Examples of Vague Language in the 2010 Special 301 Report Relating to Access to Medicines

Juan Manuel Medina
June 30, 2010

Many of the objections to other countries' intellectual property laws and practices  included by USTR in the 2010 Special 301 Report are described in vague passages. For instance, data protection is often described as "inadequate" without an accompanying statement of what type of protection is available.  This blog posting contains examples of such vague language regarding polices that may affect access to medicines.

PRIORITY WATCH LIST

China

Draft Regulations for the Administration of the Formulation and Revision of Patent-Involving National Standards, released for public comment in November 2009 by the Standardization Administration of China (SAC), raise concerns regarding their expansive scope, the feasibility of certain patent disclosure requirements, and the possible use of compulsory licensing for essential patents included in national standards.

While many provisions of the Patent Law were clarified and improved, rights holders have raised a number of concerns about the new law and implementing regulations, including the effect of disclosure of origin requirements on patent validity, inventor remuneration, and the scope of and procedures related to compulsory licensing, among other matters.

The United States encourages China to provide an effective system to expeditiously address patent issues in connection with applications to market pharmaceutical products. Additionally, the United States continues to have concerns about the extent to which China provides effective protection against unfair commercial use, as well as unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approval for pharmaceutical products. [Pgs. 21-22.]

Russia

Russia committed to fight optical disc and Internet piracy, enact legislation to protect against unfair commercial use of undisclosed test or other data generated to obtain marketing approval for pharmaceutical products... Amendments to the Law on Medicines were enacted in 2010; they did not implement the provisions of the IPR Bilateral Agreement on protection of pharmaceutical test data. [Pg. 23]

Algeria

…Algerian law that bans numerous imported pharmaceutical products and medical devices in favor of local production. Additional concerns remain over the lack of protection against unfair commercial use, as well as unauthorized disclosure, of undisclosed test and other data generated to obtain marketing approval for pharmaceutical products. Industry continues to raise concerns over the weak protection of patents in Algeria. [Pg. 24]

Argentina

The United States encourages Argentina to provide for protection against unfair commercial use, as well as unauthorized disclosure, of undisclosed test and other data generated to obtain marketing approvals for pharmaceutical products …. [Pg. 24]

Canada

The United States encourages Canada to provide its border officials with the authority to seize suspected infringing materials without the need for a court order. [Pg. 25]

Chile

For example, the legislation did not include protections against the circumvention of technological protection measures. The United States remains concerned that the relatively low rate of prosecutions and the tendency to apply minimum sentences for counterfeiting and piracy in Chile may not effectively deter future infringement.

However, the United States remains concerned about inadequate protection against unfair commercial use, as well as unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approvals for pharmaceutical products, and urges Chile to provide an effective system to address patent issues expeditiously in connection with applications to market pharmaceutical products. [Pgs. 25-26]

India

The United States encourages the continuation of efforts to reduce patent application backlogs and streamline patent opposition proceedings. (…) The United States continues to urge India to improve its IPR regime by providing stronger protection for patents. One concern in this regard is a provision in India’s Patent Law that prohibits patents on certain chemical forms absent a showing of increased efficacy. While the full import of this provision remains unclear, it appears to limit the patentability of potentially beneficial innovations, such as temperature-stable forms of a drug or new means of drug delivery. The United States also encourages India to provide protection against unfair commercial use, as well as unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approval for pharmaceutical and agricultural chemical products.’ [Pg. 26]

Indonesia

Although enforcement efforts against pirated optical discs continue, the overall level of enforcement remains insufficient to address the country’s major piracy and counterfeiting problem, including with respect to the counterfeiting of pharmaceutical products. (...) Indonesia should provide effective protection against unfair commercial use, as well as unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approval for pharmaceutical products. Serious market access barriers remain, including a law imposing requirements that restrict the importation of medicines by foreign pharmaceutical companies. [Pgs. 26-27]

