Mylan quashes morning-after pill dosage patent

Generics (UK) Limited, the UK arm of Mylan, has succeeded in invalidating a patent held by Hungarian pharmaceutical company Richter Gedeon at the English High Court.

The patent at suit, (UK) 1 448 207 B1, covers a dosage regimen for the use of levonorgestrel as a method of emergency contraception.

Mylan filed a claim for declaration that the patent is invalid on the grounds of obviousness and insufficiency and should be revoked.

It claimed that the specification of the patent “does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art”.

Richter’s patent covers the administration of levonorgestrel in a single 1.5 mg dose, which is easier to use than the established dosage regimen of two doses of 750 µg taken 12 hours apart. The judgment said that the two-dose method is “broadly equivalent” in efficacy to other forms of pill-based treatment.

In its case for obviousness, Mylan relied on common general knowledge and research published in 2000 that compared the effectiveness of a single dose of levonorgestrel with the established two-dose method.

As its expert witness, it called upon a clinician with an interest in emergency contraception, while Richter relied on evidence from an expert in medical statistics.

Justice Philip Sales agreed that the clinician who specialises in contraceptive service was a relevant person “skilled in the art”, but did not accept “the submission of the defendant that the teaching in the patent is addressed to a team which would include a clinician and a specialist medical statistician.”

Drawing upon Justice Robin Jacob’s judgment on Pozzoli Spa v BDMO SA (2007), which also dealt with “inventive concept” in relation to obviousness, he concluded that the patent was invalid for being obvious.

He added that the insufficiency challenge does not arise on the basis of his obviousness finding.

Neither Mylan nor Richter Gedeon responded to LSIPR’s requests for comment.