For the first time, English Courts have granted relief in the form of a negative declaration known as an “Arrow” declaration which allows the claimant who sought the declaration to launch their product on the market with confidence that the patentee will not threaten the claimant for patent infringement in the UK. Following a judgment from the Court of Appeal, the High Court handed down its decision in Fujifilm v Abbvie1 in relation to Abbvie’s $12.5 billion blockbuster drug, Humira.
What is an “Arrow” declaration?
It is a declaration that a product, process or particular use was not new or was obvious at a particular date and therefore could not be the subject of valid patent protection.
When is an Arrow declaration useful?
The European Patent Convention permits the filing of divisional applications as long as an application is pending. Further divisional applications may be filed from a prior pending divisional application which can lead to cascading divisionals. Since it is possible to file cascading divisionals several years after the original application and retain the original priority date, it can be impossible for any third party to determine the precise scope of patent protection covering a particular product or process. In the pharmaceutical sector it is also possible to file secondary patents covering a particular formulation or dosage regime, as a way of extending patent protection for the active pharmaceutical ingredient.
In relation to granted patents, English courts have required generic companies to ‘clear the way’ before launching or they will be at risk of injunctive relief. However, in relation to pending patents, which have not yet granted, there is no statutory basis for establishing that a particular product is free from infringement.
However, English courts have a wide discretion as to the forms of order which they can grant in commercial disputes. The Arrow declaration which is named after the 2007 case in which it was first considered, Arrow v Merck2 enables a company to avoid the commercial uncertainty of pending applications by seeking a declaration that a product which it proposes to launch cannot be the subject of a valid patent because it lacked inventive step or was not novel at a particular relevant date.
In that case Arrow sought a declaration that the product they proposed to launch in relation to the treatment of bone wasting diseases, was obvious in light of certain prior art. This declaration was sought since Merck had filed several divisional applications at the EPO and despite Arrow having revoked one of Merck’s patents at the UK High Court, Arrow remained at risk of infringement proceedings. It was the first case in which the grant of such a declaration was considered. Merck applied to strike out Arrow’s claim, but the Court refused deciding that there was an arguable case for granting such a declaration. The dispute then settled.
What did the court decide in Fujifilm v Abbvie?
Abbvie has SPC protection until 2018 in relation to its monoclonal antibody, adalimumab, sold as Humira. Humira treats various human inflammatory diseases such as rheumatoid arthritis, and is the largest selling prescription drug in the world. Abbvie has filed numerous secondary patents such as for dosage regimens. It repeatedly filed divisional applications and also made it very clear that they would seek to enforce their patents. Fujifilm intended to bring their biosimilar adalimumab product to market.
Fujifilm and Abbvie had entered into lengthy EPO and UK validity proceedings where Abbvie repeatedly withdrew their patents when they were about to be decided upon. Ultimately, Abbvie tried to avoid the grant of a declaration in this UK case by abandoning their UK designations of patents and undertook that they would not seek relief in the UK.
The High Court found that in light of the prior art adduced by Fujifilm, the skilled team would have had a high expectation that the dosage regimen would be efficacious in the treatment of rheumatoid arthritis, thereby holding that the proposed administration of Fujifilm’s products was obvious at the relevant priority date of the patent application.
Fujifilm sought an Arrow declaration arguing that the purpose of Abbvie abandoning the patents was to avoid adjudication of its patentability by the UK court and EPO whilst seeking to ensure that the subject matter of the alleged invention was maintained by a further divisional application. Fujifilm said that it would be many years before the EPO would be in a position to adjudicate on the patentability of the divisional in question, and that the granting of the Arrow declaration would serve a useful purpose, by achieving commercial certainty in respect of Fujifilm’s product by the date of its intended launch in the autumn of 2018.
The High Court held that due to: i) Abbvie’s conduct in creating a patent thicket which threatened the possibility of future action whilst repeatedly shielding its patents from judicial scrutiny; ii) the amount of money at stake for Fujifilm in terms of investment in clinical trial and the potential damages if they launch at risk; and iii) the need for commercial certainty, it was sufficient to justify granting the relief sought by Fujifilm in this this special case.
How does a claimant prepare for seeking an Arrow declaration?
In a similar situation, a claimant wishing to seek an Arrow declaration will need to prepare all details relevant to their proposed product or process as well as effectively prepare a validity attack based on lack of inventive step or novelty. The claimant will also need to put forward arguments that such a declaration will serve a “useful purpose”.
In the above case, the particular facts and especially the behaviour of Abbvie were considered sufficient to grant an Arrow declaration. It may be that the courts may not grant such declarations unless a similar conduct can be shown by future claimants.