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Lack of intellectual property protection worldwide threatens u.s. Biotechs.

As the biotech industry extends its borders, protection of intellectual property (IP) rights — arguably biotechs’ greatest asset — is one of the industry’s biggest challenges. While developing countries like China and India aggressively work to become leading players in the global biotech market, serious concerns about their commitment to upholding biotech IP rights are being voiced. 
 
Lila Feisee, director for intellectual property, at the Biotechnology Industry Organization, sees the threat to U.S. IP rights as “a major concern.” Historically, she says, India and China have turned their backs on the enforcement of patent protection laws. “There are problems in China not just with drugs, but also with intellectual property and counterfeiting. Not all countries are as up to speed on the enforcement aspects of patents as the United States.” 
 
China’s recent approval of a copycat version of a cancer therapy originally developed by a U.S. biotech, Onyx Pharmaceuticals, has fueled concerns about international pirating. Sunway, the Chinese biotech maker that copied Onyx’s research, recently received Chinese regulatory approval for a drug that was developed by Onyx but then halted so that resources could be devoted to a drug awaiting U.S. Food and Drug Administration approval. In the interim, a research paper published by Onyx scientists detailing early-stage research on the potential therapy gave Sunway enough information to copy the drug. Because Onyx did not have a patent in China, this was, technically, not an infringement of IP rights. 
 
Until recently, patents in India and China were granted on processes, not products, allowing drugs to be sold if developed by a different process. China and India have since revised their regulatory systems; both now allow for patenting of drugs, strengthening IP protection in those countries. In early 2005, India passed a patents law, granting individual drug product patents for the first time. 
 
Feisee sees India as less of a threat than China. “The amendment of India’s patent laws is an attempt to move in the right direction but does not provide enough protection for biotech inventions. It’s not that they are copying our products, but that they don’t have patent coverage for some of our inventions.”