In a recent landmark judgment (Fujifilm Kyowa Kirin Biologics v AbbVie Biotechnology [2017] EWHC 395 (Pat)), the English High Court has granted a novel type of declaratory relief which may be used to clear the route to market for a product facing a multitude of pending patent applications being withheld from challenge in the UK courts.
This ruling, the first of its kind, has the potential to greatly ease the burden of IP clearance facing generic pharmaceutical companies as they prepare to bring a generic product to market once the basic patents covering the proprietary medicament expire.
It is not unusual for holders of basic patents covering blockbuster drugs to pursue a network of secondary patent applications directed to dosage regimes and dosage forms involving the blockbuster drug. Generic companies must navigate those secondary patents as well as the expiring pioneering patents in order to bring their drug to market. Unfortunately, patent holders have been known to game the patent system by continually filing spurious new secondary applications from their existing patent network and dropping those applications prior to grant, thereby creating significant uncertainty for competitors who are not able to challenge the validity of that IP in the courts because the potentially problematic claims never reach grant.
In this case, Fujifilm Kyowa Kirin Biologics wanted to bring a monoclonal antibody biosimilar to AbbVie’s Humira medication to market upon expiry of AbbVie’s basic product patent in October 2018 (EP 0,929,578 and SPC GB/04/002). However, AbbVie’s continually refreshing patent application portfolio concerning dosage regimes for Humira had the potential to block FKKB’s route to market. Because these applications were not allowed to reach grant, FKKB could not apply to the UK courts for revocation of any such patent or for a declaration of non-infringement of any such patent.
In view of AbbVie’s gaming of the patent system (both in terms of its patent filing strategy and its strategy of avoiding grant and therefore court scrutiny of the invention) while threating to enforce any patents which might grant, the overall negative effects of on-going commercial uncertainty caused by such actions, and the amount of money at stake for FKKB in terms of investment in clinical trials, the High Court was prepared to consider a declaration to the effect that a particular product or use thereof would have been obvious or lacking in novelty at the earliest effective date of the patent applications in question. Of course, a finding of obviousness or lack of novelty would mean that the product or use being considered could never be covered by a valid claim arising from the patent applications in question and thus ever be an infringement of a valid patent.
The Court stressed that this form of declaratory relief was allowed because of the particular facts of the case and so whether such declarations could be granted with respect to a patent portfolio prosecuted in good faith remains to be seen. But at least we now have a tool against this particular form of gaming in the patent system and Big Pharma will need to take note.
“Fujifilm Kyowa Kirin Biologics v AbbVie Biotechnology [2017] EWHC 395 (Pat) marks the first declaration of its kind to be granted in the UK, and a turning point in patent litigation – allowing companies at risk of patent infringement to potentially “clear the way” even before patents are granted.”
https://gowlingwlg.com/en/united-kingdom/insights-resources/ground-breaking-declaratory-relief-from-english-high-court-clears-the-route-to-market-for-humira-biosimilar
