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Wednesday, 21 January 2009

Two recent hearty judgments

In the past few days two substantial, and clearly commerically important, judgments have issued from the Patents Court, one relating to a way of stopping heart attacks before they happen, the other relating to a way of fixing hearts when they go wrong.  

The first one, Corevalve v Edwards Lifesciences [2009] EWHC 6 (Pat), related to a type of valve covered by EP0592410, owned by Edwards. Corevalve, a competitor to Edwards in the field of artificial heart valves, applied to revoke the patent on the grounds of anticipation, obviousness and insufficiency. In return, Edwards counter-claimed that Corevalve were infringing the patent.

The claimed valve was in the form of a collapsible stent, enclosing a flexible membrane-type of valve, developed by its Danish inventor back in 1990 using heart valves retrieved from pigs. The patent claimed that the stent was deliverable by catheter, i.e. was able to be collapsed to a small enough diameter that it could be inserted via an artery (usually the femoral artery), put in place at the right position next to the patient's heart and allowed to expand to its normal diameter.  The patent said very little, however, about how this would be done in practice.  

Mr Peter Prescott QC, sitting as deputy judge of the High Court, heard much expert testimony relating to how difficult such a procedure actually was in practice, but determined that the validity of the patent was not really affected by the fact that it was clearly insufficient in this regard, particularly because it did not claim the method of installing the valve (which would, of course, be unpatentable anyway).  It was enough that the patent described the valve in terms sufficient for the skilled person to go ahead and make it.  As for Corevalve's claims for the patent being anticipated and obvious, these claims were dismissed because there were apparently no enabling disclosures around at the time the invention was made that disclosed or suggested to the skilled person a stent-type artificial valve that could be implanted by catheterisation.  The patent was held to be valid, but not infringed. 

The other judgment, Actavis v Novartis [2009] EWHC 41 (Ch), related to another European patent, EP0948320, which claimed a formulation for a drug intended to prevent heart attacks caused by high cholesterol.  The drug, fluvastatin, was one of a family of drugs together known as statins, used to lower levels of LDL cholesterol in the body by affecting its synthesis in the liver.  One alleged problem at the time the patent was applied for was that of maintaining the correct level of drug in the body, for which the patent provided a solution in the form of a 'sustained release' composition, i.e. a formulation that allowed the drug to be slowly released over time through being bound together with a material that slowed its dissolution when passing through the body.  

A huge amount of expert testimony was heard by the judge, Mr Justice Warren (presumably a result of there being a huge amount of money at stake), but in the end the judgment was one that could probably be predicted from a quick look at the claims and from two facts: i) fluvastatin was known for a long time before the patent was applied for; and ii) sustained release formulations were well known at the time.  Since the skilled person, in the form of a research team, would know of these facts, it would be an obvious step to combine them.  The patent was consequently found to be invalid for being obvious.  

More about heart valves here, here and here
How to spot evergreening here.


Anonymous said...

David thanks for Activis and its 351 paragraphs, which I have not read all through as yet. Still, the following comment might get the thread rolling. The fact-finding is magnificent, exemplary, unequalled anywhere else in the world, and proportionate to the amounts of money invested in this case by the litigating parties. But what about the way the court grasps the settled jurisprudence of the EPO, on obviousness? For the money, should not that be treated equally rigorously? Perhaps I am being unfair (readers, correct me if I'm seeing it wrong) but I have thought for a long time that those who don't understand EPO-PSA, yet have to speak about it, or write about it in books, erroneously present the famous could/would test as the essence of it. But, I remain optimistic and expect to see the pressure on the English courts intensifying and, quite soon now, the first reference to Agrevo T939/92 for its "specific technical purpose" to be imputed to the skilled person with the "objective technical problem". Then, at last, we will have English court decisions on obviousness that get treated with respect, throughout mainland Europe (and thus, throughout the world, where the clients are).

MaxDrei said...

See para 172 "The question of obviousness is one of fact, which cannot depend on what the patentee has included in his patent". Under PSA, the objective technical problem does depend on what the inventor told in his patent application. So do we have here a flat contradiction between English law on obviousness and the settled jurisprudence of the EPO? Is England softer than the EPO on obviousness, in that it allows belatedly discovered technical effects, underivable from the app as filed, to be used to beat off an obviousness attack? Is Paul Cole out there? Will he comment?

Anonymous said...

MaxDrei wrote that the "objective technical problem does depend on what the inventor told in his patent application". While this may be true if the closest prior art which the inventor/patent attorney had in mind when drafting the application corresponds to the CPA being considered in the PSA, more generally, this is not the case. Accordingly, it is usually necessary to ignore what the specification indicates to be the problem and determine the objective problem taking into account the differences between the claimed invention and the CPA. That is my understanding, anyway.

In the Actavis case, the discussion of the Conor HoL decision (para. 149 et seq.)appears to be the most interesting. By first, admittedly brief reading was that Warren J. was having some difficulty with the approach of Lord Hoffmann.


MaxDrei said...

EdT, maybe you want to brush up your understanding of what happens in EPO prosecution, when the OTP is re-formulated, following the arrival of a D1 that is "closer" than anything known to the patent attorney who wrote up the application. Whereas Applicant can rely on technical effects derivable from the app as filed, any reliance on a technical effect, of which there is no hint in the originally filed disclosure, will fail. It might be dead easy to invent such an effect, but it won't overcome the obviousness difficulty. At least, not when the EPO is doing PSA by the book. That's what Lord Hoffmann's getting at, with his "plausible". He's right, isn't he? Actually, I think Lord Hoffmann is one of the few who does actually "get" PSA. But he probably feels that the time is not yet right for him to go public on that.

As to Warren J., I take from his para 323 that he favours, over EPO-PSA, the "Is the claimed subject matter like a five and a half inch plate?" obviousness test.

Anonymous said...

MaxDrei, my comment was obviously based on a misunderstanding of your earlier post - I read it to mean that the applicant is stuck with the identification of the problem to be solved recited in the specification.

I would agree that Lord Hoffmann's approach was closer to the PSA - the determination of the 'right question to be asked' can be considered to be an expression of the EPO step of identifying the objective problem to be solved.


MaxDrei said...

Thank you EdT. For me, the elegant thing about PSA is the way it automatically excludes hindsight, by divining the objective technical problem exclusively from two documents that were both written before the legal date of the claim in suit, that is, D1 and the app as filed. I still don't see any recognition in England how potent this is. Instead, lip service is paid to the crucial importance of banishing hindsight thinking, but then the decision relies primarily on evidence adduced by a couple of technical experts who already knew, long before they testified, all about the commercial success of the subject matter of the claim. Being only human, and not computers, they are quite unable to purge their memory banks of such prior knowledge, which is indeed a problem, when they try to help the court decide what would have been obvious, back on the date of the claim.

Margaret said...

I heard and read too much about statin drugs and mostly are negative. What happened with this issue? Is this resolved now?

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