Generics (UK) Ltd (t/a Mylan) v Richter Gedeon Vegyeszeti Gyar RT

For obviousness, the court applies the structured Pozzoli approach through the eyes of the person skilled in the art. In pharmaceutical cases, an invention may be obvious where the prior art makes investigation of a particular route an obvious course with a reasonable or fair expectation of success. Information not itself disclosed or forming part of common general knowledge may nevertheless be considered where the skilled person would obtain it as a matter of routine. A patent claim for a treatment purpose must be construed in its clinical context. A claim for emergency contraception does not require statistically exact equivalence with existing treatments, but does require a reasonably high and clinically useful level of effectiveness. The patent was invalid because the disclosed research made the claimed single-dose regimen an obvious candidate for investigation and use.

The claimant sought a declaration that a patent for a single 1.5 mg dose of levonorgestrel, administered within 72 hours of intercourse for emergency contraception, was invalid and should be revoked.

Invalidity was alleged for lack of inventive step under the Patents Act 1977 and insufficiency. The obviousness case relied on common general knowledge and a late-2000 publication reporting interim results from a WHO study comparing single-dose and two-dose levonorgestrel regimens. The central issues were the identity of the skilled person, the significance of an erroneous dosage reference in the publication, the construction of the claimed treatment purpose, and whether the claimed regimen was obvious.

1. Skilled person and common general knowledge. The relevant skilled person was a clinician working in specialist contraceptive services, including emergency contraception, with ordinary clinical understanding of medical statistics. A specialist medical statistician was not required. The Killick article, reporting the WHO research, formed part of the state of the art and awareness of the research and its preliminary findings formed part of common general knowledge.
2. Correction of the dosage error. The reference in the article to 1.5 g rather than 1.5 mg was obviously doubtful to the skilled clinician. Contacting the author or researchers to check the dosage was an obvious routine step which would have disclosed the correct amount. Information obtainable in that way could properly be taken into account when assessing obviousness.
3. Construction of the claims. The words “for emergency contraception” required a regimen capable of providing a reasonable level of effectiveness in preventing pregnancy, broadly comparable with existing treatments and sufficient to make clinical use worthwhile. They did not require statistically exact equivalence with the two-dose regimen or an IUD. Clinical effectiveness had to be assessed holistically, including efficacy and practical benefits such as compliance and reduced side-effects.
4. Obviousness. Applying the Pozzoli framework and the guidance in MedImmune, the article made it obvious to investigate a single 1.5 mg dose within 72 hours, with a reasonable or fair expectation of success. The single-dose regimen was an obvious candidate within the available emergency-contraception treatments. Completing the already advanced study and confirming its preliminary results did not amount to a significant additional contribution to human knowledge warranting a patent monopoly.
5. The obviousness challenge succeeded. The insufficiency issue did not arise. The claim that the patent was invalid on grounds of obviousness succeeded.