Inc. (2004 revenue: $1-billion) biopharmaceutical drug
discovery firm has announced having entered into an agreement
with Ranbaxy Laboratories Limited to settle its pending
patent infringement dispute in the United States related
to Provigil (modafinil) Tablets [C-IV].
dispute pending in the New Jersey District Court covers
pharmaceutical compositions and methods of treatment
with the form of modafinil contained in Provigil.
two companies signed an agreement under which Cephalon
will grant a non-exclusive royalty-bearing right to
Ranbaxy to market and sell a generic version of Provigil
in the United States, which will become effective in
October 2011 in the absence of a paediatric extension
for Provigil, which would delay the entry date by six
months to April 2012. An earlier entry by Ranbaxy may
take place based upon the entry of another generic version
companies also agreed to a series of business arrangements
related to modafinil.
Ranbaxy has agreed to grant to Cephalon a non- exclusive
license, effective immediately, to certain of its world-wide
intellectual property rights related to modafinil in
exchange for milestone payments.
also has agreed to enter into certain arrangements with
Ranbaxy related to Ranbaxy's supply of the active pharmaceutical
terms of the agreement are confidential, and are subject
to review by the US Federal Trade Commission. Financial
terms of the settlement have not been disclosed.
two companies will now file for 'a dismissal with prejudice'
with the District Court of New Jersey that will conclude
all pending litigation between them regarding Provigil.
These lawsuits claim infringement of Cephalon's U S
patent RE37, 516, which covers pharmaceutical compositions
and methods of treatment with the form of modafinil
contained in Provigil. This particular patent expires
in October 6, 2014, and may be extended by six months
to April 6, 2015, upon submission of paediatric study
data that is acceptable to the U S FDA.
another case that Ranbaxy is fighting in the US courts,
the Indian drug firm had announced its decision earlier
this week to contest a District Court of Delaware ruling
against it for non-infringement and invalidation of
two Pfizer patents on atorvastatin, the largest selling
cholesterol-lowering drug in the world, marketed by
Pfizer under its brand, Lipitor. ()
Laboratories Ltd, jointly with the Geneva-based Medicines
for Malaria Venture (MMV), is developing new anti-malarial
drug, designated RBx and is also introducing two new
anti-HIV products, Virolis-E and Virocomb-E, which contain
three anti retroviral
drugs each and offer WHO recommended first line 'highly
active anti retroviral therapy' (HAART) in convenient
daily use packs in India.
also see : Ranbaxy
to appeal US District Court decision upholding Pfizer