[Pharm-policy] Court decisions relating to the validity of AstraZeneca's formulation patent for omeprazole

[Thiru Balasubramaniam]

Here are decisions from Australia, Canada, Germany, Israel, and Korea
relating to AstraZeneca's formulation patent for omeprazole (Losec,
Prilosec).  The Australian and German courts nullified AstraZeneca's
formulation patent for omeprazole.  The Israeli and Korean courts upheld
AstraZeneca's formulation patent.  In Canada, AstraZeneca successfully
blocked Apotex from marketing a generic version of omeprazole;
AstraZeneca has a formulation patent for omeprazole in Canada. 
Omeprazole (Prilosec in the U.S., Losec everywhere else) is the
bestselling prescription drug in the world with sales of US $6 billion. 
Although AstraZeneca's substance patent expires in 2001 in the U.S. in
most European countries until 2002-2004 and in Japan until 2004, the
company has an aggressive stategy of "evergreening" omeprazole through
"patents related to formulation, uses, intermediates and processes and
these expire in most markets between 2005 and 2016 (Marketletter May 17,
1999)."



Thiru





Australia

October 9, 2000

The Full Federal Court of Australia in Sydney ruled that, under
Australian patent law, AstraZeneca's formulation patent was invalid. 
The Court ruled that the patent was obvious and lacked inventive step.
AstraZeneca will appeal this ruling. 

http://www.astra-zeneca.com/NewsSection/newsreleases/51299_19.htm


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Canada

June 16, 1999

Apparently, AstraZeneca's formulation patent has blocked generic
competition for Losec.

<SNIP>

"The patent protection for omeprazole, the active substance in Losec,
expires in Canada in July 1999. However, due to national patent
legislation, in Canada the opportunity for generic competition to Losec
has existed since 1996 through compulsory licensing under AstraZeneca's
substance patent. AstraZeneca has several other patents approved in
Canada, including a formulation patent. For several years, various
companies have sought to market generic omeprazole. AstraZeneca has
successfully asserted its rights, and no generic product has reached the
market to date. In December 1997 the Canadian company Apotex advised it
was seeking approval to market three generic omeprazole products and
made allegations with respect to AstraZeneca's patents. AstraZeneca
responded by filing lawsuits which disputed Apotex' allegations. 
Recently, the Canadian Federal Court confirmed the cases were terminated
based on Apotex' stated wish to withdraw its allegations which gave rise
to the litigation."

http://www.astra-zeneca.com/NewsSection/newsreleases/61699_23.htm

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Germany

March 21, 2000

The German Federal Patent Court nullified AstraZeneca's formulation
patent for omeprazole in Germany.
"The patent covering the formulation, expiring in 2007, has been subject
to nullity actions by the generic manufacturing companies Azupharma GmbH
&amp; Co and ratiopharm GmbH.  Omeprazole is the active ingredient in
Losec."  AstraZeneca will appeal this ruling.

http://www.astra-zeneca.com/NewsSection/newsreleases/32100_68.htm

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Israel

October 18, 1999

The Tel Aviv District Court upheld AstraZeneca's formulation patents for
omeprazole in Israel.  The Court held found the patents "constituted a
significant advance over prior art and that they were not obvious."


http://www.astra-zeneca.com/NewsSection/newsreleases/101899_42.htm

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Korea



Ruling by the Suwon District Court, 95 Ka-hap 22200, June 11, 1998



"The Suwon District Court (Suwon D.Ct.) in Korea rendered a decision in
favor of a foreign company by applying the doctrine of equivalents in a
patent infringement action taken by the foreign company against a Korean
company.


The Court ruled as follows:

1)If the process for preparation disclosed in the later issued patent
(defendant's patent) infringes the patent right of the preceding patent
(plaintiff's patent), the plaintiff may file a suit against a patent
infringement although the invalidation decision of the defendant's
patent has not become final and conclusive; and

2)The stabilizing agent disclosed in the defendant's process for
preparation is not the alkali-compound disclosed in the plaintiff's
patent. Nevertheless, plaintiff's patent rights compasses
the             defendant's process for preparing the core because the
defendant (1) merely followed the three ways of inter-connective
combination, which are the most important facts of the plaintiff's
patent; (2) simply copied the process for preparation described in the
plaintiff's patent; and (3) prepared the core by using the stabilizing
agent, which is known as having the same effect to the stabilizing agent
described in the claims of the plaintiff's patent, according to the
conventional amount."


  [snip]



 Facts Involved in the Dispute

"This case concerns a patent dispute over a pharmaceutical formulation
for an oral formulation of omeprazol[e] which is being sold by a
multinational pharmaceutical company, Astra Inc. ("Astra"), and its
domestic competitor, Hanmi Pharmaceutical Co., Ltd. ("Hanmi")."

http://www.leeinternational.com/ip_news/decisions.htm