A recent judgment of the English High Court has considered how a market entrant can clear a path in the face of a concerted patent strategy of the incumbent market leader.
The judgment was a mammoth 99-page decision of Carr LJ in Fujifilm Kyowa Kirin Biologics Co Ltd & Ors v AbbVie Biotechnology Ltd  EWHC 395 (Pat). AbbVie is the proprietor of a number of patents relating to the antibody adalimumab, sold under the trade mark HUMIRA. HUMIRA is used in the treatment of, among other conditions, arthritis and is the highest selling prescription drug in the world by global sales: in excess of US$12.5 billion in 2014 alone. AbbVie's patents have protected this vast income stream. As is not uncommon for such products, AbbVie has a patent for the basic adalimumab product (which is approaching the end of its life) as well as later filed secondary patents and applications for particular dosage regimes.
There were a number of issues in this case, but this article will focus on AbbVie's conduct in relation to its dosage patent applications.
The claimants' options
With the basic adalimumab patent approaching the end of its life the claimants, Fujifilm and others, desired to market a biosimilar adalimumab product in Europe, including in the UK, after expiry of the basic adalimumab patent, but the secondary patents presented a potential road-block. There are three things a party can do in such circumstances:-
seek a declaration of non-infringement;
apply to revoke the patent; or
put a product on the market and run the risk of patent infringement proceedings being commenced and being successful with attendant risk of paying damages to the patentee.
The sums at stake were so substantial that it is unlikely that anyone would take the risky third option no matter how confident they felt. Unfortunately for the claimants neither of the other options were viable as regards AbbVie's pending secondary patent applications at the European Patent Office (EPO). In such circumstances, uncertainty existed over what form the granted patent claims may take, and it was not possible for a court to opine on whether the granted claims would be infringed or invalid.
It was, however, no accident that the dosage patent was still in its application phase at the EPO. In his judgment, Carr LJ found that AbbVie had consistently applied a systematic process of applying for patent protection, and then abandoning that protection when those patents were about to be scrutinised by the EPO, while re-filing for divisionals covering essentially the same subject matter as the abandoned patents. In this way, AbbVie could perpetually keep patent applications alive at the EPO, and thereby create commercial uncertainty in the market, and with the substantial risk factor thereby in effect prevent biosimilar products competing with HUMIRA.
Application for an Arrow declaration
The claimants therefore applied for an Arrow declaration. An Arrow declaration (so named after the case Arrow Generics v Merck  EWHC 1900 (Pat)) is a declaration that a particular product was known or obvious over the prior art at a particular date (typically the priority date of the patent application of concern). If such a declaration is made, the applicant has peace of mind: if the granted patent claims cover the product, then the patent is invalid as lacking novelty or inventive step, but if the claims do not cover the product then there is no infringement.
High Court's decision
After considering the technical arguments, Carr LJ came to the conclusion that the claimants' proposed dosage regime for adalimumab was obvious. It was necessary nevertheless to consider whether the court could and should make such a declaration.
AbbVie argued that there will "never be any UK patent claims to the dosage regimens in questions" and therefore an Arrow declaration "would not serve a useful purpose", claiming that it had "taken steps leading to revocation of all patents which are, or might have been in issue [in the UK] … and has given clear and unambiguous undertakings to the Court".
Carr LJ nevertheless concluded that he should make the declaration sought. In coming to this conclusion, he pointed to the fact that the claimants had tried to exercise their statutory rights against AbbVie by bringing revocation proceedings against three of AbbVie's granted dosage patents in the UK courts. However, AbbVie de-designated the UK from one patent, and withdrew the other two patents before the trial (but not before applying for another divisional application).
AbbVie's chosen course of conduct was designed, in Carr LJ's opinion, to prevent the claimants (and any other third parties trying to launch biosimilar products) from bringing revocation or invalidity proceedings against AbbVie. This enabled AbbVie to perpetuate the commercial uncertainty surrounding the dosing patent(s), and thereby make it practically impossible for others to launch biosimilar products into the market.
Carr LJ gave short shrift to AbbVie's assertion that an Arrow declaration was not necessary as it had revoked all patents that may cause the claimants a problem in the UK, stating that "AbbVie would not have invested the considerable resources that this trial has required unless there was a good commercial reason to resist the declarations". Carr LJ added that if "the declarations have no useful purpose, and the steps that [AbbVie] have taken have the same effect in achieving commercial certainty, there is no coherent explanation as to why it refuses to submit to judgment, or alternatively to give an acknowledgement in the same form as the declarations".
AbbVie's continued threats of infringement proceedings, coupled with its consistent cycle of patent creation, abandonment and divisional applications, created a "perfect storm" of commercial uncertainty that was unacceptable, leading to Carr LJ's judgment that it would, in all the circumstances, be useful to grant the Arrow declaration in order to create commercial certainty in the UK.
It was not a part of the case, and does not feature in the judgment, but one has to question whether AbbVie's conduct amounts to an abuse of a dominant position contrary to Article 101 of the Treaty on the Functioning of the European Union, as to which there are two sub-questions: is AbbVie in a dominant position; and, if so, has its conduct been abusive? As to the question of dominance, although there are arguments as to what the market is, and therefore AbbVie's share of the market, the facts almost speak for themselves - HUMIRA is the highest selling prescription drug in the world. As regards abuse, although the word "abuse" does not appear anywhere in the judgment, Carr LJ was strident in his criticisms of AbbVie's conduct. AbbVie's conduct clearly has had the effect of blocking competitors from the market, and it has seemingly used every trick in the patent book to deter competition.
Will this judgment lead to further applications for Arrow declarations, or actions for abuse of a dominant position against AbbVie? Only time will tell. The granting of Arrow declarations are still a matter of the court's discretion, and someone cannot seek the declaration just because it wants to know whether a pending patent application will result in a valid patent.
With thanks to Sam Woodley for her assistance in writing this blog