U.S.-Korea Free Trade Agreement: Potential Economy-wide ... - USITC

The section on measures related to regulated products contains provisions that govern the
regulatory approval and marketing of pharmaceutical or agricultural chemical products. The
data exclusivity provisions would preclude reliance by another person, without consent of
the submitter, on safety or efficacy information provided in support of a new pharmaceutical
product, or evidence of the marketing approval of that product, for a period of at least 5 years
from the date of marketing approval. The data exclusivity period for an agricultural chemical
product would be at least 10 years from marketing approval. In cases where new clinical
information, or evidence of marketing approval based on new information, is submitted in
support of a pharmaceutical product containing a previously approved chemical entity, the
data exclusivity period would be at least 3 years. 98 The section contains a new provision,
which clarifies that a party may take measures to protect public health in accordance with
the Declaration on the Trade-Related Aspects of Intellectual Property Rights (TRIPS)
Agreement and Public Health (the Doha Declaration), notwithstanding these data exclusivity
provisions. Later in the IPR chapter, the parties affirm their commitment to the Doha
Declaration and confirm that the obligations of the IPR chapter would not prevent a party
from taking measures to protect public health by promoting access to medicine for all. 99
The section on measures related to regulated products also would require the implementation
of measures in the marketing approval process to prevent the approval of generic drugs
during the term of the patent without the patent owner’s consent (a “patent linkage”
provision), including a requirement that the patent owner be notified of the identity of a
person seeking marketing approval during the patent term. 100
Enforcement
The enforcement section of the FTA contains detailed measures intended to promote full and
effective IPR enforcement. It contains general obligations, civil and administrative procedure
and remedies provisions, provisional measures, special requirements related to border
measures, criminal procedures and remedies, and provisions on liability of Internet service
providers. In particular, Korea agrees to supplement its civil remedies with a regime of
statutory damages, costs, and attorney’s fees and to provide criminal remedies for trafficking
in counterfeit labels and the illegal recording of audiovisual works (so-called
“camcording”). 101
Side Letters
The IPR chapter includes a series of side letters addressing Internet service provider
obligations, copyright infringement on university campuses, enforcement against online
piracy, and patent linkage. More specifically, the first side letter contains detailed provisions
for an effective “notice and takedown” process for Internet service providers when online
materials are claimed to be infringing and when it is asserted that online materials should not
have been removed from the Internet. The second side letter would require the Korean
98 Ibid., Article 18.9.1-2.
99 Ibid., Articles 18.9.3 and 18.11. These new provisions are the result of a “Bipartisan Trade Deal”
between the Office of the U.S. Trade Representative and certain Members of Congress. USTR, “Bipartisan
Trade Deal,” May 2007, 3.
100 Ibid., Article 18.9.5.
101 Ibid., Articles 18.10.6, 18.10.28, and 18.10.29.
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