Orange Light on Generics

Last week, I blogged on the issue of generic biologics: should companies that make vaccines, monoclonal antibodies, cell therapies, etc. get 12 years of data exclusivity before competing companies begin offering generics? Or should they be held to the same standard as makers of drugs, who get five years of exclusivity?

Looks like the U.S. Senate is caving in to pressure from Pharma and the Biotech industry by opposing the Obama's "compromise" position: the Senate bill urges 12 years. But in today's New York Times, journalist Andrew Pollack suggests the exclusivity debate might not matter in the end: most biologics are protected by patents beyond 12 years after FDA approval. Meaning: short exclusivity periods advocated by various public interest groups would have no material impact on development of generic biologics, because generics would be prevented by patents. The article contains a graphic showing that patents on several leading biologics products extend well beyond 12 years.

So is this just a symbolic debate? I think not (disclaimer: I am not a health care economist!). Towards the end of the article, Pollack acknowledges that the exclusivity debate might matter where patents do not provide strong protection. That's a crucial issue for biologics. Intellectual property law around biologics is notoriously unstable and uncertain. And owing to their complex composition, generic manufacturers might plausibly argue that their products are biosimilar while not infringing patents. Advocates of the 12 year policy will argue that longer exclusivity is necessary to entice investors who might otherwise worry that lead products will not withstand patent challenges. Advocates of the shorter policy (like myself) will argue that we owe it to present day patients and their families to take that risk. (photo credit: sortofbreakit 2008).