents Court in line with most other patent jurisdictions worldwide. It also confirms the recent trend of the English Patents Court to take a far less "anti-patentee" view when considering patent validity.

Executive Summary

In a short judgment overturning the first instance finding of 'Biogen insufficiency', Lord Hoffman has made clear that:

  1. the inventive step in a claim to a product can lie in the process which leads to that product for the first time; (ii) this follows EPO jurisprudence, which has always carried "great weight";

  2. there is only one type of "sufficiency", namely the test laid down in EPC Article 83;

  3. the concept of an 'obviously desirable goal' has no place in patent sufficiency; and

  4. the circumstances in which the principles set down in Biogen apply are "relatively rare".

The Facts

The case concerned escitalopram – an anti-depressant. The prior art, citalopram (also an antidepressant), is a "racemate" which comprises equal quantities of two mirror-image molecules called optical isomers, or enantiomers. Escitalopram is the (+) enantiomer.

The first instance Judge had found that by the priority date (1988) medicinal chemists would routinely seek to resolve racemates to determine which (if either) enantiomer had more activity. Jacob LJ set out a concise summary of the Judge's reasoning on 'Biogen insufficiency' as follows:

"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."

Lundbeck appealed this finding. There was a cross-appeal on novelty and obviousness, in relation to which only one point of interest arises (see below).

The Court Of Appeal Judgment – Sufficiency

Giving the leading judgment, Lord Hoffman made it clear early on that the finding of insufficiency was wrong. He said: "the Judge's instinctive reaction to the inherent breadth of a product claim& is not justified either by the statute or the authorities. & I will try& to explain why I do not think that case [Biogen] yields so broad a principle." His explanation may be summarised as follows:

The claim in Biogen was to "A recombinant DNA molecule characterised by [the fact that it codes for Hepatitis B antigens]". The word 'recombinant' was necessary to distinguish the product from DNA isolated from humans. The word imported a process element to the claim, extending the claim to the DNA molecule made by any recombinant DNA technology process. As such the claim was construed as being to a class of products.

It is settled law that a claim to a class of products is only 'sufficient' if every member of the class is enabled - either by empirical demonstration, or by disclosing a principle which can reasonably be expected to work across the class. The Biogen patent only disclosed one process – therefore the class of products claimed in Biogen was insufficient.

In contrast, Lundbeck's claim was to a single product. In assessing sufficiency, Lord Hoffman stressed that care is needed in distinguishing the "technical contribution" and the "inventive step" and found that the Judge had wrongly equated the two. Biogen had confirmed that the monopoly conferred by a patent must equate to the "technical contribution". EPO cases such as Kawasaki and Du Pont made it clear that if the product satisfies the requirements of novelty and inventive step, the "technical contribution" is the product. However, there is no statutory link between "sufficiency" and "inventive step".

Thus, he stated:

"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."

Both Lord Hoffman and Jacob LJ observed the apparent injustice of being granted a product claim wider than the "real invention". Jacob LJ noted, however, that this is not limited to cases of this type. Most product claims inherently provide wide protection as they confer a monopoly over all uses of the product, whereas (generally) only one use is disclosed. Nevertheless, "the concept 'that the patentee should not have more than he deserves' does not form part of the statutory test for sufficiency."

Lord Hoffman noted that after a chequered history, product claims were expressly introduced by the 1949 Patents Act. In allowing Lundbeck's appeal Lord Hoffman concludes his judgment as follows:

"There are obviously arguments of public policy on both sides: The Kawasaki Steel Corporation line of cases shows that sometimes the "real invention" does not lie in the discovery of the new substance but in finding a process of manufacture. But Parliament has chosen to allow product claims and the jurisprudence of the EPO, which we have always regarded as carrying great weight, shows that such claims can be made in the latter case as well. It is too late to have regrets about the breadth of the monopoly which the claims confer."

The Court Of Appeal Judgment – Obviousness

Although little was made of this issue at the hearing, both the Judges addressed the so-called 'obvious to try' test. Jacob LJ said as follows:

"It is not enough that an experiment revealing an invention would have been short and simple. There has to be a reason why the skilled man would have carried it out. Normally that would require at least an expectation that something might come out of it. Otherwise, short and simple though it would have been, doing the experiment would have been pointless."

Comment

With this judgment, we herald 'Lundbeck Sufficiency' as the successor to 'Biogen Insufficiency'. Had this judgment gone the other way, all enantiomers (post 1988) would have become unpatentable in the UK. Further, invalidity due to insufficiency would have extended to claims to any other "desirable" molecules. In the pharmaceutical industry where research may proceed by identifying potentially useful molecules and then seeing what they do, and where new molecules may now be "designed" to order, the limits of which products are "desirable" would have been very unclear.

This judgment therefore provides considerably more certainty for the pharmaceutical industry, than it would if the outcome had been the other way. After a decade of debate amongst patent practitioners about 'Biogen insufficiency', today's judgment lays the concept to rest, along with the concept of an "obviously desirable goal" – neither is relevant to patent law. There is only one form of sufficiency – that specified in EPC Article 83 – irrespective of whether the product claimed is desirable or not.

The case also emphasises the importance and relevance of EPO case law in the UK and may signal a greater tendency of the UK Courts to follow such jurisprudence in the future.

As regards obviousness, Jacob LJ's comments affirm the Court of Appeal's view on the 'obvious to try' test. At least some expectation of success must exist. As with the findings on sufficiency, this also brings the UK closer in line with the EPO and other patent jurisdictions around the world. We note that the pending House of Lords case, Conor v Angiotech (to be heard next month) may clarify this issue further.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Authors
Paul Inman
 
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