An article by SiliconVally.com [1] entitled "Loophole boosts biotech profits" describes the extension of patent term Amgen received for applications filed prior to June 8, 1995, the date that patent term was changed from 17 years after issuance to 20 years from the date of filing an application. The key patent covering the drug Epogen expired Oct. 27, 17 years from issuance.
Epogen and its chemical twin, Procrit, brought $6 billion in revenue last year, $19 billion worth of Epogen since 1989. Fortunately for Amgen, the revenue will continue since it won as many as 12 extra years of protection beyond that first patent, running until 2016.
While the article bemoans Amgen’s filings prior to the law change for extending patent protection and the fact that biotech generics are not available for approval by the FDA, it isn’t so clear that Amgen manipulated the system. Arguing that they took advantage of the law as it applied to everyone is a little like complaining that retirees born before 1960 are taking advantage of an earlier retirement age allowed over those born in 1960 or later.
With respect to generics, biotech and pharmaceutical industries argue that there can be small but important differences in different versions of biotech drugs and that generics should be subject to the same FDA studies as the original products. The FDA has put off considering any biotech generics until it completes a series of public workshops on the subject, set to continue next year.
See the entire article here [2].