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Friday, 29 July 2016

Hospira v Genentech - revocation of patents confirmed on appeal

The Court of Appeal handed down its decision yesterday in Hospira v Genentech (with the first instance decision reported by this Kat here).  As is often the case when an appeal decision upholds a first instance judgment, there is not meat in the decision - the whole matter is dealt with in just 56 paragraphs - and correspondingly not much to say about it.  (Regrettably, notes Merpel, the product-by-process discussion of the first instance decision, which induced a not insignificant number of comments on this blog, is not discussed in the appeal judgement.)

Genentech appealed against the first instance decision revoking a pair of patents on the grounds that the claimed subject matter is obvious.  The matter came down to an obvious to try and could-would argument; Birss J, at first instance, found that it was obvious to screen a particular selection of possible drug formulations to determine which is most stable.  Genentech argued (a) that it was not obvious to try the particular formulations and (b) that even if it were, the skilled person would not expect the particular claimed formulation to be stable from that selection of possible candidates, and so the skilled person would have no reasonable expectation of success and would not therefore arrive at the claimed invention.  

Floyd LJ agreed with Birss J, stating (in paragraphs 50 and 51):
Given that the screening methods were part of the common general knowledge, that the tests involved were routine, that the excipients were common general knowledge excipients and that there was no a priori reason why a successful lyophilised formulation could not be made, it seems to me that it was beyond argument that the claimed combination in this case was one that could be made by the skilled team. The question is whether this is the type of case where it is necessary to go further and ask whether the skilled person would necessarily have made the precise combination claimed. In an empirical field it will be seldom be possible to predict in advance that any individual experiment will work. In many cases, the fact that a routine screening exercise could be carried out will be inadequate to establish obviousness.  
Nevertheless, on the facts of an individual case such as the present, the team may have a reasonable degree of confidence that a series of experiments will produce some which will work. To impose a requirement that the skilled team must be able to predict in advance which would be the successful combinations is wholly unrealistic. It would lead to the grant of patents for a whole variety of combinations which in fact involved no inventive effort. 
Finally, in paragraph 53, the judgement concludes:
It is always necessary to remind oneself that it is not the function of this court to second-guess the judge's finding of obviousness. The judge was evaluating a large number of inter-dependent factors. Despite Mr Tappin's very clear and well sustained arguments, I do not think that the judge fell into any error of principle which would justify this court in undertaking its own evaluation.
 Lord Justice Kitchin and Lord Justice David Richards concurred.


Peter Smith said...

At the end of the second paragraph, you write, "Lord Justice Kitchin and Lord Justice David Richard concurred." You thereby imply that they concurred with Genentech's arguments, which doesn't seem to be the case. Was this sentence mistakenly duplicated from the end of the article?

Darren Smyth said...

Thank you Peter - yes indeed there seems to have been a pasting error here, for which I apologise. Corrected now.

@'+ said...

If one is going to use could/would or reasonable expectation of success then the answer will depend on the exact question which is asked, and that works for the EPO problem/solution approach. However in the UK the exact questions always seems to vary, including whether it is an a priori expectation test or post-invention 'surprise' test, and to what extent arbitrary selection or hindsight is considered. However the UK courts do not seem to feel the need to provide more structure to their decisions which is disappointing because it means case law cannot develop. If the only case law one has is 'depends on the facts' then does not provide much certainty to the patent system.

Ashley Roughton said...

(1) it is Richards and not Richard and
(2) judges concur when they come to the same conclusions on different reasoning; if they come to the same conclusions on the basis of the same reasoning then they are said to agree. Get with it kitty!

Anyway none of that is what I wanted to say, which is this. The judgment of the CoA is problematic in many respects and I could go on (and on) about bulls eyes and how close does one have to be. What is good about this judgment is the brief but very clear analysis by Floyd LJ of the 'law' of obviousness which is, in effect, that there isn't really any law of obviousness at all and that determining whether an invention wants for inventive step is really a matter of fact. Various approaches may be used (such as obvious to try) but ultimately it is a matter of fact. This might explain the brevity of this clear judgment.


Darren Smyth said...

Applying blogging conventions I have corrected the typo but not the use of language. Apologies I was was clearly having a proof-reading blind day.

@'+ said...

In response to Ashley an inventive step analysis cannot only be a 'matter of fact'. Some rules for the analysis need to be present, if only in the judge's head. If those rules are not described in the decision then the rest of us don't really know why the case was decided as it was. By reducing inventive step to deciding on the facts judges are not doing their fair share of formulating case law, and they are also escaping proper review of their decision by the Court of Appeal which is going to be shy of relooking at all the 'facts'.

Suleman Ali said...

Below is a quote from a report of a patent case at the US Supreme Court, see I am quoting this as an example of how much 'discretion' should be allowed in court judgments.

"The immediate issue in the case, Halo Electronics v. Pulse Electronics, was the meaning of the provision of patent law that says in cases of infringement, lower courts “may increase the damages up to three times the amount found or assessed.” That provision, Section 284, doesn’t say when or how the enhanced damages -- known as treble damages -- should be assessed. That silence implicitly gives discretion to the courts to decide on special damages.

Appellate courts don’t care for unfettered discretion in lower courts. Such discretion makes it much harder for an appellate court to do its job of reviewing lower court decisions: How do you know whether discretion has been abused if there is no standard against which it can be measured?

Worse, appellate judges tend to think that too much discretion threatens the rule of law, which requires like cases to be treated alike."

At some point the lack of a clear inventive step test turns into 'discretion', and the system needs to be mindful of how much 'discretion' the lower courts are allowed. The Court of Appeal therefore needs to be extra-cautious when the lower court is applying an almost discretionary test for inventive step.

Anonymous said...

When issues first come before the courts, judges always create some rule/list of questions that can be used to decide the issue. Invariably, these rules benefit from hindsight analysis of the problem and are specifically targeted at that specific issue. Hence, their uselessness at general applicability.

Next few cases the judges invariably, blindly, apply the rules created earlier. Later on, questions are asked, the rules are changed, but yet again, specific to the issue at hand.

The next stage is when the judges (and the EPO) suddenly remember that the question to be asked is whether the invention was obvious, as defined in the law, and not whether the judicially created questions are answered in the affirmative.

So, ultimately, there are no rules, no questions to be asked to decide the issue, other than "was the invention obvious to the skilled person". It is therefore always fact-dependent. This may not suit the lawyers who want simple rules to make life easier, but it is the correct approach. The role of the court is, therefore, to take on the mantle of the skilled addressee and determine whether the invention would have been obvious to that person, or team.

The instant case highlights that formulation development is standard practice int he pharmaceutical industry. Occasionally, non-standard technologies may be used or developed, but usually, standard methodologies are utilised in order to provide an expected, necessary, outcome of a formulation suitable for the required task.

Suleman Ali said...

Anonymous of Sunday, 7 August 2016, it cannot be there are no rules. One important reason for that is that even the judges need rules. There must be a reasoning why a certain decision was reached, and it must be based on some logic. The world needs to know that the same logic is being applied to each case. I don't think that the reasonable expectation of success test is being applied consistently at the moment by the UK courts, but that cannot be reviewed properly, or fixed if need be, if the courts say the decision depends on the facts.

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