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UK – Generics (UK) (Mylan) v. Gedeon Richter

30 May 2014

Generics (UK) Ltd (Trading As Mylan) v. Richter Gedeon Vegyeszeti Gyar RT, Patents Court (Chancery Division), High Court of Justice, London, UK, 22 May 2014, Case No. [2014] EWHC 1666 (Pat)

Mr Justice Sales sitting in the Patents Court has held that Richter Gedeon Vegyeszeti Gyar RT’s (“Gedeon Richter”) EP (UK) Patent No. 1 448 207 concerning a single-dose regimen for the use of levonorgestrel for emergency contraception to be invalid for obviousness on a revocation action brought by Generics (UK) Ltd (“Mylan”).

Mylan’s case was that the patent was invalid for (i) obviousness over the common general knowledge together with a publication reporting on a presentation of the interim results of a WHO study on the effectiveness of a single dose of levonorgestrel compared to the common two-dose regimen (“Killick”); and (ii) insufficiency. As Mylan’s insufficiency attack was pleaded in the alternative if the obviousness attack failed, the judgment does not assess the insufficiency attack.

The main patent claim was as follows:
“Use of 1.5+ 0.2 mg levonorgestrel for the preparation of a pharmaceutical for emergency contraception.”

Gedeon Richter, while accepting that the expertise of a clinician was relevant to the issues in the case and a clinician formed part of the skilled team, argued that the most relevant expert was a medical statistician because only such a person could assess the validity of the patent relevant to the prior art. Therefore, Gedeon Richter only called an expert statistician to give evidence. Mylan argued that a clinician with an interest in emergency contraception was the relevant expert and provided evidence from an expert clinician. Mylan later introduced evidence from an expert medical statistician to reply to Gedeon Richter’s expert evidence.

Sales J held that the relevant skilled addressee was a clinician because the patent’s teaching was directed towards a person who would have a practical interest in the use of the single-dose regimen in treating patients desiring emergency contraception. He found that the references to statistical concepts in the patent were well within such a clinician’s knowledge, that statistics are not the determining guide for deciding whether the patent taught something worthwhile and that a clinician would have full confidence in relying upon the patent’s teaching without requiring the assistance of an expert medical statistician.

In construing the state of the art, Sales J held that an awareness of the WHO study examining the effectiveness of the single dose regimen and that its preliminary findings had been reported in Killick were part of the CGK as well as Killick forming part of the state of the art.

Killick contained a transcription error which recorded the single dose of levonorgestrel that was being tested in the WHO study as 1.5g rather than 1.5mg. While Sales J did not accept that the skilled clinician would have immediately understood 1.5g to have meant 1.5mg, the clinician would have immediately thought that 1.5g was likely to be an error.

Therefore, it would have been an obvious course of action to contact the article’s author or the presenters at the meeting upon which Killick reported. Sales J held that doing this could be described “as a matter of routine” and so the information gained from taking this course (i.e. that the WHO study was testing 1.5mg as opposed to 1.5g) could be taken into account as part of a case of obviousness (applying Arnold J’s judgment in KCI Licensing Inc v Smith & Nephew Plc [2010] EWHC 1487 (Pat) as approved by the Court of Appeal in the same case).

In defining the inventive concept, Sales J rejected Gedeon Richter’s submission that the words “for emergency contraception” meant that the dosage regime had to be effective in providing emergency contraception and for that reason the skilled team had to include a medical statistician. Sales J also rejected the opposite submission by Mylan that the claim meant no more than the regime had to work in some patients or would have some benefit. Sales J distinguished the field of emergency contraception from medical conditions which are known to be difficult to treat successfully such as cancer and where a patent claim for the treatment of the condition might not be construed as meaning it would successfully treat the disease. Instead, Sales J held that the claim was that the invention “will provide a reasonable level of effectiveness in achieving prevention of pregnancies, broadly comparable to other existing treatments which are available for that purpose”.

As a result Sales J held that the claimed invention was not that the single dose regime was statistically as effective as the two dose regime. Instead the clinician would be concerned with the clinical effectiveness in a broad, holistic sense.

In assessing obviousness, Sales J held that there was no settled prejudice that a single dose regime would not be effective. He concluded that Killick made it obvious that use of a single dose of 1.5mg was likely to be a viable method of contraception, in particular that it was obvious that such a regime could be pursued and investigated with a reasonable or fair expectation of success.

Having applied the Windsurfing/Pozzoli test, in order to cross-check his conclusion on obviousness, Sales J also stated that he did not consider the additional technical contribution provided in the patent over the preliminary findings reported in Killick justified a patent monopoly over the single dose regime. The possibility of using the regime had already been substantively revealed and was thought by clinicians at the time as the obvious likely way forward in the field of emergency contraception notwithstanding one of the presenter’s caveats reported in Killick that the WHO study needed to be finished to confirm the preliminary findings.

Read the judgment (in English) here.

Head note: Scott Parker and Rafi Allos