Pakistan

The United States continues to encourage Pakistan to provide effective protection against unfair commercial use, as well as unauthorized disclosure, of pharmaceutical test or other data generated to obtain marketing approvals for pharmaceutical products. Pakistan also lacks an effective system to address patent issues expeditiously in connection with applications to market pharmaceutical products.  [Pg. 27]

Thailand

Thailand acceded to the Patent Cooperation Treaty, implementation of which should help to expedite patent application processing. Thailand also proposed legislation to address landlord liability for infringement, to address illegal camcording, and to enhance the authority of Thai Customs to take enforcement actions ex officio. Thailand is also considering possible amendments to its patent law… Thailand acceded to the Patent Cooperation Treaty, implementation of which should help to expedite patent application processing. Thailand also proposed legislation to address landlord liability for infringement, to address illegal camcording, and to enhance the authority of Thai Customs to take enforcement actions ex officio. Thailand is also considering possible amendments to its patent law. [Pgs. 27-28]

Venezuela

In 2006, when Venezuela withdrew from the Andean Community, it reinstated the 1955 Industrial Property Law. That version of the law prohibits patents for pharmaceuticals, foodstuffs, and other products. (...) In 2009, Venezuela revoked two pharmaceutical patents for antibiotics after a foreign company sued domestic producers of generic copies. The United States urges Venezuela to provide protection against unfair commercial use, as well as unauthorized disclosure, of undisclosed test and other data generated to obtain marketing approval for pharmaceutical products.’ [Pg. 28]

WATCH LIST

Belarus

Enforcement officials continue to lack ex officio authority to investigate, seize infringing goods, and prosecute IPR cases, and Belorussian law does not allow adequate scope for ex parte searches. [Pg. 28]

Bolivia

Enforcement officials continue to lack ex officio authority to investigate, seize infringing goods, and prosecute IPR cases, and Belorussian law does not allow adequate scope for ex parte searches. (...) Despite a notable enforcement action resulting in the seizure of more than 30 tons of counterfeit pharmaceutical products and corresponding prosecutions, substantial additional resources and a commitment by enforcement and judicial authorities are needed to improve enforcement actions against piracy and counterfeiting. [Pg. 29]

Brazil

Patent concerns remain, including about the scope of patentability and the uncertain role of ANVISA, Brazil’s sanitary regulatory agency, in examination of certain patent applications. Brazil also does not provide for the adequate protection against unfair commercial use, as well as unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approval for pharmaceutical products.’ Pg. 29.

Colombia

The United States encourages Colombia to develop an effective system to address patent issues expeditiously in connection with applications to market pharmaceutical products. [Pg. 30.]

Costa Rica

In addition, Costa Rica recently published regulations to provide for the protection of undisclosed information submitted in support of the registration of new agricultural chemical products in Costa Rica. [Pg. 30]

Dominican Republic

The United States is also concerned about excessive delays in the issuance of patents. The United States will continue to monitor the Dominican Republic’s implementation of its bilateral and multilateral obligations to provide an effective system for protecting against unfair commercial use, as well as unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approvals for pharmaceutical and agrochemical products, and to provide an effective system to address patent issues expeditiously in connection with applications to market pharmaceutical products. [Pg. 31]

Ecuador

The United States is also concerned about excessive delays in the issuance of patents. The United States will continue to monitor the Dominican Republic’s implementation of its bilateral and multilateral obligations to provide an effective system for protecting against unfair commercial use, as well as unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approvals for pharmaceutical and agrochemical products, and to provide an effective system to address patent issues expeditiously in connection with applications to market pharmaceutical products. [Pg. 31]

Egypt

The United States continues to urge the Ministry of Health to clarify its commitment to protect against unfair commercial use, as well as unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approvals for pharmaceutical products, and to provide an effective system to address patent issues expeditiously in connection with applications to market pharmaceutical products. [Pg. 32]

