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Last year, the State Intellectual Property Office (SIPO), (now, the China National Intellectual Property Administration (CNIPA)), announced Administrative Measures for Prioritized Examination[1] (“the Measures”), which took effect as of August 1, 2017.  At the anniversary of the measures, we explain how domestic and foreign applicants can use the measures to expedite examination of their patent applications.

Patent applications are entitled to Prioritized Examination if they:

(1) Relate to industries whose development is prioritized by the State, such as energy conservation and environmental protection, new-generation information technology, biology, high-end equipment manufacturing, new energy, new materials, alternative fuel vehicles, smart manufacturing, etc.;

(2) Relate to industries that are encouraged by local governments; or

(3) Relate to technologies or products that rapidly become obsolete, such as the Internet, big data, cloud computing etc.;

Alternatively, patent applications are also entitled to prioritized examination if

(4) The patent applicant is ready to implement or has already begun implementing the claimed invention, or has evidence that others are implementing their claimed inventions;

(5) The patent applicant filed a patent application(s) on the same subject matter in other countries or regions after filing a patent application for the first time in China; or

(6) Where prioritized examination is otherwise necessary due to great significance to the national interest or public interest.  Note the definition for of great significance to national interest or public interest are not defined.

To request prioritized examination, the applicant must submit:     (1) A written request for prioritized examination, (2) prior art references from a search[2];  (3) documents supporting that the application falls into one of the related industries or technologies, such as a declaration by the requester declaring that the technology claimed by the application falls into relevant technical field included in Strategic Emerging Industry Key Products and Services Guidance Catalog[3]; and (4) a recommendation from the relevant department of the State Council or the relevant local intellectual property office except if based on foreign filing.  Further, note for an invention application, the application should have entered substantive examination.[4]

For an invention patent application, the CNIPA shall issue the first Office Action within 45 days from approval by CNIPA for prioritized examination, and complete the examination by granting or rejecting the application within one year (12 months), as opposed to 22 months of average pendency for invention patent applications according to latest 2017 patent examination statistics[5].  Note according to practice, CNIPA will normally process the prioritized examination request in 3-5 days.

For a UM application or design patent application, the CNIPA will complete formalities examination within two months of approval.

The applicant for invention application needs to respond to any Office Action within 2 months, and the applicant for UM or design applications needs to respond to an Office Action within 15 days.  Note the applicant is not entitled to a 15-day grace period on postal delivery which it is otherwise entitled for normal examination. Further, the applicant is not entitled to extensions if the applicant wants to maintain prioritized examination.

CNIPA will cease prioritized examination where:

(1) the applicant voluntarily amends application;

(2) the applicant responds to an Office Action beyond 2 months;

(3) Where the applicant submits false materials; or

(4) Where the patent application is found to be abnormal during examination, such as simply copying a prior application[6].

Note that while CNIPA has geared prioritized examination towards Chinese applicants[7] and no published mechanism exists for foreigners to use prioritized examination[8], calls to CNIPA have confirmed that foreigners are not excluded from this program.  Further, as there are no local CNIPA branches overseas, a call to ZhongGuanCun IP Promotion Bureau (the Bureau), which is authorized by the Beijing IP office to handle recommendations for prioritized examination, confirmed they would issue required recommendations to foreigners if they meet the above requirements and the foreigner’s retained patent law firm is located in Beijing. Applicants using patent law firms in other cities can obtain the recommendations from the local IP office wherein their retained patent law firm resides.

Accordingly, when PPH is unavailable, applicants can use the prioritized examination program instead, which unlike US Track 1 prioritized examination, is free.  Further, the prioritized examination is also available for reexamination and invalidation, which we’ll discuss in another entry.

[1] http://www.sipo.gov.cn/zcfg/zcfgflfg/flfgzl/zlbmgz/1020137.htm

[2] Note the applicant or their agent can perform the search on their own, and do not need to submit a formal search report, according to our call with ZhongGuanCun IP Promotion Bureau.

