The team is joined by Guest Kats Rosie Burbidge, Stephen Jones, Mathilde Pavis, and Eibhlin Vardy, and by InternKats Verónica Rodríguez Arguijo, Hayleigh Bosher, Tian Lu and Cecilia Sbrolli.

Sunday, 5 November 2017

The rise of "obvious to try" is over as Court of Appeal finds CIALIS dosage regimen patent obvious

Although it was obvious for the AmeriKat
to try being nice to Merpel, she knew
there was little expectation of success...
Unpredictable. Through the ages, humans and Kats have had to deal with the unpredictable, random and the volatile nature of life and, in particular, human behavior.  After the events of 2016/7, many of us may instituted more robust psychological tools to deal with unpredictable times - with varying degrees of success.  But an area where you cannot employ such tools is in patent litigation, where the fate of your patent or your defence depends on an inherently unpredictable fictional character/s - the skilled person/team - viewed through the prism of expert evidence and weighted with the perception of whatever judge you are before.  The Court of Appeal's decision last week in Actavis v ICOS [2017] EWCA Civ 1671 is a reminder that the uncertainty that can plague this and the resulting outcome of a court hearing, may not extend to the skilled team embarking on a routine clinical trial program.

The Court of Appeal consisting of Lord Justice Kitchin, Lord Justice Floyd and Lord Justice Lewison overturned Mr Justice Birss' first instance decision (handed down last August - see here) that the '181 Patent was valid and infringed.  The '181 Patent covers the dosage regimen for tadalafil - a PDE5 inhibitor - sold under the brand name CIALIS (for male erectile dysfunction) and ADCIRCA (for pulmonary arterial hypertension).  The 2014 market for CIALIS in the UK amounted to $99 million and ADRICA amounted to $1 million.  Actavis and Teva appealed the decision on the '181 Patent on five grounds - construction/infringement, lack of entitlement to priority, added matter, novelty and obviousness. The Court of Appeal held that the '181 Patent was invalid for obviousness.  Birss J had held that the other patent at issue in the first instance proceedings - the '092 Patent - which covered the formulation was invalid.  ICOS (patent owner)/Lilly (exclusive licencee) did not appeal that decision.

This is a decision about obviousness and, in particular, the role of obviousness and the "obvious to try" when the skilled person/team embarks upon a routine clinical trial program.   Although there is some nice Kitchin LJ dicta to digest in relation to the other appeal grounds (all which were ultimately dismissed) this post will look at the obviousness attack. However, the AmeriKat includes a link to a (ever color-coded) table she pulled together which sets out the key extracts on the other grounds, summary of the arguments and legal tests.

Given the scale of the first instance and Court of Appeal judgment on this issue, the AmeriKat is splitting the post into two.  This first post will quickly summarize the facts and pull out the key extracts.  A longer, more analytical post will follow about what it means in terms of what is left of the "obvious to try" case law and what it practically means for innovators who are faced with defending their so-called follow-on patents.

The Claims

Claims 7 and 10 are the relevant claims at issue.  The claims are as follows:


1.         A pharmaceutical unit dosage composition comprising 1 to 5mg of a compound having the structural formula:            


          said unit dosage form suitable for oral administration up to a maximum total dose of 5 mg per day.
2.          The dosage form of claim 1 comprising 2.5mg of the compound in unit dosage form.
3.          The dosage form of claim 1 comprising 5mg of the compound in unit dosage form.
4.          The dosage form of any one of claims 1 through 3 wherein the unit dose is in a form selected from a liquid, a tablet, a capsule, or a gelcap.
5.         The dosage form of any one of claims 1 through 3 wherein the unit dose is in the form of a tablet.
6.          The dosage form of any of claims 1 through 3 for use in treating a condition where inhibition of PDE5 is desirable.
7.         The dosage form of claim 6 wherein the condition is a sexual dysfunction.

