USTR pushes for drug data exclusivity [India]

The thorny issue of providing data exclusivity to pharma MNCs has come under limelight. The United States Trade Representative (USTR) seems to be lobbying hard with the health ministry for data exclusivity, which if allowed, will adversely affect domestic pharma companies that are making generic versions of patented drugs. Data exclusivity, if implemented, will stop or delay marketing approval of many generic drugs as the domestic pharma companies will not be able to rely on the clinical data which has been submitted by MNCs to the drug regulator, when they seek approval.

The Indian health ministry has not been in favour of granting data exclusivity to pharma MNCs, which effectively offers monopoly to the developer of a new drug even without a patent, restricting cheaper generic versions for several years. While one round of negotiations have been held earlier this year between USTR representatives and health ministry officials, the issue is expected to come up again soon, sources said. "The focus (of USTR) has shifted to the health ministry which is being urged to take a decision on the issue," sources said. For USTR, a change in the ministry's view is important before WHO-established Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) meets in Geneva this month, to negotiate an action plan for R&D that prioritizes the health needs of developing countries. Data exclusivity can be introduced through an amendment in the Drugs and Cosmetics Act, which is under the purview of the health ministry. The health ministry had then suggested data protection and not data exclusivity, which is compliant with TRIPs. Data protection prevents disclosure of clinical test data to competitors, but allows the drug regulator to use it for granting approval to generic companies. On the other hand, if data exclusivity proposal is accepted, the regulator cannot use the clinical test data submitted by an innovator company, to give marketing approval, which are developing cheaper generic versions.

Says Indian Pharmaceutical Alliance secretary general DG Shah: "India is not obliged to grant data exclusivity under TRIPS. Protecting the originators data against 'unfair commercial use' is agreed by all sections of the industry. So why are attempts being made to get it (data exclusivity) back?" Developing countries along with the WHO, feel that the draft action plan being negotiated in Geneva should focus on a global strategy on health and innovation, and intellectual property should be managed in a pro-public health manner. Intellectual property rights should not become an obstacle to access low cost generic medicines public health groups say.

USTR Plans Another Year Of Elevating IP Protection With Trading Partners [International]

The Office of the United States Trade Representative (USTR) last week delivered to Congress its 2008 National Trade Estimate Report (NTE), which includes many intellectual property-related challenges in 62 trading partners around the world. The report shows USTR’s plan to pursue ever-stronger IP protection with its trading partners, large and small.

Many of the report’s highlights were also included in USTR’s 2008 Trade Agenda, delivered to Congress in early March.
USTR has been seeking stronger intellectual property rights provisions in many of the free trade agreements (FTAs) pursued with various countries. For example, in 2007, USTR worked on FTAs with Peru, Colombia, Panama and South Korea; the United States-Peru Trade Promotion Agreement was implemented via legislation in Congress. Colombia agencies, for one, have extensive backlogs in the granting of patents, copyrights and trademarks. A proposed United States-Colombia Trade Promotion Agreement would include calls for state-of-the-art protections for digital products like software and music, stronger protection for US patents and test data, and criminalising end-use piracy.
“Approval and entry into force of these pending FTAs will make American goods and services more competitive in these markets, and more competitive relative to other trading partners,” US Trade Representative Susan Schwab said of Colombia, Panama and South Korea.
Some intellectual property protection success stories of 2007 include, according to USTR: lodging complaints at the World Trade Organization against China for inadequate enforcement of intellectual property rights and market access barriers to US products; including “world-class IPR provisions” in the three pending FTAs; Oman and the Dominican Republic reformed their intellectual property laws as part of the FTA process; raids of unlicensed optical disc plants in Russia; implementation of measures to reduce end-user software piracy in China; prosecutions for business software piracy in Taiwan; and seizures of counterfeit drugs in Indonesia and Nigeria.
The USTR said in 2008, the United States will continue to pursue its rights at the WTO in the cases that are still pending, and will seek additional action, as needed, to ensure China’s compliance with its WTO obligations.
This year, the United States also will pursue trade opportunities and stronger intellectual property protections in India, Israel, Taiwan, China, and Africa, among other countries and regions. An issue that it said continues to hamper US exporters in several of the sub-Saharan African countries is import bans on certain products, onerous customs procedures, corruption, and ineffective enforcement of intellectual property rights. The US also is calling on Chile to provide more patent and test data protection in the pharmaceutical sector and crack down on copyright piracy of movies, music and software. Chile is on the 2007 Special 301 Priority Watch List of countries identified by USTR as having deficiencies in intellectual property rights protection. USTR will release its 2008 list on 30 April.
Other issues highlighted by USTR include:
-The United States-Korea Free Trade Agreement (KORUS-FTA), signed last year, will provide strong intellectual property rights protections and “meaningful market access” to US providers; the United States continues to push Korea to strengthen its legal regime to protect temporary copies, and address internet service provider liability and copyright term extension, among other things.
-The US-Russia IPR Working Group meets quarterly to discuss Russia’s implementation of intellectual property-rights provisions of a bilateral agreement between the two countries; piracy in Russia reportedly resulted in losses of nearly $1.5 billion to the copyright industry in 2007. Internet piracy and trademark squatting are among the serious concerns. Russia also is on the 2007 Special 301 Priority Watch List.
-The United States has been engaging Middle Eastern countries on a variety of issues. Bilateral TIFA Councils (Trade and Investment Framework Agreement) established under TIFA agreements with countries such as Saudi Arabia, Egypt, and United Arab Emirates allow the US to work with those countries to promote market access, liberalisation of investment rules, intellectual property rights, and, where applicable, accession to the WTO. Some intellectual property enforcement has been added but more needs to be done.
-The Central American-Dominican Republic-United States Free Trade Agreement (CAFTA-DR), signed in 2004, continues to improve standards and enforcement on broad intellectual property rights issues but there is still a lack of enforcement; piracy of copyrighted materials such as audio and video recordings remains common and prosecutions are slow.
“The free trade agreements negotiated during this administration have set a new international standard for strong IPR protection and enforcement, in line with the high standards reflected in US law,” reads the 2008 trade agenda.
- Thailand, which has been under pressure from the brand-name pharmaceutical industry for its use of compulsory licences to increase availability of some medicines, was cited by USTR, which “expressed concern” about the practice and urged that it pursue policies that recognise IP rights. Some academics and activists cried foul on that message, saying it serves to undermine Thailand’s legitimate use of WTO rules that allow nations to decide for themselves when to use such licences.