Press and Information Division

PRESS RELEASE No 58/96

5 December 1996

Judgment of the Court of Justice in Joined Cases C-267/95 and C-268/95
Merck & Co.Inc. and Others v Primecrown Ltd and Others and Beecham Group plc v Europharm of Worthing Ltd

THE COURT RULES ON PATENTEES' RIGHTS AND THE PRINCIPLE OF FREE MOVEMENT OF GOODS


IMPORTANT: This Press Release, which is not binding, is distributed to the Press by the Press and Information Division. The summary of the judgment which follows must be considered in the context of the judgment as a whole. For additional information or for a copy of the judgment, please contact Tom Kennedy - tel. (00352) 4303-3355.

  1. "The transitional periods provided for in Articles 47 and 209 of the Act concerning the Conditions of Accession of the Kingdom of Spain and the Portuguese Republic and the Adjustments of the Treaties expired on 6 October 1995 in the case of the Kingdom of Spain and on 31 December 1994 in the case of the Portuguese Republic.

  2. Articles 30 and 36 of the EC Treaty preclude application of national legislation which grants the holder of a patent for a pharmaceutical product the right to oppose importation by a third party of that product from another Member State in circumstances where the holder first put the product on the market in that State after its accession to the European Community but before the product could be protected by a patent in that State, unless the holder of the patent can prove that he is under a genuine, existing legal obligation to market the product in that Member State."

  1. FACTS OF THE CASE
  2. Merck holds patents in the United Kingdom for a drug for hypertension (Innovace), a drug prescribed in prostate treatment (Proscar) and a drug for glaucoma (Timoptol) whilst Beecham holds a patent for an antibiotic (Augmentin).

    Those drugs were marketed by Merck and Beecham in Spain and Portugal at a time when drugs could not be patented in those two States (they became patentable in Spain on 7 October 1992 and in Portugal on 1 January 1992).

    Merck and Beecham complain that Primecrown and Europharm have infringed their United Kingdom patents by importing the drugs in question into the United Kingdom from Spain and Portugal, thereby taking advantage of the price difference between those Member States.

    The two cases referred to the Court of Justice by the High Court in London therefore concern cases in which drugs are patented in one Member State and the patent holders seek to oppose import of the drugs from another Member State where they could not be patented and where the patent holder was under a legal or ethical obligation to market them.

  3. THE COURT'S JUDGMENT
  4. The Court cites its case-law according to which patent protection may impede free movement of goods only in so far as this is justified in order to safeguard rights constituting the specific subject-matter of a patent, which is, in particular, to guarantee to the patent holder the exclusive right to use an invention with a view to manufacturing products and putting them on the market for the first time.

    Once the patent holder decides, in the light of all the circumstances, to market his product, even in a Member State where the law provides no patent protection for the product, he must then accept the consequences his choice has for the free movement of the product within the common market. He cannot oppose importation of a product freely marketed by him in a Member State even if the product was not patentable there.

    In the present judgment, the Court reaffirms that balance between the principle of free movement of goods in the Community and the principle of protection of patentees' rights.

    The High Court also asked in its reference whether that case-law should be qualified to exclude cases in which the patentee in the Member State of importation has a legal or ethical obligation to put his product on the market in a Member State in which he could not obtain patent protection. In reply, the Court of Justice accepts that, where a patentee is legally bound under either national law or Community law to market his products in a Member State, he cannot be deemed to have given his consent to the marketing of the products concerned and he is therefore entitled to oppose importation and marketing of those products in the State where they are protected.

    However, ethical obligations to provide supplies of drugs in Member States where they are needed, even though they are not patentable there, cannot provide a basis for derogating from the rule on free movement of goods.