Fujifilm's second Arrow declaration survives AbbVie's strike out application as Humira biosimilar battle rages on

The AmeriKat normally needs to swim around
in coffee to wake up, but Mr Justice Arnold's
decision had the same impact this morning...

This morning Mr Justice Arnold handed down his decision in Fujifilm Kyowa v AbbVie  [2016] EWHC 2204 dismissing AbbVie's application to strike out or, in the alternative, obtain summary judgment of Fujifilm's claims in its second action commenced against AbbVie concerning its intended launch of FKB327.  FKB327 is a biosimilar to Abbvie's adalimumab, marketed under the trade mark Humira which is used in the treatment of rheumatoid arthritis.  The first action was subject to a decision of Mr Justice Carr relating to Fujifilm's Arrow declaration of non-infringement (see AmeriKat post http://micromyaw.blogspot.com /2016/03/fujifilm-kyowa-biologics-can-use.html"> here).  This decision is under appeal, with the appeal set to be heard on 29-30 November 2016.

The subject of the application before Mr Justice Arnold was Fujifilm's second action against AbbVie seeking an Arrow declaration focused on the subject matter of a family of secondary patent applications in the AbbVie Humira portfolio, particularly the pending European Patent Application No 1 737 491, which are primarily concerned with dosing regimens of adalimumab.  The declaration sought is that:

"importing into the United Kingdom and offering to sell and dispose of, and to sell and dispose, and to keep for such sale or disposal in the United Kingdom, the Claimant's products containing their biosimilar antibody to … adalimumab (Humira) would insofar as the Higher Initial Dosing Regimens are concerned have been obvious and/or anticipated at the date from which EP (UK) 1,737,491 is entitled to claim priority. Such Higher Initial Dosing Regimens are dosing regiments for each of psoriasis, Crohn's disease and ulcerative colitis in the Humira SmPC comprising higher initial doses (as multiple initial doses of 40 mg via subcutaneous injection) as follows: 

a. 80 mg for psoriasis; 

b. 80 mg, or 160 mg then 80 mg, for Crohn's disease; and 

c. 160 mg then 80 mg for ulcerative colitis 

each of which is followed by one or more doses of 40 mg."

Fujifilm also seek an injunction against AbbVie to restrain it from threatening or commencing proceedings for patent infringement in respect of acts covered by the declaration.  The second action is designed to protect Fujifilm against subsequent claims for patent infringement for any of the patents within this family of patent applications.

At the end of June, Abbvie applied to set aside the order of Master Bowles who granted Fujifilm permission to serve the Claim Form in the second action outside of the jurisdiction on AbbVie Bermuda (one of the defendants).  It also applied to strike out or alternatively obtain summary judgment, to dismiss Fujfilm's claims for an Arrow declaration and injunction.   In response Fujifilm applied for permission to amend its Particulars of Claim to further particularize its claim for an injunction by adding the following paragraph:

"Further, the claimant is entitled to an injunction to retrain the defendants from threatening, commencing or pursing in the United Kingdom any action for infringement of a patent against the Claimant (or its customers and agents) in respect of any act to which the declaration in paragraph 29 above pertains. By way of particulars of the Claimant's cause of action for the injunction, the defendant's present and threatened future conduct has been and will be objectively (and it can be inferred subjectively) vexatious and oppressive. (1) If the declaration is granted, it would be vexatious and oppressive for the Defendants to threaten, commence or pursue in the United Kingdom proceedings for infringement of a patent against the Claimants (or its customers or agents) in respect of any act to which the said declaration pertains. It is to be inferred that the Defendants would commence such proceedings (and they have not undertaken that they would not). (2) Further, independent of the declaration, the Defendants' conduct as set out above is vexatious and oppressive and an abuse of process insofar as it illegitimately manipulates a persisting threat of patent infringement proceedings and shields from potential examination any patent which the Defendants may be able to obtain pursuant to [EPA491]. Such vexation and oppression presently exists because of the threat of patent infringement proceedings and would be realised by eventual patent infringement proceedings or further threats thereof in respect of the Claimant's products."

AbbVie argued that Fujifilm's case "was a phantasm and unsupportable" and had no real prospect for obtaining an Arrow declaration as the circumstances in this case were not "most unusual" (as Kitchin J, as he then was, described it in Arrow).  Fujifilm argued that AbbVie was guilty of similar conduct as in in the first action where AbbVie was alleged to attempt to shield its EP (UK) '656 Patent from the scrutiny of the English courts and Opposition Division by filing a divisional, then abandoning the patent.

