Combination therapies are often used to treat medical conditions that have proved difficult to cure with single-agent therapies, including, for example, tuberculosis, leprosy, cancer, malaria and AIDS. According to the 2013 annual meeting of the American Society of Clinical Oncology, cancer drug combinations represent the future, because single-drug therapy often fails as cancer cells develop resistance to the treatment.
Patent protection is vital for the development of combination therapies, because the process can require years of extremely costly research and clinical testing for drug developers. Combination use with other drugs is also a common strategy for pioneers who are seeking ways to protect new investments made in their previously marketed drugs. The Federal Circuit's decision in Novo Nordisk A/S v. Caraco Pharmaceutical Labs. Ltd., No. 11-1223 (Fed. Cir. June 18, 2013), however, indicates that patent protection for combination therapies likely will be significantly more difficult to obtain in the future.
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