On 3 July 2018 the Lazio Administrative Court decided that, as a rule, parallel importers of medicinal products have no right to change the trademark affixed thereon in their country of origin unless this change is strictly necessary due to safety grounds or national regulatory restrictions.

Facts

On 28 February 2017 the Italian Medicines Agency (AIFA) granted Medifarm Srl authorisation for the parallel import of a medicinal product commercialised in France by Menarini Sa under the trademark BILASKA. The same medicinal product is commercialised by Menarini in Italy under the trademark ROBILAS.

The applicant did not put forward a specific request to change the name from BILASKA to ROBILAS. However, it nonetheless expected the AIFA to approve the parallel import under the trademark ROBILAS as a matter of course, which did not happen.

The applicant appealed the AIFA's decision on the ground that an authorisation for parallel importation must approve the importation with the name currently used for the product in Italy (in this case, ROBILAS), as otherwise it would de facto make it impossible to market the product in Italy.

Decision

The Lazio Administrative Court first clarified that the parallel import of medicines for human use involves the distribution of medicines already authorised, manufactured and marketed in one EU member state to another. A parallel imported medicinal product is subject to authorisation granted by the AIFA following a simplified procedure provided that:

  • the imported product has been granted a marketing authorisation in its EU member state of origin; and
  • the imported product is essentially similar to a product which has already received a marketing authorisation in the destination EU member state.

As regards the alleged infringement of EU and Italian legislation on free trade among member states, the court found that, based on trademark and ECJ case law, parallel importers must retain the name of medicinal products used in the country of origin as a general rule. Such a rule may be derogated from when:

  • regulatory restrictions on or impediments to the marketing of the imported product exist in the country of destination under the trademark used in the country of destination; or
  • the use of the trademark from the country of origin may pose a "risk of confusion to public health" – namely, confusion between the imported product and other medicinal products (eg, with a different composition or therapeutic indication) already on the market in the destination country.

According to the court, in the case of BILASKA, there was no regulatory restriction regarding the use of the trademark in its country of origin or a risk of confusion that could adversely affect public health that merited the need for the parallel importer to change the product's name. Instead, the court found that the name had been changed to obtain a commercial advantage.

Comment

The Lazio Administrative Court's decision is subject to appeal. The case is particularly interesting with regard to the importation of medicinal products which are placed on the EU market under different trademarks and which enjoy a reputation on the market due to their longstanding use or significant to promote a brand. The court found that the right to the parallel importation of medicinal products should not unduly take advantage of the national reputation and trust built by the marketing authorisation holder in the product's state of origin.

For further information on this topic please contact Riccardo Fruscalzo or Carlotta Busani at Hogan Lovells Studio Legale by telephone (+39 02 7202 521) or email (riccardo.fruscalzo@hoganlovells.com or carlotta.busani@hoganlovells.com). The Hogan Lovells Studio Legale website can be accessed at www.hoganlovells.com.

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