DATA EXCLUSIVITY FOR PHARMACEUTICALS IN FREE TRADE AGREEMENTS: MODELS IN SELECTED UNITED STATES FREE TRADE AGREEMENTS.

• Author: Armouti, Wael

1. INTRODUCTION II. EXTENDED DATA PROTECTION AND DATA EXCLUSIVITY III. LINKAGE BETWEEN PATENT STATUS AND REGULATORY APPROVAL IV. COMPARISON BETWEEN FTAS IN TERMS OF DATA EXCLUSIVITY AND OTHER RELATED MEASURES OF DRUG REGULATORY APPRO VAL A. Jordan-United States Free Trade Agreement 1. Data Exclusivity 2. Linkage 3. Patent Term Extension B. Chile-U.S. Free Trade Agreement 1. Data Exclusivity 2. Linkage 3. Patent Term Extension C. Australia-U.S. Free Trade Agreement 1. Data Exclusivity 2. Linkage 3. Patent Term Extension D. Morocco-U.S. Free Trade Agreement 1. Data Exclusivity 2. Linkage 3. Patent Term Extension E. CAFTA-DR-U.S. Free Trade Agreement 1. Data Exclusivity 2. Linkage 3. Patent Term Extension F. Korea-U.S. Free Trade Agreement 1. Data Exclusivity 2. Linkage 3. Patent Term Extension V. FT AS COMPARISON TABLE VI. CONCLUSION I. INTRODUCTION

   Although the United States did not succeed in its effort to see data exclusivity adopted as the official means of intellectual property protection in the final text of the Trade Related Intellectual Property Rights Agreement ("TRIPS"), it remained undeterred by this setback, choosing instead to pursue its data exclusivity agenda in subsequent bilateral agreements--free trade agreements or TRIPS-plus agreements--signed with other countries; (1) to this end, the United States included the principal tenets of data exclusivity in almost all these bilateral free trade agreements. (2) Moreover, with the TRIPS Agreement disappointment perhaps still in mind, the United States was careful to insist upon the maximum constraints possible in these agreements, a result accomplished by incorporating various protective mechanisms not present in the TRIPS Agreement.

   The first way in which the United States imposed these additional constraints was by expanding the reach of data exclusivity protection to include, in addition to new chemical entities ("NCEs"), new uses of old chemical entities and new dosage forms. (3) In addition to increasing the subject matter falling under the data exclusivity umbrella, these agreements also include a linkage requirement. (4) Under the concept of linkage, a decision by regulatory authorities to grant marketing approval for drugs that enjoy patent protection is ultimately dependent on the will of the patent holder. (5) Ensuring there were no loopholes to exploit, these agreements added an additional point which prevented an applicant from receiving registration recognition from other drug regulatory authorities. In case there was recognition from another drug regulatory authority ("DRA"), the agreement provided that this country should employ the same data exclusivity term as would have been implemented domestically. (6) These agreements lack time periods within which the product must be submitted to the DRA. (7) The linkage requirement is problematic because it requires the DRA to determine the validity of patents, which may be beyond its capabilities.

   A further constraining mechanism added in almost all the signed free trade agreements ("FTAs") was the extension of the patent term for pharmaceutical companies, a measure intended to compensate these companies for the portion of the product's patent term that elapsed while awaiting a regulatory decision regarding marketing approval. (8) This extension in the FTAs goes beyond the requirements of the TRIPS Agreement, which does not include any such compensation period, only specifying that the protection period of a patent is twenty years. (9)

   A final way in which the United States heightened intellectual property protection in these agreements was by defining the grounds for compulsory license issuance. Conversely, as to compulsory licenses, the TRIPS Agreement left it to each country to determine the grounds for compulsory license issuance. (10)

   Given the above-mentioned strictures, those countries that signed FTAs with the United States are essentially deprived the benefits of the flexibilities found in the TRIPS Agreement. (11) Consequently, the impact will be critical on the public health and access to affordable medicines by increasing the monopoly period of the originator drug companies and delaying the entry of the cheap generic products. (12) Such impact will mainly affect developing countries who have signed an FTA with the United States namely, Bahrain, Chile, Columbia, Jordan, Korea, Oman, Morocco, Panama, Peru, Singapore, and the Central American parties to CAFTA (Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras and Nicaragua). (13)

   This paper discusses different perspectives and various points of view to analyze the data exclusivity requirements in the signed FTAs for selected countries at issue. This paper will tackle how earlier FTAs have fewer constraints than do later ones. From the Jordan to the Korean FTA, the United States added many additional constraints with respect to data exclusivity and intellectual property rights related to the pharmaceutical and drug industry. The paper will conclude with a comparison table illustrating the differences between how data exclusivity is incorporated into each selected country's FTA with the United States.

