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Friday, 3 March 2017

BREAKING: High Court grants declaration that products obvious/anticipated at claimed priority dates

The High Court has granted declarations to FKB and SB to the effect that their products lacked novelty or an inventive step at a particular date - Fujifilm Kyowa Kirin Biologics Company Limited and Samsung Bioepsis UK Limited v AbbVie Biotechnology Limited [2017] EWHC 395 (Pat).  Although there are many inviting issues addressed in Carr J's 100 page decision handed down this morning - namely priority (chain of title), anticipation and obviousness of the dosage regimes - this post focuses on the issue of the Court's jurisdiction and appetite for granting such declarations. The long running-procedural history and detailed factual background to the litigation is set out in Annsley's post of last night (here), and is summarised below for those who could do with a brief re-cap.   

Background - re-cap
The IP Kitten on the edge of her seat

The dispute concerns the antibody adalimumab, marketed by AbbVie under the trade mark Humira.  Humira is approved for the treatment of rheumatoid arthritis, psoriatic arthritis and psoriasis.  The dosage regimes for those indications include the administration of 40mg of adalimumab every other week as a single dose via subcutaneous injection.  AbbVie has obtained or applied for a number of patents and divisionals for adalimumab which claim the use of this dosage regime, and applied for a fifth divisional patent.  

Fujifilm Kyowa Kirin Biologics (FKB) and Samsung Bioepsis and Biogen Idec (SB) issued separate proceedings in 2015 and 2016 to revoke two of AbbVie's dosage regime patents (EP UK 2,940,044 and EP UK 1,944, 322) in an attempt to clear the way for their proposed biosimilar product launches after the SPC on Humira expires in Oct 2018.  Those patents were subsequently withdrawn by AbbVie.

FKB and SB allege that AbbVie is implementing a well-established strategy of dragging out proceedings for as long as possible, causing maximum expense and inconvenience to its opponents, and then throwing in the towel by withdrawing its patents, just before they are scrutinised by the court, whilst covering the same subject matter with further divisionals. 

Form of and motivation for declarations sought by FKB and SB

The Claimants sought declarations that their products were obvious and/or anticipated at the claimed priority dates of certain of AbbVie’s patents, namely 8 June 2001 and 18 July 2003.  The reason behind these declarations to is to prevent their biosimilar products being threatened by any future divisional patents.  The declarations sought by FKB and SB/Biogen are in the following terms:

A Declaration pursuant to CPR 40.20 and/or the inherent jurisdiction of the Court that importing into the United Kingdom and offering to sell and dispose of, and to sell and dispose of, and to keep for such sale or disposal in the United Kingdom, the Claimant's products containing their biosimilar monoclonal antibody to the antibody adalimumab (Humira) for the treatment of rheumatoid arthritis, psoriatic arthritis and/or psoriasis by the administration of 40mg every other week by subcutaneous injection for:

(a) rheumatoid arthritis would, in so far as the dosing regimen is concerned, have been obvious and/or anticipated at the date from which EP (UK) 1 406 656 was entitled to claim priority, whether or not co-administered with methotrexate (as would administration of 40 mg by subcutaneous injection every week in the case of monotherapy in rheumatoid arthritis); and

