Harvard experts champion 5-year window on generic protection

A pair of high-profile Harvard professors have teamed up with lawyer and generic advocate Alfred B. Engelberg to make their case in the New England Journal of Medicine that provisions in proposed healthcare reform bills which provide 12 years of market exclusivity [1] for biologics is so long that it will discourage manufacturers from ever considering their development. They believe that the protection period should only be five years, an idea that has been fought tooth and nail by the biotech industry's main trade group.

"As currently fashioned, the biosimilar legislation would have no value, because it would create a pathway that would scarcely be used,'' write Engelberg and Harvard's Dr. Jerry Avorn and Dr. Aaron S. Kesselheim. The public "would not get the benefit of the enhanced price competition that would result from increasing the number of competitors." Avorn and Kesselheim are both well known healthcare policy experts.

But don't expect their argument to persuade anyone at BIO. The trade group has championed the notion that biotech companies need to be protected for a longer period than traditional therapeutics in order for them to recover their heavy investments in R&D.

- check out the NEJM argument [2] here
- here's the New York Times piece [3] from Andrew Pollack

Related Articles:
Editor's corner: Examining the generic biologics debate [4]
Senate committee backs 12-year IP protection status [1]
NYT: Biosimilar bills are neither a threat nor boon [5]