An Arrow declaration is a declaration by a UK court that a specific intended commercial product or process would have been obvious at a specific date. It is the mirror image to a successful Gillette defence in UK patent infringement proceedings, in which a defendant contends that its product or process was known at the priority date of the asserted patent, with the necessary implication that the asserted patent claims cannot both cover the product and be valid. Arrow declarations take their name from the first case in which a declaration of its kind was sought (Arrow v Merck¹) although that case settled before the court was called on to decide whether to actually grant the declaration requested.
A Gillette defence is only available to a party which is faced with a claim for infringement of a granted patent. A party may also seek to ‘clear the way’ for its intended product by seeking a declaration of non-infringement (“DNI”), but again a DNI may only be granted in respect of a granted patent. Arrow declarations have therefore arisen as a potential means of clearing the way in respect of patent rights which have yet to be granted, since any future granted patent whose claims cover the subject matter of an Arrow declaration will be summarily held invalid in a UK court.
Arrow declarations are a relatively new innovation by the UK courts. They have attracted considerable interest in the past few years, perhaps because the value of obtaining them may extend to their ‘spin off’ value in proceedings in other EPC states.
When will the Court grant an Arrow declaration?
The court has a broad discretion to grant an Arrow declaration. In doing so, it will take into account:
- justice to the claimant;
- justice to the defendant;
- whether the declaration will serve a useful purpose; and
- whether or not there are any other special reasons why the court should or should not grant the declaration.
There have so far been four cases in which the UK Patents Court has considered whether or not to grant Arrow relief, summarised in Table 1. The judgments in these cases point to specific issues which will inform the court’s assessment under the four-pronged approach above. We cover some of these below.
Shielding patents from scrutiny
If a patentee engages in a prosecution strategy which the court perceives is designed to maximise commercial uncertainty for competitors whilst shielding the patents from the court’s scrutiny, the court will regard this as a factor in favour of granting Arrow relief. An allegation of this kind is the typical background to most claims for an Arrow declaration.
An extreme example is Fujifilm v Abbvie², the first case in which an Arrow declaration was granted. The case concerned AbbVie’s blockbuster Humria (adalimumab) product, and in particular AbbVie’s portfolio of patent applications directed to dosing regimens for second medical uses of adalimumab. Fujifilm (and other claimants) sought Arrow declarations for dosing regiments of their adalimumab biosmiliars.
Henry Carr J held that “the extensive history of the proceedings in the EPO and the UK…shows, in my judgment, that AbbVie has made every effort to shield the claims of its patents from scrutiny”. That history showed that AbbVie had filed numerous applications directed towards various dosage regimes essentially for adalimumab, but whenever an application granted and became the subject of a revocation action before the Patents Court, AbbVie would file a subsequent divisional application and either de-designate the EP(UK) or disapprove the text of the patent in suit, depriving the Patents Court of the opportunity to adjudicate on issues of validity and infringement. One such family had reached its fifth-generation divisional. Henry Carr J accordingly held that the declarations would constitute justice to the claimants, cause no injustice to the defendant, and would serve a useful purpose.
Undertakings
One common technique for patentees to fend off an Arrow declaration is to provide undertakings not to sue which reflect the declaration sought, and thereby obviate any “useful purpose” of such a declaration.
However, these can backfire, and the devil is in the detail. In GSK v Vectura³, it was the terms of the undertaking offered that turned out to be the “most significant” factor in favour of granting a declaration. In that case, the judge specifically asked counsel for Vectura at trial why Vectura had given an undertaking only in respect of some (but not all) relevant patent families, and why it would not extend the undertaking to at least one further identified, relevant patent family. The judge considered that he had received no satisfactory answer to this question, and recorded this in the judgment.
In Fujifilm v Abbie, AbbVie provided undertakings not to apply for patent protection in the UK for certain dosage regimes, but only in certain limited circumstances. Those circumstances were set out in a form of undertaking which ran to some ten clauses or sub-clauses, culminating in a final clause beginning “for the avoidance of doubt”.
The undertakings were described by the judge as “complicated and very long” and “certainly not a masterpiece of drafting” and were held not to provide the commercial certainty that the Arrow declarations sought by FKB would provide.
