The fight against counterfeit medical products entering the market has stepped up under EU law that puts in place tough measures to deal with anyone who flouts intellectual property rights.

The EU Directive on the Enforcement of Intellectual Property Rights (No 2004/48/EG) was created to provide a more consistent, harmonised intellectual property (IP) legal system throughout the EU, a move much welcomed by the medical sector. The industry will find the Directive particularly useful in fighting counterfeit products, which will now be more easily detected, seized and removed from distribution channels.

Passed in April 2004, the law was drawn up to target professional criminals and counterfeiters who make copies of anything – music, clothing and even medicine. The directive allows companies (IP-rights owners) to raid homes, factories and warehouses to seize property and ask courts to freeze bank accounts to protect trademarks, patents or intellectual property they believe are being abused or stolen.

Directive detail

By 29 April 2006, all EU Member States must create or adapt laws, regulations and administrative provisions to comply with the Directive (Chapter V, Article 20). The Directive is closely based on TRIPS provisions, in particular those of articles 41 to 60. Its structure reflects the typical history of most IP conflicts:

  • Establishing the fact of infringement by obtaining, presenting and preserving evidence (item 20 of the preamble; chapter II, sections 2 and 3 of the Directive)
  • Provisional measures for the immediate termination of infringements (item 22 of the preamble; chapter II, section 4 of the Directive)
  • Measures for preventing infringements, and measures to insure appropriate compensation in case of infringement (items 24 through 28; chapter II, sections 5 through 7 of the Directive)

The Enforcement Directive aims at reinforcing the IP-rights owner’s position. It is replete with requests that only the IP rights owner can make. It has little to offer to the alleged infringer, nor is it concerned with counterclaims to non-infringement and/or invalidity.

German application

In Germany, the DŸsseldorf court (where the overwhelming number of German IP cases are tried) has already applied some of the Directive’s rules. In 2003, the DŸsseldorf Lower District Court decided (Faxkarte, GRUR 2002, p 1046) that even based on Section 809 German Civil Code, a court may order an accused infringer, in the context of a full trial, to produce evidence.

In current practice, the Court is granting injunctions for evidence to the extent of devices being dismantled at trade fairs. It appears that even before 29 April 2006, the DŸsseldorf Court, as well as other German IP courts, will increasingly interpret the laws in conformity with the Enforcement Directive. Similar developments are expected in the other EU Member States. As a consequence, the importance of owning IP rights will increase dramatically, in particular in the area of controlling market share.

The possibility of freezing the infringer’s economical assets (article 9) and having already delivered goods called back (article 10) will render IP right enforcement more effective. Unauthorised ‘early entry’ scenarios will more easily be prevented, for example by earlier and easier access to evidence for infringing product characteristics (article 7) and pre-emptive injunctions prohibiting infringement (article 9), which may include seizure of goods.

If a convincing prima facie case can be made, although this may still be difficult, easier access to information (Articles 6 to 9) will increase the usefulness of claims with product-by-property features, such as in vivo data. The Directive works for the originators and against the generics.

Convincing case

Using these tools, however, requires careful preparation. For example, the more interpretation a patent claim requires in comparing it with the features of the infringing product or process, the harder it will be to convince the court that the rights-owner has made a sufficient prima facie case. This speaks for simple claims, based on easily determinable features, which may mean more, but more narrowly focused, patents.

Proper drafting and prosecution of IP rights applications will become more important. Even more so, since the enhanced enforceability of IP rights in litigation appears to be accompanied by an increased readiness of the courts to find invalidity or basic unenforceability of IP rights. With a well-prepared case based on a solid IP right, any IP-rights owner has much to gain from the EU’s Enforcement Directive.