EPLAW Patent Blog

NL - Bayer v. Sandoz

Bayer Pharma AG v. Sandoz B.V., District Court The Hague (preliminary relief judge), the Netherlands, 24 January 2013, case no. C/09/432919 / KG ZA 12-1391
 
Bayer is the owner of two process patents concerning the synthesis of the compound drospirenon.Sandoz has introduced a generic product which is manufactured by the Italian company Industriale Chimica (IC). IC also holds patents for the production of drospirenon.

In case of both patents invoked by Bayer, there is no literal infringement as IC applies another reagent/reactant in the process than the one specified in the claims of the concerned patent. The question is therefore in both cases whether the reagent/reactant used by IC can be regarded as equivalent measure. The judge comes to the conclusion that this is not the case. In its reasoning the court applies the function-way-result test, and concludes that it is insufficiently substantiated that the alternative compounds work in the same way. Furthermore the judge attaches value to the fact that the use of the alternative compounds is itself the subject of patent protection and has certain advantages compared to the use of the compounds mentioned in the processes patented by Bayer.

Read the judgment (in Dutch) here.

Head note: Paul van Dongen

NL - Lundbeck v. Sandoz / escitalopram

H. Lundbeck S/A v. Sandoz B.V., District Court The Hague, The Netherlands, 14 August 2012, Case No. 424154 / KG ZA 12-787, with thanks to Willem Hoyng, Jeroen den Hartog and Geert Theuws, Hoyng Monegier, for sending in the judgment and a translation in English

*** Now with translation in English ***

The Judge in Interlocutory Proceedings of the District Court in The Hague ordered a preliminary injunction against Sandoz based on Lundbeck’s  escitalopram patent.

The Judge followed Lundbeck’s reasoning that an earlier decision of the Dutch Court of Appeal (which may be read here), stating (in brief) that a substance may only be patented if the substance itself is inventive, is likely to be erroneous. The Judge awarded the injunction based on a process claim in the patent. Sandoz, according to the Judge, did not successfully argue that it did not implement the patented process.

Interestingly, the Judge awarded a provisional injunction already at the oral hearing, for the duration of the preliminary injunction proceedings.

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

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 v. AstraZeneca / Seroquel

Joined cases Sandoz B.V. and Hexal AG v. AstraZeneca AB and Accord Healthcare B.V. and Accord Healthcare Ltd v. AstraZeneca AB, District Court The Hague, The Netherlands, 7 March 2012, Case numbers 397921 / HA ZA 11-1977 and 397925 / HA ZA 11-1978, with thanks to Willem Hoyng and Jeroen den Hartog, Hoyng Monegier, for sending in the case and a translation in English

Sandoz et al sought to invalidate AstraZeneca’s patent for a sustained release formulation of quetiapine (Seroquel). According to Sandoz et al., AstraZeneca’s patent lacked inventive step as on the priority date there would have been a strong motivation for the skilled man to  make sustained release formulation, with a reasonable expectation of success. The District Court of The Hague applied the following test:

“The District Court will take as its point of departure that in the assessment of the inventive step of the patent, also if the problem-solution approach is applied, the question must be answered as to whether the average skilled person - assuming all the knowledge at his disposal on the filing date - was motivated to develop a sustained-release formulation of quetiapine and whether he would have a reasonable expectation of success, i.e. that this would solve the objective problem. In this respect, motivation on the one hand and a reasonable expectation of success are communicating vessels, in the sense that if he is strongly motivated, a less-high expectation of success will be sufficient for the skilled person, whereas he will need a high expectation of success if he is not very motivated. In other words, what is a ‘reasonable’ expectation, depends on the level of motivation.”

In applying this test, the Court held that the motivation to make a sustained release formulation of quetiapine was very limited on the priority date. As the skilled man moreover did not have a high expectation that he could make a sufficiently efficacious sustained release formulation of quetiapine with success, the Court concluded that such formulation was not obvious on the priority date and denied the requested invalidation of the patent.

Read the decision (in Dutch) here.

Read the decision (in English) here.   

