This article pertains to a very recent patent strategy adopted by Fujifilm Kyowa Kirin Biologics Co. Ltd & Anor (FKB) to cater to UK patents of AbbVie. They have used an important strategic option called "Arrow declaration."
The term "Arrow declaration" refers to a declaration that the subject matter of an invention is not patentable. An Arrow declaration is a declaration that a product (or process) was old or obvious at a particular date. The term stems from the case Arrow v Merck wherein such a declaration was first issued. Unlike "traditional" declarations issued by courts in patent cases, the Arrow declaration does not refer to a specific patent, but instead covers any patent (particularly those which have not yet been granted) that covers the subject matter which is the subject of that declaration.
Arrow declarations are important in determining the patent strategy, particularly in those cases where the patent proprietor files or is likely to file several divisional applications, which he/she can then consecutively attempt to enforce after grant. This increases the time and cost required for third parties to clear the way for their planned commercial activities.
As we all are aware that in the UK, a patent cannot be challenged in a court until it grants. However, under Section 69, a patentee can, after grant, claim damages for acts committed prior to grant if he/she would have infringed the patent (subject to certain exception provisos relating to changes in the claims). This regime has the potential to create a substantial damage liability for businesses which commercialize technology that is subject to patent application and not granted yet.
An Arrow declaration allows a claimant to obtain a declaration that their intended product or process was disclosed or would have been obvious at the priority date of a patent application of concern. Obtaining such a declaration does not have any effect on the validity of any patent application or its ability to grant.
However, if a patent grants in the future and is asserted against the party which has obtained the Arrow declaration, the declaration can be deployed by way of a "Gillette" defense: If the product or process was obvious than a patent which it infringes. The advantage of using the Arrow declaration is that the claimant can test the position before launching his/her product and thereby prevent incurring any damage.
The recent case pertains to AbbVie's flagship antiinflammatory drug Humira (Adalimumab), which tops worldwide prescription drug tables. But it is threatened by several close-to-market biosimilar drugs. AbbVie has been very public about its intention to fight back with patent litigation in the US and elsewhere, with London courts playing host to litigation against biosimilar producers.
Fujifilm sought an Arrow declaration that the subject matter of a pending divisional application owned by AbbVie that covered the antibody Adalimumab (marketed as Humira) was not patentable. Fujifilm also sought an injunction against AbbVie, commencing infringement proceedings or threatening with infringement proceedings in relation to these acts.
AbbVie applied to have the request for the declaration and injunction struck out from the claim. AbbVie argued that Fujifilm's case was unsupportable and had no real prospect of success. Further, in Arrow v Merck, the declaration was issued on the basis that the circumstances of the case were most unusual, whereas AbbVie did not believe this to apply to their case.
In summary, Arrow declarations sought are that FKB's own product, a biosimilar of Adalimumab, is anticipated or obvious at the priority dates of several patent applications for particular dosages and indications of Adalimumab that are still in prosecution. This successful Arrow declaration would imply that any patent that is infringed by the Adalimumab product must also be invalid by anticipation or obviousness using the so-called "Gillette" defense.
The judge agreed with Fujifilm's arguments that there was a real prospect of AbbVie shielding at least some of the subject matter of its European application from UK courts as it had done in previous proceedings, where it had filed a divisional and abandoned the parent patent to attempt to shield the patent from UK courts.
On March 3, 2017, the judge decided to award the first "Arrow declaration" in the English Patents court, concerning FKB’s biosimilar of Adalimumab, stating that “I consider that, on the most unusual facts of this case, there are special reasons which support the grant of the declarations. These include AbbVie’s conduct of threatening infringement whilst abandoning proceedings at the last moment; the amount of money at stake for the claimants in terms of investment in clinical trials and potential damages if they launch at risk; and the need for commercial certainty, having regard to AbbVie's threats to sue for infringement throughout the world."
A significant advantage of this strategy of using the pathway of "arrow declaration" is that it will free UK sales of biosimilar Humira-like products from the threat of patent litigation, particularly from family patent applications and futura. The court's ruling that the biosimilar products and dosing regimens planned by FKB and Samsung Bioepsis/ Biogen were obvious by the priority date of AbbVie's patent application means that no future divisional filed by AbbVie can impede sales.
Disclaimer – The views expressed in this article are personal views of the author and are purely informative in nature.