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Data Exclusivities In The Age Of Big Data, Biologics, And Plurilaterals, Peter K. Yu

Peter K. Yu

The past decade has seen many new developments impacting the intellectual property system. The introduction of big data analytics has transformed the fields of biotechnology and bioinformatics while ushering in major advances in drug development, clinical practices, and medical financing. The arrival of biologics and personalized medicines has also revolutionized the healthcare and pharmaceutical industries. In addition, the emergence of bilateral, regional, and plurilateral trade agreements have raised serious, and at times difficult, questions concerning the evolution of domestic and international intellectual property standards.

One topic linking all three developments together concerns the establishment of international standards to protect clinical …

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 …