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'arrow' declarations - lessons from Fujifilm v AbbVie, case law webinar update

20 March 2017
The Patents Court has granted declarations that dosage regimens were obvious at the claimed priority dates of certain of AbbVie’s patents and patent applications.

This is the first time that a party has been able to get this certainty before a patent has been granted.

This webinar will provide an overview of the decision and discuss some of the issues arising from it, including:

  • how does this affect your patent strategy?
  • why was this declaration granted?
  • could these declarations become a common relief?
  • and, as Carr J has said that calling them 'Arrow' declarations is potentially misleading, what are we meant to call them?
In addition to these declarations, we will also discuss some of the other issues raised in the judgment, including:
  • inventive step and dosage regimens
  • guidance for experts
  • information acquired as a matter of routine in obviousness cases.


transcript

Here is a transcript of the information Mark shares in this video.

Speaker Key

MD Mark Daniels

00:00:00

MD Good afternoon, everybody. I'm going to be looking today at a decision that's been handed down in the the English Patents Court fairly recently, and potentially heralds a new forum for declaratory relief. So, a little bit of context-setting first. As many of you know, the English Patents Court is well-known for its robust, authoritative, and often lengthy judgments; and its recent innovation when it comes to controlling parties' investment, in terms of cost and time in litigation, and providing numerous forums in which to conduct patent litigation.

Increasingly, over the last 15 years, it has also shown innovation in the context of the nature of relief it's prepared to grant to successful parties. It recognises that patent litigation is conducted not in a vacuum, but in the context of the real commercial world. And this has been most recently seen in the FKB case; which I'll walk through today. But first, let's immerse ourselves into the world of declaratory relief in the UK.

00:01:05

Civil Procedure Rules, CPR 40.20, have long since given the courts inherent jurisdiction to make binding declarations whether or not any other remedy is claimed. It's a discretionary remedy, and of course it's not, by any stretch, limited to patent actions. So, recognising the desire for would-be defendants to avail themselves of this relief, Lord Woolf in Messier Dowty v Sabena back in 2001 - held that the court should not be reluctant to grant negative declarations. They can, and do, assist in achieving justice. 

Well, how do you know when they assist in achieving justice? So, Mr. Justice Neuberger, in the FSA case, Financial Services v Rourke - it's on the right hand of your screens - in 2002, gave some guidance. He held that when considering whether to grant a declaration, the court should take into account: one, the justice to the claimant. Two, the justice to the defendant. Thirdly, whether the declaration would serve a “useful purpose”. And finally, whether there are any other special reasons why or why not the court should grant the declaration. 

Well, what is a useful purpose? So, the initial, and perhaps superficial, guidance given by Mr Justice Pumfrey, who tackled this issue twice, in the Nokia v InterDigital series of cases. 

00:02:30

He neatly summed up his thoughts as follows: would the declaration, if granted, be the legal equivalent of shouting into an empty room? Or is there some point in it? He was upheld on appeal. 

But we do know that one such useful purpose is the attainment of commercial certainty. And that was held by Mr Justice Kitchin in Arrow Generics v Merck , the case from which today's subject date takes its name. Mr Justice Kitchin held in that case, that there is a public interest in commercial certainty in patent matters as in any others. Business needs to know where it stands. I believe this court should assist in providing that certainty where it can. 

I thought it worth mentioning and reminding ourselves of some of the examples of the various forms which negative declarations in patent cases can take before we look at the FujiFilm case. 

So, two categories of declarations which are available in the UK: firstly, on the statutory side. So, Section 71 of the Patents Act provides that would-be defendants are able to, or may be able to, obtain declarations of non-infringement. It is a statutory right. And secondly, would-be defendants are able to obtain declarations of invalidity, provided that that is coupled also with a corresponding revocation of the patent. And that's set out in Section 74(2) of the Patents Act.

