Pfizer v Hoffman-La Roche – evading Arrow declarations

12.05.2020

Arrow declarations are a relatively newly-developed form of relief that allow a party to gain commercial certainty against pending patent applications, often for the purpose of clearing the way prior to generic or biosimilar launch. The possible existence of the jurisdiction to grant such negative declarations in the UK was first floated a decade ago in Arrow v Merck before the Court of Appeal finally confirmed their availability in FKB v AbbVie in 2017. In the case of Pfizer v Hoffman-La Roche, Birss J has further clarified the extent of the court’s discretion to grant these negative declarations. In summary, he found that the court’s power to grant Arrow declarations is wide, but should be limited to the extent that it will serve a useful purpose within the UK.

Arrow declarations to date

In the landmark case of Arrow v Merck [1], Kitchin J (as he then was) first recognised that the English courts might have jurisdiction to grant eponymous Arrow declarations, although the court did not have to decide the matter as the case settled before trial. As readers may be aware, Arrow declarations are associated with the so-called Gillette defence[2]. In essence, this provides an alleged infringer with an absolute defence during patent infringement proceedings on the basis that its product or process was disclosed in the prior art or is an obvious modification, and as such could not therefore infringe any valid patent claim, regardless of the form or scope of those claims. In an Arrow declaration case, the applicant therefore seeks a declaration that its product or process would have been anticipated and/or obvious as at the priority date of the pending patent application(s) of concern. If granted, the declaration therefore allows the applicant to launch its biosimilar product (by way of example) without the threat of future infringement action based on the pending patent applications.

As mentioned above, the Court of Appeal finally confirmed that the jurisdiction to grant such declarations existed in the seminal case of FKB v AbbVie[3]. In the Court of Appeal, Floyd LJ held that there was no issue of principle against the granting of Arrow declarations in appropriate cases, and that “whether such a declaration is justified depends on whether a sufficient case can be made for the exercise of the court’s discretion in accordance with established principles”[4]. The Court of Appeal also approved the approach proposed by Neuberger J in Financial Services Authority v Rourke[5] for determining whether to grant discretionary negative declaratory relief, in that the court should take into account: “justice to the claimant, justice to the defendant, whether the declaration would serve a useful purpose and whether there are any other special reasons why or why not the court should grant the declaration”.

Carr J provided further guidance in his judgment following trial in the same case (FKB v AbbVie[6]), in which he granted the first ever Arrow declarations, this time in relation to biosimilar adalimumab. As we will see in the Pfizer v Roche case analysis, the court’s interpretation of what would serve a useful purpose appears to be wide and places great emphasis on the existence of an impact on the UK market.

Background to the present case

Pfizer brought a claim for Arrow declarations in relation to its biosimilar VEGF monoclonal antibody medicinal product (bevacizumab), which is for treatment of various cancers in combination with other drugs. This was in the context of Roche’s originator bevacizumab product, Avastin, which is the subject of an SPC expiring in June 2020, for which the basic patent is to bevacizumab itself. Pfizer’s stated intention is to launch its product following SPC expiry. However, Roche had further patents and patent applications to combinations of bevacizumab with other known cancer drugs for use in treating various types of cancers, including two forms of cancer included in the summary of product characteristics in the marketing authorisation for Avastin. Hence Pfizer’s claim for Arrow declaratory relief prior to product launch.

By the time of the trial however, Roche had de-designated the UK from all pending applications, either before or shortly after commencement of the proceedings, and no longer had any granted UK patents, in the concerned patent families. Nevertheless, Pfizer contended that Arrow declarations would still be useful to establish certainty in the UK market considering that it planned on supplying its biosimilar product from Belgium, which was not de-designated from the pending European patent applications. As a result, it was claimed that the supply chain to the UK would be disturbed, should Roche initiate and succeed in any infringement action before Belgium courts, including by way of an application for a preliminary injunction.

In response Roche submitted that the Court did not have jurisdiction over the issue as it had de-designated the UK from all pending patent applications and thus abandoned any future relevant rights regarding Avastin, whereas Pfizer contended that the Court’s discretion to grant an Arrow declaration was “almost unfettered” and could apply even in these circumstances. The claimant thus took the position that the useful purpose criteria should be interpreted widely to encompass any benefit such declaration could grant, including the use of a favourable UK judgment before foreign courts.

Shielding conduct

At a high level, there were two issues at trial: (i) the technical issues regarding novelty or obviousness of the use of the various bevacizumab combinations for the relevant indications; and (ii) whether the court should examine the technical issues in detail if it had decided that an Arrow declaration would not be granted.