[3] http://zgcip.org.cn

[4] http://www.sipo.gov.cn/zhfwpt/zlsclcggfw/yxsc/index.htm

[5] http://www.sipo.gov.cn/gk/gkndbg/2017ngjzscqjnb/index.htm

[6] http://www.sipo.gov.cn/zfgg/1097905.htm

[7] The measures say the purpose of the measures is to “promote the optimization and upgrading of the industrial structure, pushing forward the implementation of the national intellectual property rights (“IPR”) strategy and the development of China into an IPR power.” See Article 1 of the Measures.

[8] Published requirements from ZhongGuanCun IP Promotion Bureau only provide instructions for Chinese applicants. See http://zgcip.org.cn.

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The China National Intellectual Property Administration (CNIPA) will be closed from October 1, 2018 to October 7, 2018 for the Chinese National Day holiday. All official deadlines falling on the above dates will be automatically extended to October 8, 2018.  Accordingly, please provide your Chinese counsel with instructions for actions due as soon as possible to avoid a rush immediately after the holiday.

Similar to Independence Day in the U.S., Chinese National Day celebrates the founding of the People’s Republic of China (PRC) (in 1949). During the National Day holiday (which is actually a week-long holiday period commonly referred to as a “golden week”), Chinese often travel both domestically and internationally (with Southeast Asia being particularly popular) during the holiday.  Many Chinese cities also host fireworks, concerts and light shows.

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On April 25 this year the China National Drug Administration (CNDA) published a proposed draft on Implementing Measures for Pharmaceutical Trial Data Protection.  The measures prevent other drug manufacturers from relying on earlier trial data to receive sales approval without permission from the owner of the earlier trial data.  The proposed draft extends the trial data protection term to up to 12 years compared with that of up to 6 years previously.  During the protection term, the CNDA will not approve marketing of the same drug[i] from a third party without permission of the owner whose drug gets a trial data exclusivity, except if the third party independently runs a trial and collects trial data.

In contrast to the previous trial data protection measures which applies to drugs with new chemical components, the proposed measures are also applicable to drugs including 1) innovative drugs, 2) innovative biological products for therapy, 3) orphan drugs, 4) pediatric drugs, and 5) generic drugs manufactured by a pharmaceutical company that invalidated relevant patents of original drugs successfully.  The trial data refers to non-clinical and clinical experimental data related to drug efficacy other than drug safety, and should meet the following conditions:

  1. i) submitted with the purpose for getting approval for marketing and is required for drug registration application;
  2. ii) not published or disclosed prior to applying for drug registration;

iii) self-achieved and not dependent on trial data or published research results of others.

The proposed draft involves in a variety of protection terms for different conditions as shown in Table I below.

Table I

 

Drugs/Products Conditions Protection Term
Innovative drugs Use the clinical trial data or Multi-regional Clinical Trial (MRCT) data carried out in China to apply for marketing domestically or apply for marketing domestically and overseas simultaneously 6 years from the date of approval for marketing in China
Innovative biological products for therapy 12 years from the date of approval for marketing in China
Innovative drugs Use the Multi-regional Clinical Trial (MRCT) data carried out in China to apply for marketing domestically after first applying overseas 1 to 5 years from the date of approval for marketing in China (Note: If applying for marketing domestically is 6 years later than that first applying overseas, the CNDA will not provide a protection term.)
Innovative biological products for therapy
Innovative drugs Only use the clinical trial data carried out overseas to apply for marketing domestically 1.5 years from the date of approval for marketing in China
Innovative biological products for therapy 3 years from the date of approval for marketing in China
Innovative drugs Use the clinical trial data carried out overseas and supplement clinical trial data on Chinese subjects to apply for marketing domestically 3 years from the date of approval for marketing in China
Innovative biological products for therapy 6 years from the date of approval for marketing in China
Orphan drugs None 6 years from the date of the first approval of the indication of a newly-recognized disease in China
Pediatric drugs
Generic drugs Invalidate relevant patents of original drugs successfully No official information yet

In practice, the Applicant should submit the application for trial data protection at the same time as applying for marketing approval, and explain the requested protection term and reasons for protection.  After acceptance by the Receiving Office, the CNDA will publicize the trial data protection application for 30 days.  If the application passes examination performed by the CNDA, the trial data protection term will come into force when the corresponding drug gets approved for marketing.  The information of drug trial data will be recorded by the CNDA in “Catalog of Marketed Drugs.”

