patent (2016) plus pediatric exclusivity (2017), and a vitamin dosage regimen patent (2021) plus pediatric exclusivity (2022); Cialis is protected by compound and use patents (2017); Cymbalta was protected by a compound patent plus pediatric exclusivity until December 2013; Effient is protected by a compound patent (2017); Evista is protected by patents on the treatment and prevention of osteoporosis (March 2014); Humalog was protected by a compound patent until May 2013; Strattera is protected by a patent covering its use in treating attention deficit-hyperactivity disorder (2016) plus pediatric exclusivity (2017); and Trajenta and Jentadueto are protected by a compound patent (2023), and Boehringer Ingelheim has applied for a patent extension to 2025 under the patent restoration laws. Outside the U.S., primary patent protection or data protection includes Alimta in major European countries (compound patent 2015, vitamin dosage regimen patent 2021) and Japan (compound patent 2015, patent covering use to treat cancer concomitantly with vitamins 2021); Cialis in major European countries (compound patent 2017); Cymbalta in major European countries (data package protection second half of 2014) and Japan (data package protection 2018); and Zyprexa in Japan (compound patent 2015). Patent Licenses The compound patent for Cialis is the subject of a license agreement with GlaxoSmithKline (Glaxo), which assigns to the company all rights in the compound. The compound patent for Alimta is the subject of a license agreement with Princeton University, granting the company an irrevocable exclusive worldwide license to the compound patents for the lives of the patents in the respective territories. Government Regulation Pursuant to the Federal Food, Drug, and Cosmetic Act, the U.S. Food and Drug Administration has jurisdiction over all of the company’s human pharmaceutical products and certain animal health products in the U.S. and administers requirements covering the testing, safety, effectiveness, manufacturing, quality control, distribution, labeling, marketing, advertising, dissemination of information, and post-marketing surveillance of those products. The U.S. Department of Agriculture and the U.S. Environmental Protection Agency also regulate some animal health products. Outside the U.S., the company’s products and operations are subject to similar regulatory requirements, notably by the European Medicines Agency in the EU and the Ministry of Health, Labor and Welfare in Japan. Research and Development The company’s research and development expenses were $5.53 billion in 2013. Its human pharmaceutical research and development focuses on five therapeutic categories, such as cancer; endocrine diseases, including diabetes and musculoskeletal disorders; central nervous system and related diseases; autoimmune diseases; and cardiovascular diseases. Significant Events In April 2014, T1D Exchange and Eli Lilly and Company announced they have entered into a research collaboration that would enable both organizations to gain deeper, real-world insight about the experience of people with type 1 diabetes, to identify new ways to improve care and advance outcomes. In May 2014, QIAGEN N.V. announced a collaboration with Eli Lilly and Company to co-develop universal and modular assay panels for the simultaneous analysis of DNA and RNA biomarkers targeting multiple cellular pathways involved in common cancer types. In July 2014, Eli Lilly and Company and Immunocore Limited announced they have entered into a co-discovery and co-development collaboration to research and potentially develop novel T cell-based cancer therapies. In September 2014, AstraZeneca plc and Eli Lilly and Co. announced that they reached a deal to jointly develop and commercialise AZD3293, an oral beta secretase cleaving enzyme or BACE inhibitor currently in development as a potential treatment for Alzheimer's disease. In December 2014, Eli Lilly and Company, Anthem, Inc. and HealthCore, Inc. announced that they have formed a five-year, real-world evidence research collaboration intended to improve health outcomes for patients.
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