10.      Use of a unit dose containing 1 to 5mg of a compound having the structure [of tadalafil] for the manufacture of a medicament for administration up to a maximum total dose of 5mg of said compound per day in a method of treating sexual dysfunction in a patient in need thereof.”

Daugan prior art

The prior art for the purposes of obviousness was citation called Daugan - a patent application published on 6 February 1997 (before the earliest priority date of the '181 Patent) that teaches the use of PDE5 inhibitors for the treatment of  erectile dysfunction.  Compound A - tadalafil - is specifically disclosed.  It also discloses tadalfil's  IC50 against PDE5.  IC50 is the measure of the potency of a drug inhibiting a specific function.  It describes the in vitro concentration of a drug that is required for 50% inhibition.   Examples of a tablet containing a 50mg dose are described in Daugan and it explains that doses of tadalafil will generally be in the range of 0.5mg to 800 mg/day for the average adult patient.  The difference of Daugan and Claim 1 is that it does not specifically disclose a tablet containing 5mg of tadalafil and, similarly, with Claims 7 and 10, as well as not stating that such a dose will be an effective treatment for sexual dysfunction.  

The parties arguments 

Actavis/Teva argued that at the priority date it would have been obvious for the skilled team, given Daugan, to take tadalfil forward into a routine pre-clinical and clinical trail program to assess its use as an oral treatment for sexual dysfunction.  In the course of this exercise, a 5mg/day dose of tadalafil would be used in patients and would reveal the invention (i.e. its safe, tolerable and effective).

Lilly argued that this argument was really an "obvious to try" case.  An invalidity finding could only be arrived at if the skilled team would consider the program had a fair prospect of success.  There is no way the skilled team could have thought so given, on the basis of Daugan, the team would have no idea whether a 5mg/day dose would be safe, tolerable or efficacious (with minimal PDE5 related side effects) in the treatment of sexual dysfunction.  It was, therefore, not obvious.

The skilled team's steps at first instance 

Birss J agreed - it was not obvious. As a whole, the judge commented, a clinical progam has many routine and obvious steps.  In this case the skilled team had two avenues to explore - on demand dosing and daily dosing.  Fast forwarding to the daily dosing avenue (although the skilled team would purse the on demand dosing first), although a 25mg/day dose would be obvious, a 5mg/day dose was not.  This was because it was so much lower than the 50mg disclosed in the prior art and the marketed doses of sildenafil.  It was on this basis that it would not be chosen in the routine first dosing range.   The team would have, in the earlier dosing studies, found that 10mg was effective and safe.  The drive to go lower than 10mg would be reduced but not eliminated.  They would eventually try 5mg/day but would have no reasonable expectation of success and indeed would be surprised that it was useful with reduced side effects (see the conclusions of the judge at [343(iv)-(vi)].

The parties' arguments

Actavis/Teva argued that the judge having found that the skilled team would take tadalafil into a clinical testing program where they would, eventually, test a dose of 5mg and would find it to be safe and efficacious, was "irrational and wrong" to conclude that the 5mg/day dose claim was still inventive.  Much reliance was placed by Actavis' counsel on the Court of Appeal in Actavis v Merck [2008] EWCA Civ 444 which stated that:
“32. So holding is far from saying that in general just specifying a new dosage regime in a Swiss form claim can give rise to a valid patent. On the contrary, nearly always such dosage regimes will be obvious – it is standard practice to investigate appropriate dosage regimes. Only in an unusual case such as the present (where, see below, treatment for the condition with the substance had ceased to be worth investigating with any dosage regime) could specifying a dosage regime as part of the therapeutic use confer validity on an otherwise invalid claim.”
Lilly argued that was not the right question - the evidence established the team would have "no expectation that a dose of 5mg/day wold be efficacious" and they would have been "surprised to find that a dose of 5mg was both efficacious and had reduced side effects".  Expectation of success argued Lilly, was a "critical consideration in all "obvious to try" cases."

