chapter  Chapter 2
42 Pages

Intellectual property issues for biosimilars

WithSarfaraz K. Niazi

Intellectual property (IP) laws such as Patent Act, Copyright Act, Trademark Act, Design Act, and Unfair Competition Prevention Act are included there. In addition, the Industrial Property Digital Library offers public access to IP Gazettes of the Japan Patent Office free of charge through Internet. The three markets, the United States, Europe, Japan, and other developed countries' markets would constitute the majority of biosimilar markets, and given that the rest of the world might supersede in the unit sales, the profit margins are only going to come from the developing country markets. A biological patent is a patent on an invention in the field of biology that by law allows the patent holder to exclude others from making, using, selling, or importing the protected invention for a limited period of time. Biological products can obtain market exclusivity from a combination of three primary sources: regulatory exclusivities, patents, and trade secrets or proprietary information.