According to him, it is fiction that 12 years of data exclusivity would not be workable for patients. “Patient advocacy groups support 12 years of data exclusivity”, he writes. Mr Quinn points out that US groups supporting 12 years of data exclusivity include the ALS Association, Alliance for Aging Research, AIDS Institute, National Minority AIDS Council, Children’s Tumor Foundation and National Kidney Foundation. “They understand how important it is for biotech companies to be able to continue to innovate”, he stresses.

According to Mr Quinn, his data protection period would permit innovators to recoup their billion-dollar investments in a reasonable period of time. Without such a reasonable “break even” point, investors simply will put their money somewhere else and not in biotech. That ultimately is bad for patients, and for society at large. “Whether you like it or not, the truth is that less than 12 years of data exclusivity is not workable for patients because it would kill the industry. It is foolish to believe that not having advances that save and improve lives is better or more workable than having and encouraging such advances”, he argues.

Furthermore, Mr Quinn states it is fiction that 12 years of data exclusivity would be anticompetitive. “It’s a fact that the biotech industry is – at its heart – competitive”, he argues. Mr Quinn explains that the biotech industry currently exhibits robust competition as innovators compete against other innovators, with similar products targeting similar diseases or conditions. “The fact that an industry is against the government forcing them to turn over their data to competitors does not mean the industry is against competition, it just means the industry is for fairness”.

He asks what business owners out there would accept the government telling you that you must open up and allow your competitors to take whatever they want? For crying out loud, throughout trade-secret law fighting over customer lists happens all the time. “Businesses don’t want to have their customer lists fall into the hands of competitors because it took time, money and energy to create that list and identify customers. Having an employee run off with a customer list to start a new company that competes is unfair and illegal in every state, yet there are some who think that biotech companies who invest billions of dollars should allow copy-cat companies to do exactly what the law prohibits everywhere else. How could that make any sense to anyone, unless of course the goal is not to encourage medical advances but only to keep costs down?” Mr Quinn finally asks. (see also Data exclusivity is not the same as market exclusivity, Minimal 12 years of biologicals data exclusivity required and Innovative biologicals development must be preserved)

Reference:

Gene Quinn. Fact vs. Fiction: The Truth on Biologics and Biosimilars. IP Watchdog. 2009 December 6.