On 3 March 2017, Carr J of the Patents Court granted a novel form of “Arrow” declaration (so-called because a case brought some years ago by Arrow Pharmaceuticals first raised the possibility of such a declaration in the court’s inherent jurisdiction before settling). The 3 March 2017 decision in Fujifilm Kyowa Kirin Biologics Co. Ltd & Anor (FKB) v AbbVie Biotechnology Ltd was also in the pharmaceutical sector but the form of declaration has relevance and applicability in other sectors, including electronics and communications.
The FKB v Abbvie case
Abbvie was the owner of granted patents and pending applications for its commercially successful Humira product (the monoclonal antibody adalimumab). FKB wished to launch a biosimilar. Though it had sought revocation of some Abbvie patents, there were also pending patent applications that might grant later and be asserted. FKB therefore sought declarations to the effect that certain activities were obvious and/or anticipated at specified dates. The activities related to the intended uses of FKB’s biosimilar product (dosing regimens) and the specified dates related to the priority dates of Abbvie patents for dosing regimens. Earlier in the FKB v Abbvie case, the Court (at first instance and on appeal in procedural hearings) had accepted jurisdiction to hear the claims for the declarations sought by FKB.
Though Abbvie gave undertakings not to sue on patents, it was unwilling to submit to judgment and declaration of the Court that certain activities were obvious and/or anticipated at specified dates. At trial, Carr J considered the technical evidence as to the state of the art at the specified dates and went on to grant the declarations sought. His decision to grant the declarations appeared to be influenced by Abbvie’s conduct, threatening infringement whilst abandoning proceedings at the last moment (in order to shield its patent portfolio from scrutiny); the amount of money at stake for the Claimants in terms of investment in clinical trials and potential damages if they launched at risk; and the need for commercial certainty, having regard to AbbVie’s threats to sue for infringement throughout the world. In future cases, the Court may provide further guidance when such Arrow declarations will be entertained and whether simply the amount of money at stake and the need for commercial certainty will suffice.
Use of “Arrow“ Declarations
In some sectors, including electronics and communications, there can be pending patent applications and e.g. divisional patent applications in a portfolio where there is a threat of being sued for infringement throughout the world. There may also be pending EPO proceedings where the scope of granted claims may change considerably and present potentially new and different validity and infringement issues. In such circumstances, third parties seeking to launch may consider seeking Arrow declarations that their proposed product or process was obvious and/or anticipated at a specified date. If the case goes to trial and a detailed reasoned decision, such a declaration may be persuasive in other jurisdictions. Alternatively, parties sued for infringement in the UK may consider pursuing not just a counterclaim that a given asserted patent is invalid, but also an Arrow declaration that the product or process of the defendant was obvious and/or anticipated at a specified date.