The Latest: Drug Patent Link System Is Coming

"Opinion" has two bright spots:highlights one: opinion requirements, improve the new industry protection system in new areasExplore the establishment of drug patent link system, drug patent term compensation systemhighlights II: study and formulate protection measures in traditional culture, traditional knowledge and other fields, and strengthen the protection of intellectual property rights in Chinese medicinehighlightsthe drug patent link system, the drug patent term compensation system
the system is a major reform measure in the pharmaceutical intellectual property system, showing that China is committed to strengthening the protection of intellectual property rights of innovative drugs and promoting the innovation and development of the pharmaceutical industryas early as 2017, the General Office of the Cpc Central Committee and the General Office of the State Council issued the Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Pharmaceutical Medical Devices, which states:(16) to explore the establishment of a drug patent link systemIn order to protect the legitimate rights and interests of patentees, reduce the risk of patent infringement, encourage the development of generic drugs, explore the establishment of drug review and approval and drug patent link systemwhen the applicant for registration of aa drug submits an application for registration, he shall state the relevant patent involved and its ownership status, and inform the relevant drug patentee within the prescribed time limitIf there is a dispute over the patent right, the parties concerned may bring a lawsuit to the court and shall not stop the technical review of the drug during that periodthe food and drug regulatory authority may approve the listing of drugs that have passed the technical review, and the food and drug regulatory authority may approve the listing if the court has not obtained an effective judgment, ruling or mediation for a certain period of time(17) to carry out a pilot drug patent compensation systemSelect some new drugs to carry out pilot, due to clinical trials and review and approval of delayin time to market, to give appropriate patent term compensationthe current situation of our country
Article 18 of the Current Measures for the Administration of Drug Registration in China stipulates that for drugs patented by others in China, the applicant for drug listing license shall submit a declaration that the patent of another person does not constitute infringementIf a patent dispute occurs during the registration process of a drug, it shall be resolved in accordance with the relevant laws and regulations on patentspractice, often the original research drug patent either the patent either the dispute between the generic drug enterprises, the generic drug approval process will be suspended until the expiration of the patent period, may cause unfair situation to the generic drug enterprisesthe implementation of the foreign drug patent link system
the United Statesthe United States in 1984 passed the Drug Price Competition and Patent Recovery Act (also known as the Hatch-Waxman Act), establishing a complete set of pharmaceutical intellectual property rights legal systemIn order to promote the development of generic drugs, the Act provides for a simplified new drug approval procedure (ANDA) and the Bolar exception (Bolar exception), which refers to the non-infringement of patent rights in patent law for the use of patented drugs before the expiry of a patent by another person without the patentee's consent), greatly simplify the approval process for generic drugs, reduce their costs, and promote their time to market as soon as possibleIn order to promote the development of the original drug, the Act provides for the protection of drug data and patent protection period compensation, to compensate for the strict drug approval process on the adverse effects of the original drugin the generic drug market approval process, in the event of a patent infringement dispute, the drug approval process will be suspended for 30 months, pending the court's ruling on the disputeIf a court decision is obtained before the expiration of the suspension period, the decision shall be made on whether to approve the listing of generic drugsIf the suspension period expires without obtaining a court decision, the patent dispute will no longer be taken into account and the approval process will continuethe U.Sdrug patent link system provides for a complex set of rules, including: orange book system, generic patent declaration, approval suspension period and first generic drug market exclusive period systemEurope and Japan
Europe and Japan do not have a drug patent link system similar to those in the United States the European the European Commission believes that the task of drug regulators is to verify the safety and efficacy of drugs and not to take into account other factors such as whether the product infringes patents, otherwise it violates the provisions of the Patent Law on the Bolar exception patentee can resolve potential patent infringement disputes in the process of approval of generic drugs, and patentees can apply to the court for a "temporary injunction" drug patentees need to get a temporary court injunction to block generics in Europe, apparently a much higher threshold than in the Us Japan Japan in order to resolve potential patent disputes before the generic drug market, took another approach: first, the new drug active ingredient product patent period has not expired, do not approve the generic drug market ; from the implementation of drug patent links, the vast majority of patent disputes for follow-up improved drug patents, new active ingredient patents are really difficult to bypass Therefore, Japan simply prohibits generic applications until the patent for the active ingredient of the new drug expires other countries
Canada, Australia and South Korea have all introduced drug patent links through free trade agreements with the United States It is only slightly different in terms of specific provisions such as the duration of the stay India has made clear through court precedents that in the case of the exception of The Patent Law, the drug market approval authority only needs to review the safety and effectiveness of the drug, regardless of the factors of the patent dispute Highlights II strengthen the protection of intellectual property rights in Chinese medicine
the current situation of intellectual property protection of Chinese medicine
the current legal system of intellectual property rights is far from meeting the needs of the protection of Chinese medicine intellectual property rights, resulting in the loss of a large number of Chinese medicine intellectual property rights, traditional knowledge and biological resources according to statistics, at present, China has more than 900 kinds of Chinese herbal medicine projects by Japan, South Korea and other countries enterprises preemptively applied for patents overseas, the domestic Chinese medicine market nearly 30%, the international market more than 90% of the share occupied by foreign enterprises the State introduced the Law on Chinese Medicine and strengthened the protection of intellectual property rights in Chinese medicine
in December 2016, the Chinese Medicine Law of the People's Republic of China (hereinafter referred to as the Chinese Medicine Law) was issued, listing a variety of ways of protecting the intellectual property rights of Chinese medicine: includes encouraging the protection of Traditional Chinese medicine in measures such as the protection of geographical indication products; the State to establish a database, a list of protection and protection system for traditional chinese medicine, the holders of traditional knowledge of Chinese medicine have the right to inherit and use the traditional knowledge of Chinese medicine, the right to know consent and benefit-sharing to others to obtain and use the traditional knowledge of Chinese medicine held by others, and the State shall exercise special protection over the composition and production process of traditional Chinese medicine prescriptions that are recognized as state secrets in accordance with the law October 2019, the State Council of the CPC Central Committee and the State Council on promoting the development of Chinese medicine heritage and innovation pointed out that to accelerate the promotion of scientific research and innovation in Chinese medicine: "strengthen the protection and application of intellectual property rights in the Chinese medicine industry." We will improve the management system that gives chinese medicine scientific research institutions and personnel greater autonomy, and establish a mechanism for safeguarding the rights and interests of intellectual property rights and the transformation of scientific and technological achievements References: Perfect ingenuity and strengthening the protection of intellectual property rights in Chinese medicine, People's Court, By Ding Wenyan Zhang Yonghua Interpretation and Recommendations of the Drug Patent Link System The Law of the People's Republic of China on Chinese Medicine the General Office of the Cpc Central Committee and the General Office of the State Council issued the Opinions on Strengthening intellectual property protection
the General Office of the CPC Central Committee and the General Office of the State Council issued opinions on deepening the reform of the examination and approval system to encourage innovation in pharmaceutical medical devices
Yang Li, etc., the Bolar Exception Study on the Protection of Pharmaceutical Patents, 16 volumes 15 issues of the China New Drug Journal in 2007