Minimal 12 years of biologicals data exclusivity required

Biosimilars/News | Posted 26/01/2010 post-comment0 Post your comment

As reported by Gene Quinn on, for many months we have been hearing about the US government attempts to “reform” health care in the United States.


Mr Quinn: “We love generic drugs, but we also know that without an appropriate length of exclusivity to reward the tremendous risk undertaken we won’t get new drugs, and that is just unacceptable. So why should biotech medicines be any different?”

He stresses this kind of copy-cat competition, which allows a competitor to “use” (i.e., steal) the innovator’s research, does not exist in virtually any other industry outside of drugs. In fact, such copy-cat competition does not even exist today for biologicals at all, which is why in order to authorise such a short-cut, non-innovative path to market US Congress must enact legislation to authorise the FDA to use an abbreviated approval process for biosimilars. Despite the misrepresentations made by many, the innovator biotechnology industry has never argued that short-cut competition should exist, but has advocated for a fair and reasonable length of exclusive protection before such short-cut competition is allowed to exist.

“So the question is not whether this kind of competition should be possible, but rather how long an innovators’ data should be protected before they can be used by non-innovators who will piggyback on the large R & D investment made by the innovator to gain approval of a competitive product”, Mr Quinn points out. This period of time is referred to as data exclusivity. The innovator biotech community has urged Congress for 12 to 14 years of data exclusivity, the Federal Trade Commission has concluded in a lengthy report that zero years of data exclusivity is appropriate, President Obama has suggested that 7 years of data exclusivity is appropriate and US Congress has so far agreed with the biotech industry and supported 12 years of data exclusivity.

Mr Quinn: “Before going any further, allow me to point out that the FTC position is ridiculous. The FTC essentially wants innovator biotech companies to spend US$1 billion over 10 years and then immediately turn over their data to non-innovators. This irresponsible and intellectually dishonest position would ensure that biotech innovators cease to exist, medical advances in the biotech sector would end and it should be clear to everyone (except those at the FTC apparently) that this would not benefit society. So the real debate is whether it should be between 7 to 14 years. President Obama has not specified why he thinks 7 years is appropriate, and all of the research and data available show that a minimum of 12 years is required to make the risk-benefit calculus make sense for innovator biotech companies. So what Congress is leaning toward, 12 years of data exclusivity, seems right on target”. (see also 12 years exclusivity workable for patients; not anticompetitive, Data exclusivity is not the same as market exclusivity and Innovative biologicals development must be preserved)


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

Source: IP Watchdog

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