The Law

The question of obviousness is, in light of all the relevant evidence:
was it obvious to the skilled but unimaginative addressee in light of the prior art and the common general knowledge to make a product or carry out a process falling within the claim?  (see MedImmune v Novartis [2012] EWCA Civ 1234)
Whether it was obvious to try a particular route with a fair expectation of success can be considered "where appropriate".  This and what these terms mean will depend on the circumstances and will vary from case to case.  In Novartis AG v Generics (UK) Ltd (trading as Mylan) [2012] EWCA Civ 1623 the Court explained:
"Sometimes, as in Saint Gobain, it may be appropriate to consider whether it is more or less self-evident that what is being tested ought to work. So, as this court explained in that case, simply including something in a research project in the hope that something might turn up is unlikely to be enough. But I reject the submission that the court can only make a finding of obviousness where it is manifest that a test ought to work. That would be to impose a straightjacket upon the assessment of obviousness which is not warranted by the statutory test and would, for example, preclude a finding of obviousness in a case where the results of an entirely routine test are unpredictable.” 
On Robin LJ's dicta in Actavis v Merck it is "important" but it should not be taken too far, held Kitchin LJ.  In particular:
"It does not establish that investigations into appropriate dosage regimens cannot yield patentable inventions. Indeed, Jacob LJ made it clear at [29] of his judgment that research into new and better dosage regimens is clearly desirable and that there is no policy reason why the discovery of a novel and non-obvious dosing regimen should not be rewarded by a patent." 
The Court of Appeal

It all fell down at the Phase IIb study.  Lord Justice Kitchin found that this was not a case in which the skilled team would be faced with a series of parallel avenues of study, with no expectation that any of those avenues would be fruitful/more fruitful than any other.  It was a case of two avenues - daily and on demand - with both avenues revealing tadalafil's half life and where each would lead the skilled team to the invention.   He continued:
"Rather than focussing on these important points, as I believe he should have done, the judge has instead attached weight to the fact that a dose of 5mg is considerably less than the 50mg dose which would be used in Phase IIa efficacy test, and to the fact that a dose of 5mg would not be chosen for the routine first dose ranging study in Phase IIb. It is of course true that a dose of 5mg is considerably less than a dose of 50mg but it must also be borne in mind that the two parts of Phase II have different purposes. Phase IIa is designed to provide proof of concept and is generally carried out at one dose selected to be high enough to provide the best chance of showing a positive effect while not causing serious side effects. Phase IIb is carried out at different doses chosen to provide an understanding about the dose response relationship. It is also true that a dose of 5mg would not be chosen for the first study in Phase IIb. However, as the judge himself found, the skilled but uninventive team would very likely investigate it thereafter."
 He concluded:
"Drawing the threads together, I am satisfied that Mr Speck has made good his criticisms of the judge’s reasoning. The judge has lost sight of the fact that, on his own findings, the claimed invention lies at the end of the familiar path through the routine pre-clinical and clinical trials’ process. The skilled but non-inventive team would embark on that process with a reasonable expectation of success and in the course of it they would carry out Phase IIb dose ranging studies with the aim of finding out, among other things, the dose response relationship. It is very likely that in so doing they would test a dose of 5mg tadalafil per day and, if they did so, they would find that it is safe and efficacious. At that point they would have arrived at the claimed invention. In my judgment claims 7 and 10 are therefore invalid."
Lord Justice Floyd, agreeing with Kitchin LJ, continued:
"I think that it was in these final steps in his reasoning that the judge fell into error.  The whole purpose of embarking on the routine Phase IIb dose ranging study was to identify a dose response. The discovery of a plateau indicated that the routine study would have to be repeated at a lower dose, because it was not complete.  Completion of the study would inevitably lead the skilled team to test 5 mg/day, whether that dose was still on the plateau, or in a region of the curve where a dose effect is observed.  Which it is does not matter, because the result is that the skilled person would at this stage have arrived at a dosing regimen within the claim.

