Date: 17 August 2020
The first and oldest granting authority for patents in the UK is the UK Intellectual Property Office (UKIPO). Patents granted by the UKIPO only apply in the UK, which means that a British patent can’t be infringed elsewhere; for example, in Ireland or Germany.
From 1 June 1978, it’s also been possible to get a patent to protect inventions in the UK by applying to the European Patent Office (EPO).
From a commercial point of view, applicants who want to file in the UK or in a few countries will find it cheaper to apply to the respective national offices. However, there comes a point when the balance is tipped and the cumulative cost of applying to several national offices will exceed the cost of a European application.
Rather than granting a single, pan-European patent, the EPO grants a bundle of national patents. Consequently, an important strategic consideration that may affect the route taken is the relative vulnerability of the patent.
A national patent can only be challenged in national tribunals. In contrast, the European Patent Convention (EPC) allows for a central challenge to be made against a European patent, which takes the form of an “opposition” to the grant of the patent application and can be brought within the nine-month period after grant.
A successful central attack on a European patent is undesirable for the patent owner, as it would knock out protection in all designated states.
Formalised patent revocations or limitations sought by patent owners at the EPO during pending opposition or appeal proceedings are precluded under the EPC. However, patents owners are generally free to surrender a patent for tactical purposes at any time. This is prior to a final decision in contentious EPO proceedings by a mechanism known as “withdrawing approval of the text of a patent as granted”.
Since the EPO can only decide on a European patent in the version as it was filed by the applicant or patent owner, the consequence of the patent owner’s withdrawn approval is to terminate the pending proceedings by “a patent revocation ex tunc”, i.e. as if the patent never existed.
This practice makes it possible for patent owners to avoid a negative final written decision on the merits of a patent’s subject matter, which could also have a prejudiced effect on a later registration.
However, the main benefit of surrender is that it allows a patent owner to pursue protection for subject matter similar to that of the ex tunc ineffective application or patent for grant (the surrendered “parent patent”) by filing one or more patent applications of the same patent family (“divisional applications”) in good time.
In this way, potential violators can be held for a long time in a stasis where they are unsure of whether or not rights will ultimately arise. In principle, this is possible. But repeated use of a series of withdrawals and divisional applications can lead to a situation that can be illegal, as third parties have no clarity as to whether they fall under potentially disruptive claims and infringe a patent or not.
In Great Britain, an instrument was created to check the patentability of products to be marketed instead of the patentability of a patent: the so-called "Arrow declaration".
These declarations take their name from Arrow Generics Ltd v Merck & Co Ltd  EWHC 1900 (Pat);  Bus. L.R. 487, and differs from a “traditional” declaration issued by courts in patent cases because it does not refer to a specific patent but rather to any patents (usually those which have not yet been granted) covering the matter that is the subject of the so-called “Arrow declaration”.
The aim of an Arrow declaration is to prevent the tactic of abandoning patents and continuing in divisional applications into an enforceable patent against the non-new and non-inventive product. If the product is found to be neither new nor inventive at the relevant filing date of a patent, then any patent that was granted later would be invalid. This gives potential infringers the certainty of not having to fear any risk of injury despite the divisional registrations still pending.
A similar situation arose in Fujifilm v Abbvie  EWHC 395 (Pat), in which Mr Justice Henry Carr granted the declaration sought by the claimants that the dosage regimes for the biosimilar adalimumab products they intended to launch in Europe were obvious and/or anticipated at the claimed priority dates of certain European (UK) patents owned by AbbVie relating to the antibody adalimumab, sold under the trade mark HUMIR.
See our full article on this case published in the European Intellectual Property Review: Kunst, M. and and Strath, J. (2017) vol. 39, no. 8, pp. 518-524Humira patent rights shot by "Fujifilm declaration"
Aside from the UK, it seems that only a few European jurisdictions have adopted the concept of Arrow declarations: a similar decision was made public in the Netherlands.
Germany differs from the UK in that infringement proceedings and nullity proceedings for patents have to be conducted before different courts (two-tier jurisdiction, so-called “separation principle”).
On February 2020, the Regional Court of Munich I (first instance) issued a kind of “anti-waiver” order as a preliminary injunction, in which, among other things, a violation of the antitrust regulations played a role. However, there is no time limit for an objection and, if the outcome is negative, appeal (or complaint about costs) is possible, so the matter may not yet have been finally decided.
The core of the decision is the order against the patent owner, which restrains them from surrendering a patent (EP 2 949 335) prior to a validity decision by the EPO’s Board of Appeal. This is unless the patent owner agreed to lift a previously granted German injunction blocking sales of a competing generic drug produced by the opponent.
In its decision, the Regional Court of Munich I highlighted that the opponent had sought only a territorially limited injunction “due to violation of German law”, citing German unfair competition law (“UWG”), anti-trust law (“GWB”) and other civil law statutes.
It is interesting that an Arrow Declaration was rejected for the same patent in Great Britain - this is mainly explained by the fact that the court there was able to rule directly on the nullity of EP 2 949 335 B1 without dual movement. In Germany, the interim injunction was based primarily on an injunction because of an impending unfair commercial act, UWG §§ 3, 4 No. 4, UWG § 8, in particular paragraph 1.
The disadvantage in all cases is that the respective decisions are only valid in the countries in which court decisions have been made. However, the new type of “anti-waiver” may be a tried and tested new means of finding a solution for competitors against patent applicants who make use of the waiver / divisional application strategy.
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