UPDATE: GlaxoSmithKline: German Court Revokes Advair Patent
20 Mai 2010 - 3:42PM
Dow Jones News
GlaxoSmithKline PLC (GSK, GSK.LN) Thursday said a German revoked
its patent for inhaled product Advair, handing a victory to generic
drug makers Mylan dura GmbH, Hexal AG, Neolab Ltd., and IVAX
International B.V. and highlighting the worldwide generic threat to
Glaxo's blockbuster lung treatment.
The ruling by Germany's Federal Patents Court relates to the
combination of Advair's active ingredients salmeterol and
fluticasone propionate.
Glaxo, the U.K.'s biggest drug maker, said the Munich-based
court's decision relates solely to the German combination patent
for Viani, Advair's German brand name, and is not binding in any
other jurisdiction.
The decision is the conclusion to a hearing that was conducted
in February.
"This is not the end and we will be considering whether to
appeal to a higher court," a spokeswoman at Glaxo said.
Glaxo also owns a number of other patents in Germany relevant to
Advair, including the Diskus dry powder inhaler and HFA aerosol
formulation patents which expire in 2011 and 2012 respectively. The
company in a statement noted there are significant technical
hurdles and complexities associated with the introduction of
inhaled respiratory products.
The trial is part of a complex legal struggle between Glaxo and
a group of generic drugmakers which hope to sell copies of the
two-in-one inhaler for asthma and chronic obstructive pulmonary
disease, or "smoker's lung". Teva bought Ivax in 2006 $7.4 billion.
Hexal is part of Novartis' Sandoz generics unit.
Advair, which last year had sales of GBP5 billion, representing
18% of group turnover, is seen as crucial to Glaxo's future
prospects.
Shares in Glaxo at 1300 GMT were down 1.4% at 1,161 pence, in
line with a lower London market, but the stock was up roughly 10%
from year-ago levels.
Analysts noted the German court decision could benefit U.K. drug
developer Vectura Group PLC (VEC.LN), which is believed to be
developing a generic version of Advair with Novartis's Sandoz
unit.
The loss of the patent paves the way for Vectura and Sandoz to
launch their version in Germany, said FinnCap analyst Keith
Redpath, who added the two companies wouldn't be hamstrung by the
Diskus patent because they are believed to have developed their own
device using Vectura's technology.
Chirag Talati at broker Noble Execution said the patent decision
means Vectura and Sandoz could be in a position to launch a generic
Advair by late 2011.
Talati added the German court victory may spur Sandoz to be more
aggressive in challenging the patent in other European
countries.
Vectura and Sandoz have never formally confirmed they are
working on a version of the GlaxoSmithKline drug. But observers
agree a project known as VR315 is almost certainly generic
Advair.
At 1300 GMT, shares in Vectura were 1.75 pence or 4.8% higher at
38.25 pence. The stock has lost 49% year-to-date over investor
concerns about VR315 making it to market in the U.S., where the
regulatory pathway for generic versions of respiratory medicines
isn't clear.
Company Web site: www.gsk.com
-By Sten Stovall, Dow Jones Newswires; +44 207 842 9292;
sten.stovall@dowjones.com