Omeprazole SPC Case Refered to ECJ

AstraZeneca PLC
1 February 2000

   ASTRAZENECA WELCOMES GERMAN SUPREME COURT DECISION TO REFER
         OMEPRAZOLE SPC CASE TO EUROPEAN COURT OF JUSTICE

AstraZeneca today welcomed a decision by the German Supreme Court
to refer a number of questions about the company's Supplementary
Protection Certificate (SPC) for omeprazole to the European Court
of Justice (ECJ).

The Court agreed with AstraZeneca's submission that issues
involved in the case were of such a nature that the ECJ should
decide if Germany can interpret and apply European Union (EU)
legislation on SPCs to the detriment of the company.

The dispute is a result of the German generics company ratiopharm
GmbH challenging the SPC for omeprazole on formal grounds.

Omeprazole is the active ingredient in 'Losec', a treatment for
such acid-related disorders as peptic ulcers.  In 1998, Losec had
sales of USD 185m in Germany, representing 4 per cent of total
sales of the product.  In Germany, omeprazole is marketed under
the brand name 'Antra MUPS' (MUPS - Multiple Unit Pellet System).

'The referral means that the German interpretation of the
applicability of SPCs will be judged against the overall context
of what happens elsewhere in member states of the EU,' said Dr.
Martin Nicklasson, Executive Vice-President of AstraZeneca's
Gastrointestinal (GI) Franchise.  'The German interpretation has
not been as supportive of the research-based pharmaceutical
industry as other countries and, in our view, does not reflect the
original intention of SPCs.'

AstraZeneca has filed requests in Germany for preliminary
injunctions against ten companies, has filed six main actions and
is currently defending its patent rights in eight other patent
cases related to omeprazole.  In August 1999, AstraZeneca was
granted an interlocutory injunction to prevent ratiopharm GmbH and
Merckle GmbH selling a generic version of omeprazole. This ruling
is not affected by the Supreme Court decision and is still in
force.

Background :

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 industry-supportive 
transitional rule.

In addition, the German patent court in 1997 interpreted the 
legislation in a more restrictive fashion in making its decision 
regarding AstraZeneca's SPC for omeprazole.  This decision negated 
the intention of the legislation to support an innovative 
pharmaceuticals 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 expires in the USA in 2001, 
in most European countries in 2002-2004, and in Japan in 2004.  The 
product is also protected by patents directed to formulations, uses,
intermediates and processes.


1 February 2000

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