EPLAW Patent Blog

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

NL - Merck Sharp & Dohme v. Sandoz

Merck Sharp & Dohme Corp. v. Sandoz B.V., the preliminary injunction judge of the District Court of The Hague, The Netherlands, 4 June 2010, Case No. 363158 / KG ZA 10-427

Merck claimed that Sandoz infringes its EP 752 and SPC 990041 for ‘ophthalmic compositions comprising combinations of a carbonic anhydrase inhibitor and a beta-adrenergic antagonist’ by marketing a dorzolamide/timolol-product (anti-glaucoma eye drops). The preliminary injunction judge rules that the fact that EP 752 (in amended form) was invalidated in parallel UK proceedings is in and of itself not sufficient for the judge in preliminary injunction proceedings to rule that there is a non-negligible chance that the (Dutch part of) the patent will be invalidated in proceedings on the merits. The Dutch judge must make up its own mind. However, the view of a respected fellow patent-judge in parallel proceedings on the merits will be given considerable weight. Merck also failed to explain or criticize the English verdict in any meaningful way, according to the preliminary injunction judge.

A point of interest was the discussion on whether or not the so-called Nardin-abstract was indeed to be considered prior art. Merck initially argued that the abstract was from a later date than the priority date (17 April 1991), but Sandoz obtained inter alia a statement from the British Library to the effect that the abstract had been received by the Library on April 11, 1991 and had been cataloged on April 16, 1991 ‘and would have been available for public use from that date’. The preliminary injunction judge refers to the Enlarged Board of Appeal T314/99 decision, in which it was held that a document “by its mere arrival in the archive [of a library; ed.] publicly available, since that did not mean it was as of that point in time cataloged or otherwise prepared for the public to acquire knowledge of it’. Since the Nardin-abstract had been cataloged the day before the priority date, the preliminary injunction judge therefore judged it to be prior art.

After reviewing the prior art (and especially the Nardin-abstract) the preliminary injunction judge came to the conclusion that there is a non-negligible chance that the Dutch part of the patent will be invalidated in proceedings on the merits. Therefore, the requested injunction was denied.

Read the judgment (in Dutch) here.

Head note: Maurits Westerik

NL - Mundipharma Pharmaceuticals v. Sandoz

Mundipharma Pharmaceuticals B.V. v. Sandoz B.V. District Court The Hague, The Netherlands, 7 April 2010, Docket No. 340373 / 09-2029, including the English translation, both with thanks to Willem Hoyng, Howrey

*Now including the English translation*

In today's judgment the District Court of The Hague ruled that Mundipharma's EP 730 as granted relating to the controlled release oxycodone formulation, OxyContin®, is valid and infringed by Sandoz' 10 and 20 mg dosages. The District Court grants a provisional injunction against Sandoz while awaiting the outcome of the appeal in the pending opposition proceedings.

The judgment deals extensively with the invalidity arguments as put forward by Sandoz (added matter; (undisclosed) disclaimer; insufficient disclosure; lack of novelty; lack of inventive step).

A comment on the decision will follow shortly.

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

DE - Mundipharma v. Sandoz/Preliminary Injunction Oxycodone patent

Mundipharma GmbH v. Sandoz Pharmaceuticals GmbH et al, Landgericht Düsseldorf, Germany, 30 March 2010, Case No. 4a O 13/10

In the international dispute between Mundipharma and various suppliers of generic versions of the controlled release oxycodone formulation, OxyContin®, the Landgericht Düsseldorf granted a preliminary injunction against Sandoz. The Landgericht Düsseldorf dismissed the various non-infringement arguments raised by Sandoz and considered the patent to be valid.

In coming to its decision on validity, the Landgericht extensively dealt with the invalidity-arguments raised by Sandoz and specifically referred to previous decisions of the courts in the UK and The Netherlands which had upheld parallel oxycodone patents. Interestingly, the Landgericht Düsseldorf did not follow the decision of the Bundespatentgericht which had invalidated one of Mundipharma's oxycodone-patents in view of the same prior art that was put before the Landgericht by Sandoz in the preliminary injunction proceedings.

Read the decision (in German) here.

UK - LEO Pharma v. Sandoz Limited / Appeal

LEO Pharma A/S and LEO Laboratories Limited v. Sandoz Limited, invalidity proceedings, High Court of Justice, Court of Appeal (Civil Division), UK, 17 November 2009, Docket No. No: A3/2009/131, with thanks to Marc Döring and Rowan Freeland, Simmons & Simmons

Unusual obviousness attack (that is, where the skilled person would have come upon the invention without any expectation of successfully finding a better product) should be scrutinised with great care.

Referring to Biogen the Court of Appeal states about obviousness that "the Judge’s conclusion must be reached as an overall assessment of the relevant evidence, both technical and non-technical. If he has made such an assessment, weighing all the factors involved, then it will be difficult indeed to show that he has made an error of principle."

LEO Pharma's patent was upheld.

Read the judgment (in English) here.

Read the judgment in first instance (in English) here.

Read an extended summary here (provided by Marc Döring and Rowan Freeland who represented LEO Pharma).

UK - LEO Pharma v. Sandoz Limited / First instance

LEO Pharma A/S and LEO Laboratories Limited v. Sandoz Limited, invalidity proceedings, High Court of Justice, Chancery Division, Patents Court, UK, 15 May 2009, Docket No. HC08C00391, with thanks to Marc Döring and Rowan Freeland, Simmons & Simmons

Sandoz unsuccessfully challenges Leo's patent on the basis that the claimed invasion is anticipated by and/or it is obvious in light of an earlier LEO patent application. None of the claims of the patent (for a new crystalline form of calcipotriol, calcipotriol monohydrate, used in the treatment of psoriasis) was found to be invalid. The infringement claim had been admitted by the defendant on the eve of trial and the counterclaim for revocation was dismissed.

Read the judgment (in English) here.

Read an extended summary of the case here (provided by Marc Döring and Rowan Freeland who represented LEO Pharma). 

Read the judgment on appeal (in English) here.