Fujifilm Kyowa Biologics Co Ltd v Abbvie Biotechnology Ltd (Rev 1), Court of Appeal - Patents Court, March 01, 2016, [2016] EWHC 425 (Pat)

Resolution Date:March 01, 2016
Issuing Organization:Patents Court
Actores:Fujifilm Kyowa Biologics Co Ltd v Abbvie Biotechnology Ltd (Rev 1)
 
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Neutral Citation Number: [2016] EWHC 425 (Pat)

Case No: HP-2015-000053

IN THE HIGH COURT OF JUSTICE

CHANCERY DIVISION

PATENTS COURT

Royal Courts of Justice

Rolls Building

Fetter Lane

London EC4A 1 NL

Date: 01/03/2016

Before :

THE HON MR JUSTICE HENRY CARR

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Between :

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Andrew Waugh QC and Geoffrey Pritchard (instructed by Gowling WLG (UK) LLP) for the Claimant

Daniel Alexander QC and Jeremy Heald (instructed by Herbert Smith Freehills LLP) for the Defendant

Hearing dates: 19 February 2016

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Mr Justice Henry Carr :

Introduction

  1. The Defendant (``AbbVie'') is the proprietor of a number of patents relating to the antibody adalimumab, sold under the trade mark Humira. Humira is the highest selling prescription drug in the world by global sales, achieving net sales in 2014 in excess of US$12.5 billion. Adalimumab is a fully human antibody that binds and neutralises the activity of TNFá. The basic patent for adalimumab (EP 0,929,578) and its associated UK SPC (GB/04/002) will expire on 15 October 2018.

  2. Humira has been approved for the treatment in adults of rheumatoid arthritis, psoriatic arthritis and psoriasis. The basic dosage regimes for those indications, as set out in the Summary of Product Characteristics, specify or include the administration of 40 mg adalimumab every other week as a single dose via subcutaneous injection (``40 mg sc eow''). AbbVie has obtained or applied for a number of patents and divisionals for adalimumab which claim the use of this dosage regime in the treatment of various indications.

  3. The Claimant (``FKB'') is a joint venture between FUJIFILM Corporation and Kyowa Hakko Kirin Co., Ltd, established in March 2012 to conduct development and manufacture of biopharmaceuticals and to offer biosimilar pharmaceutical products. It intends to market a biosimilar adalimumab product (``FKB327''). This product is in Phase III clinical trials and FKB intends to market FKB327 in the UK after expiry of the basic adalimumab patent and its associated UK SPC if it can clear the way of secondary patents before then. That is the purpose of this Claim.

  4. This judgment concerns an application by FKB to amend the Claim Form and Particulars of Claim and a cross-application by AbbVie to strike out certain parts of the pleading as originally served.

    The facts

  5. This claim was issued by FKB on 29 October 2015. The Particulars of Claim in its original form sought to revoke two granted patents, namely EP (UK) 1, 406,656 (``the 656 Patent'') and EP (UK) 1,944,322 (``the 322 Patent''). Both of these patents relate to the 40 mg sc eow dosage regime for the use of adalimumab in the treatment of various indications. However, FKB was also concerned about a number of divisional applications which have been applied for by AbbVie and which relate, in some way, to adalimumab. Relying on the judgment of Kitchin J. (as he then was) in Arrow Generics Ltd v Merck & Co Inc [2007] EWHC 1900 (Pat): [2007] F.S.R. 39, FKB applied for a declaration that ``products containing a biosimilar monoclonal antibody to the antibody adalimumab for the treatment of rheumatoid arthritis, psoriatic arthritis and/or psoriasis by the administration of 40mg every other week by subcutaneous injection...'' would have been obvious at the priority dates of the 656 and 322 Patents.

  6. This declaration was intended to prevent AbbVie from commencing infringement proceedings in the United Kingdom against FKB327 under pending applications once they have been granted. If it was obvious at the relevant priority date to treat these various indications by the 40 mg sc eow dosage regime, then the declaration would create a squeeze between infringement and validity, such that an action for infringement could not succeed in the United Kingdom. AbbVie seeks to strike out this declaration and the pleading in support of it.

