[Ip-health] AstraZeneca Loses Ruling Over Nexium-Related European Patent

Tahir Amin tahir at i-mak.org
Sat Jun 18 09:12:52 PDT 2011

Teva Pharmaceutical Industries Ltd.
(TEVA)<http://www.bloomberg.com/apps/quote?ticker=TEVA:IT>and 12 other
generic-drug makers won a challenge at the European
Patent Office <http://topics.bloomberg.com/european-patent-office/> to
invalidate one of the patents on AstraZeneca Plc
ulcer treatment Nexium.

The European patent agency’s opposition division overturned the
after a three-day hearing due to a “lack of inventiveness,”
Danielle Wagner, a spokeswoman for the Munich, Germany-based EPO said in an

The setback for AstraZeneca comes as it defends some of its European patents
for Nexium at a U.K. trial against Ranbaxy Laboratories Ltd. and two years
after it settled related litigation in the U.S. Generics makers are vying
for a share of Nexium’s $4.97 billion in annual sales, which made it
AstraZeneca’s second-best selling drug last year.

AstraZeneca will decide about its next steps once it has reviewed the
decision, said Isabelle Jouin, a spokeswoman for the London-based company.
She declined to comment on how the decision affects Nexium’s protection
against generics.

The EPO will publish its written decision within the next two months.
AstraZeneca then has the right to appeal.

Other opponents of the patent, which was granted in 2009, include Novartis
AG’s Hexal and Sanofi’s Zentiva.

The patent number is EP1020461.

LONDON (Dow Jones)--AstraZeneca PLC (AZN) Tuesday said it has yet to decide
whether to contest a decision by the European Patent Office to revoke a key
patent underpinning its top-selling heartburn medicine Nexium.

Last Friday, the U.K. drug maker lost a patent challenge brought by a group
of generic drugmakers that challenged the validity of patent EP 1020461,
which covers the oral administration of Nexium. The European Patent Office
ruled that the patent covering esomeprazole magnesium was invalid and
overturned it, on grounds that it lacked inventiveness.

"We will decide whether to file an appeal once we have reviewed the written
reasons for the decision," an AstraZeneca spokeswoman said Tuesday in an

"AstraZeneca is disappointed by the decision ... but has confidence in its
intellectual property portfolio protecting Nexium. This portfolio includes
many patents with expiration dates ranging from 2014 through to 2019," she

"After the patent was granted in 2009, AstraZeneca has enforced this patent
in several countries in Europe. We will continue to decide on a case by case
basis whether it is appropriate to continue to assert this patent," the
spokeswoman said.

The patent protection on the drug, which generated $5 billion in sales for
AstraZeneca last year, has expired in a number of EU countries, but generic
competition has so far has been limited.

Several generic drugmakers launched cheap copies of Nexium in Germany in
late 2010, and AstraZeneca said in October that a generic had also gone on
sale in Spain.

Nexium was always expected to face earlier generic competition in Europe
than in the U.S., its most important market, with the timing of European
launches varying from country to country.

In the U.S., cheap copies of Nexium aren't expected until 2014 following
settlement deals struck between AstraZeneca and generic firms.

Still, Matrix analyst Navid Malik said the EPO's ruling on the Nexium patent
"in our view leaves the door wide open for a generic to enter the market,
subject to an appeal by AZN."

-By Sten Stovall, Dow Jones Newswires; +44 207 842 9292;
sten.stovall at dowjones.com


Tahir Amin
Co-Founder and Director of IP
Initiative for Medicines, Access & Knowledge (I-MAK)
Email: tahir at i-mak.org

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