Amgen 2012 Annual Report Download - page 38

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31
Phase 3 Product Candidate Patent Information
The following table describes our outstanding composition of matter patents that have issued thus far for our product
candidates in phase 3 development that have yet to be approved for any indication. Patents for products already approved for one
or more indications but currently undergoing phase 3 clinical trials for additional indications are previously described. See Marketed
Products.
Molecule Territory General Subject Matter Estimated Expiration*
AMG 145 U.S. Polypeptides 2029
Brodalumab (AMG 827) U.S. Polynucleotides and polypeptides 2027
Romosozumab (AMG 785) U.S. Polypeptides 2026
Talimogene laherparepvec U.S. Modified HSV1 compounds and strains 2021
Europe Modified HSV1 compounds and strains 2021
Trebananib (AMG 386) U.S. Polynucleotides and polypeptides 2025
Europe Polynucleotides and polypeptides 2022
* Patent expiration estimates are based on issued patents which may be challenged, invalidated, or circumvented by competitors.
The patent expiration estimates do not include any term adjustments, extensions or supplemental protection certificates that
may be obtained in the future and extend these dates. Corresponding patent applications are pending in other jurisdictions.
Additional patents may be filed or issued in the future and may provide additional exclusivity for the product candidate or
its use.
Business Relationships
From time to time, we enter into business relationships, including joint ventures and collaborative arrangements, for the
R&D, manufacture and/or commercialization of products and/or product candidates. In addition, we also acquire product and
R&D technology rights and establish R&D collaborations with third parties to enhance our strategic position within our industry
by strengthening and diversifying our R&D capabilities, product pipeline and marketed product base. These arrangements generally
provide for non-refundable, upfront license fees, development and commercial performance milestone payments, cost sharing,
royalty payments and/or profit sharing. The activities under these collaboration agreements are performed with no guarantee of
either technological or commercial success, and each is unique in nature.
Trade secret protection for our unpatented confidential and proprietary information is important to us. To protect our trade
secrets, we generally require counterparties to execute confidentiality agreements upon the commencement of the business
relationship with us. However, others could either develop independently the same or similar information or obtain access to our
information.
Kirin-Amgen, Inc.
K-A is a 50-50 joint venture with Kirin. K-A develops and then out licenses to third parties certain product rights which
have been transferred to this joint venture from Amgen and Kirin.
K-A has given us exclusive licenses to manufacture and market: (i) G-CSF and pegfilgrastim in the United States, Europe,
Canada and Australia, (ii) darbepoetin alfa, romiplostim and brodalumab in the United States, Europe, Canada, Australia, New
Zealand, Mexico, all Central and South American countries and certain countries in Central Asia, Africa and the Middle East, and
(iii) recombinant human erythropoietin in the United States. We currently market pegfilgrastim, G-CSF, darbepoetin alfa,
recombinant human erythropoietin and romiplostim under the brand names Neulasta®, NEUPOGEN®/GRANULOKINE®,
Aranesp®, EPOGEN® and Nplate®, respectively. Under these agreements, we pay K-A royalties based on product sales. In addition,
we also receive payments from K-A for milestones earned and for conducting certain R&D activities on its behalf. See Note 7,
Related party transactions, to the Consolidated Financial Statements.
K-A has also given Kirin exclusive licenses to manufacture and market: (i) G-CSF and pegfilgrastim in Japan, Taiwan and
South Korea, (ii) darbepoetin alfa, romiplostim and brodalumab in Japan, China, Taiwan, South Korea and in certain other countries
and/or regions in Asia and (iii) recombinant human erythropoietin in Japan. K-A also gave Kirin and Amgen co-exclusive licenses
to manufacture and market G-CSF, pegfilgrastim and recombinant human erythropoietin in China, which Amgen subsequently
assigned to Kirin, and as a result, Kirin now exclusively manufactures and markets G-CSF and recombinant human erythropoietin
in China. Kirin markets G-CSF, pegfilgrastim, darbepoetin alfa, romiplostim and recombinant human erythropoietin under the