   We will examine the FTAs for the following countries:

   Jordan: Signed in October of 2000 and enforced in December of 2001, the Jordan-United States agreement was the first FTA with an Arab country. (14) This analysis is undertaken in order to clarify the data exclusivity obligations imposed on Jordan as a consequence of signing the FTA.

   Chile: This FTA was signed in June of 2003. (15) Chile, in particular, was selected as a representative of a developing country from South America.

   Australia: This agreement was signed in May 2004. (16) Australia was chosen as an example of an FTA with a developed country.

   Morocco: This FTA was signed in June of 2004. (17) Morocco was chosen as an example of another Arab country from Africa, in addition to Jordan, that signed an FTA with the United States.

   Central American Free Trade Agreement (DR-CAFTA): (18)

   Signed on August 2005. (19) This FTA functions as an example of a multilateral regional agreement which includes five Central American countries (Costa Rica, El Salvador, Guatemala, Honduras and Nicaragua) and the Dominican Republic.

   Republic of Korea: This FTA entered into force in March of 2012. (20) Korea is considered as a major trading nation. (21)

2. EXTENDED DATA PROTECTION AND DATA EXCLUSIVITY

   Article (39). (3) of TRIPS states that the protection at issue applies to new chemical entities (NCEs); (22) the United States, however, used its post-TRIPS Agreement FTAs as an opportunity to expand the scope of the protection term. (23) New applications for new indications, new formulations, and new combinations are ordinarily entitled to three years of exclusivity if at least one new clinical investigation is essential for regulatory approval. (24) The United States also extended the protection term to include new products instead of only new chemical entities; as a result, the protection in its FTAs will be extended to include both chemical entities and biological ones. (25) Additionally, the FTAs defined "new" as being new in the drug regulatory of the country, excluding the patent novelty definition. (26) In some FTAs, as with Morocco's and the Republic of Korea's, the condition of "undisclosed test data," is no longer a prerequisite for a company to receive the protective benefits of data exclusivity, in effect disallowing generic producers from utilizing said data without any inquiry into whether the originator company had intended to keep its assumedly valuable information confidential. (27)

   Another new constraint related to drug regulatory approval that was added in almost all the signed FTAs is patent term extension. (28) In this new restriction, the patent term will be extended to compensate the patent holder for unreasonable curtailment of the patent term due to regulatory delay during the marketing approval of the product. (29) In most FTAs, this was related to the product patent, but in the Korean FTA, this was extended to the method of use and method of making patents. (30) This is an example of the United States' FTA becoming stricter over time.

   The difference between patent term extension and data exclusivity is that the former will be granted after the expiration of the patent and will compensate for the duration needed to obtain the regulatory approval for the originator product.31 While the latter will be effective immediately after the originator product's marketing approval, the generic company will be prevented from relying on the originator's submitted data, but can generate its own data and submit it during the data exclusivity period. (32)

3. LINKAGE BETWEEN PATENT STATUS AND REGULATORY APPROVAL

   The Patent Linkage term was introduced by the United States in the FTAs, in which the generic approval is linked to the expiration of the originator's patent. (33) Consequently, a generic product will not be approved until the expiration or invalidation of the related patent. (34) To ensure the patent linkage requirements were met, the United States devised a system wherein the originator submits a list of patents that cover its product to the United States FDA. This information about the available patents for each product is published on the FDA's website or Orange Book. (35) Generic drug applicants can then review the published data and decide either to wait until the expiration of the patent or to apply for Paragraph IV Certification. In this latter situation, those filing an Abbreviated New Drug Application ("ANDA") must notify the originator drug company of its filing, and explain that the applicant is not infringing his patent or, in the alternative, assert that the patent at issue is invalid. (36) In response, the originator drug company has the right to file an infringement lawsuit. (37) Accordingly, the generic drug registration will be suspended for...