Key Facts
- •Three actions concerned EP (UK) 1 893 196 B2 (the “Patent”) and SPC/GB13/079 (the “SPC”), both owned by Astellas Pharma Europe Ltd.
- •Claimants (Accord, Sandoz, Teva) sought revocation of the Patent and invalidation of the SPC, claiming obviousness based on two prior art disclosures: a poster and slides presented at a conference.
- •The Patent claims the compound enzalutamide, marketed as Xtandi for prostate cancer treatment.
- •The prior art disclosed a molecule (RD162) closely related to enzalutamide (RD162’), differing only in substituents at position X.
- •Claimants argued enzalutamide was obvious, or the Patent lacked plausibility/sufficiency.
- •The case involved expert evidence from cancer biologists and medicinal chemists.
Legal Principles
Obviousness must be considered on the facts of each case, considering factors like motivation to solve a problem, research avenues, effort, and expectation of success.
Generics (UK) Ltd v H Lundbeck [2007] EWHC 1040 (Pat)
Whether something was ‘obvious to try’ with a reasonable prospect of success is relevant, but it's not required that success is manifest; routine tests with unpredictable results can be obvious.
Actavis v ICOS [2019] UKSC 15
Multiple obvious avenues don't make an obvious route less obvious; value judgments in research programs don't necessarily point against obviousness.
Actavis v ICOS [2019] UKSC 15
Routine testing with a pre-determined target is sufficient for obviousness, even if the result is unexpected.
Actavis v ICOS [2019] UKSC 15
A patentee cannot rely on a perceived problem in taking a particular course of action unless the patent overcomes that problem.
Philips v Asustek [2019] EWCA Civ 2230
A ‘golden bonus’ doesn't make a patent valid if the invention was obvious for another purpose.
Actavis v ICOS [2019] UKSC 15
A seemingly small structural change isn't automatically an obviously immaterial one in medicinal chemistry.
Various cases cited in [197]-[211]
The claimed invention, not a watered-down version, must involve an inventive step.
Conor v Angiotech [2008] UKHL 49
The patent monopoly should be justified by the actual technical contribution to the art.
Takeda v Roche [2019] EWHC 1911 (Pat)
A disclosure must demonstrate that a claimed therapeutic effect is plausible; a bare assertion or mere possibility isn't enough; reasonable scientific grounds are needed.
Warner-Lambert v Generics [2018] UKSC 56
Outcomes
Dismissed all three actions brought by the Claimants.
The court found that claim 1 of the patent was not obvious over the prior art (poster and slides), and the insufficiency/plausibility attack failed.