IPR protection for pharmaceutical products
The United States has engaged intensively with China to address troubling obstacles to obtaining and maintaining patents on pharmaceutical innovations. Although SIPO guidelines governing the review of patent applications were once generally consistent with those of the United States and leading patent offices in other countries, China's revised interpretation severely restricted a patent applicant's ability to provide supplemental information in support of an application. As a result, China has denied pharmaceutical patent applications and invalidated existing patents, even with respect to applications and patents consistently awarded by U.S. and other patent offices. This problem was the subject of great attention during Vice President Biden's visit to Beijing in November 2013 and the annual meeting of the JCCT the following month. These engagements resulted in China's revision of the policy on information supplementation, and a commitment to work with the United States to follow up on implementation, including the examination of individual cases.
In addition, 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. Under Chinese law and international commitments, China is required to ensure that no subsequent applicant may rely on the undisclosed test or other data submitted in support of an application for marketing approval of new pharmaceutical products for a period of at least six years from the date of marketing approval in China. However, there are reports that generic manufacturers have been granted marketing approvals by the China Food and Drug Administration (CFDA) prior to the expiration of this period, and in some cases, even before the originator's product has been approved. The United States was encouraged by China's 2012 JCCT commitment to define "new chemical entity," a term that is central to the marketing approval process, in a manner consistent with international practice. Given that more than a year has passed since that time, the United States is urging China to implement its commitment without delay.
On November 12, 2013, CFDA invited comment on draft amendments to the Drug Registration Rules (DRR). The United States and industry expressed concern that the proposed deletion of Article 19 from the DRR would weaken regulatory pharmaceutical patent enforcement. CFDA subsequently issued a revised draft that retained Article 19, albeit in modified form. The United States will continue to engage with China on this and other issues.
Utility model and design patents
For years, the U.S. Government and U.S. rights holders have expressed concerns about the quality of China's utility model and design patents, which SIPO grants without substantive examination and which China encourages through subsidies and other incentives. The poor quality of many of these patents has led to abusive litigation, and burdens on legitimate businesses seeking to make patentability or freedom to operate determinations. After receiving comments on a prior draft, amendments to SIPO's patent examination guidelines for utility model and design patents came into force on October 15, 2013. Although the new guidelines do not require substantive examination, they permit examiners to gather additional information in certain cases at their discretion. The impact of the recent change is still difficult to assess, but the amendments appears to be a welcome initial step.
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