Caselaw Digest
Caselaw Digest

Accord Healthcare Limited & Ors v The Regents of The University of California & Anor

8 October 2024
[2024] EWHC 2524 (Pat)
High Court
Three companies tried to get a patent on a prostate cancer drug cancelled, saying it was obvious from earlier research. The judge looked closely at the earlier research and expert opinions. The judge decided the drug wasn't obvious and the patent was valid, so the companies lost.

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.

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