Roche declined to respond to the technical allegations brought by Pfizer (other than one point on priority). Therefore Pfizer was the only party to present written expert evidence on these issues, and Roche chose not to cross-examine Pfizer’s experts. On the material before him, Birss J was of the view that there was a compelling case in favour of a Gillette defence. Although the judge decided not to go further and decide the various technical issues, he stated that it was nevertheless relevant to examine the apparent merit of the technical case as it might help explain the motives of the patentee. In this case, he inferred that the motive for de-designating the UK (whilst maintaining the patents and applications in other countries) was to shield the portfolio from the risk of an adverse decision of the English Patents Court. This was notwithstanding that the UK market was significantly smaller in value than the rest of the European market. Birss J emphasised that Roche’s prosecution strategy was not unlawful, and that it was entitled to try to obtain a valid patent for one of the indications claims through its filing strategy, even if that caused uncertainty to third parties. However, this should not prevent the court from making an Arrow declaration in light of the shielding behaviour if the circumstances were in Pfizer’s favour.

UK rights and foreign spin-off value in the assessment of useful purpose

Pfizer contended that the FKB v AbbVie case suggested the Court should grant an Arrow declaration even when no UK rights were in existence. In that case, AbbVie offered complicated undertakings to abandon future UK rights and yet the Court decided nevertheless to grant the relief sought. However, Birss J was satisfied that the Court in that case had established a useful purpose in the declarations based on the commercial uncertainty in the UK market, that would remain despite the undertakings offered, and that Arrow declarations would dispel uncertainty in the UK. The judge alsos noted that although Carr J in the FKB v AbbVie case acknowledged the potential effect of the Arrow declaration on the rest of the European market he had expressly not taken into account the spin-off value of the judgment abroad in his assessment of useful purpose.

In the present case, it was contended that the supply chain for Pfizer’s bevacizumab product would be impaired if Roche decided to enforce its pending patents in Belgium. Birss J, however, distinguished Roche’s actions to abandon all existing and future UK patent rights in question and found them to leave no uncertainty as to the rights in the UK following expiry of the SPC, as opposed to AbbVie’s unclear undertakings in the earlier case which did not provide certainty for third parties.

The Judge also conducted a detailed analysis of Belgian law, including expert evidence presented by the parties on Belgian law, and the potential effect of a UK judgment on Belgian court decisions. Although he acknowledged that a Belgian court would undoubtedly consider a reasoned UK judgment, it was unlikely for it to rely completely on a foreign court’s reasoning and would thus proceed to analyse the facts itself. He did acknowledge that an Arrow declaration from the English Court, along with the reasoned judgment, would be taken into account and would play a significant role in resisting preliminary measures such as a preliminary injunction on the basis that it would rebut the presumption of validity of a Belgian patent in interim proceedings.

Overall, Birss J noted that if there had been any pending UK patent applications in any of the families then this would have been a plain case for an Arrow declaration and he would have gone on to examine the technical merits of the Gillette defences (i.e. lack of novelty/ obviousness) in detail. However, the complete absence of UK rights meant in reality that the commercial value of the declaration was the utility it might have in helping Pfizer defend itself against actions brought by Roche in other countries. Unlike the FKB v AbbVie case, there was no outstanding uncertainty relating to UK rights. Although there was uncertainty to the supply chain, that was a result of uncertainty created by pending Belgian patent applications. Although the result of a Belgian action could have an impact in the UK, that had nothing to do with any UK legal right.

The judge was not persuaded that use of the Arrow declarations and judgment in foreign courts was enough basis on which to grant the declarations, and so he refused to grant the declarations sought. As a result, he did not examine the merits of the Gillette defence in any detail.

Ultimately, Birss J adopted a wide interpretation of the discretionary power of the Court, and Roche were only able to resist the grant of the Arrow declarations (and a fully reasoned judgment) on the technical issues by abandoning all present and future UK rights. The judgment suggests that in many cases, anything short of this nuclear option by the patentee will result in a case proceeding to trial[7] and potentially unfavourable findings (to the patentee) being made at trial. Even in this case, the judge made a series of unfavourable observations about the likely strength of Roche’s patent portfolio in light of various decisions made during both prosecution and the course of the UK action. Parties should therefore take heed of the potential that a claim for an Arrow declaration for causing damage to a patentee even if the claim is ultimately dismissed.

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[1] Arrow Generics v Merck & Co [2007] EWHC 1900 (Pat)
[2] Named after the case of Gillette Safety Razor v Anglo-American Trading Co (1913) 30 RPC 465
[3] Fujifilm Kyowa Kirin Biologics v AbbVie [2017] EWCA Civ 1
[4] See paragraph 98 of the judgment of Floyd LJ
[5] FSA v Rourke [2002] CP Rep 14
[6] Fujifilm Kyowa Kirin Biologics v AbbVie [2017] EWHC 395 (Pat)
[7] In fact Roche had previously attempted (unsuccessfully) to have the action dismissed at an interim stage on the basis that the UK rights had been abandoned. However, the Court held that the exercise of a discretionary power required an analysis of the facts at trial and so did not dismiss the action on a summary basis

Gregory Bacon

Author