Whilst the existence of value judgments on the road to the invention are of course highly material, the judgments identified by the judge in this passage of his reasoning were collateral ones which had no impact on the decision to complete the Phase IIb study, or were not true value judgments at all.  ... "
Floyd LJ also provided an excellent summary of the case law and its bounds from [156]-[162] and in particular warned of extending the "obvious line of enquiry" principle too far:
"It is important not to let this approach to obviousness extend beyond its proper bounds.  There will hardly ever be an invention for which it is not possible to “show how it might be arrived at by starting from something known, and taking a series of apparently easy steps”: see per Moulton LJ in British Westinghouse v Braulik (1910) 27 RPC 209 at 230.  Nearly 100 years later, Moulton LJ’s view that this approach was “not countenanced by English law” was said by Jacob LJ (with whom Mummery and Pill LJJ both agreed) in Technip France’s SA’s Patent [2004] RPC46 at [112] to be “as true today as when it was first said”.
I said something about the dangers of too relentless an approach to the “obvious line of enquiry” principle in Gedeon Richter v Bayer Schering [2011] EWHC 583 (Pat), in the context of experimentation. "
Lord Justice Lewison put the "obvious to try" case law firmly back in its box stating that "it is not the law" that "an expectation of success is an integral component of an "obvious to try" case "some tests are taken in ignorance of the results (see Gedeon Richter v Bayer Schering).  Although whether a skilled person/team has an expectation of success can be relevant to whether or not they undertake such a test/experiment, it is not a precondition (see Novartis AG v Generics).   With a final blow at[180] he concluded that:
"This court has been at pains to warn against the over-elaboration of the “obvious to try” line of cases. While there are a number of factors which, depending on the circumstances, may bear on the question it is not always necessary for all of them to be ticked off as if on a checklist. As Kitchin and Floyd LJJ have demonstrated, in a case which involves routine pre-clinical and clinical trials, what would be undertaken as part of that routine is unlikely to be inventive."
Well then...

15 comments:

Anonymous said...

It might be worth asking again whether, on that basis, pemetrexed potassium is obvious after all.

Mr Blobby-Obvious said...

This is a fair judgement in this case. The idea of being able to patent the result of a process cannot be decided solely on the unpredictability of the outcome. If a positive outcome is reasonable to expect, but the actual outcome (here = value of dose) cannot be reasonably predicted, then the outcome is obvious. The only aspects to question are whether the process was something that would have been conducted/was reasonable to have conducted, and the reasonableness of the predictability of a positive outcome.

There have bee a lot of dosage regimen patents granted, which should have been rejected, although I am in full agreement with the court that there will be true patentable examples.

This case is important not just for dosage regimens, but also for other results of pharmaceutical research in the case of processes that are inevitably conducted, especially to meet regulatory requirements.

Chris said...

Case law at the UK courts is becoming very Judge-specific. Jacob would have said the regimen is inventive (always being pro-patentee). Poor Birss, as a first instance judge who tries to follow the prevailing case law, is caught in the middle, knowing that there there are plausible ways of deciding in a pro-patentee 'Jacob' way (see TEVA v Leo) or in a sceptical 'Kitchin' way (not enough has been achieved to have invented something).

Given how often we get reversals in appeal at the UK courts one wonders whether everything is working OK in patent litigation in the UK

Anonymous said...

Once you make the process of research "obvious," then nothing will NOT be obvious.

Grant said...

It's a shame that the problem and solution approach wasn't used to give more of a framework here. Defining the problem (in exact terms) would have would have allowed a more precise analysis, i.e. what exactly needs to have been predictable of what was achieved. 'Obvious to try' is a bit of a primitive tool when a problem hasn't been properly defined.

Uninventive said...

Once you make the obvious and standard steps of researching dosing regimes for known drugs "obvious" then normal and unsurprising dosage regimes will NOT be obvious.

