[Ip-health] Patent approval linkage and bio-medicine

Heesob Nam hurips at gmail.com
Mon Dec 1 21:44:31 PST 2014


There is a debate on whether the patent-approval linkage is applied to
biological product in the U.S. Here the linkage is within the meaning
of Article 18.9:5 of the Korea-US FTA.

Article 18.9:5 Where a Party permits, as a condition of approving the
marketing of a pharmaceutical product, persons, other than the person
originally submitting safety or efficacy information, to rely on that
information or on evidence of safety or efficacy information of a
product that was previously approved, such as evidence of prior
marketing approval in the territory of the Party or in another
territory, that Party shall:

(a) provide that the patent owner shall be notified of the identity of
any such other person that requests marketing approval to enter the
market during the term of a patent notified to the approving authority
as covering that product or its approved method of use; and

(b) implement measures in its marketing approval process to prevent
such other persons from marketing a product without the consent or
acquiescence of the patent owner during the term of a patent notified
to the approving authority as covering that product or its approved
method of use.

My view is that the US does not implement the linkage under the FTA
(as there is no obligation to do so) because two elements of the
linkage, ie, notification and prevention of marketing, are not
codified in the BPCI Act.

But the Korean government posits that it is controversial and tries to
expand the linkage to cover all of the biological product.

Best,
Heesob




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