An executive meeting of the State Council of China was held on April 12, 2018 and presided by Premier Mr. Li Keqiang. According to the meeting, a series measures will be taken to encourage the importation of innovative medicines into Chinese market, to enhance intellectual property protection, and to lower medicine price. The measures include exemption certain medicines from customs duty, reduction of drug price, expedition and optimization of the process for authorization on the commercialization of imported innovative medicines, enhancement in intellectual property protection, and augmentation in quality monitoring.
It is worth noting that, the measures on enhancement in intellectual property protection is exciting for innovative medicines and pharmaceutical companies. The data exclusivity period for innovative chemical medicines is 6 years at maximum, and medicines of the same species will not be authorized to commercialize within this period. In addition, a maximum of 5 years’ compensation of patent term will be offered for innovative new medicines which are applied for commercialization on domestic and oversea markets simultaneously.
Undoubtedly, the above is good news for pharmaceutical companies. But the specific rules on how to determine the duration of the data exclusivity period and patent term extension have not been available. We will keep you informed of the updates in the future.
With the availability of these measures, it is expected that more innovative medicines will be imported into China in the future, and the intellectual property protection for innovative medicines will be enhanced.
Please find the specific information announced by the official authority.
1. Exemption from customs duty
China will exempt all normal medicines including anti-cancer medicines, alkaloid medicines with anti-cancer effect, and Chinese traditional medicine with actual import from customs duty, and to realize a zero customs duty for all anti-cancer medicines.
2. Reduction of drug price via comprehensive measures
Comprehensive measures will be explored. Manners include, for example, centralized purchasing by the government, timely incorporating imported innovative medicines particularly anti-cancer medicines with urgent desire into the category of medical insurance, research on oversea online channels, and the like, so as to make the public realize that the price for urgent desired anti-cancer medicines is significantly reduced.
3. Expedition the commercialization of imported innovative medicines
Application for clinical trials will be amended from the manner of authorization to duly default approval. Chemical medicines will be imported with the support of testing results of enterprises, and compulsory testing by batch is not necessary any more.
4. Enhancement in intellectual property protection
The data exclusivity period for innovative chemical medicines is 6 years at maximum, and medicines of the same species shall not be authorized to commercialize within this period. In addition, a maximum of 5 years’ compensation of patent term will be offered for innovative new medicines which are applied for commercialization on domestic and oversea markets simultaneously.
5. Augmentation in quality monitoring
Quality monitoring of imported medicines will be enhanced. Inspection on the oversea manufacturing sites of imported medicines will be augmented. Severe measures will be taken towards the activities of manufacturing or selling false medicines.
On February 1, 2010, the State Intellectual Property Office released the updated Electronic Patent Filing System (hereafter "EPFS"). The new version provides the applicants and agencies with more conveniences than before. CCPIT Patent and Trademark Law Office has already equipped with the technical and procedural conditions to submit patent applications electronically and has successfully filed some patent applications via EPFS since July 1, 2010. This marks that CCPIT has been qualified to provide the applicants with a quicker and easier way of submission of patent applications electronically.
Disgruntled with ruling by the Trademark Review and Adjudication Board (TRAB) under the State Administration for Industry and Commerce (SAIC) over registration of the their car model of A3, A4, A5, A6 as trademark, Audi sought legal remedy to reverse the decision before the Beijing No.1 Intermediate People’s Court. The court recently handed Audi another defeat. Trademark office under SAIC and TRAB also rejected Audi’s application of TT and Q7 as trademarks in class 12 and application of letters and numbers such as S3, S4 as trademarks in the similar commodities by territory extension of PCT.
The court held that characters such as A4 and A8 is constituted by common letters and numbers without special form of expression, which stand for Audi car model only and made the marks devoid of distinctiveness as a whole, so they can not be granted as trademarks. The trademark office and TRAB held the same reason of the rejection.
(Source: China Intellectual Property News)
With most applications globally, China looks to deter malicious filings
New standards of proof for ownership and a ban on malicious registration will be included in the next draft of China's trademark law, which has been under discussion, according to a senior government official.
Copying registered trademarks and applying to use the marks on other types of goods will also be illegal, Li Jianchang, chief of the trademark department of the State Administration of Industry and Commerce (SAIC), told China Daily.
Under current legal system, only well-known trademarks are eligible for protection beyond their specific industry. Well-known trademarks are the most vulnerable to counterfeit attack and have long been a priority worldwide.
"Since China joined the Paris Convention in 1985 and the World Trade Organization in 2001, our trademark system is in accordance with international practice," Li noted. "We fulfilled the promises we pledged to the WTO and provide like protection to both domestic and foreign well-known trademark holders."
Compared with most countries where only the courts settle issues surrounding infringement, China has a double mechanism that combines the judicial system and administrative departments in industry, commerce and customs, Li said.
Various levels of administration are also legally authorized to initiate investigations into suspected trademark violations.
The authorities' efforts also include regular visits to companies to gauge their needs in trademark protection, offering consultancy services for corporate brand-building and crackdowns on counterfeits, Li said.
To date, 112 foreign trademarks from 15 countries and regions have been recognized as well-known trademarks in China, accounting for 6 percent of the nation's total. Illustrating the appeal of its market, China is among the most popular nations for foreign trademark applicants, Li cited World Intellectual Property Organization Director Francis Gurry saying.
Increased protection of intellectual property and an improved investment environment have also contributed to boosting overseas business confidence in China, Li added.
Trademark applications by foreign-funded companies increased nearly 2 percent to about 6,600 in the first half of this year, bringing the total to some 148,000.
More than 490,000 applications from both home and abroad have been filed in China in the same period, a 35 percent year-on-year increase.