Businessweek

portfolio includes 3 U.S. patents that would expire between 2023 and 2025, and 13 U.S. patent applications from which any patents, if granted, are expected to expire between 2022 and 2029, as well as 60 foreign patents that would expire between 2022 and 2029, and 118 foreign patent applications from which any patents, if granted, are expected to expire between 2022 and 2029. The company’s SCORPION patent portfolio includes 4 U.S. patent applications from which any patents, if granted, are expected to expire in 2027, as well as 31 foreign patent applications from which any patents, if granted, are expected to expire in 2027. Its TRU-ADhanCe patent portfolio includes 1 U.S. patent that would expire in 2027 and 2 U.S. patent applications from which any patents, if granted, are expected to expire in 2027, as well as 12 foreign patent applications from which any patents, if granted, are expected to expire in 2027. The company owns two U.S. patents and three corresponding foreign applications that contain claims supporting Thravixa. Absent any patent term extension, these patents would expire in 2024. Agreements The company has a license agreement with the Bavarian State Ministry of the Environment and Public Health relating to its MVA vector technology that the company might use in the development of future product candidates. Government Regulation In the United States, BioThrax and the company’s product candidates are regulated by the FDA as biological products. Biological products are subject to regulation under the Federal Food, Drug, and Cosmetic Act (the FDCA), the Public Health Service Act (the PHSA), the regulations promulgated under the FDCA and the PHSA, and other federal, state, and local statutes and regulations. The company’s status as a government contractor in the United States and elsewhere means that it is also subject to various statutes and regulations, including the Federal Acquisition Regulation, which govern the procurement of goods and services by agencies of the United States, as well as the specific procurement requirements of other countries. Competition The company’s major competitors include Merck & Co.; GlaxoSmithKline; Sanofi Pasteur; Pfizer; and Novartis, as well as Human Genome Sciences, Soligenix, Dynport Vaccine Company, Elusys, Bavarian Nordic, and PharmAthene. It also competes with Amgen; Takeda; Centocor Ortho Biotech; Mitsubishi Tanabe; Abbott Laboratories; Eisai; Celgene; Bristol-Myers Squibb; UCB; Otsuka; Roche; Chugai; Genentech; Biogen Idec; Spectrum Pharmaceuticals, Inc.; Bayer Schering AG; GSK; Genzyme; Cephalon Oncology; Genmab; Allos Therapeutics; AstraZeneca; Boehringer Ingleheim; and ImmunoGen, Inc. History Emergent BioSolutions Inc. was founded in 1998.