  7. The 656 patent claims the use of adalimumab in the treatment of rheumatoid arthritis by the 40 mg sc eow dosage regime. The application for the 656 patent was filed on 5 June 2002. It was not granted by the EPO until eleven years later, on 9 June 2013. During the nine month opposition period following grant, fifteen oppositions were submitted. AbbVie eventually filed its observations in response to the oppositions, together with no less than nineteen statements of fact and expert reports, on 22 December 2014. On 24 April 2015 AbbVie requested the grant of a divisional from the 656 patent (``the Fourth Divisional Application''), having previously requested the grant of three other divisionals. Between August and October 2015 various opponents submitted replies to the observations filed on behalf of AbbVie. However, on 4 November 2015, six days after the Claim Form was issued in these proceedings, AbbVie wrote to the EPO stating that it no longer approved the text of the granted 656 patent. Accordingly, the EPO revoked the 656 patent on 16 November 2015. The Fourth Divisional Application, which claimed essentially the same subject matter as the 656 patent, was published on 4 November 2015.

  8. FKB applies to plead these facts by amendment to its Particulars of Claim. It alleges that AbbVie intends to delay the entry of competing Humira biosimilar products by prolonging commercial uncertainty. FKB claims that the purpose of abandoning the 656 patent was to avoid adjudication on its patentability by the UK court and the Opposition Division, whilst seeking to ensure that the subject matter of the alleged invention of the 656 patent was maintained by the Fourth Divisional Application. The object, according to FKB, is to prevent FKB from clearing the way in respect of its FKB327 biosimilar after expiration of the SPC for the basic adalimumab patent. FKB submits that it will be many years before the EPO will be in a position finally to adjudicate on the patentability of the subject matter of the Fourth Divisional Application. FKB relies upon these allegations to demonstrate why the granting of the declaration which it now seeks would serve a useful purpose, by achieving commercial certainty in respect of its FKB327 product by the date of its intended launch in the autumn of 2018.

  9. AbbVie does not accept that there was any connection between its decision to abandon the 656 patent and the commencement of the UK proceedings by FKB. It explains that on 23 September 2015 one of the opponents raised a new insufficiency objection concerning an in vitro L929 assay (``the L929 Requirements'') which was a feature of the claims of the 656 patent. Several opponents had objected to the presence of the L929 Requirements on the ground of added matter. The new objection alleged that the L929 Requirements rendered the claims of the 656 patent insufficient as the skilled person would not be able to determine whether a particular antibody satisfied those Requirements. On 4 November 2015 Mewburn Ellis LLP wrote to the EPO to explain that AbbVie no longer approved the text in which the 656 patent was granted and had decided to address the objections to the validity of the patent through pursuit of its existing divisional applications, which did not contain the L929 Requirements. It was asserted that this would avoid any controversy arising under Article 123(3) EPC that might be caused if the L929 Requirements were removed from the claims of the 656 patent by amendment.

  10. FKB strongly disputes this explanation. It points out that it is difficult to succeed on an insufficiency objection in the EPO because such an objection has to be proved on the basis of serious doubts, substantiated by verifiable facts. It alleges that this insufficiency objection appears weak and certainly no better than the other insufficiency objections to which AbbVie had already responded in the opposition proceedings. It also claims that the timing of the abandonment, so soon after commencement of the UK proceedings, cannot have been a coincidence.

  11. I am unable to resolve this dispute on these applications, although, on the material which I have seen, there is a good arguable case that the allegations which are sought to be added by amendment are correct, for the reasons advanced by FKB. Mr Alexander QC, who appeared for AbbVie, was quite right to accept that, when considering whether to refuse permission to amend and whether to strike out, I should assume that the pleaded allegations of fact are true. His case is that this makes no difference, as there is no jurisdiction to grant the relief sought, or alternatively, it would be a wrong exercise of discretion to do so, even if the pleaded facts are established.

  12. Mr Waugh QC, who appeared on behalf of FKB, invited me to find that AbbVie has generated a dense thicket of patents around uses and doses of adalimumab. He referred me to a ``patent map'' which was a graphical illustration of seventeen patent families, each family deriving from the same application, where AbbVie has often filed at least one divisional application and sometimes more, within each such family. However, many of the patent families do not concern the 40 mg sc eow dosage regime and appear to be irrelevant to these proceedings. Mr Alexander pointed out that in a ground-breaking invention such as Humira, it is unsurprising to find a portfolio of patents and patent applications directed to many different aspects of the invention. It is neither necessary nor appropriate for me to find, on these applications, that AbbVie has created ``a dense thicket of patents'' around Humira.

  13. The 322 patent covers use of adalimumab in accordance with the 40 mg sc eow dosage regime for the treatment of psoriasis. The patent is in force and the validity of its UK designation will be determined by this Claim. In addition, there are a variety of pending divisionals in different patent families which concern the treatment of different indications by adalimumab in accordance with the 40...

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