GESTIÓN DE CALIDAD

TRIPS Agreement does not use the term ―compulsory license‖ but there are some provisions under the title of ―[o]ther [u]se [w]ithout [a]uthorization of the [r]ight [h]older‖ in Article 31 that serves similar purpose of allowing the use (of patented invention) in limited circumstances and conditions being fulfilled.⁷⁷ In order to avail the options of Article 31, the company or person seeking the license/approval/permission to use the patent must have tried to ―obtain authorization from the right holder on reasonable commercial terms and conditions‖ and was unsuccessful.⁷⁸ This requirement may be waived for ―national emergencies‖, ―other circumstances of extreme urgency‖ or ―public non-commercial use‖ or use by the government or to remedy an anti-competitive practice.⁷⁹ However, Doha WTO Ministerial Declaration on the TRIPS Agreement and Public Health expressly use the term ―compulsory license.‖⁸⁰ Article 30 of the TRIPS Agreement known as ―Bolar‖

provision is implemented in national laws to allow the generic drugs‘ manufacturers to use the patented information for availing the marketing authorization from the regulatory authority. But the generic cannot enter the market until the patent and the data exclusivity right has expired.

Article 10 of the Directive 2004/27/EC states: ―A generic medicinal product authorised pursuant to this provision shall not be placed on the market until ten years have elapsed from the initial

76 Supra note 65.

77 Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994) [hereinafter TRIPS Agreement].

78 TRIPS Agreement art. 31(b).

79 TRIPS Agreement art. 31(b)(k).

80 World Trade Organization, Ministerial Declaration on the TRIPS Agreement and Public Health of 14 November 2001, art. 5 (b)(c), WT/MIN(01)/DEC/2, [hereinafter Doha Declaration], also available at http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm.

authorisation of the reference product.‖ ⁸¹ Apart from this 10 years, one additional year of protection

Anthony Tridico revisited and summarized the prevailing legal and policy landscape surrounding the Bolar provision, Regulatory Data Exclusivity (RDE) and generic drug manufacturing and commented:

In the US, the Hatch-Waxman Act established a regulatory framework to encourage the marketing of generic pharmaceutical products. The Act also created a research exemption, indicating that ―it shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.‖ 35 U.S.C. § 271(e)(1) (―Bolar exemption‖). This provision overturned the Federal Circuit decision in Roche Products, Inc. v. Bolar Pharmaceutical Co., Inc., 733 F.2d 858 (1984), which held that the traditional experimental use exemption to patent infringement (35 U.S.C. § 271(a)) did not apply to pre-market testing done by a generic manufacturer and submitted to a regulatory agency. [….]. Notwithstanding the EU Directive, the exact language, scope and interpretation of Bolar exemptions vary across Europe. (Tridico 2014, 17--20)

The national laws on ―Regulatory Data Exclusivity‖ protects the information of the initial authorization of the reference medicinal product for 10 to 11 years in Germany, Italy, Lithuania, Spain and UK (CMS Legal Services EEIG 2007).The Regulatory Data Exclusivity (RDE) right⁸⁴ is independent of other IP rights (such as patent or trade secret). Hence, this RDE right shall be protected for that tenure (10-11 years) independent of the term of patent. If this RDE goes parallel with the patent, then patent lasts longer and RDE exhausts within the term of protection of the patent.

But if the patented invention is delayed to enter the market as product, this RDE can extend the life of the IP protection of that original invention. Data Exclusivity Right (DER) exist in the US and the EU to offer protection in varying length. Section 355 of the US Federal Food, Drug, and Cosmetic Act⁸⁵ provides provision for the protection of similar/same right. Article 39 of the TRIPS Agreement, which calls for protection against unfair competition,⁸⁶ is interpreted by the US and EU to extend the

81 Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community Code Relating to Medicinal Products for Human Use, 2004 O.J. (L 136) 34, 39.

82 Id. art. 10(5).

83 Id. art. 10(6).

84 Judit Rius Sanjuan explained: ―The terms "marketing exclusivity," "market exclusivity," "new drug product exclusivity," "Hatch-Waxman exclusivity," "sui generic protection," "data exclusivity," and "data protection" are all found in the U.S. and/or E.U. legal literature. Usually the term "marketing exclusivity" is more used in the U.S.

regulatory system, and both the terms "data protection" and "data exclusivity" are more used in the E.U. system.‖ (2006, 2n5).

85 21 U.S.C.§ 355 (2010). http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec355.htm.

86 Art. 39 (3) TRIPS Agreement states: ―Members, when requiring, as a condition of approving the marketing of pharmaceutical […] products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition,

DER in favor of the IP right owner potentially delaying the chance of the generic entering the market Moreover, the exercise of compulsory licensing have to take into account the ―patent and the data exclusivity right‖ both. Much stronger IP protection exist in the US and EU than the TRIPS required for the protection of pharmaceutical test data. Judit Rius Sanjuan made the following criticism of offering strong DER:

The granting of exclusive rights in test data will delay the entry of generic products into the market, impeding the access to affordable medicines. [….]. The exportation of the U.S. Hatch-Waxman regime to other countries with very different income and needs has been strongly criticized by one of its proponents, Representative Henry A. Waxman.

It is a form of double protection, since the strong patent rights are justified by the cost of investments in test data. According to this line of thinking, stronger rights in the data should be offset by weaker protections for the patent. […]

Unless the exclusive rights in the data can be overridden, it can make compulsory licenses of patents or government use orders ineffective.

It undermines the Bolar/ Early Working patent exception which seek to encourage quick access to the post patent market for generic medicines by exempting from patent liability certain conducts. (Sanjuan 2006, 16;

footnote omitted)

When the double protection of patent and DER are offered to the Biotech companies for the ―stem cell based invention‖ and the test data of ―stem cell based therapies,‖ the IP protection may substantially delay the generic manufacturer entering into market. Bolar exemption will not do much to increase the access to the therapy. Stem cell patents raises other concerns too. Granting broad patent in emerging techniques of biomedical science creates the fear of blocking the downstream research. Because the upstream inventions having no direct application for therapeutic purpose, might be essential for downstream research for drug development. They form the ―essential facility‖

for further innovation (for example, WARF patents on ES cell derivation) (McCoy 2008-2009, 86).

The competition law and the compulsory licensing regime may not be enough tool to break the power of monopoly.

The respondents were asked (question no. 8): ―How many years of protection (term of protection for commercial exploitation) is appropriate for human stem cell based inventions/innovations?‖. The following Major Key Themes derived from the responses to question no. 8 shows that a few of them made comments and they supported 20 years or more for the IP protection of hSCI:

 ―Regulatory approvals‖;

 Current protection;

 20 or more than 20 years is appropriate;

Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.‖ TRIPS Agreement art. 39.

The interpretation of the Major Key Themes derived from responses to question no. 8 can be found in ch. 5.

4.4.3 CONTROVERSIES, SLIM DIFFERENCES AMONG INVENTIONS, FUTURE LEGAL