Now, do take note that the courts are not prepared to grant a declaration that a patent, if granted, would be invalid. So the normal course envisaged by the statute is that the defendant should wait and see what, if any, patent is granted. 
 And that was referred to in the Court of Appeal hearing, which I'll come back to, in the FKB series of cases.

00:04:20

So, that's the statutory declarations. The court also has inherent jurisdiction under the Civil Procedure Rules 40.20. And so, examples of declarations that have been granted by the UK courts are declarations of non-essentiality, and essentiality, to a relevant technical standard. And that's the Nokia v InterDigital cases. Also in the telecoms sphere, declarations may be granted as to whether or not licences offered in respect of standard essential patents are fair, reasonable, and non-discriminatory. The latest we will hear on that is the Unwired Planet case, in respect of which the judgment is due out fairly shortly.

And then turning to the subject that we're discussing today: a declaration that the defendant's product was obvious at the priority date of a patent application not yet granted; and that is a declaration that was contemplated and allowed in principle in Arrow, and is now here for real in the FKB decision. 

So, with that context, let's have a look at the development in this area and the FujiFilm case. Well, firstly, in relation to the background, why did this matter? So let's look at the market and the patents. Now, AbbVie markets the drug Humira. Humira is the highest-selling prescription drug in the world by global sales. Its worldwide sales in 2014 exceeded $12.5 billion.

00:05:50

And the daily UK sales are calculated at around 1.2 million. The drug is used to treat, amongst other things, rheumatoid arthritis, psoriatic arthritis, and psoriasis. In short, the market around this drug is huge. AbbVie has a patent portfolio relating to Humira. The SPC to the basic product patent will expire in 2018; and so, in light of this, AbbVie has applied for a number of European patents to dosage regimens of Humira to treat various inflammatory diseases. These applications have a number of divisionals, some of which have not yet been published, although the underlying applications are in some cases quite old. And the claimants, which I’ll conveniently call ‘FKB’ together, intend to market biosimilar versions of Humira. So let's look at the proceedings.

FKB commenced proceedings in October, 2015 against AbbVie, seeking revocation of two of AbbVie's dosing regimen patents. Mindful of the effect of Section 74 of the Patents Act, and the fact that it does not allow for pure declarations of invalidity without corresponding revocation, and therefore does not permit parties to challenge the validity of a patent application, FKB also sought Arrow declarations; namely a declaration that the use of its own products of the priority date would not be new or inventive. If successful, this would give FKB the Gillette defence; namely, it could not infringe any valid patent on the subject matter if that were granted in the future.

Now, an equivalent claim was commenced by SB and Biogen in March, 2016; 

And you probably have seen this case in March, 2016, and again in January of this year, as AbbVie sought to strike out that part of FKB's claim, that related to the declaratory relief.

Mr Justice Carr in the High Court refused to strike the claim out, and the Court of Appeal upheld his decision. So the case proceeded to trial in January of this year.

00:07:56

Now, shortly before trial, AbbVie took two courses of action, which turned out to have been important actions when eventually the case did come on to trial. Firstly, it abandoned two of its relevant patents, the 656 and the 322, and it de-designated the UK from a third patent, the 044. That left no relevant granted patents. Secondly, it offered an undertaking to the court not to obtain future patent protection in the UK for the relevant dosage regimen. It also offered to pay the cost of the proceedings if that proposal was accepted. But FKB refused this offer and invited AbbVie to submit to judgment, which would have resulted in the grant of the declarations. And AbbVie refused to do so. 

At trial, and in the judgment, the court looked first at the arguments on priority, and on the sole question which remained on obviousness; and that question was whether the administration of FKB's proposed products, at a particular dose of 40 mg, by subcutaneous injection, every other week for the treatment of rheumatoid arthritis, was inventive at the priority date. And the court found that it was not inventive.

So having dealt with the technical issues, which we will come back to, the court then turned to whether or not the declarations should be granted. 

