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Data Exclusivities In The Age Of Big Data, Biologics, And Plurilaterals, Peter K. Yu Mar 2019

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 …


The Illusion Of Interchangeability: The Benefits And Dangers Of Guidance-Plus Rulemaking In The Fda's Biosimilar Approval Process, Jonathan Stroud Jan 2013

The Illusion Of Interchangeability: The Benefits And Dangers Of Guidance-Plus Rulemaking In The Fda's Biosimilar Approval Process, Jonathan Stroud

Jonathan R. K. Stroud

On March 23, 2010, President Obama signed into law the ambitious Patient Protection and Affordable Care Act. While media attention focused largely on the sweeping changes the bill makes to the nation’s healthcare system, there was also a less-noticed rider to the bill, the Biologics Price Competition and Innovation Act of 2009 (Biosimilars Act). The Biosimilars Act grants the Food and Drug Administration (FDA) broad new authority to create an accelerated premarket approval pathway for generic competition to biologics in an attempt to drive biologic drug prices down and reduce the overall costs of health care. Traditionally, inventors of medical …


Will Fda Data Exclusivity Make Biologic Patents Passé?, Vincent J. Roth Esq Aug 2012

Will Fda Data Exclusivity Make Biologic Patents Passé?, Vincent J. Roth Esq

Vincent J Roth Esq

Much controversy has ensued over the current 12 year data exclusivity period afforded biosimilars pursuant to the Biologics Price Competition and Innovation Act of 2009 (the “BPCI”) that was recently enacted in March 2010, as part of President Obama’s Patient Protection and Affordable Care Act (the “PPACA”), to create a biosimilar market in the US. In fact, the BPCI, itself, has been controversial and just barely survived judicial scrutiny when the US Supreme Court upheld the PPACA on June 28, 2012 in a 5-4 vote. Many commentators speculate whether data exclusivity will overtake patents as the preferred method of intellectual …


Will Fda Data Exclusivity Make Biologic Patents Passé?, Vincent J. Roth Esq Aug 2012

Will Fda Data Exclusivity Make Biologic Patents Passé?, Vincent J. Roth Esq

Vincent J Roth Esq

Much controversy has ensued over the current 12 year data exclusivity period afforded biosimilars pursuant to the Biologics Price Competition and Innovation Act of 2009 (the “BPCI”) that was recently enacted in March 2010, as part of President Obama’s Patient Protection and Affordable Care Act (the “PPACA”), to create a biosimilar market in the US. In fact, the BPCI, itself, has been controversial and just barely survived judicial scrutiny when the US Supreme Court upheld the PPACA on June 28, 2012 in a 5-4 vote. Many commentators speculate whether data exclusivity will overtake patents as the preferred method of intellectual …


Interests In The Balance: Fda Regulations Under The Biologics Price Competition And Innovation Act, Parker Tresemer Dec 2011

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 …


Regulatory Approval Of Follow-On Biologics: Takings Implications Of Twelve Years Of Market Exclusivity And Future Conflict In Determinations Of Bioequivalence, Aileen Mcgill Dec 2009

Regulatory Approval Of Follow-On Biologics: Takings Implications Of Twelve Years Of Market Exclusivity And Future Conflict In Determinations Of Bioequivalence, Aileen Mcgill

Aileen M McGill

Congressional interest in the availability of low-cost pharmaceuticals has focused on the increasingly important class of drugs known as “biologics.” Biologics are protein-based pharmaceuticals derived from living matter or manufactured in living cells, which are more complex than the chemically synthesized molecules found in most pharmaceutical products. While there are many scientific differences between small-molecule pharmaceuticals and biologics, one of the most significant is the inability to reproduce them in generic form, creating a legislative division between generic entry for standard pharmaceuticals governed by the Hatch-Waxman Act and a similar approval process for “follow-on biologics” (FOBs). With the passage of …