During the protection term, if a third party obtains the trial data independently and applies for approval of the same drug, the CNDA will notify the relevant data protection right owner within 30 days after its receipt of the application.  The right owner, if it believes the data was obtained fraudulently, can object to the use of the trial data obtained by the third party within 30 days after receiving the notification.  The CNDA will complete the data verification within 90 days after its receipt of the objection, and promptly notify the right owner.  If the CNDA determines the trial data is fraudulent, it will not give approval to the third party.  If not determined to be fraudulent, the third party can get approval for marketing without being blocked by earlier trial data of the right owner.

Additionally, if a drug with trial data protection is not sold within 1 year of approval for marketing in China, an interested party can apply to the CNDA for revocation.  It is expected that the proposed procedure for trial data protection may come into force late this year or early next year.

[i] “the same drug” refers to drugs that contain the same active ingredients and apply to the same indications.

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Unlike the U.S. Patent & Trademark Office (USPTO) which substantially increased some of its fees as of January 16, 2018[1], China’s State Intellectual Property Office (SIPO) has waived[2] some of its patent fees as of August 1, 2018.  This approach aims at reducing the financial burden to applicants and patent owners, and encouraging patent filings.

Starting from August 1, 2018, SIPO has waived 1) patent registration fee of 200RMB, 2) patent publication fee of 50RMB, 3) fee for changing the recordal of patent agency and patent agent of 50RMB, and 4) PCT transmittal fee in international phase[3] of 500RMB.

Note that even if the Applicant receives the notice to pay such fees (for example patent registration fee of 200RMB and patent publication fee of 50RMB) before August 1, 2018, the Applicant, after August 1, 2018, will not need to pay them.  The applicant will still need to pay other fees due, e.g., the annuity and the patent certificate tax due in a Notice to Grant.

SIPO will also refund 50% of the examination fee (1,250 RMB of 2,500 RMB) before the expiration of the time limit to respond to the First Office Action if the applicant voluntarily withdraws the application without responding to the First Office Action. By contrast, previously no examination fee would be refunded.  Accordingly, this should encourage Applicants to cease prosecution if they receive a negative First Office Action, freeing up SIPO examination resources to  speed up prosecution of other applications.

For Chinese patent applicants or patent owners who meet the relevant requirements of the “Measures for Reduction of Patent Fees” (“Measures” for short. Cai Shui [2016] No. 78)[4], the period for the reduction of the annual fee shall be extended to 10 years as opposed to 6 years from the date of grant. The requirements include: 1) (1) Individuals whose monthly average monthly income is less than 3,500 RMB (42,000 RMB per year); (2) Enterprises with taxable income of less than 300,000 RMB in the previous year; and/or (3) Institutions, social organizations, and non-profit scientific research institutions. Note for an individual or an enterprise to qualify, the individual should submit either income certificate from his/her employer if he/she has a job, or proof issued by a civil department or local government if he/she does not have a permanent job, the enterprise needs to submit their tax return issued by Chinese tax authorities, and the institution or organization needs to submit its Certificate of Incorporation issued by Chinese local authorities.[5]  Therefore, foreign enterprises, institutions, or organizations will not be able to qualify for the patent fee reduction since they cannot submit a tax return or Certificate of Incorporation issued by Chinese local authorities.

[1] https://www.uspto.gov/learning-and-resources/fees-and-payment/uspto-fee-schedule

[2] http://www.sipo.gov.cn/zfgg/1125525.htm

[3] http://www.sipo.gov.cn/zhfwpt/zlsqzn/zlsqfy/gjzscqjsfgs.pdf

[4] http://pjzx.mof.gov.cn/zhengwuxinxi/zhengceguiding/201611/t20161109_2454301.html

[5] http://www.runping.com/201608/1745.html

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