Lundbeck lose Cipralex protection

A recent decision from the High Court illustrates how it might be overambitious to claim patent rights over a new product when all you have done is show one way of making it.

In Generics (UK) Ltd & Ors v H Lundbeck A/S, decided last Friday by Mr Justice Kitchin at the High Court, Lundbeck's patent covering Cipralex (citalopram, right) was partially revoked on application by the claimants under section 72 for being insufficiently disclosed. The patent claimed not only a novel way of making the more active (+) enantiomer of citalopram, but effectively all ways of making it. Kitchin J stated (at paragraphs 265-267),

"I accept that if a patentee describes a new and non obvious compound which has a beneficial effect and describes a way by which it can be made then he is entitled to a patent for the compound. [...] In such a case the technical contribution lies in the provision of the new and useful compound. Others might find different ways of producing it. But this does not render the original patent insufficient because in each case they are making use of the technical contribution – the knowledge they are making the new and useful compound.

In my judgment this is not such a case. For the reasons I have set out at length earlier in this judgment I am satisfied that medicinal chemists working in the field of SSRIs at the priority date considered it obviously desirable to separate out and test the enantiomers of active racemates. True it is that in the case of citalopram no one knew the activity would lie in the (+) enantiomer. However it was entirely obvious that the activity might lie primarily in one enantiomer rather than the other. Further, once the enantiomers had been separated the tests which the inventors carried out to determine where the activity lay were routine and straightforward, as were the steps necessary to formulate the (+) enantiomer into a pharmaceutical composition. The inventive step taken by the inventors of the Patent was not deciding to separate the enantiomers of citalopram but finding a way it could be done. The technical contribution they made was the discovery that the diol intermediate could be resolved and then the enantiomers of the diol converted into the enantiomers of citalopram whilst preserving their stereochemistry.

Claims 1 and 3 of the Patent cover all ways of making the (+) enantiomer of citalopram. For example, they cover resolving citalopram on a preparative chiral HPLC column. Does this method of resolution owe anything to the teaching of the Patent or any principle it discloses? In my judgment it does not. By June 1988 the preparation of the individual enantiomers of citalopram was an obviously desirably goal and their testing was trivial. There is no teaching in the Patent as to how that goal is to be achieved other than by the use of the diol intermediate. Just as in Biogen, it not enough to say that the inventors showed that resolution could be done and that they found the activity lay in the (+) enantiomer. The first person to find a way of achieving an obviously desirable goal is not permitted to monopolise every other way of doing so. Claims 1 and 3 are too broad. They extend beyond any technical contribution made by Lundbeck".
The claims to the product itself, either in the form of (+) citalopram or a pharmaceutical composition comprising (+) citalopram, were therefore deemed to be invalid. This left Lundbek with only the particular method of making the enantiomer.

The IPKat thinks that this decision must be right. If the more active (+) enantiomer was obvious (i.e. ob via: lying in the way) once activity for the racemic mixture was known, a claim covering that enantiomer itself could not be inventive. A claim to a novel and inventive process for making the enantiomer would, however, be a different thing altogether.

He also wonders whether similar reasoning applied in the recent Monsanto case at the EPO (blogged here), where the patent in question claimed all GM soybeans, even though the specification disclosed only one particular way of making them.

Merpel says that one can't blame the patentees for trying it on, and at least they (in both cases) got 18 good and highly profitable years of protection before having it taken away from them.
Lundbeck lose Cipralex protection Lundbeck lose Cipralex protection Reviewed by David on Monday, May 07, 2007 Rating: 5


Luke Ueda-Sarson said...

Does anybody have a web-accessible copy of the US District Court of Delaware's judgement from last year affirming validity over there? I'd like to see how the two cases compare.

I note that once again the skilled address is said to have no inventive capability here; cf. the pronouncement in KSR that a PHOSITA in the States is supposed to have ordinary creativity. Is there supposed to be a distiction between "creativity" and "inventiveness"? Or does KSR make a US PHOSITA a fundamentally different creature from the UK skilled addressee?

Regards, Luke

genericipguy said...

I have documents from the US Dist. Ct. proceedings.
Do revert to rathodsandeep [at] gmail [dot] com

David said...

If you would like to email them to theIPKat [at] gmail [dot] com, he will happily make them more widely available.

twr57 said...

The reasoning in this case should definitely apply to the GM soybeans (and it will be interesting to see if the Appeal Board take the same line). GM soybeans were an obvious target, and any contribution could only be in providing a process to make them. If I remember correctly, we actually cited Lord Hoffmann in Biogen in the course of the opposition proceedings. It's usually different with pharmaceuticals - they may be structurally obvious, but until you've actually made them, you can't verify their specific value: and they will normally have some specific problem-solving advantage. But the 'problem and solution' approach really demonstrates the vacuity of the GM product claims: "Problem - find a way to make GM soya: Solution - GM soya!" Again, unlike a specific novel pharmaceutical, GM soya (as a class) has no specific improved utility compared with ordinary soya (though of course particular GM genes may add extremely useful properties). But it's much more difficult to argue that a claim is disproportionate after grant, as S84 is no longer available.

twr57 said...

...oh, and I disagree with Merpel. I think you can blame the patentee for trying it on, at least in some cases. Under the old English law, those who made covetous claims used not to be allowed to amend. And overbroad claims attract oppositions. But Examiners have the prime responsibility here, particularly since S84 is not available after grant. Patentees should never be allowed to distinguish their inventions solely by the result to be obtained.

Luke Ueda-Sarson said...

Thanks to Sandeep Rathod, I've had a look at the corresponding US decision. Rather interestingly, sufficiency was never litigated there, since it was agreed between the parties beforehand that the battle for invalidity would be about novelty, obviousness, and possible reissue problems due to an error being typographical or not.

A potential scorecard in the making for Duncan Bucknell in Australia?

As an aside, when I read the UK decision, I wondered about the wisdom of a litigant (yet again) employing someone as eminent as Davies an an expert witness by one of the sides; but was even more suprpised to see two such big guns deployed in the US case, one on each side. These really high-powered types are often subject to problems because they are so much more skilled than the skilled addressee: didn't a UK case recently refer to Oxford's Jack
Baldwin as being unsuitable, since he wasn't even close to being of ordinary skill, but a "world-champion"? And yet his successor (Davies) is involved here... Yes these guys can talk about who the skilled person should be, but they aren't in a particulalrly good position to talk about what the skilled person actually knew. Furthermore, and this seemed to be a problem in the US case (though one would have to dig into the transcript to be sure), such high fliers can be criticised because they haven't done any actual experiments "themselves" for so long - they head their research efforts, but the leg-work is done by post-docs etc.

Regards, Luke

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