00:09:23

And it looked at the criteria as set out in the FSA v Rourke case to consider whether or not it should exercise its discretion to grant the declaratory relief which was sought. The key factor in this case turned on whether the declaration served a useful purpose. Now, AbbVie had argued that there was no such useful purpose; effectively, they said, the way had been cleared in the UK because all relevant patents had been abandoned or de-designated, and their undertaking had been offered. But FKB argued that there must be useful purpose, otherwise why would AbbVie have not submitted to judgment? 

This, said FKB, led to great commercial uncertainty, and was exacerbated by the fact that AbbVie had adopted a strategy of delaying its patent applications from being granted, and abandoning patents when granted and even just before grant, and then filing subsequent divisionals.

Notably, there had also been various statements made by AbbVie's CEO expressing AbbVie's intention and threat to block biosimilar Humira through its patent portfolio, and that these threats applied to European commercial activity.

So, the court found that the declarations did serve a useful purpose, and was keen to stress that the useful purpose applied specifically to the UK. And I’ll run through the factors that persuaded the court. 

The declarations would provide commercial certainty, said the court. AbbVie had publicly stated that they would make every effort to enforce its patent portfolio against biosimilar competition anywhere in the world.

00:11:00

It had also made every effort to shield the claims of its patents from scrutiny, both in the EPO and the UK court. AbbVie's continued resistance to giving declarations showed that they would be more damaging to its strategy than the undertakings that they had proposed. If the declarations were refused, FKB would have succeeded in their technical case, but would have failed to obtain the relief they sought. And this, said the court, would be a recipe for uncertainty.

Thirdly, the declarations would protect FKB's supply chain for the UK market. Without them, the international make of the industry meant that there would be a ‘chilling effect’ on FKB's UK operations. 

Finally, the declarations would promote a settlement, which would have a direct benefit in the UK.

Now, having found that the declarations served a useful purpose, the court found it quite easy to decide that there was no injustice to AbbVie in granting the declarations, and that conversely, it was just for FKB to do so. 

Equally, the court found that there were no special reasons not to grant the declarations, and as a combination of AbbVie's conduct, the sheer size of the money at stake, and the need for commercial certainty, had led to special reasons to grant them.

00:12:21

So, that's a summary of the case. The interesting aspect in all of this is what has been taking up the time of the commentators since a week ago, and specifically, the question of whether or not this case leads to the opening of some floodgates. Now, it's fair to say at this stage, the commentators can't agree; they rarely do. Some commentators have heralded the decision as a turning point in patent litigation, and some at the other end of the spectrum have guarded against a green light for the availability of such declarations.

It's fair to say here that the facts of the case were particularly unusual. Here we had a particularly obfuscating patentee, and the court itself was keen to stress the unusual nature of the case. I think it mentioned unusual at least three times in the judgment. Furthermore, it noted that the Arrow case itself dated back to 2008, and the decision in that case, at the strike-out hearing, had not resulted in many such cases being brought since that time. But Arrow was an application for strike out, and it's fair to say that the FKB case has thrown a spotlight on the availability of these declarations. We do know, for example, that the parties to this litigation are listed for a further trial in June this year, to hear FKB's claim for a similar declaration relating to a further AbbVie patent, the 491; which the Court of Appeal has also refused to strike out.

We also know that the Dutch court has already granted a similar declaration in a case between Merck and Ratiopharm, and that was back in 2008. That case related to a particular dosage regimen for the treatment of osteoporosis, and the Dutch court granted the declaration for commercial certainty in circumstances where the patentee had filed subsequent divisionals concerning the same subject matter which was still at the application stage at the EPO. 

00:14:23

Incidentally, I do recall Mr Justice Pumfrey in Nokia v InterDigital expressing the same floodgate concerns. And now, it's fair to say that whilst they're not common, standard essential declarations are making appearances in the UK courts, in the right circumstances.

