Eli Lilly 2009 Annual Report Download - page 84

2010 and method-of-use patent expiring in 2013), and alleging that these patents are invalid. Sandoz
Inc. (Sandoz) and APP Pharmaceuticals, LLC (APP) have similarly challenged our method-of-use
patent. We filed lawsuits in the U.S. District Court for the Southern District of Indiana against Teva
(February 2006), Hospira (October 2006 and January 2008), Sandoz (October 2009), APP (December
2009), and Fresenius (February 2010), seeking rulings that our patents are valid and are being
infringed. Sandoz withdrew its ANDA and the suit against it was dismissed in February 2010. The trial
against Teva was held in September 2009 and we are waiting for a ruling. Teva’s ANDAs have been
approved by the FDA; however, Teva must provide 90 days notice prior to marketing generic Gemzar
to allow time for us to seek a preliminary injunction. Both suits against Hospira have been
administratively closed, and the parties have agreed to be bound by the results of the Teva suit. In
November 2007, Sun filed 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. In August
2009, the District Court granted a motion by Sun for partial summary judgment, invalidating our
method-of-use patent. We have appealed this decision. This ruling has no bearing on the compound
patent. The trial originally scheduled for December 2009 has been postponed while the court
considers Sun’s second summary judgment motion, related to the validity of our compound patent.
Sun and APP have received tentative approval for their products from the FDA, but are prohibited
from entering the market by 30-month stays, which expire in June 2010 for Sun and May 2012 for
APP.
• Alimta: Teva Parenteral Medicines, Inc. (Teva), APP, and Barr Laboratories, Inc. (Barr) each submit-
ted 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, filed lawsuits in the U.S. District Court for the
District of Delaware against Teva, APP, and Barr seeking rulings that the compound patent is valid
and infringed. Trial is scheduled for November 2010 against Teva and APP.
• Evista: In 2006, Teva Pharmaceuticals USA, Inc. (Teva) submitted an ANDA 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 June 2006,
we filed a lawsuit against Teva 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 Teva. The trial against Teva
was completed in March 2009. In September 2009, the court upheld our method-of-use patents (the
last expires in 2014). Teva has appealed that ruling. In addition, the court held that our particle-size
patent (expiring 2017) is invalid. We have appealed that ruling.
• Strattera: Actavis Elizabeth LLC (Actavis), Apotex Inc. (Apotex), Aurobindo Pharma Ltd. (Aurobindo),
Mylan Pharmaceuticals Inc. (Mylan), Sandoz Inc. (Sandoz), Sun Pharmaceutical Industries Limited
(Sun), and Teva Pharmaceuticals USA, Inc. (Teva) each submitted an ANDA seeking permission to
market generic versions of Strattera prior to the expiration of our relevant U.S. patent (expiring in
2017), and alleging that this patent is invalid. In 2007, we brought a lawsuit against Actavis, Apotex,
Aurobindo, Mylan, Sandoz, Sun, and Teva in the United States District Court for the District of New
Jersey. The court has ruled on all pending summary judgment motions, and granted our infringement
motion. The remaining invalidity defenses will be decided at trial, which could take place as early as
the third quarter of 2010. Several companies have received tentative approval to market generic
atomoxetine, but are prohibited from entering the market by a 30-month stay which expires in
November 2010.
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
assurance 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 financial 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
patent (expiring in 2011). In April 2007, the Canadian Federal Court ruled against the first challenger,
Apotex Inc. (Apotex), and that ruling was affirmed 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 justified 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. In September 2009, the Canadian Federal Court ruled against us
in the Novapharm suit, finding our patent invalid. We have appealed this decision. If the decision is
upheld, we could face liability for damages related to delays in the launch of generic olanzapine
products; however, we have concluded at this time that the damages are not probable or estimable.
• In Germany, the German Federal Supreme Court upheld the validity of our Zyprexa patent (expiring in
2011) in December 2008, reversing an earlier decision of the Federal Patent Court. Following the
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