The Generic Biologics Debate: Industry's Unintended Admission that Biotech Patents Fail Enablement

Abstract

This Article reveals that many already issued and actively enforced medical biotechnology patents may be invalid. Biologics, medical therapeutics derived through biotechnology techniques, are the fastest growing and most promising pharmaceutical sector. They represent a $45 billion a year industry that is anticipated to double in five years and that already provides novel treatments for cancer, diabetes, and heart disease. Due to unforeseen consequences of past decisions, manufacturers currently are significantly limited in their ability to sell generic copies of biologics even after the pioneer biologic patents expire. As early biologics are starting to go off-patent, this regulatory mix-up is having a notable impact on the availability of biologics and raising the cost of health care. The generic biologics debate has dramatically heated-up recently due to proposed legislation to create a new regulatory process for generic biologics, the biotechnology and pharmaceutical industry defending the status quo, and the Food and Drug Administration struggling to handle the situation. This Article exposes for the first time that industry's own arguments have an unintended, striking consequence — many of their biologic patents fail enablement, and therefore are not valid in the first instance.