Arnold J held that Fujifilm had a real prospect of establishing similar conduct in the second action, namely Abbvie shielding all or some of the subject matter of its European Patent Application No 1 737 491 from "from timely scrutiny by this Court, or least to prolong the uncertainty as to whether such subject matter founds a valid patent" by "filing the amendments to EPA491, requesting a further rule 71(3) communication and reserving the right to pursue the deleted subject matter by way of one or more further divisional applications ".  Like Mr Justice Carr's earlier decision, this factor played heavily in the Court's determination as to whether there was a real prospect a trial judge would exercise his or her discretion to grant the Arrow declaration.

AbbVie also argued that in this event, the Arrow declaration against AbbVie UK should be struck out as the Bermuda entity was the applicant for European Patent Application No 1 737 491 and, thus only it had committed the acts in the EPO that Fujifilm (and now the judge) relied upon as evidencing a "real prospect" in relation to the Arrow declaration.  AbbVie UK had no interest in the subject matter of the application.  Fujifilm also argued that it was probable that the Bermuda entity would grant an exclusive licence to the UK entity at some point in the future in order to later seek lost profits.  Further, the UK entity, even if it is not granted an exclusive licensee, would have a significant financial interest in the inventions in the patent family because it will be the one who exploits the inventions in the UK.   An Arrow declaration binding on the UK entity thus served a purpose so as to "forestall the possibility of AbbVie making threats to its customers or making statements that its product infringed".

Mr Justice Arnold accepted these points, holding:

1. As to FKB's second reason, counsel for AbbVie submitted that an Arrow declaration, if it could be granted at all, could only be granted against a defendant with a legally enforceable interest in the prospective patents. In my judgment, however, it is arguable that this is not the law. It is now well-established that it is not necessary in a claim for positive declaratory relief for the claimant to have a cause of action against the defendant. In particular, in a claim for a declaration concerning the interpretation of a contract, it is not necessary for the claimant to be party to the contract. It is sufficient for the claimant to be affected by the court's determination: see Rolls-Royce plc v Unite the Union[2009] EWCA Civ 387, [2010] 1 WLR 318 at [120] (Aikens LJ), Feetum v Levy [2005] EWCA Civ 1601, [2006] Ch 585 at [82] (Jonathan Parker LJ) and Milebush Properties Ltd v Tameside Metropolitan Borough Council [2011] EWCA Civ 270, [2012] 1 P&CR 3 at [44] (Mummery LJ). Accordingly, I consider that it is arguable that, in a claim for negative declaratory relief, it is not necessary for the claimant to show that the defendant would be a necessary party to any claim against the claimant, and it is sufficient for the claimant to show that it has a legitimate interest in ensuring that the defendant is bound by the declaration.


2. Counsel for AbbVie also submitted that there was no evidence that AbbVie UK intended to threaten FKB's customers. He could have added that, if it did, FKB would have a remedy under section 70 of the 1977 Act, although that would potentially give rise to an issue as to whether it would be open to AbbVie UK to rely upon infringement of a patent owned by AbbVie Bermuda and not the subject of an exclusive licence to justify such a threat (cf. Global Flood Defence Systems Ltd v Johan van den Noort Beheer BV [2016] EWHC 1851 (Pat)). I accept that there is no evidence that AbbVie UK intends to threaten FKB's customers. I do not accept that it necessarily follows that FKB has no legitimate interest in obtaining a declaration binding on AbbVie UK given that AbbVie UK is the party with the most direct financial interest in FKB's proposed acts in relation to FKB327. Whether such a declaration would be justified would be a matter for argument based on all the relevant circumstances."

On Fujifilm's claim for an anti-suit injunction, after a careful analysis of the cases, Arnold J held that it had a real prospect of obtaining an injunction and granted Fujifilm permission to amend its Particulars of Claim.  The remainder of the decision relates to Article 24(4) of the Recast Brussels I Regulation and the service out point (referred to above) which ends with Arnold J finding in favor of Fujifilm, yet again.

The AmeriKat is looking forward to pouring over this decision in greater detail, especially in relation to the anti-suit injunction point, and will be back with further analysis.  In the meantime, we will have to wait for the Court of Appeal to determine the substantive fate of the Arrow declaration in the first action.