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INDIA
BUSINESS WORLD -
NOVEMBER 2005
THE MONTH THAT WAS
US COURT RULES IN FAVOUR OF RANBAXY
Giving a shot in
the arm to Pharma major Ranbaxy Laboratories, a US court today
ruled in its favour in a patent battle with Abbot Laboratories,
paving the way for launch of the Indian company's generic
version of anti-bacterial clarithromycin.
Ranbaxy, which
won two patent claims at US Court of Northern Illinois, however,
lost the third one that pertains to labelling and can now
launch the drug (1,000 mg extended release) in US only after
amending the label.
"A US district
court for the district of Northern Illinois has ruled for
the company on two patents and against the company on a single
claim of a third patent. The court preliminary enjoined the
company from marketing its clarithromycin, one gram extended
release product.
"While this
decision does not apply to the 500 mg ER product, the courts
ruling provided clear direction for the changes in the company's
labelling to make both products non infringing," a Ranbaxy
statement said here.
The company will
be entering into discussion with Food and Drug Administration
to amend its labelling for the as-yet unapproved 500 mg ER
tablet to remove language that implicates the single claim
at issue in the third patent.
The judge's opinion
will be taken into consideration in these discussion with
FDA and when amending the labelling for the 500 mg ER formulation
such that the company can launch the 500 mg ER tablets immediately
upon approval.
According to company
president and executive director Malvinder M Singh, "The
ruling on clarithromycin 1,000 mg ER does not impact Ranbaxy's
plan to introduce clarithromycin 500 mg ER which, subject
to USFDA approval, remains on-course."
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