Amgen 2011 Annual Report Download - page 23

Neutroval™. If approved in the United States, this drug would compete with NEUPOGEN®and Neulasta®
subject to the terms of the injunction and settlement agreement discussed below.
On November 30, 2009, Teva Pharmaceutical filed a declaratory judgment action against us alleging that
certain of our NEUPOGEN®patents are invalid and not infringed by Neutroval™, and on January 15, 2010, we
filed an answer and counterclaims seeking a declaratory judgment that our patents are valid and infringed. On
July 15, 2011, we announced that the U.S. District Court in Pennsylvania entered final judgment and a permanent
injunction against Teva Pharmaceutical and Teva Pharmaceuticals USA, Inc. (together defined as Teva)
prohibiting them from infringing our patents relating to human G-CSF polypeptides and methods of treatment.
The Court’s injunction extends until November 10, 2013, after which date Teva will no longer be prohibited by
the injunction from selling Neutroval™ in the United States, subject to receiving FDA approval for human
therapeutic use. Teva also agreed not to sell Neugranin™ in the United States before November 10, 2013, unless
it first obtains a final court decision that our patents are not infringed by Neugranin™. Pursuant to the parties’
settlement, the launch date for either product could be sooner if certain unexpected events occur: a third party
launches a similar G-CSF polypeptide product and we fail to sue that third party, or the patents are held invalid
or unenforceable in a final court decision in an action brought by a third party.
Enbrel®(etanercept)
ENBREL is our registered trademark for etanercept, our TNF receptor fusion protein that inhibits the
binding of TNF to its receptors, which can result in a significant reduction in inflammatory activity. TNF is one
of the chemical messengers that help regulate the inflammatory process. When the body produces too much TNF,
it overwhelms the immune system’s ability to control inflammation of the joints or of psoriasis-affected skin
areas. ENBREL binds certain TNF molecules before they can trigger inflammation.
We acquired the rights to ENBREL in July 2002 with our acquisition of Immunex Corporation (Immunex).
ENBREL was launched in the United States in November 1998 and in Canada in March 2001 for the treatment of
rheumatoid arthritis (RA). In addition, ENBREL is now indicated for the treatment of adult patients with the
following conditions: moderate to severe active RA; chronic moderate to severe plaque psoriasis patients who are
candidates for systemic therapy or phototherapy; active psoriatic arthritis; and active ankylosing spondylitis.
We market ENBREL under a collaboration agreement with Pfizer Inc. (Pfizer) in the United States and
Canada, which expires in the fourth quarter of 2013. (See Business Relationships — Pfizer Inc.) The rights to
market and sell ENBREL outside the United States and Canada are reserved to Pfizer.
ENBREL sales for the years ended December 31, 2011, 2010 and 2009, were $3.7 billion, $3.5 billion and
$3.5 billion, respectively.
In November 2011, we announced the issuance of U.S. Patent No. 8,063,182 related to ENBREL, which is
owned by F. Hoffmann-La Roche Ltd. (Roche) and exclusively licensed to Amgen. This patent, which has a term
of 17 years from issuance, is reflected in the following table along with our other outstanding material patents for
etanercept.
Territory General Subject Matter Expiration
U.S. TNFR DNA vectors, cells and processes for making proteins 10/23/2012
U.S. Aqueous Formulation(1) 2/27/2023
U.S. Fusion protein, and pharmaceutical compositions 11/22/2028
(1) This formulation patent relates to the currently approved liquid formulation of ENBREL, which formulation
accounts for the majority of ENBREL sales in the United States. However, ENBREL is also sold as an
alternative lyophilized formulation that requires reconstituting before it can be administered to the patient.
Any products or technologies that are directly or indirectly successful in treating rheumatologic conditions,
which includes moderate to severe RA; moderate to severe polyarticular juvenile idiopathic arthritis; ankylosing
spondylitis and psoriatic arthritis; and dermatologic conditions, which includes moderate to severe plaque
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