Home  Media Press releases 2003
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| 11 December 2003 | 2003-12-11T00:00:00.0000000-00:00 |
| EUROPEAN COURT JUDGMENT DOES NOT SUPPORT ASTRAZENECA IN OMEPRAZOLE PATENT CASE
AstraZeneca today announced that the European Court of Justice had ruled against its arguments in a case relating to the duration of patent protection for omeprazole, the active ingredient in Losec, the anti-secretory treatment. | The Court determined that Supplementary Protection Certificate (SPC) relating to the substance patent for omeprazole is invalid in Germany. The case had been referred to the ECJ by the German Supreme Court in February, 2000, to resolve a number of questions following a legal challenge to the SPC for omeprazole brought by ratiopharm GmbH.
The ECJ judgment does not alter the current marketing situation in Germany where the substance patent expired in 1999 and generic manufacturers are already selling their versions of omeprazole. AstraZeneca believes that the judgment will not result in material exposure for the Group.
“We are disappointed by the judgment,” said Ola Ronn, Vice President and Head of the Gastrointestinal Therapy Area, of AstraZeneca. “The German interpretation of SPCs in our view does not support and encourage the innovation of the research-based industry. However, we will continue to defend our intellectual property rights relating to omeprazole, including the formulation patents which expire in 2007.”
Media Enquiries:
Edel McCaffrey, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Relations:
Mina Blair Robinson, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
Notes to Editors:
In 1992, the EU introduced legislation to restore patent term to support the innovative European research-based pharmaceuticals industry and compensate it for the long, regulatory medical approval procedures. All EU member states were in favour of the legislation.
· However, Germany, together with Denmark, decided to limit the scope of the legislation and opted for the least supportive transitional rule for the research- based industry.
The substance patent for omeprazole began expiring in the first countries in 1999. In most countries, AstraZeneca has been granted Patent Term Extensions or Supplementary Protection Certificates (SPCs). This extended coverage for the substance which expired in the USA in 2001; and expires in most European countries between 2002-2004; and in Japan in 2004. The product is also protected by patents directed to formulations, uses, intermediates and processes.
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