Form of declarations
The UK Patents Court is keen to avoid declarations that are overly-broad, since this risks further uncertainty and undesirable litigation. Parties seeking such declarations should therefore be aware of the importance of formulating them in suitably specific terms. For example, in GSK v AbbVie, GSK succeeded only in achieving its narrower declaration for the specific processes and products in issue, rather than for a broader process which GSK necessarily followed.
Forum shopping
The attainment of commercial certainty in patent cases can constitute a useful purpose. The spin-off value of a judgment in other countries may also be a factor weighing in favour of a declaration, but a declaration sought solely for the benefit of foreign courts will rarely be justified. This may be rooted in a judicial anxiety over potential forum shopping. This was recently seen in Pfizer v Roche⁴, in which Birss J refused an Arrow declaration which had been sought on the main basis that it would be of utility in future Belgian injunction proceedings.
Final observations
The four cases that have been decided since Arrow v Merck all arose in the context of a claimant seeking commercial certainty against a backdrop of multiple granted or pending divisionals. However, it is clear that the existence of multiple divisionals is not enough in itself for the court to exercise its discretion and grant an Arrow declaration: rather, the court will carefully scrutinise the surrounding circumstances of the case before deciding whether to grant this discretionary remedy. The decision in GSK v Vectura is currently subject to appeal, which will allow the Court of Appeal to offer further guidance in this developing area of law.
Table 1: Four cases in which the UK Patents Council has considered whether or not to grant Arrow relief
| Case | Was an Arrow declaration granted? | Key factors in the Court's reasoning |
|---|---|---|
| FujiFilm v AbbVie [2017] EWHC 395 (Pat) | Yes | - The court found that the patentee had “consistently adopted a policy of publicly expressing its confidence in its Humira patent portfolio, and its intention to enforce it against competition from biosimilars, whilst at the same time shielding patents within the portfolio from scrutiny by the court. When patent protection has been abandoned by [the patentee], another sub-divisional has been applied for, thereby perpetuating commercial uncertainty.” - The patentee had offered undertakings which were found to be “complicated and very long” and which did not provide the “necessary clarity”. |
| Generics (UK) Ltd v Yeda Research and Development Co Ltd [2017] EWHC 2629 (Pat) | No | - The patentee had not shielded its patents from scrutiny; on the contrary, the court held it had “vigorously defended” its patents. - The factual finding that the claimant’s product was obvious at the priority date was sufficient commercial certainty for the claimant, and the court considered that making a declaration would add nothing further. |
| GSK v Vectura [2018] EWHC 3414 (Pat) | Yes (in the narrower form) | - The terms of the undertaking were described by the court as the “most significant” factor. The patentee had offered an undertaking which covered only a selection of the relevant patent families, and had no explanation as to why it would not offer an undertaking in respect of all relevant families. - The patentee had failed to establish infringement of one family of patents because it had not been able to identify a suitable analytical technique to demonstrate that certain requirements of the claims were satisfied. However, the court noted that the patentee would not necessarily face the same difficulty based on future divisionals with differently formulated claims, hence a declaration would serve a useful purpose. - The patents at issue had not been found obvious (they had been found to lack sufficiency), and the court noted that it would be an open question as to whether patents with differently formulated claims were obvious or not. |
| Pfizer v Roche [2019] EWHC 1520 (Pat) | No | - The patentee had de-designated all relevant patent families in the UK, removing the possibility of any future rights. - The judge acknowledged that a declaration would likely have assisted the claimant in resisting a preliminary injunction brought in Belgium (where the claimant planned to manufacture its biosimilar and where the patentee held a patent), but the judge reiterated that the utility of a declaration in foreign proceedings would rarely be sufficient in itself for an Arrow declaration. The judge held that, whilst an Arrow declaration would have been of “real commercial value” for the claimant, this was not enough to constitute a “useful purpose”. |
¹ [2007] EWHC 1900 (Pat)
² [2017] EWHC 395 (Pat)
³ [2018] EWHC 3414 (Pat)
⁴ [2019] EWHC 1520 (Pat)
