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.
Antitrust: Commission sends Statement of Objections to Lundbeck and others for preventing market entry of generic antidepressant medicine
The European Commission has informed the Danish pharmaceutical company Lundbeck of its objections regarding agreements concluded with four generic competitors concerning citalopram, a blockbuster antidepressant. The Commission is of the preliminary view that the agreements aimed at preventing the market entry of cheaper generic medicines, in violation of EU antitrust rules. The Statement of Objections is also addressed to Merck KGaA, Generics UK, Arrow, Resolution Chemicals, Xellia Pharmaceuticals, Alpharma, A.L. Industrier and Ranbaxy, which belonged to the generic groups that concluded the agreements. The sending of a Statement of Objections does not prejudge the final outcome of the investigation.
In its Statement of Objections, the Commission takes the preliminary view that Lundbeck concluded agreements with generic companies to prevent the market entry of competing generic versions of its best-selling medicine citalopram. Generic entry became in principle possible when certain of Lundbeck's citalopram patents had expired. But the companies entered into agreements that foresaw substantial value transfers from Lundbeck to its four generic competitors, who subsequently abstained from entering the market with generic citalopram. The value transfers included direct payments from Lundbeck to the generic competitors and also occurred in other forms, such as the purchase of generic citalopram stock for destruction or guaranteed profits in a distribution agreement.
Merck v. Teva, District Court The Hague, the Netherlands, 27 March 2012, Case number 412750 / HA ZA 12-138
The President of the District Court of the Hague confirms earlier jurisprudence of the court in which it is held that obtaining a marketing authorization for a generic drug as such is not a sufficient threat of infringement of a patent. Additional circumstances need to be present to justify the rendering of an injunction. In the case at hand, the patentee (Merck) had stated that such additional circumstances were present, inter alia as the generic manufacturer (Teva) had previously introduced generics of patented drugs onto the market before the end of patent protection, as generic manufacturers have a high interest in entering the market in the earliest stage possible, and as market authorizations had also already been obtained by Teva for other drugs, intended to be used in combination therapy with the generic drug at issue. The President held that these circumstances were insufficient to justify a real threat of infringement and thus to render an injunction. The fact that Teva had not been willing to sign an undertaking that it would not enter the market before the expiry of the patent and/or that it would inform Merck well before introduction of the generic onto the market, according to the President did not change this. A patentee should not be able to create a threat of infringement unilaterally by requesting such undertaking. Teva moreover has no general obligation to inform Merck of an upcoming introduction of its products. The interest in keeping such information confidential outweighs Merck’s interest to be informed in order to be able to start litigation. Moreover, an introduction of the generic drug is preceded by inclusion of it in the G-Standard, giving Merck at least 10 days notice, the President concluded.
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 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.
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.
Teva Pharmaceuticals Industries Ltd, Teva Sweden AB, Arrow Läkemedel AB, Arrow Generics Ltd, Ratiopharm AB and ratiopharm GmbH v. Istituto Gentili SpA, MSD Overseas Manufacturing Co (Ireland) and Merck Sharp & Dome Sweden AB, Stockholm District Court, 11 June 2010, Docket Nos. T 16665-04 T 252-05, T 15175-05, T 7337-05, T 15141-05, T 30912-05 and T 13939-05 (joint cases)
In joint infringement and invalidity proceedings, the District Court of Stockholm denied Teva’s, Arrow’s and Ratiopharm’s claims that Merck’s SPC (for the pharmaceutical product Alendronat) was invalid. Consequently, Teva and Arrow were found to have infringed the same SPC. The invalidity action was first initiated by Teva already in October 2004. This judgment was also preceded by a preliminary injunction against Teva and Arrow, prohibiting them to handle generic Alendronat, granted by the Stockholm District Court in February 2006. However, the preliminary injunction was cancelled by the Svea Court of Appeal in October 2006. According to the Svea Court of Appeal, probability of patent infringement had not been shown (with respect to the validity of the basic patent (and thus also the SPC) not having been established as probable).
Actavis UK Limited v. Merck & Co Inc, Court of Appeal (Civil Division) London, UK, 21 May 2008, Case No. [2008] EWCA Civ 444, with thanks to Marc Döring and Rowan Freeland, Simmons & Simmons
"The Court of Appeal's decision in Actavis v Merck (England & Wales Court of Appeal, 21 May 2008) is a landmark in pharmaceutical patent law and its finding on the patentability of (non-obvious and new) dosage regimes will be welcomed by pharmaceutical companies. However, it is also of relevance to patent litigators in all industries since it emphasises the importance of settled case law of the European Patent Office Boards of Appeal and creates a new exception, where such settled EPO jurisprudence exists, to the rule that the Court of Appeal is bound by its previous decisions."
Read the first instance decision (in English) here.
Read the Court of Appeal decision (in English) here.
Read the extended summary (provided by Rowan Freeland) here.
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