BPCIA Exclusivity: An Unconstitutional Commerce Clause Patent

BPCIA Exclusivity: An Unconstitutional Commerce Clause Patent

Journal article

1 online resource

The Biologics Price Competition and Innovation Act of 2009 (the BPCIA) created a twelve-year period of exclusive rights for investors in securing FDA approval for biologic products -- even though those products may be unpatented, or even patented by someone else. This BPCIA Exclusivity is a patent in all but name. The U.S. Constitution authorizes grants of exclusive rights (monopolies in certain goods) only to inventors of inventions -- not to investors in regulatory approvals for goods that may be in the public domain or invented by others. This understanding of the Constitution is consistent with legal traditions inherited from England, with policies of colonial governments, and with centuries of judicial interpretation of the Intellectual Property Clause itself, which authorizes the grant of exclusive rights only to inventors. It is also consistent with the well-established principle that affirmative limitations on an enumerated power (such as the limitations in the Intellectual Property Clause) cannot be circumvented by resort to another enumerated power, especially the Commerce Clause. There is no constitutional source of authority for the BPCIA's grant of exclusive rights without regard to the presence of an invention, and the BPCIA exclusivity provisions are unconstitutional.

Crossref

AIPLA Quarterly Journal, Fall 2024, Volume 52, Issue 4, p. 641.

[New York, NY] : Thomson Reuters, 2024.

English

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