EPLAW Patent Blog

NL - MSD v. Sandoz

Court of Appeal The Hague, 1 May2012, case number: HA ZA 09-4241, MSD v. Sandoz B.V. and Hexal A.G.

In its judgment of 1 May 2012, The Court of Appeal in The Hague confirmed the decision of the District Court that EP 0 509 752 and the corresponding SPC 990041 are invalid for lack of inventive step. Both the patent and the SPC relate to a combination of a β-blocker, timolol, and a carbonic anhydrase inhibitor (CAI), dorzolamide having (according to MSD’s auxiliary request) a pH value of 5.5-6.0. The combination (co-formulation) product is used for the treatment of glaucoma, an eye condition caused by excessive interocular pressure, in patients that do not sufficiently respond to the administration of only a β-blocker.

UK – Teva v. AstraZeneca

Teva UK Limited, Teva Pharmaceuticals Industries Limited, Accord Healthcare Limited, Intas Pharmaceuticals Limited, Hexal AG, Sandoz Limited v. AstraZeneca AB, High Court of Justice, Chancery Division, Patents Court, London, UK, 22 March 2012, [2012] EWHC 655 (Pat)

The Claimants applied to revoke AstraZeneca’s patent EP (UK) 0 907 364 which was for a sustained release formulation of an anti-psychotic drug known as quetiapine (marketed as SEROQUEL).

The Claimants argued that the patent was invalid for obviousness in view of an item of prior art referred to as Gefvert. If claim 1 was invalid, AstraZeneca asserted that the only other independently valid claim was claim 15.

It was common ground that the only difference between Gefvert and claim 1 was that Gefvert did not disclose a sustained release formulation of any kind. Mr Justice Arnold held that the skilled team would consider that a sustained release formulation was likely to be efficacious and would be an obvious possibility to try and that the skilled team would not be deterred from developing a sustained release formulation because of quetiapine’s high first pass metabolism. As a result, claim 1 was invalid. Mr Justice Arnold also rejected the validity of claim 15 as it was directed towards the use of sodium citrate as a pH modifier for any purpose and not limited to its use to decrease solubility.

Read the judgment in English here.

Head note: Robert Fitt

NL - Sandoz and Hexal v. Glaxo

Sandoz B.V. and Hexal AG v. Glaxo Group Limited, The Hague District Court, The Hague, The Netherlands, 26 January 2011, Case no./docket no. 343983 / HA ZA 09-2540.
 
The court invalidates Glaxo's patent for a combination of salmeterol and fluticason because of lack of inventive step, just like the British, Irish and German judges have invalidated the respective national counterparts. The court gives an elaborate motivation on the application of the problem-solution approach and the could/would test. According to the court the skilled person would look for a better corticosteroid component and then find fluticason. Arguments from the side of Glaxo relating to - among other things - synergistic effects and 'negative pointers' towards fluticason and the combination are all dismissed. Throughout the judgment the court regularly refers to the case law of the Technical Boards of Appeal of the EPO to support its conclusions.

Read the decision (in Dutch) here.

Read the English translation of the decision here (with thanks to Brinkhof Advocaten).

Headnote: Paul van Dongen

FR - Hexal and Sandoz v. Boehringer Ingelheim Pharma

Hexal A.G. and SAS Sandoz v. Boehringer Ingelheim Pharma GbmH & CoKG, Tribunal de Grande Instance, Paris, France, 7 May 2010, Docket No. 08/12537, with thanks to Pierre Véron, Véron & Associés for sending in the case and the translation

In a case dealing with the use of (S)(+)-2-ethoxy-4-[N-[1-(2-piperidinophenyl)-3-methyl-1-butyl]aminocarbonylmethyl]-benzoic acid as the active principle in a drug for the treatment of diabetes, the First Instance Court of Paris recently decided:

That both prior art documents produced by the claimants weren’t novelty-destroying prior art since “none of these two patents studied the specific effect of the S(+) enantiomer compared with the racemate of 2-ethoxy-4-[N-[1-(2- piperidinophenyl)-3-methyl-1-butyl]aminocarbonylmethyl]-benzoic acid.”

Regarding the inventive step, the Court points out that an effect considered as unexpected may involve an inventive step but also that “in the cases where the state of the art is taken into consideration, the person skilled in the art would arrive in an obvious manner at a result which corresponds to the terms of a claim, considering that he could expect the combination of the teachings of the documents comprised in the state of the art to bring an advantage, such a claim lacks inventive step, independently from the fact that a possibly unexpected additional effect is obtained.”

Whereas the Court ruled that claim 1 shall not be invalidated for lack of novelty, it nevertheless held claims 2 and 3 invalid for lack of novelty.

Read the decision (in French) here.
Read the decision (in English) here.

Head note: Gwendal Barbaut