(b) psoriasis and/or psoriatic arthritis would, in so far as the dosing regimen is concerned, have been obvious and/or anticipated at 18 July 2003 (as would administration of 40 mg by subcutaneous injection every week) (whether as an initial or continuing dosing regimen).”
FKB and SB/Biogen’s position was that AbbVie is not prepared to offer the relief sought, or even an acknowledgement in terms of the declarations, because it would be an unambiguous indication that the biosimilar products have been cleared in the United Kingdom. The Claimants argued that AbbVie had threatened to pursue proceedings for infringement throughout the world. They suggested that AbbVie refuses to submit to the declarations precisely because they will serve a useful purpose, by removing any confusion in the marketplace, promoting settlement, preventing interference with the Claimants’ supply chains between Europe and the United Kingdom and by influencing other courts throughout Europe.
Furthermore, the Claimants submitted that AbbVie has engaged in a course of conduct whereby it has dragged out proceedings for as long as possible whilst threatening to sue for infringement, and then has abandoned its patent rights at the last moment, whilst filing further divisionals with very similar claims. According to the Claimants, this strategy is designed to encourage market uncertainty, whilst shielding AbbVie’s patents from the risk of a finding of invalidity.
The details of AbbVie's conduct are set out in earlier IPKat posts.  One further illustrative example
Carr J. in a less sceptical mood
emerging from the trial judgment is that AbbVie originally served evidence in the form of a witness statement from its solicitor to explain that the decision to 'disapprove' the text of its '656 patent leading to its revocation was not connected to the commencement of the UK proceedings.  Instead, AbbVie stated that a late insufficiency objection had given rise to its decision.  When the Claimants sought to cross-examine AbbVie's solicitor at trial, the evidence was withdrawn (although AbbVie continued to proffer the same explanation in the form of a letter from its Patent Attorney to the EPO).  No witness statement was provided by the Patent Attorney and the letter was not admitted in evidence under a Civil Evidence Act notice.  Carr J , whilst noting that it was no reflection on the solicitor who had originally given the statement, stated that he did not believe AbbVie's explanation for its decision to abandon the '656 patent because it was not credible given the context.  Subsequent events also confirmed to the judge that "AbbVie has abandoned all relevant UK patent protection in order to avoid scrutiny by the UK Court and to prolong commercial uncertainty as to the validity of those patents". 

Grant of declarations (paras 343-418 of Judgment)

The Claimants had to demonstrate that the declarations sought would serve a useful purpose, and that they should be granted taking into consideration justice to the Claimants, justice to the Defendants, and any special reasons as to why the Court should grant the declaration. 

AbbVie submitted that the declarations would not serve a useful purpose. It claimed that it had taken steps leading to revocation of all patents which are or might have been in issue in these proceedings, and had also given clear and unambiguous undertakings to the Court which are just as useful as the relief sought by the Claimants in the declarations. It argued that since there will never be any UK patent claims to the dosage regimens in question, it would be wrong in principle, and would not serve a useful purpose, to make the declarations. However, AbbVie served no evidence on these issues, and submitted that it was unable to advance an explanation for its conduct in evidence without waiving privilege.  This was not accepted by the Court (particularly given that the withdrawn witness statement had been carefully drafted to avoid waiver of privilege). 

The Claimants relied upon evidence from both FKB and SB's solicitors (which had been served in relation to the earlier strike out applications - previously reported on the IPKat here).  Shortly before cross-examination, AbbVie indicated that they would not be cross-examined, and the Claimants' evidence therefore stood unchallenged.    


 The new declaration in town
The Court noted that AbbVie would not have invested the considerable resources that the trial required unless there was a good commercial reason to resist the declarations, and that the declarations would be more damaging to AbbVie's strategy in relation to its Humira patent portfolio than the complex set of undertakings and abandonment of UK patent protection that it has chosen to provide. 


Carr J emphasized "the most unusual facts of this case" and explained that there are "special reasons" which support the grant of the declarations. "These include AbbVie’s conduct of threatening infringement whilst abandoning proceedings at the last moment (in order to shield its patent portfolio from scrutiny); the amount of money at stake for the Claimants in terms of investment in clinical trials and potential damages if they launch at risk; and the need for commercial certainty, having regard to AbbVie’s threats to sue for infringement throughout the world." 

Comment

The facts of this case are extreme. This decision should not be taken as a green light for the availability of such declarations for all product launches - it remains a discretionary remedy of the Court, and one which is only likely to be granted in unusual situations where there is a legitimate commercial rationale for doing so.  

The judge also cautioned that the purpose of the declarations in the present proceedings is different to the motivations for the declarations sought in Arrow Generics Limited v Merck & Co. Inc. [2007] EWHC 1900 (Pat) and that describing these declarations as "Arrow" declarations is potentially misleading shorthand [Fujifilm declarations have landed! cries Merpel].  

1 comment:

Peter Bonetti said...

There are going to have to be a lot of trials of preliminary issues on these, I think.

If every single one will have to go to trial before the discretionary issues are considered then it will effectively be a remedy of right rather than discretion, as it's the judgment rather than the declaration that claimants really want.

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