Astrazeneca AB v Hexal AG & Ors

Obviousness is principally a question of fact, degree and overall impression. The court must evaluate the evidence as a whole, including the motive to find a solution, the possible avenues of research, the effort involved and the expectation of success. A structured analysis of the reasons why a skilled person might or might not pursue an invention is permissible, provided that it does not artificially divide the inventive step into impermissible stages. On appeal, the Court of Appeal reviews the trial judge’s conclusion for an error of principle or a plainly wrong outcome; it does not retry the evidence or substitute its own evaluation. The composition and interaction of a multidisciplinary skilled team may be assessed realistically.

AstraZeneca appealed from Arnold J’s decision in the Patents Court, reported at [2012] EWHC 655 (Pat), revoking European Patent (UK) No 0,907,364 for obviousness. The patent concerned a sustained-release formulation of quetiapine using a gelling agent. Claim 1 was held obvious in light of the common general knowledge and the Gefvert abstract, which addressed once-daily dosing of an immediate-release formulation. AstraZeneca challenged the findings concerning the skilled team, motivation for once-daily dosing, expectation of success, and the alleged stepwise approach to obviousness. The central issue was whether the finding that claim 1 was obvious was wrong in principle or plainly wrong.

1. Appeal dismissed. Arnold J’s order revoking claim 1 was neither wrong in principle nor plainly wrong. The Court of Appeal would not interfere with his evaluation of the evidence.
2. Obviousness is a question of fact, degree and overall impression. The inquiry is whether the claimed invention would have been obvious to the skilled person, having regard to the state of the art at the priority date. Relevant considerations may include the motive to find a solution, the number and extent of possible research avenues, the effort required, and the expectation of success. The evidence must be assessed as a whole.
3. An appeal against a finding of obviousness is a review, not a retrial. Intervention is justified for an error of principle or a plainly wrong outcome. The appellate court should not re-argue the multifactorial merits or substitute a fresh evaluation for that of the trial judge.
4. The notional skilled person may be a multidisciplinary team. The assessment must reflect how that team, without knowledge of the patent, would have operated in the prior art. Different members may have different primary roles at different stages, but those roles may overlap and involve discussion.
5. The judge was entitled to find that a convenient once-daily formulation was an obvious motivation, supported by the expert evidence and literature. A sustained-release formulation was an obvious possibility for achieving once-daily administration, and the skilled team would not be deterred by the matters advanced by AstraZeneca.
6. The judge’s structured consideration of those matters was permissible. He was entitled to examine separately the reasons said to discourage development while keeping the overall picture in view. He was also entitled to regard as evidentially significant the patent’s own recognition that sustained-release formulations were desirable for stable dosing and less frequent administration.
7. The Dutch decision concerning the same patent did not determine the appeal. It was reached by different judges on different evidence and argument, and Arnold J was neither bound by it nor required to justify his conclusion by reference to it.

• Court of Appeal (Civil Division): [2013] EWCA Civ 454. Appeal dismissed.
• High Court of Justice, Chancery Division, Patents Court: Arnold J revoked the patent by order dated 24 April 2012, holding claim 1 obvious; decision reported at [2012] EWHC 655 (Pat).