In this case, the claimed dosage regime is nothing more than the dose that is at the lower limit of the therapeutic plateau (see the decision on this point, it is very good). Something that would be investigated as a matter of routine. Simply being the first party to carry out an obvious piece of research should not result in a patent. Quite often the process of research is obvious and provide obvious results. Those obvious results are not patentable.

Proof of the pudding said...

Are we to understand that the Court of Appeal is of the view that obviousness can sometimes be decided by reference to a single criterion, namely: would the skilled person have included the embodiment in question in a research program?

This does not seem right to me, at least for the "Swiss" format claim (Claim 10). Successful treatment of sexual dysfunction is a technical limitation of Claim 10. I would therefore have thought that it would be necessary (for assessing the validity of Claim 10) to analyse whether the prior art rendered it obvious that treatment with max. 5 mg tadalafil would be successful.

In other words, to invalidate the "Swiss" format claim, is it not (at the very least) necessary to demonstrate a reasonable expectation of success for the treatment defined in that claim?

Chris said...

This judgement essentially boils down to the skilled team doing what they would normally do arriving at the invention. However that is not the test for inventive step! The Court ought to be using the test derived by case law.

In TEVA v Leo Jacob used the Pozzoli test and as quoted by IPKat:

The Court of Appeal held:
"In effect the Judge was saying that the idea of including this solvent as part of a research project amounted to obviousness. The “obvious to try” standard requires a higher expectation of success than that. Otherwise, as I observed in St Gobain at [35]:
"Mere possible inclusion of something within a research programme on the basis you will find out more and something might turn up is not enough. If it were otherwise there would be few inventions which were patentable. The only research which would be worthwhile (because of the prospect of protection) would be in areas totally devoid of prospect.”
Putting this point into a Pozzoli structured analysis, the difference between the prior art (Turi) and the invention was that Turi was a mono active product using Arlamol E. The invention is a double active product. Turi would be seen as using one of a large number of possible non-aqueous solvents. It might provide stability for the two actives, just as any of the others might. But there was no reasonably optimistic expectation that it would. Finding that it really did was an invention and an advance in human knowledge.
So I think the judge did err in principle and we are obliged and entitled to revisit the question of obviousness de novo."

(http://ipkitten.blogspot.co.uk/2015/08/taking-ph-trial-judges-decision-on.html)

See also the following on predictability and inventive step: http://ipkitten.blogspot.co.uk/2015/09/why-is-reasonable-expectation-of.html

Mr Blobby-Obvious said...

"Anonymous Anonymous said...
Once you make the process of research "obvious," then nothing will NOT be obvious."

When that happens, you deserve an award. if you are suggesting that is what this decision says, you are not deserving of an award.

"Proof of the pudding said...
Are we to understand that the Court of Appeal is of the view that obviousness can sometimes be decided by reference to a single criterion, namely: would the skilled person have included the embodiment in question in a research program?"

Ans. No. And, the reasonableness of expectation of success of the treatment working would be a requirement of obviousness. See Point 34:

"Finally, I should say a word about the concept of second in class. Sildenafil was a first in class drug which validated the rationale for trying to treat ED using an oral PDE5 inhibitor. Any other PDE5 inhibitor for ED would be known as a second in class drug. A clinical pharmacologist would have an enhanced expectation that a second in class drug would also be efficacious.""

Chris, I'm not sure the comparison is helpful (much as ipkat may be considered legal basis in some quarters). The dose-ranging study would have been conducted and would have identified the 5mg dose as a suitable dose. Teva v Leo is more complicated.

Comparison may be had with Pfizer's besylate salt outcome in the US.

Chris said...

