Eli Lilly 2008 Annual Report Download - page 31

FINANCIALS
29
U.S. District Court for the Southern District of Indiana
against Activis Elizabeth LLC; Aurobindo Pharma Ltd.;
Cobalt Laboratories, Inc.; Impax Laboratories, Inc.;
Lupin Limited; Sandoz Inc.; Sun Pharma Global, Inc.;
and Wockhardt Limited, seeking rulings that the patents
are valid, infringed, and enforceable. Answers to the
complaints are pending.
• Gemzar: Sicor Pharmaceuticals, Inc. (Sicor), Mayne
Pharma (USA) Inc. (Mayne), and Sun Pharmaceutical
Industries Inc. (Sun) each submitted an ANDA seeking
permission to market generic versions of Gemzar
prior to the expiration of our relevant U.S. patents
(compound patent expiring in 2010 and method-of-
use patent expiring in 2013), and alleging that these
patents are invalid. We fi led lawsuits in the U.S. District
Court for the Southern District of Indiana against Sicor
(February 2006) and Mayne (October 2006 and January
2008), seeking rulings that these patents are valid
and are being infringed. The suit against Sicor has
been scheduled for trial in July 2009. Sicor’s ANDAs
have been approved by the FDA; however, Sicor must
provide 90 days notice prior to marketing generic
Gemzar to allow time for us to seek a preliminary
injunction. Both suits against Mayne have been
administratively closed, and the parties have agreed to
be bound by the results of the Sicor suit. In November
2007, Sun fi led a declaratory judgment action in the
United States District Court for the Eastern District
of Michigan, seeking rulings that our method-of-use
and compound patents are invalid or unenforceable,
or would not be infringed by the sale of Sun’s generic
product. This trial is scheduled for December 2009.
• Alimta: Teva Parenteral Medicines, Inc. (Teva) and APP
Pharmaceuticals, LLC (APP) each submitted ANDAs
seeking approval to market generic versions of Alimta
prior to the expiration of the relevant U.S. patent
(licensed from the Trustees of Princeton University and
expiring in 2016), and alleging the patent is invalid. We,
along with Princeton, fi led lawsuits in the U.S. District
Court for the District of Delaware against Teva and
APP, seeking rulings that the compound patent is valid
and infringed. Trial is scheduled for November 8, 2010.
•
Evista: Barr Laboratories, Inc. (Barr) submitted an
ANDA in 2002 seeking permission to market a generic
version of Evista prior to the expiration of our relevant
U.S. patents (expiring in 2012-2017) and alleging
that these patents are invalid, not enforceable, or not
infringed. In November 2002, we fi led a lawsuit against
Barr in the U.S. District Court for the Southern District
of Indiana, seeking a ruling that these patents are
valid, enforceable, and being infringed by Barr. Teva
Pharmaceuticals USA, Inc. (Teva) has also submitted an
ANDA seeking permission to market a generic version
of Evista. In June 2006, we fi led a similar lawsuit
against Teva in the U.S. District Court for the Southern
District of Indiana. The lawsuit against Teva is currently
scheduled for trial beginning March 9, 2009, while no
trial date has been set in the lawsuit against Barr. In
April 2008, the FDA granted Teva tentative approval of
its ANDA, but Teva’s ability to market a generic product
is subject to a statutory stay, which has been extended
to expire on March 9, 2009. Teva has appealed the
extension of the statutory stay. If the stay expires and
the company cannot obtain preliminary relief from the
court, Teva can launch its generic product, regardless
of the status of the current litigation, but subject to our
right to recover damages, should we prevail at trial.
We believe each of these Hatch-Waxman challenges
is without merit and expect to prevail in this litigation.
However, it is not possible to determine the outcome of
this litigation, and accordingly, we can provide no assur-
ance that we will prevail. An unfavorable outcome in any
of these cases could have a material adverse impact on
our future consolidated results of operations, liquidity,
and fi nancial position.
We have received challenges to Zyprexa patents in a
number of countries outside the U.S.:
•
In Canada, several generic pharmaceutical
manufacturers have challenged the validity of our
Zyprexa compound and method-of-use patent (expiring
in 2011). In April 2007, the Canadian Federal Court
ruled against the fi rst challenger, Apotex Inc. (Apotex),
and that ruling was affi rmed on appeal in February
2008. In June 2007, the Canadian Federal Court held
that an invalidity allegation of a second challenger,
Novopharm Ltd. (Novopharm), was justifi ed and
denied our request that Novopharm be prohibited from
receiving marketing approval for generic olanzapine in
Canada. Novopharm began selling generic olanzapine
in Canada in the third quarter of 2007. We sued
Novopharm for patent infringement, and the trial began
in November 2008. We expect the trial to run through
the fi rst quarter of 2009, with a decision in the second
half of 2009. In November 2007, Apotex fi led an action
seeking a declaration of the invalidity of our Zyprexa
compound and method-of-use patents, and no trial
date has been set. We have brought similar actions
against Pharmascience (August 2007), Sandoz (July
2007), Nu-Pharm (June 2008), Genpharm (June 2008)
and Cobalt (January 2009); none of these suits has
been scheduled for trial. Pharmascience has agreed to
be bound by the outcome of the Novopharm suit, and,
pending the outcome of the lawsuit, we have agreed
not to take any further steps to prevent the company
from coming to market with generic olanzapine tablets,
subject to a contingent damages obligation should we
be successful against Novopharm.
• In Germany, generic pharmaceutical manufacturers
Egis-Gyogyszergyar and Neolab Ltd. challenged the
validity of our Zyprexa compound and method-of-use
patent (expiring in 2011). In June 2007, the German