Law Commons^™

The Anti-Patent: A Proposal For Startup Immunity, Amy L. Landers

Amy L. Landers

The controversy surrounding the current implementation of the patent system is well known. Some question whether the system has become entirely dysfunctional and disincentives innovation, particularly as the law operates within some industries. Moreover, early stage companies, particularly those just beginning to gain success, are particularly vulnerable targets for lawsuits. Notably, these same companies can be rich sources of important technological innovation.

Because the U.S. has always had a patent system, it is impossible to understand the intended and unintended consequences of eliminating this form of intellectual property protection even in a limited manner. As economist Fritz Machlup stated in …

Interests In The Balance: Fda Regulations Under The Biologics Price Competition And Innovation Act, Parker Tresemer

Parker Tresemer

Recent biotechnology advances are yielding potentially life-saving therapies, but without FDA regulations designed to minimize product costs, patients will continue to be unable to afford these expensive biologic products. Many believe that these prohibitive costs stem from weak competition from generic biologic products, also known as follow-on biologics. To correct this deficiency, and to address the often conflicting regulatory and policy concerns associated with biologic products, Congress enacted the Biologics Price Competition and Innovation Act. The Act created an abbreviated approval pathway for biologic products and, if effective, could increase competition while driving down product costs. But legislation alone is …