BPCIA UPDATE: ENTROPY IS THE PRICE OF AN ORDERED FRAMEWORK

The pharmaceutical industry has often relied on patent law to protect its investments, recoup costs associated with research and development (e.g., clinical trials), and encourage innovation. Simultaneously, because of patent law's strong protections, a premium is added to drug prices--which li...

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Bibliographic Details
Published in:Berkeley technology law journal 2019-04, Vol.33 (4), p.1277
Main Author: Kulathila, Rithika
Format: Article
Language:English
Subjects:
Access
Affordability
Amendments
Biological products
Clinical research
Clinical trials
Drug prices
Entropy
Flexibility
Incentives
Innovations
Investments
Licensing
Lifesaving
Patent law
Pharmaceutical industry
Prices
R&D
Research & development
Settlements & damages
Supreme courts
Violations
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Summary:The pharmaceutical industry has often relied on patent law to protect its investments, recoup costs associated with research and development (e.g., clinical trials), and encourage innovation. Simultaneously, because of patent law's strong protections, a premium is added to drug prices--which limits accessibility and affordability to these life-saving therapies. In order to address this concern, Congress created the Hatch-Waxman Amendments in 1984 for small molecule drugs. The Act sought to balance incentives for the pharmaceutical industry as well as increase accessibility and affordability of life-saving drugs for patients. While the Supreme Court settled questions about remedies for statutory violations, the Court's interpretation of the timing of 180-day notice may have some unintended consequences. First, 180-day pre-licensure can lead to parties blindly litigating over controversies that may or may not fully crystallize. Second, by giving the biosimilar manufacturer flexibility on when it can provide 180-day notice, the biosimilar manufacturer may use notice to encourage pay-for-delay settlements.
ISSN:1086-3818
2380-4742
DOI:10.15779/Z388P5V921