Merck Canada Inc and Merck Sharp & Dohme Ltd -v- Sigma Pharmaceuticals plc, Court of Appeal (Civil Division), Patten LJ, Black LJ and Kitchin LJ, London, UK, Case No. [2013] EWCA Civ 326
Following an appeal by Sigma against a decision of HH Judge Birss QC on 27 April 2012 that the Specific Mechanism (the special derogation from the normal free movement rules which was negotiated as part of the accession arrangements of Poland and a number of other Member States that acceded to the EU in 2004 and is set out in Annex IV, Chapter 2 of the Act of Accession) does not require the patent holder to demonstrate its intention to oppose importation before such activity is rendered an infringement, the UK Court of Appeal has agreed to make a reference to the Court of Justice of the European Union (“CJEU”) requesting clarification as to the proper interpretation of the Specific Mechanism.
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.
Merck Sharp Dohme Corp and Bristol-Myers Squibb Pharmaceuticals Limited v. Teva Pharma BV and Teva UK Limited, High Court of Justice, Chancery Division, Patents Court, London, UK, 15 March 2012, [2012] EWHC 627 (Pat)
Merck Sharp Dohme Corp. and Bristol-Myers Squibb Pharmaceuticals (together “BMS”) applied for an interim injunction to restrain Teva from infringing EP (UK) 0 582 455. Teva applied to strike out the action in its entirety.
Teva Sante, Teva Pharmaceutical Industries Ltd v. Merck Sharp & Dohme Corp, Tribunal de Grande Instance de Paris 3rd Chamber 1st Section, 9 November 2010, with thanks to Pierre Véron, Véron & Associésfor sending in the judgment, translation and summary
"This is another judgment about Merck’s patent EP 0 724 444 for the use of finasteride for the treatment of androgenic alopecia which has already been scrutinized in the UK and in Germany:
- the UK Court of Appeal (Civil Division) London, UK, 21 May 2008, Case No. [2008] EWCA Civ 444, Actavis v. Merck / Dosage Regime which held that a dosage regime was patentable and that, in the particular circumstance, it was novel and non-obvious;
- the German Bundespatentgericht on 26 June 2008, Ni 58/06 (EU), which decided that a dosage regime was patentable (but that it was lacking novelty in the specific situation).
In France this patent has already been held invalid by a former judgment of the Tribunal de Grande Instance de Paris upon Actavis’ request on 28 September 2010 (see the earlier post here) where the court held that: “A specific dosage for the treatment of an illness constitutes neither a first nor a second therapeutic application but simply an indication of the range within which this substance is efficacious so as to treat such or such an illness in light of the tests and research completed and explained in the patent.”
It is again held invalid, for the same reason, this time upon Teva’s request.
Murder me twice is normally impossible (except for Alfred Hitcock).
Teva UK Ltd v Merck Sharp & Dohme Corp, Court of Appeal, London, UK, 8 April 2011, Case No. A3/2010/0126/CHPCF
The English Court of Appeal has upheld the finding of the Patents Court that Merck's European Patent (UK) No. EP 0 509 752 B1 was invalid for lack of inventive step, due to a paper - whose authors included three representatives of Merck - published just six days before the priority date of the patent. In doing so the Court of Appeal dismissed the appellant's argument that a relevant consideration when applying the test of obviousness was whether there was sufficient time between the publication of the prior art paper relied upon and the priority date of the patent for the skilled addressee to carry out certain routine tests that would have been necessary to arrive at the claimed invention.
The patent was concerned with a treatment for glaucoma which involved the co-formulation of timolol (a beta blocker), which was already widely prescribed for the treatment of glaucoma, and a carbonic anhydrase inhibitor designated by Merck as MK 507 and which came to be known as dorzolamide. The paper, referred to as "Nardin" by the Court, disclosed the concomitant administration of these two drugs, that is, they were administered at effectively the same time, but not their co-formulation. Nardin further disclosed that the results were clinically and statistically significant.
Tribunal de grande instance de Paris, third chamber, 28 September 2010, N° RG : 07/16296, Actavis Group and Alfred E. Tiefenbacher GmbH v. Merck Sharp & Dohme Corp
The judgment handed down on 28 September 2010 by the Tribunal de grande instance, Paris in Actavis v. Merck decides that a dosage regime is not patentable because it is “plainly not” a second therapeutic application: “A specific dosage for the treatment of an illness constitutes neither a first nor a second therapeutic application but simply an indication of the range within which this substance is efficacious so as to treat such or such an illness in light of the tests and research completed and explained in the patent.”
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.
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.
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