Head note: Geert Theuws

FR - Sandoz v. Eli Lilly

SAS Sandoz v. Eli Lilly and Company, Court of Appeal of Paris, France, 13 January 2012, Case No. 10/17727, with thanks to Dominique Menard and Stanislas Roux-Vaillard, Hogan Lovells, for providing the judgment and an extended summary in English

On 13 January 2012, the Court of appeal of Paris confirmed the judgment which found that the French part of Eli Lilly's patent No. EP 0 577 303 regarding a process for stereoselective glycosylation shows inventive activity, is sufficiently disclosed and consequently valid. The failing generics company is ordered to pay half a million Euros in attorney's fees.

Read the entire summary (in English) here.

Read the judgment (in French) here.

DK - Sandoz v. AstraZeneca / Appeal

Sandoz A/S v. AstraZeneca AB, High court of Eastern Denmark, Kopenhagen, Denmark, 28 February 2011, with thanks to Peter-Ulrik Plesner and Kasper Frahm, Plesner, for sending in the cases and the translations

The Danish High Court has for the first time upheld a preliminary injunction based on fingerprint analyses and differences in process yield.

AstraZeneca is the owner of patent concerning the process for manufacturing the active pharmaceutical ingredient ("API") esomeprazol.In September 2009 AstraZeneca A/S and AstraZeneca AB submitted a preliminary injunction request against Sandoz A/S for the marketing and sale of a generic pharmaceutical named 'Esomeprazol "Sandoz"'.

The esomeprazol in Sandoz' product was being manufactured by the Indian producer Hetero. AstraZeneca claimed that the API was being produced according to AstraZeneca's protected process ("the AstraZeneca process"). Sandoz claimed that the API was being produced according to a different process ("the Hetero process").

AstraZeneca claimed during the case that the use of the AstraZeneca process would leave small amounts of four different impurities in the final product and that the finding of these impurities in Sandoz' product should be considered "fingerprints", i.e. indications of the use of the AstraZeneca process.

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

NL - Sandoz cs v. Merck

Sandoz B.V. and Hexal AG v. Merck Sharp & Dohme Corp., District Court The Hague, The Netherlands, 27 October 2010, Case No. HA ZA 09-4241

The District Court of The Hague has invalidated the Dutch part of MSD's European Patent relating to an ophthalmic drug for treatment of glaucoma. The patent claims describe a medicinal product consisting of a combination of dorzolamide, a carbonic anhydrase inhibitor, and timolol, a β-blocker. In earlier preliminary injunction proceedings, it had already been decided that there was a serious, non-negligible chance that the patent would be invalidated (read that decision here). The District Court has now confirmed in proceedings on the merits that the patent lacked inventive step over the Nardin abstract, a document which disclosed the concomitant administration (one after the other, but not together) of timolol and dorzolamine, in combination with common general knowledge. The Nardin abstract was found to be prior art, inter alia since it had been received by the British Library and made available for public use at the priority date.
 
The Court took Nardin as the closest prior art, found that the skilled person would know that concomitant administration lead to therapy adherence problems and, applying the problem and solution approach, ruled that the objective technical problem to be solved was how to enhance the ease of administration and the therapy adherence of the combination thereapy disclosed in Nardin. The obvious answer was: by creating a topical co-formulation, combining timolol and dorzolamine. MSD had argued that the skilled person would be dissuaded from trying to create a co-formulation, since timolol had a less than optimal bioavailability at a pH value lower than 7.0, whereas dorzolamine should be formulated at a somewhat acidic pH, to maintain the stability and solubility. However, the Court disagreed and ruled that the skilled person would know to try to come to a compromise. He would know from prior art that dorzolamine was clinically effective at a pH of 6.0 and he would routinely try whether a co-formulation with a pH value of 6.0 would also be clinically effective. The fact that he knew that the bioavailability of timolol was less than optimal at a pH of 6.0, is irrelevant; what is relevant, is whether there is clinically sufficient bioavailability. The skilled man would know to add a viscosity enhancer, to increase the contact time of the drug with the cornea. In light of this, the Court found there is no prejudice against attempting to create a topical co-formulation of timolol and dorzolamine.

Read the judgment (in Dutch) here.

Head note: Jaap Bremer

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