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European IP Bulletin, Issue 22, May - Patents
Patents
7. Of Merck Sharp & Dohme LTD v The Licensing AuthorityOn 28 April 2004, Moses J. gave his judgement in the case of (on the application of Merck Sharp & Dohme Ltd) v The Licensing Authority [2005] EWHC 710 (Admin)
Merck Sharp and Dohme Ltd (MSD) hold market authorisations for Fosamax 5mg, 10 mg and 70 mg (Fosamax Once weekly), used for treating osteoporosis. These marketing authorisations were granted in July 1993, May 1995 and November 2000 respectively after submission of relevant regulatory data by MSD as required under Article 8 (3) of the Directive 2001/83/EC. The generic companies sought to manufacture and market the generic version of Fosamax Once weekly by relying and cross-referencing to the previous data submitted by MSD for all three versions of Fosamax.
The reliance and cross-reference by an applicant is permitted under Article 10 of the directive for certain situations. One such situation is under Article 10 (1) (iii) of the directive. This stipulates that an applicant need not be required to provide the relevant data where his medicinal product is essentially similar to a medicinal product that has been authorised within the Community for not less than six or ten years (ten years in UK) - a procedure also known as “the abridged procedure”. The proviso to Article 10 further provides that where the two medicinal products are not essentially similar, an applicant can rely on the original data and submit additional “bridging” data to cover the aspects of differences between the two, a procedure called “hybrid abridged procedure”.
The authorisation was accordingly granted in favour of generics by the competent authority in the UK without the need for any additional data. This was notwithstanding the fact that Fosamax 10mg and 70 mg have been authorised for less than ten years. Unhappy with the decision, MSD filed the present appeal contending that such reliance by generic manufacturers and the competent authority on its data is outside the scope of Article 10. It further contended that the present case does not fall within the previous ECJ decisions of Generics, Novartis and APS as these decisions do not cover the following two situations of the present case: first, the dosage and administration of Fosamax 70 mg is different than the other two products; and secondly, there are multiple differences between the three Fosamax products.
The court rejected the submissions of MSD by holding that ECJ decisions given in the cases of Generics, Novartis and APS also apply with full force to the present case. The Could held that:
- The difference in posology, that is
dosage and administration, will not prevent the generic company
cross-referring to the regulatory data submitted by the original
innovator for their original product such as Fosamax 5 mg
(authorised for more than six or ten years) and its line
extension such as Fosamax 70 mg (authorised for less than six or
ten years). Product B is a line extension of product A where the
differences between them are either expressly identified in the
proviso or generally implied.
- A generic company seeking to market a product C, identical to product B, is not required to produce any fresh data where the product B has been authorised earlier despite having multiple differences with product A. The generic company can make a cross-reference to the data submitted earlier for both the original product and its line extension.
8. When is a Non-EEA Marketing Authorisation An EEA Marketing Authorisation?
The European Court of Justice (ECJ) recently handed down its decision in the joined cases C-207/03 and C-252/03 Novartis AG, UCL and the Institute of Microbiology and Epidemiology v Comptroller-General of Patents, Designs and Trade Marks for the United Kingdom and Ministre de l’Économie v Millennium Pharmaceuticals Inc., relating to Supplementary Protection Certificates (SPC) and marketing authorisations.
The first case was referred to the ECJ by the UK High Court. In this case, the parties, Novartis AG, University College London and the Institute of Microbiology and Epidemiology, sought an SPC for Basiliximab, an immunosuppressant and the other for an antimalarial combination of Artemether and Lumefantrin. The second case concerned Millennium Pharmaceuticals Inc’s application for an SPC in Luxembourg for Eptifibatide an anti-blood clotting agent.
SPCs are granted pursuant to Regulation No 1768/92 to compensate for the long period that elapses between the filing of a patent application in respect of a medicinal product and the granting of authorisation to place that product on the market. The object of the SPC is to allow an overall maximum of fifteen years of exclusivity from the time the medicinal product in question first obtains authorisation to be placed on the market in the Community. A patent must have been granted for the product and a marketing authorisation in force. The term of the SPC is determined by reference to the date of grant of the patent and the date of the first marketing authorisation in the EEA.
In both cases, the Swiss marketing authorisation had been the first relevant authorisation to be considered only because it extended automatically to Liechtenstein. The UK Patent Office and the Luxembourg government said that the Liechtenstein authorisation was relevant. Grubb (Patents for Chemicals, Oxford, 3rd Edn, p149-150) was also of this opinion. The parties all argued that a relevant marketing authorisation was only one granted within an EEA state. Given that Swiss procedures may be quicker than that of EEA states, this would give the parties a greater SPC period.
The ECJ found that the EEA agreement recognised that two parallel marketing authorisations may exist in Liechtenstein, the Swiss and the EC/EEA compliant. This reciprocal recognition thus characterised the Swiss-Liechtenstein authorisation as a relevant marketing authorisation. Submissions by various governments that a Swiss marketing authorisation was not relevant to circulation of products on the EEA market were dismissed by the ECJ on the basis that authorisations within the EEA were territorially limited in nature as well.
The ECJ said that to not take into account a Swiss marketing authorisation could give greater than 15 years marketing authorisation to a medicinal product. The Court held that although the SPC regime granted additional protection to pharmaceuticals, it was not intended to provide a complete solution to patent holders where there are delays in marketing authorisations which affect their patent rights. The Court considered that the preamble to Regulation 1768/92 recognises that the interests of all parties connected with the health sector, not just the patent holders, must be taken into account.
The lesson patent holders can take from this decision is that patents are not considered to grant a right to market a product, rather there is a right to exercise a veto over others’ use of the invention. Therefore, more imaginative ways of exploiting these rights, such as cross-licence trading to enhance collaborative research, should be pursued. It is time the pharmaceutical industry learnt this and opened up to technology collaboration over mere monopoly profits.
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