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

protection to life of the author plus 70 years for most works, subject to a 2-year transition
period. The section also contains a requirement that the two governments issue decrees
mandating the use of noninfringing software in government agencies. 103
The FTA would require Korea to bring all means of digital dissemination of sound
recordings within the scope of the exclusive rights of recording producers and would
obligate Korea to allow right holders to exercise economic rights in their own names. 104 The
FTA also includes provisions similar to those in NAFTA that protect against the theft of
encrypted satellite and cable signals and the manufacture of, and trafficking in, tools to steal
those signals. 105
Patents and Measures Related to Certain Regulated Products
The patents section would provide that patents shall be available for any invention if it is
new, involves an inventive step, and is capable of industrial application, including new uses
of known products. Exclusions from patentability would be recognized where necessary to
protect public order or morality and for diagnostic, therapeutic, and surgical procedures and
inventions. The patents section identifies permissible grounds for revocation of a patent and
precludes opposition proceedings that occur before the patent is granted. 106
The patents section also includes limitations on how a third party may use a patented
invention to generate data needed for the marketing approval of a generic pharmaceutical.
It would provide for extension of the patent term beyond 20 years to compensate for
“unreasonable delays,” defined as the later of 4 years from the filing of an application or
3 years after a request for examination, or delays in the marketing approval of a new
pharmaceutical product. The patents section also includes procedural definitions that
facilitate patent examination and establish a framework for cooperation between patent
offices in the United States and Korea. 107
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. 108 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
103 Ibid., Articles 18.4.1, 18.4.7, 18.4.4, and 18.4.9.
104 Ibid., Articles 18.6.3 and 18.4.6.
105 Ibid., Article 18.7.
106 Ibid., Articles 18.8.1, 18.8.2, and 18.8.4
107 Ibid., Articles 18.8.5, 18.8.6, and 18.8.8-18.8.11.
108 Ibid., Article 18.9.1-2.
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