So, what we do know from this, is that the courts are increasingly keen to allow the parties to achieve, or to look to achieve, commercial certainty. Another example of this is the IPCom v HTC case, which went to the Court of Appeal, and the Court of Appeal said in that case: “in the context of patent proceedings which were in the UK and parallel proceedings in the EPO, that the court is entitled to refuse a stay of the national proceedings where the evidence is that some commercial certainty would be achieved at a considerably earlier date in the case of the UK proceedings than in the EPO.” It's true that it will not be possible to attain certainty everywhere until the EPO proceedings are finally resolved, said the Court of Appeal, but some certainty, sooner rather than later, and somewhere, such as in the UK, rather than nowhere, is in general, preferable to continuing in uncertainty everywhere.

00:15:37

So, my own view on the floodgates issue is: well, we're not going to see hundreds of cases flowing through the UK courts on this particular issue, but the courts, I think, will be sympathetic and receptive to parties' attempts to clear the way through patent thickets. And provided the claim for a declaration related to the proposed product can withstand a strike out application, the normal course, as in this case, is that the technical issues will be considered first, and then the declaration may well flow as a matter of course from those technical findings; which is what had happened here.

Some other points to note in relation to this particular judgment: Mr Justice Carr in his judgment gave some guidance concerning expert evidence. Firstly, he commented in relation to AbbVie's experts, that if experts are used across multiple jurisdictions - which, is itself, perfectly acceptable - it's not acceptable for an expert to refuse to comment on a point in the UK proceedings if they have considered that point in other proceedings. So here, Professor Pope, for AbbVie, had already given evidence in the Canadian Patent Appeal Board proceedings, but didn’t cover that point or refused to comment on a similar issue in the UK proceedings, and attracted some criticism for that. 

She also failed to mentioned some of her previous work in relation to the treatment of rheumatoid arthritis, the results of which were in contradiction to material parts of her evidence, and that also attracted some criticism.

And then finally, on experts - and I think this is consistent with warnings against witness training, which are frequently given by the English High Court judges - the judge here criticised one of AbbVie's experts for adhering doggedly to the party line under cross - examination when it became clear that her evidence was mistaken.

00:17:29

So, there's some learning points there in terms of handling expert evidence. 

The final point in relation to guidance from this particular judgment relates to the approach that the court took towards the design of dosage regiments. So the court gave some guidance on this, in so far as it relates to the question of obviousness. 

AbbVie had approached the question of obviousness from the perspective of looking at regimens which would have had the maximum effect in relation to every patient; and the court's approach here was that which was adopted by FKB as well - namely that what the skilled technician would look for is a dosage regimen which would help the majority of patients, also having regard to the cost considerations, patient convenience, and patient compliance.

And the effect of this may make the claims to dosage regimens more susceptible to a finding of obviousness, which of course is what happened here. But equally, it must be said that each case turns on its facts. 

The final point I will mention is just a bit of an aside, really; but it's a branding issue, and the question of whether or not these declarations should actually be called ‘Arrow’ declarations.

00:18:45

So, AbbVie had said that the claimants had cleared the way of patent protection in the UK, and so achieved the commercial purpose that was set out by the declarations as set out in Arrow; that was the basis upon which they said that such declarations would serve no useful purpose. Now, Mr Justice Carr commented that this may have been the point of the declarations in Arrow, and even in the earlier FKB 1 hearings, so before trial - but what he found was that the circumstances now relied on at trial, in January, were not the same as in Arrow, and nor were they the same as were originally pleaded. His view is that there were still good reasons for the declarations, over and above clearing the way.

And so, he said that describing the declarations as ‘Arrow’ declarations is potentially misleading shorthand, as the purposes of the declarations is different. So, we may need to take a poll on what the precise declarations will be called; whether they'll be rebranded ‘FujiFilm’ declarations in due course will remain to be seen.

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The opinions expressed on this video are provided for the purposes of general interest and information and should not be relied upon. They contain only summaries of aspects of the subject matter at the time of publishing and do not provide comprehensive statements of the law. They do not constitute legal advice and do not provide a substitute for it. So why not talk to us and seek advice that's tailored to you? You can look up one of our experts on this website or call on 0370 270 6000.

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