Actavis UK Ltd v Janssen Pharmaceutica NV

For novelty, a prior disclosure anticipates where carrying it out would necessarily result in infringement. The necessary result is assessed on the balance of probabilities, not to a quasi-criminal standard, unless the evidence shows that different results may occur under different conditions.

A newly discovered mechanism or technical effect does not create novelty where it merely explains an old use for the same purpose. A new-use claim requires a genuinely new purpose or a distinct technical effect underlying that purpose. Obviousness is assessed using the structured approach requiring identification of the skilled person, common general knowledge, the inventive concept, the differences from the prior art and whether those differences require invention.

Actavis sought revocation of Janssen’s patent concerning stereoisomers of nebivolol and their use in potentiating blood-pressure-reducing agents. Janssen applied to amend the pharmaceutical-composition claims by replacing “comprising” with “consisting of”.

Actavis alleged lack of novelty and obviousness over an earlier Janssen patent and an oral and visual disclosure at a scientific forum in Guildford. The central issues were the construction of the use and composition claims, whether the earlier disclosures inevitably produced the claimed potentiation effect, whether the claimed use remained novel under the new-use authorities, and whether the amended composition claims were obvious.

1. Construction. The use claims were limited to use of the RSSS isomers which actually achieved the technical effect of potentiating another, non-RSSS, blood-pressure-reducing drug. “Potentiating” meant improving the effect; it did not require the potentiating agent to be inactive alone. The composition claims using “comprising” were open-ended and were not limited to one additional blood-pressure-reducing agent.
2. Novelty over the earlier patent. Applying Synthon v SmithKline Beecham [2006] RPC 10, the court held that the earlier patent disclosed compound 84, a mixture containing the relevant isomers, and that use of it as a medicine would inevitably produce the potentiation effect. The inevitable-result test was satisfied on the balance of probabilities.
3. The new-use authorities did not save claim 1. G2/88 MOBIL/Friction reducing additive [1990] EPOR 73 concerned a genuinely different purpose and technical effect. Here, the claimed effect merely explained the performance of compound 84 for the same therapeutic purpose. Claims 4, 6 and 7 were anticipated before amendment, while the amended claims were novel over the earlier patent because it gave no clear and unmistakable direction to make a composition containing only the RSSS and SRRR isomers.
4. Obviousness over the earlier patent. Applying the structured approach in Pozzoli v BDMO SA [2007] EWCA Civ 588, the proposed investigative routes involved too much research and uncertainty. The skilled team would not necessarily discover the relevant potentiation effect or make the claimed composition. Claims 4 to 7 were therefore not obvious over that patent.
5. Guildford disclosure. The court found that the presentation disclosed nebivolol’s stereochemical structure and its RSSS/SRRR mixture. Claims 1, 4, 6 and 7 lacked novelty or were obvious over that disclosure. Claim 5 was neither anticipated nor obvious because the presentation did not disclose how the enantiomers worked together. The amendment application therefore failed.