USTR Report Reinforces Global IP Challenges and Opportunities

USTR Report Reinforces Global IP Challenges and Opportunities

05.01.14 | By Jay Taylor

Yesterday’s release of the Special 301 report by the Office of the United States Trade Representative (USTR) once again underscores the challenges faced by innovators when confronted with deteriorating protections for intellectual property across the globe. With more than 5,400 medicines currently in development, IP protections are more important than ever to ensure that the incentives for finding new cures for our most pressing health care needs are not impeded. We appreciate all of the hard work by the Office of the United States Trade Representative and other U.S. Government agencies in working to ensure that our trading partners respect American intellectual property.

Countries that don’t play by the rules can have a significant negative impact on the drug development pipeline, and the Special 301 report serves as a reminder of the importance of internationally recognized standards. In short, it’s up to all of us to ensure protection of IP for future innovation and the patients who rely on it.

While India’s status on the Priority Watch List (reserved for serious offenders of IP rights) remains unchanged, USTR also recommended conducting an out-of-cycle review and subjecting India to further scrutiny given the nature of its practices, particularly the practice of denying or revoking patents for innovative new medicines. This is a positive development and we welcome the opportunity to constructively engage with USTR and the Government of India, especially as the country’s new government takes office in the coming weeks, to address these issues and promote reforms that will put India on a path toward greater cooperation with the rest of the world. Patients across India and around the globe stand to benefit as a result.

Given its unfortunate track record, Canada is also a nation that merits scrutiny. USTR again found that Canada has not taken the necessary steps to revisit its discriminatory IP policies and, as a result, is making it harder for biopharmaceutical innovators to get innovative medicines to the patients who need them. As Canada is our largest export market and a key diplomatic ally, concerns about these practices – from availability of appeal rights in certain types of infringement cases to discriminatory invalidation of pharmaceutical patents and overall uncertainty – must be addressed. Recently, 32 members of Congress echoed this concern in a letter they sent to USTR Michael Froman, specifically mentioning Canada’s new interpretation of an internationally accepted patent utility standard. This judicial rule has resulted in the Canadian government’s revocation of 19 patents for innovative medicines because they are not “useful” even though they have been approved by Health Canada and used not only around the world, but by hundreds of thousands of patients in Canada alone.

Promoting strong IP protections is a responsibility of every government and innovative sector, regardless of geographic location. It is our hope that next year’s report will be able to show some positive changes in the global IP landscape – changes that will help promote access and innovation for patients everywhere. We look forward to helping to lead this conversation and sharing our ideas on how we ensure progress going forward.


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