Case update: Gedeon Richter v Mylan - Sir Robin Jacob’s final say

In brief

The Court of Appeal recently handed down judgment in the patent dispute between Gedeon Richter and Mylan relating to a dosage regimen of levonorgestrel (an emergency contraceptive) [Richter Gedeon Vegyeszeti Gyar RT v Generics (UK) Limited (t/a Mylan) [2016] EWCA Civ 410]. Unusually, the Court consisted of three specialist IP judges. Sir Robin Jacob, giving the lead judgment, started by saying that this is his final say in the Court of Appeal (poignantly delivering the judgment on World IP Day 2016). The other two judges were Mr Justice Arnold (a high court judge sitting in the court of appeal for this case) and Lord Justice Floyd.

It is settled law in the UK that the court’s assessment of obviousness can include, as part of the common general knowledge, matter which the skilled person would find out on consulting the literature, if to do so would have been routine or obvious. The Court of Appeal’s main finding was that this principle also extends to matters learned as a result of oral enquiries which a skilled person might make, for example, to query what appeared to be a mistake in a prior art publication.

First instance

At first instance, Mr Justice Sales had held the patent invalid for obviousness [Generics (UK) Limited (t/a Mylan) v Richter Gedeon Vegyeszeti Gyar RT [2014] EWHC 1666)].

The patent in question covered a new dosing regimen of levonorgestrel, a form of emergency contraception, claiming a single dose of 1.5 mg (which was said to be more convenient and as effective as the two dose regimen of the prior art (comprising two doses of 0.75 mg taken 12 hours apart)).

The obviousness argument turned on a prior publication by Professor Killick (Killick article). The Killick article published interim results from a clinical study in which the efficacy of a regimen involving a single dose of 1.5 mg levonorgestrel (ie the very subject matter of the patent) as compared to the well-established two dose regimen of the prior art. However, the Killick article misstated the single dose as 1.5 g (instead of 1.5 mg). The question was therefore whether it was obvious for the skilled person to make an enquiry and reveal the true dose amount.

Sales J considered the distinction between common general knowledge (CGK) and information that it was obvious for the skilled person to obtain, referring to Arnold J’s summary of the law in KCI Licensing Inc v Smith & Nephew plc [2010] EWHC 1487 at [112]. In this case, Arnold J found that “even if information is neither disclosed by a specific item of prior art nor common general knowledge, it may nevertheless be taken into account as part of a case of obviousness if it is proved that the skilled person faced with the problem which the patent is addressed would acquire that information as a matter of routine.” As such, Sales J found that it would have been obvious to the skilled person that something was amiss in the Killick article and so it was obvious for them to make enquiries and correct the mistake, a path that led to the patent being held invalid for obviousness.

Court of Appeal

On appeal, Gedeon Richter argued that Sales J had erred in law and had substituted the private knowledge of a third party to that of the skilled person, whereas the proper approach should be to base the question of obviousness on the CGK of the skilled person alone.

Sir Robin Jacob, considering KCI v Smith & Nephew, found that it was well established that when assessing obviousness, the notional person may, where it is obvious to do so, consult a reference work. He found that there was no logical distinction between this and the situation where it would be obvious to ask a question (when it was clear that the answer would be given). Sir Robin Jacob states (at [23]): “The notional asking is equivalent to the notional looking up. In both cases, the prior art spurs the finding out in a non-inventive way”.

However, Sir Robin Jacob notes that on the facts of this case there was an obvious error, a clear source to ask for clarification and a clear finding that an unambiguous answer would be given: “it does not necessarily follow that the "skilled man would ask" route to obviousness would follow for cases where the facts are not so precise or sure.”

Floyd LJ, agreeing with Sir Robin, stresses that “obvious to ask” is not applicable to the law of novelty and could not correct a mistake in the disclosure of the prior art in that context, eg stating (at [29]) that: “The absence of the correct dosage in Killick means that the invention is novel over Killick and one cannot make Killick disclose something which it does not.” In addition, in the context of the permissible use of this route for obviousness, Floyd LJ comments (at [29]) that there is no requirement that the results of such an enquiry have been published and “far less that they be common general knowledge”, which highlights the distinction between CGK and the information obtained by the skilled person following an obvious route, as held in KCI.

Arnold J (whose judgments are normally noted for their length), said simply, “I agree”.

The appeal was accordingly dismissed.