In response to Mr Blobby-Obvious, thank you for your comment, but like the Appeal Court you've not structured it according to the Pozzoli test. Unless we all agree to use the same test court decisions will continue to come to different conclusions. Whilst I've derived much amusement and entertainment from observing Laddie, Hoffmann, Jacob, Kitchin, Arnold, Birss and Neuberger take their different approaches (some more imaginative, more just, more European than others) one wonders whether they need to talk to each other more to establish a little more harmony. Birss I think is the only one that really makes effort to do this and looks at the bigger case law picture, and I'm looking forward to his future appeal court judgements which I predict will be more visionary.

Sunk Cost Fallacy said...

Re: Anonymous @ 6/11, 13:24: "Once you make the process of research "obvious," then nothing will NOT be obvious."

This is a wholly flawed point. The only way this argument stands is the presumption that all research is "inventive".

While it is true that the whole concept of a skilled person/team is a work of legal fiction, there does need to be a line drawn, particularly in the life sciences, where you cannot simply make the skilled person so stupid as to not even be able to carry out basic investigatory tasks and reach a logical conclusion.

As has been stated in the other comments, the point this decision is trying to make is that especially when there is a Phase II study, there is fundamentally going to be a test on the relevant dosage, as this will eventually be required for drug approval. There is nothing inventive about performing this test, so why should someone get inventive merit for simply citing the same results that other people would have arrived at?

To be honest this case represents an important step in curtailing some of the ridiculous evergreening strategies that have come about. Going back to the basic fundamentals of the purpose of intellectual property rights as a reward for innovation, gaining a monopoly for a product on the basis of a completely normal "dosage regimen" is nothing more than a mockery. I agree that there is an argument to be had in cases where the dosage is so unusual that no logical experimentation would have reached it (for example, when the dosage becomes so far removed that inhibition would never have been thought to occur, or when the dosage is at a level which would in most cases be toxic but is somehow rescued by a particular combination) - this is simply not one of those cases.

Proof of the pudding said...

@Mr Blobby-Obvious

Re: para 34 of the judgement, do you really think that a statement such as "A clinical pharmacologist would have an enhanced expectation that a second in class drug would also be efficacious" has a direct bearing on the expectation of success for a 5 mg dose of a specific second-in-class drug?

I can see where things went wrong, though. The Court of Appeal has allowed hindsight to infect the assessment of obviousness. That is, they have presupposed knowledge of the outcome of a (dose-finding) study that yielded an unexpected result.

Salami-slicing a research campaign in this way will always tend to provide skewed results that are infected with hindsight. That is, if there is an allegedly obvious starting point and an "obvious" first study that those skilled in the art would conduct, then the CoA's approach might allow one to daisy-chain together a series of studies that lead to a conclusion of "obviousness" for a result that could not have possibly been predicted at the outset.

I find little comfort in the application of the CoA's approach only to those steps that "can be characterised as so routine that the skilled person would carry them out simply because they are routine, and irrespective of any prospect of success". The reason for this is that there is no discernible point of principle behind the CoA's approach, thus making the assessment of obviousness on this ground both capricious and unpredictable.

I would have been able to understand the decision more if the CoA had relied upon a "one way street" leading directly and unerringly to the claimed invention. But that does not appear to have been the case here. I mean, is there any reason why the skilled person would have selected 5 mg (as opposed to eg 7.5 mg), even in hindsight of the results of the dose finding study?

To be frank, I cannot see how this approach fits with the ethos of the patent system - as it discourages investment in "obvious" avenues of research. That is, no matter how low the likelihood of success of the research programme, and no matter how unexpected the outcome, there is a chance that patent protection will be unavailable (because, in hindsight, the invention can be alleged to be the inevitable product of a series of obvious avenues of investigation).

Personally, I prefer Henry Carr's approach to assessing obviousness as set out in the atomoxetine case from 2015... though I guess that the writing is now on the wall for that approach.

Sunk Cost Fallacy said...

Re: Proof of the Pudding @ 7/11, 10:31

"I would have been able to understand the decision more if the CoA had relied upon a "one way street" leading directly and unerringly to the claimed invention. But that does not appear to have been the case here. I mean, is there any reason why the skilled person would have selected 5 mg (as opposed to eg 7.5 mg), even in hindsight of the results of the dose finding study?"

