Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_101_библиотеки_им_акад_М_И_Перельмана

One of the most signicant breakthroughs in the eld of biotechnology was achieved in the third quarter of the past century when scientists could clone the gene and combine it with the host DNA to produce the desired target molecules; thus, recombinant technology evolved. Insulin was the rst endogenous hormone that was produced through recombinant technology and that beneted millions of patients worldwide. Indeed, today, the only major source of insulin is synthesis through recombinant technology in Escherichia coli cells. However, the recombinant techniques became useful only after the US Supreme Court ruling that a recombinant bacterium or a life form can be patented; since then, hundreds of endogenous molecules have been produced by recombinant techniques to bring a solution to humanity for diseases that were once thought of as incurable. Indeed, mortality from diseases related to the deciency of endogenous proteins in patients has signicantly decreased; yet, these drugs are very expensive, mainly because of the high investment required to develop and manufacture drugs. Delays also occur in the introduction of biosimilars owing to intellectual property constraints. Professor Niazi is also a patent law practitioner in the US, and he has described many strategies for managing IP risks effectively in this book.