Finland

U.S. industry continues to express concern that the regulatory framework in Finland regarding process patents filed before 1995, and pending in 1996, denies adequate protection to many of the top-selling U.S. pharmaceutical products currently on the Finnish market. [Pg. 32]

Italy

The lack of an expeditious legal mechanism for right holders to address Internet piracy and a recent Data Protection Agency decision affecting a rights holders’ ability to monitor peer-to-peer networks are obstacles to effectively combating this trend. [Pg. 33]

Jamaica

The United States urges the government of Jamaica to reform its patent law in accordance with international standards for patent protection. [Pg. 33]

Kuwait

Kuwait will remain on the Watch List in 2010. Kuwaiti officials, particularly Customs authorities, continue to make progress on enforcement against piracy and counterfeiting, and to pursue cases through the judicial process. However, the lack of deterrent criminal penalties limits the effectiveness of these efforts. [Pg. 34]

Lebanon

Lebanon also does not provide effective protection against unfair commercial use, as well as unauthorized disclosure, of undisclosed test data or other data generated to obtain marketing approval for pharmaceutical products. The United States encourages Lebanon to pass the pending legislative amendments to strengthen IPR protection, and will continue to engage with Lebanon through its WTO accession process and through an ongoing review under the U.S. Generalized System of Preferences program. [Pg. 34]

Malaysia

The United States encourages Customs officials to initiate IPR investigations ex officio, as authorized under Malaysian law. (...) The United States also encourages Malaysia to provide effective protection against unfair commercial use, as well as unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approval for pharmaceutical products, and to provide an effective system to address patent issues expeditiously in connection with applications to market pharmaceutical products. [Pgs. 34-35]

Mexico

Mexico’s enforcement efforts continue to improve, demonstrated by an increase in the number of raids, arrests, and indictments in 2009, and the imposition of the longest prison sentence on record in Mexico for an IPR violation... Legislation is still needed to provide ex officio authority to Customs officers. (...) The United States encourages Mexico to provide effective protection against unfair commercial use, as well as unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approval for pharmaceutical products. The United States also welcomes recent efforts by Mexican authorities to improve Mexico’s system to address patent issues in connection with applications to market pharmaceutical products; the existing system has generated considerable litigation and uncertainty. [Pg. 35]

Norway

U.S. industry has expressed concerns that Norway’s regulatory framework for process patents filed prior to 1992, and pending in 1996, denies adequate patent protection for a number of pharmaceutical products currently on the Norwegian market. [Pg. 35]

Peru

Peru should clarify its system for protecting undisclosed test or other data submitted to obtain approval of agricultural chemical products, particularly in light of recent measures that appear to provide for automatic approval of generic products. [Pp. 36]

Philippines

The United States remains concerned about amendments to the patent law that prohibit patents on certain chemical forms unless the applicant demonstrates increased efficacy. [Pg. 36]

Romania

Additionally, some Romanian judges continue to dismiss IPR cases for a “lack of social harm. [Pg. 37]

Turkey

Turkey is also becoming a major exporter, as well as a transshipment point, for counterfeit and pirated products. (...) The United States encourages Turkey to maintain deterrent penalties for all categories of IPR infringements. The United States also encourages Turkey to clarify its protection against unfair commercial use, as well as unauthorized disclosure, of pharmaceutical test data or other data generated to obtain marketing approvals for pharmaceutical products. [Pg. 38]

Turkmenistan

Customs officials do not have ex officio authority to interdict suspected infringing material at the border. [Pg. 38]

Ukraine

However, serious concerns remain regarding the transshipment of counterfeit and pirated goods through Ukraine and that Customs officials lack ex officio authority to effectively address such transshipment. [Pg. 39]

Uzbekistan

Additionally, amendments are needed to provide enforcement officials, including Customs officials, with ex officio authority to initiate enforcement actions and investigations. The United States will continue to work with Uzbekistan through its WTO accession process and the ongoing review under the U.S. Generalized System of Preferences program. [Pg. 39]
   



 

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