I do not think this is a correct assessment of the inventiveness of a 5 mg dose overall - the inventive concept as argued lied in the discussion as to whether it was obvious that a 5 mg dose would be efficacious. This isn't selecting a dose that is particularly beneficial for treatment. It is again fairly routine logic that drugs that have a degree of toxicity needs to be balanced in its dosage for toxicity and efficacy.

I would therefore argue that the skilled person would always look for a lower dosage which can be equally efficacious when dealing with drugs which have problematic side effects. Again, to deny this would be simply making the skilled person one that is just abundantly stupid.

"To be frank, I cannot see how this approach fits with the ethos of the patent system - as it discourages investment in "obvious" avenues of research. That is, no matter how low the likelihood of success of the research programme, and no matter how unexpected the outcome, there is a chance that patent protection will be unavailable (because, in hindsight, the invention can be alleged to be the inevitable product of a series of obvious avenues of investigation)."

I spent several years doing academic research where most of it was probably "obvious avenues" because when making conclusions it is fairly routine to be able to justify those conclusions even with "obvious" data in order to ensure that the right conclusion is reached.

However, there is always the chance that the data is different to expected and that can lead to a new discovery and, in the forunate cases, a chance that it will lead to a patentable product or process. But this is ultimately not the goal of every experiment that is conducted. A person performing a routine PCR or making a genetic mutant in a virus or bacteria does not normally expect that to generate an invention.

As stated in my previous post, the question should be whether there is any investment or effort into the avenues explored. For the identification of a dosage regime based on its known chemical properties, I would argue there is not - it is necessary in order to secure drug approval before regulatory bodies, and by that point, much of the hard work has already been done in identifying a suitable candidate that has passed at least Phase I studies.

I think there is also a confusion here between an "obvious avenue of investigation" and the obvious result. This is a case where both would happen. There is no denying that by looking for a dosage regime that I would find a dosage regime. I think you could still quite easily argue for inventive step based on a finding that an obvious avenue of approach would not lead to the claimed invention, and that the invention is actually contrary or unexpected from the result.

Such strict criteria for patentability can already be seen in other aspects of life sciences patenting, such as antibodies. It is already difficult to get any sort of broad protection for antibodies, and most divisions and boards at the EPO would require you to recite at least some CDR sequences for it to be patentable. The cost and investment into finding an antibody is great and many simple functional features are considered to be an "obvious avenue of investigation" - and this is fairly accepted practice now.

Mr Blobby-Obvious said...

It is not just par.34. The prior art disclosed tadalafil as a potent PDE5 inhibitor for use in erectile dysfunction. The trial judge determined it was very obvious to take tadalafil into the clinic (para. 110-112).

Once this decision was deemed obvious, every inevitable result of routine testing is also obvious.

Fine to argue whether running clinical trials is obvious, but that is not the point at issue.

A point maybe not raised, and a side-issue to this discussion, is once tadalafil was tested in Phase I - healthy male volunteers - the efficacy of the compound would have been apparent. This is how Viagra was born.

Chris, I am not a fan of tests ruling the roost. Such tests are designed to fit the facts of a case and subsequently amended when they are found inappropriate. Eventually, judges and EPO Board members remind everyone that the law is as written in the statutes.

Anonymous said...

So, it would seem that unexpected results achieved by routine research methods are no longer patentable in the UK. The problem with that is that there are very few inventive methods of carrying out research, most research being carried out using tried and tested methodology, otherwise it would not be regarded as reliable. This is particularly true in the pharmaceutical area. It is routine for pharmaceutical companies to put compounds through a battery of screens with completely new and unexpected utilities sometimes emerging. The logic in this case would mean that use patents based on that routine process would be at risk. Robin Jacob's approach is preferable.

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