Interpretation of Relevant Policies on Encouraging Pharmaceutical and Medical Device Innovation and Protecting Innovators' Rights and Interests (Part I)

55 [2017] Announcement of the General Administration of the People's Republic of China on Soliciting Comments on Relevant Policies on Encouraging Innovation in Pharmaceutical and Medical Devices and Protecting the Rights and Interests of Innovators (Draft for Solicitation of Comments)

In order to further deepen the reform of the review and approval system, promote the structural adjustment and technological innovation of the pharmaceutical and medical device industry, improve the competitiveness of the industry, and meet the clinical needs of the public, the State Food and Drug Administration, in consultation with relevant departments of the State Council, organized the drafting of the ''About Encouraging Pharmaceutical and Medical Device Innovation "Relevant Policies for Protecting the Rights and Interests of Innovators (Draft for Solicitation of Comments)", is now open to the public comments. It is suggested that the revised opinions should be fed back to china food and drug administration (drug and cosmetics registration administration department) by email before may 25, 2017. The deadline for comments is June 10.

The contents of the draft for comments concerning the revision of laws and regulations shall be carried out in accordance with the relevant procedures.

Email:yhzcszhc@cfda.gov.cn

It is hereby announced.

Annex: Policies on Encouraging Innovation in Pharmaceutical and Medical Devices and Protecting the Rights and Interests of Innovators (Draft for Comments)

Food and Drug Administration

12 May 2017

A few days ago, the Food and Drug Administration issued relevant policies (draft for comments) on encouraging drug and medical device innovation and protecting the rights and interests of innovators. There are four articles in total. The following will focus on the establishment of a drug patent link system and the implementation of the confidentiality responsibilities of national staff. Interpretation.

1. establishes drug patent link system

When submitting an application for registration, the applicant for drug registration shall submit a statement involving relevant rights that he knows and should know. To challenge the relevant drug patent, the applicant shall declare that it does not constitute infringement of the relevant drug patent, and inform the relevant drug patentee within 20 days after filing the registration application; if the relevant drug patentee believes that his patent right has been infringed, he shall file a patent infringement lawsuit with the judicial organ within 20 days after receiving the notice from the applicant, and inform the drug evaluation institution. After the drug review agency receives the relevant certification documents of the judicial organ for patent infringement, it may set a waiting period for approval of no more than 24 months; during this period, it will not stop the technical review of the accepted drugs. During the waiting period for approval, if the two parties reach a settlement or the judicial organ makes an effective judgment on infringement or non-infringement, the drug evaluation institution shall not approve or approve the drug for listing according to the settlement between the two parties or the relevant effective judgment of the judicial organ; if the waiting period for approval is exceeded and the judicial organ fails to make an infringement judgment, the drug evaluation institution may approve the drug for listing. If the applicant does not declare that the relevant patent is involved in the accepted drug application, and the patentee file an infringement lawsuit, the drug review institution shall include the application in the approval waiting period according to the acceptance of the judicial organ. Where intellectual property litigation is triggered by the marketing of drugs, the judgment of the judicial organ shall prevail.

Interpretation: This is similar to the patent link system under the US patent system. The specific implementation regulations and procedures include: the submission of the patent status of the new drug application, the publication of the orange peel book, the statement in paragraph IV, the 45-day litigation period, the 30-month containment period, and the 180-day market monopoly period. The significance of the patent linkage system is to protect patent rights and prevent unfair competition. The FDA does not approve drug applications that clearly infringe patent rights, stifling patent infringement in its infancy and strengthening factory protection of drug patents. Reduce litigation, improve efficiency and save resources. The patent link system balances the innovation and imitation of drugs, speeds up the listing of generic drugs, and increases the proportion of generic drugs used. At the same time, it also intensifies the competition in the drug market. A direct impact is the reduction of drug prices. The price of generic drugs is generally 20%-60% lower than that of new drugs, which greatly reduces drug expenditures.

2. implement the confidentiality responsibility of national staff

The staff involved in the review and approval of drug and medical device registration applications and the staff involved in verification, inspection and supervision shall have the obligation to keep confidential the technical secrets and test data submitted by the applicant. The person responsible for violating the obligation of confidentiality shall be dealt with by the competent department of drugs and medical devices in accordance with relevant laws and regulations and disclosed to the public.

Interpretation: this system strengthens the protection awareness of the participants, prevents the leakage of relevant information to a certain extent, and protects the interests of the registered applicants to the greatest extent.