Eli Lilly 2008 Annual Report Download - page 62

FINANCIALS
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earliest of which expires in 2013). Of these challengers, all allege non-infringement of the patent claims directed
to the commercial formulation, and eight allege invalidity of the patent claims directed to the active ingredient
duloxetine. Of the eight challengers to the compound patent claims, one further alleges invalidity of the claims
directed to the use of Cymbalta for treating fi bromyalgia, and one alleges the patent having claims directed to
the active ingredient is unenforceable. Lawsuits have been fi led in 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