Abstract
The “Specific Mechanism” as part of the accession of new Member States to the EC limits the free movement of goods between new and old Member States with respect to certain pharmaceuticals that could not find patent protection in the new Member States prior to accession. While the Specific Mechanism derogates from the principles of intra-Community free trade, it does not alter the rules of domestic patent law applicable in the respective Member States. As a consequence, the Specific Mechanism can only have an effect where domestic patent law gives the patentee the right to prevent parallel importation from other Member States or third countries. At least in the UK, this does not seem to be the case.
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Notes
English Court of Appeal, Merck Canada Inc. v. Sigma Pharmaceuticals, 18 April 2013, (2013) RPC 35. The case was referred to the Court of Justice on 14 October 2013 and is currently pending as case C-539/13.
For a first evaluation, see Heath (2004, p. 776).
O.J. L 236 of 23 September 2003.
The “more complicated angles” concern the fact that notification was not given to the patentee, but an affiliated company, and not made by the importer, but the UK distributor. Accordingly, two of the referral questions to the ECJ concern these two specifics that are relevant to this case, but of less interest to the general working of the Specific Mechanism:
Question 2: “Where, as permitted by the national regulatory system, an application for regulatory approval is made by someone other than the intended importer, can prior notification given by the applicant for regulatory approval be effective if that person does not itself intend to import or market the pharmaceutical product but where the intended importation and marketing will be carried out under the applicant’s regulatory approval?; and
Does it make any difference if the prior notification identifies the person that will import or market the pharmaceutical product?
Does it make any difference if the prior notification is given and the application for regulatory approval is made by one legal person within a group of companies which form a single economic unit, and the acts of importation and marketing are to be carried out by another legal person within that group under licence from the first legal person, but where the prior notification does not identify the legal person that will import or market the pharmaceutical product?
To whom must prior notification be given under the second paragraph of the Specific Mechanism? In particular:
Is the beneficiary of a patent or supplementary protection certificate limited to persons who have a legal right under national law to bring proceedings to enforce that patent or supplementary protection certification?”
Question 3: “In a case where a group of companies forms a single economic unit comprising a number of legal entities, is it sufficient if the notification is addressed to a legal entity which is the operating subsidiary and marketing authorisation holder in the Member State of importation rather than the entity within the group that has a legal right under national law to bring proceedings to enforce that patent or supplementary protection certificate, on the basis either that such legal entity may be characterised as a beneficiary of the patent or SPC, or that it is to be expected that such notification in the ordinary course of events will to come to the attention of the persons who make decisions on behalf of the patent or SPC holder?
If the answer to Question 4(b) is yes, is a notification which is otherwise compliant rendered non-compliant if it is addressed to ‘the Manager, Regulatory Affairs’ of a company when that company is not the entity within the group that has a legal right under national law to bring proceedings to enforce that patent or supplementary protection certificate but is the operating subsidiary or marketing authorisation holder in the Member State of importation and when that Regulatory Affairs department in practice regularly receives notifications from parallel importers regarding the Specific Mechanism and other matters?”
ECJ, Hoffman Laroche v. Centrafarm, 23 May 1978, 9 IIC 580 (1978).
English High Court, Boehringer Ingelheim v. Swingward, [2000] FSR 529, at para. 92.
Feddersen (2003), regards the lack of notification as a reason for the state authorities to withhold marketing authorisation. His answer to the silence of a duly notified proprietor is not clear, either.
English Patents County Court, Merck Canada et al . v. Sigma Pharmaceuticals, 27 April 2012, [2012] EWPCC 18.
ECJ, case C-191/90, Generics and Harris v. SmithKline and French, (1992) ECR-I, 5335. Also the ECJ decision Merck v. Stephar, 14 July 1981, 13 IIC 70 (1982), is crystal clear in mentioning that the patentee in marketing the goods “must then accept the consequences of his choice as regards the free movement of the product within the Common Market”.
E.g. http://mpasearch.co.uk/the-specific-mechanism; http://www.avidity-ip.com/assets/pdf/20110901025659_1907.pdf; http://www.bristows.com/assets/documents/specific_mechanism_article.pdf; http://kluwerpatentblog.com/2012/06/19/pharmaceutical-patent-infringement-and-the-specific-mechanism-merck-canada-inc-and-merck-sharp-dohme-ltd-v-sigma-pharmaceuticals-plc-2012-ewpcc18/.
Industrial Property Code, Sec. 5 (Esaurimento): “Le facoltà esclusive attribuite dal presente codice al titolare di un diritto di proprietà industriale si esauriscono una volta che i prodotti protetti da un diritto di proprietà industriale siano stati messi in commercio dal titolare o con il suo consenso nel territorio dello Stato o nel territorio di uno Stato membro della Comunità europea o dello Spazio economico europeo.”
Intellectual Property Code, Sec. L 613-6: “Les droits conférés par le brevet ne s’étendent pas aux actes concernant le produit couvert par ce brevet, accomplis sur le territoire français, après que ce produit a été mis dans le commerce en France ou sur le territoire d’un Etat partie à l’accord sur l’Espace économique européen par le propriétaire du brevet ou avec son consentement exprès.”
Germany has no explicit exhaustion rule in the Patent Act, yet the courts have affirmed the principle of Community-wide exhaustion: German Federal Supreme Court, 14 December 1999, 32 IIC 685 (2001) – Karate: “The exhaustion of the rights deriving from a patent issued with effect for Germany in any event takes place as a matter of principle if the protected product has been put into circulation by the patent holder or with his consent in Germany, a member state of the European Community or in a state belonging to the European Economic Area.” In the following, the court somewhat confusingly bases this doctrine on the free movement of goods, though.
Regulation No. 1257/2012, Art. 6: “The rights conferred by a European patent with unitary effect shall not extend to acts concerning a product covered by that patent which are carried out within the participating Member States in which that patent has unitary effect after that product has been placed on the market in the Union by, or with the consent of, the patent proprietor unless there are legitimate grounds to oppose further commercialisation of the product.”
English Court of Appeal, 30 January 1871, Betts v. Willmott, L.R. 6 Ch 239–245.
English Privy Council, 3 February 1911, National Phonograph Company of Australia Ltd. v. Menck, [1911] Reports of Patent, Design, and Trade Mark Cases 229–249.
English Patents Court, 9 October 1995 – Roussel Uclaf S.A. v. Hockley International Ltd., [1996] Report on Patent Cases (R.P.C.) 441–445 (a decision rendered by Lord Robin Jacob, no less).
Note that the Roussel Uclaf case also concerned intra-Community trade, as the goods originated from France and were ultimately imported into the UK. No question was raised as to whether the patentee held a patent in France, or whether under Community law the patentee could prevent parallel importation into the UK. The court simply applied the above common law principles of implied consent.
For Europe, see the guidelines issued by the European Medicines Agency: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000120.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac05800265cc.
References
Feddersen C (2003) Parallel trade and pharmaceuticals in the Europe of 25: what the “specific mechanism” achieves and what it does not. EIPR, 545
Heath C (2004) Parallel imports of patented pharmaceuticals from the new EU accession states. IIC 35:776
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Heath, C. Patent Rights and the “Specific Mechanism” to Prevent Parallel Imports. IIC 45, 399–408 (2014). https://doi.org/10.1007/s40319-014-0203-1
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DOI: https://doi.org/10.1007/s40319-014-0203-1