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Wednesday, 10 August 2016

BREAKING: Puns at the ready, Mr Justice Birss delivers epic CIALIS judgment

It's how long? ! 
A judgment of Arnoldian proportions has just landed on the AmeriKat's desk, but it is not from its namesake.  It is instead from Mr Justice Birss.  At an eye watering 113 pages consisting of 491 paragraphs, his decision in Actavis v ICOS [2016] EWHC 1955 is recommended beach reading for those ready to jet off the south of France for their August holidays.  Two patents were in issue - '181 (dosing) and '092 (formulation) relating to tadalafil.  Tadalafil is the generic name for the product sold under the brand names CIALIS (for male erectile dysfunction) and ADCIRCA (for pulmonary arterial hypertension).  The judge held at least Claim 7 of the '181 patent is valid and infringed and the '092 patent is invalid.

Although the AmeriKat is only just digesting the judgment, there are treats in store for everyone including:
  • What is the the role of Teva v Leo?  
  • Can a generic's "clearing the way" revocation action really not be construed as a threat to infringe the patent (when coupled with a contingent intention to launch a product if the action succeeds)?
  • The role of chemical names and priority documents.  
  • The ability to exercise your pun-tastic skills in talking about this decision.
Assuming the AmeriKat can last until the end of the judgment, she will be back with a more fulsome summary later on.   

13 comments:

Anonymous said...

It's so hard to think of a good pun on demand though.

Anonymous said...

Did the arguments stand up?

Graham said...

Never mind the quality...feel the width.

Proof of the pudding said...

Sounds like a lengthy trial indeed. It's a wonder that the participants could keep it up for so long.

Harry said...

Reasonable expectation of success is undermined in this decision. Birss says:

"281.Pharmaceutical development work involves a number of rounds of routine testing which are costly and have an uncertain outcome. A good example is routine pre-clinical testing. A skilled team will carry out routine testing of that kind without any expectation as to what any particular result will be. That lack of expectation does not turn the results of truly routine testing into an invention.
282.The reason phase I, phase IIa and IIb, and phase III studies are carried out is because they have uncertain outcomes. But they are routine tests and the fact their outcome is uncertain does not on its own turn their results into an invention. The fact one cannot say before pre-clinical and phase I or IIa tests have been performed what particular doses would be tested in a phase IIb dose ranging study does not by itself make those doses inventive if some or all of them are found to work."

But one must ALWAYS have reason expectation of success for obviousness, no? Otherwise it is inventive. How does reasonable expectation of success interact with 'routine testing'. The Courts need to elucidate that principle. Surely Birss cannot rely on what it done in pharmaceutical research as routine (and without expectation) to do away with the legal test of 'reasonable expectation of success'?

Ashley Roughton said...

I think that the position is a little more subtle and very fact dependent. As Birss J said @ [273] "... one has to take care ... formulate[ng] ... the legal question which [in the present case] just asks what are the prospects of success of a 5mg dose over [prior art which suggests that the compound is effective but not the dose claimed in the dosing patent]").

Clinical trials (CTs) work on a number of phases which are intended to answer the questions, which are (in round and general terms): does the compound kill or damage the patient, does it do its intended job at its lowest effective dosage, what other doses are a good idea and finally can the drug be rolled out across the population. Coupled to that is the endpoint, what are you trying to show the drug is good for. Does it cure the disease (a rare end point) or does it attenuate it and if so how and for how long. So CT success is a very different concept to the "success" which Floyd LJ talks about in Hospira. The test (thought to be appropriate in "obvious to try" cases; it does not work every time) is whether it would be obvious to go down a particular testing route given a particular starting point. Here comes the fact specific stuff:- if there is some evidence of efficacy and a patent is a dosing patent then working out the minimum effective dose is a matter of routine. In the Actavis case Birss J held that the compound was known to be effective but not what the minimum effective dose (MED) was. Though not strictly relevant, he then also added that if you go down the finding the MED path and find something surprising (like an unpredicted reduction in side effects) then that surprising discovery is not patentable. He called it a bonus.

Importantly what Birss J was not saying was that CT routes always implied obviousness or lack thereof but that in this case given that it was known that the compound was effective to some degree, finding out the MED was obvious to try and hence the dose claimed was obvious.

Ashley

Harry said...

In response to Ashley, you are of course correct and the decision is correct in this respect. There is going to be a lowest effective dose and you will find it by routine means, and it thus cannot be inventive even though it could not have been predicted beforehand. But then Birss adopts a different rationale later in the paras I have quoted below. Here Birss does consider reasonable expectation of success of the 5mg/ day dose of tadalafil. So the test is different for the 2 drugs. Again the decision is correct, I am sure, but what is disconcerting is that parts of the decision use or don't use reasonable expectation of success as per the requirement to explain the eventual outcome, rather than as part of a comprehensive consistent test. My complaint is the way 'reasonable expectation of success' is selectively, without a clear indication of the basis for it being used or not used. A Court of Appeal could I am sure write an equally convincing judgment coming to different conclusions on inventive step by using reasonable expectation of success in different ways.
_________
Places in the decision where 'reasonable expectation' comes to the fore:

331.The position on this is clear. The skilled team would regard a 25 mg dose of tadalafil as a marketable dose. It would be safe, tolerable and effective. The skilled team will have defined a minimum clinically relevant effect for their own purposes. I am not satisfied that the team would have any expectation that the minimum effective dose was substantially lower than 25 mg. The team would clearly expect that somewhere below 25 mg there would be a dose of tadalafil which did not work, but that is really the limit of their expectations. The skilled team would hope to see a dose response but even if they expected to see any statistically significant effect at 10 mg, they would have no reasonable expectation that 10 mg tadalafil would produce a clinically relevant effect as they had defined it. In terms of expectations, an entirely feasible outcome would be that the minimum effective dose would to be found to be between 10 and 25mg. Dr Brock's evidence was that he could not predict whether 10 mg had efficacy in the light of Daugan. Although that was expressed at an earlier stage in the exercise, it is germane.

Anonymous said...

Back to the puns please gents

'*^' said...

Harry, remember that Birss was knocked down by Jacob in Teva v Leo for getting too complicated over reasonable expectation of success and predictability in a situation where empirical testing is the norm. The Court of Appeal is not ready to go beyond 'depends on the facts', and so don't expect a consistent approach soon.

Anonymous said...

The US Supreme Court very recently told the Federal Circuit to ditch its "reasonable expectation of success" rule.

Certain pharmaceutical development screening is what the skilled person would have done, irrespective of the outcome, so is routine and therefore not inventive.

Other testing isn't routine. Other times, routine testing results in the identification of something that is inventive.

All depends on the facts as elucidated earlier this week in Hospira.

This is all said without having yet glanced at this Lilly decision. The legal principles being determined irrespective of the facts.

'*^' said...

Anonymous of 16:18 which Supreme Court decision are you referring to? I know that MacDermid has recently gone up to the Supreme Court on this question (http://patentlyo.com/media/2016/07/MacDermid.pdf).

If the US system does ditch reasonable expectation of success it will lead to more uncertainty and more incorrect decisions. We need more guidance, not less, on how to determine inventive step. More importantly the question why would we ditch it? What circumstances have changed that lead to us ditching it?

Anonymous said...

we should ditch rules that have no basis in the statute

Anonymous said...

My mistake. I was pre-empting the Supreme Court decision. Upon reading the writ, I am in agreement with the petitioner. Such rules are too restrictive where development work is routine.

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