Overview of IPR System

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1 Overview of IPR System In Healthcare Industry in China China Huake Pharmaceutical Intellectual Property Consultative Center April. 9, 2014 Beijing, China 1

2 Contents Intellectual Property IPR Authorities in China Patents in China Undisclosed Date Protection in China Relevant IPR Articles in the Provisions for Drug Registration Conclusions 2

3 Intellectual Property Copyright literary artistic scientific works Neighbouring right interpretations recording broadcast Industrial design Lay-out design integrated circuitries Industrial Property Inventions Trademark Unfair competition Patent for invention Utility model Administratiive protection(ap) Goods Services Geographical indications Undisclosed Information Undisclosed Date Protection (Data exclusivity) 3

4 IPR Authorities in China NCA Copyright Trademark SAIC SIPO Patent for inventions Utility Model Industrial design Lay-out design IPR Litigation Courts Diagram 2 CFDA Administrative protection Data protection 4

5 Patents in China Patent What they protect Duration inventions utility model (innovation patent or utility innovations) design (industrial design) Products : compound, composition, formulation, device Processes: Products: device, scored-tablets Design (shape, pattern or color): packing box, label 20 y 10 y 10 y Duration is counted from the application date in China 5

6 Patents in China Conditions of patentability Novelty Before Oct 1, 2009: relative novelty Since Oct 1, 2009: absolute novelty (strictest definition) Inventiveness Practical applicability 6

7 Patents in China Unpatentable subject matter scientific discoveries; rules and methods for mental activities; methods for the diagnosis or for the treatment of diseases; animal and plant varieties; substances obtained by means of nuclear transformation. 7

8 Patents in China Medicinal products protection Before 1993: only method-claim Since 1993:claim on chemical substances including medicine possible 8

9 Patents in China Rights from protection titles Exclusive right, to exclude a third from the commercial use of a creation/idea Patent Inventions Utility model Design Commercial use production use offer/publicity sale import production offer/publicity sale import 9

10 Patents in China Experimental Use Exception Since Oct 1, 2009 Is especially relevant to drugs and medicine devices Allow generic manufacturers to prepare generic product in advance of the patent expiration For the purpose of obtaining marketing approval Patent Term Extension NOT provide a regime for extending the term of a pharmaceutical patent 10

11 Undisclosed Date Protection in China Since 2002 Relevant Articles TRIPS Article 39.3 Regulations for the Implementation of Drug Administration Law of PRC Article 35 Provisions for Drug Registration Article 20 11

12 Undisclosed Date Protection in China TRIPS Article 39.3 Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities (NCE), the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use. 12

13 Undisclosed Date Protection in China Regulations for the Implementation of Drug Administration Law Article 35 The State protects undisclosed data of drug study and others which are independently acquired and submitted by drug manufacturers or sellers to obtain production or marketing approval of the drugs in question which contain new chemical entities. No one may make unfair commercial use of the said data. Within six years from the date a drug manufacturer or seller obtains the approval documents for producing or marketing a drug containing new chemical entities, if any other applicant uses the data mentioned in the preceding paragraph to apply for approval for production or marketing of the drug in question without permission of the original applicant who has obtained the approval, no approval may be given to any other applicant by the drug regulatory department except that the data submitted are acquired independently. No drug regulatory department may disclose the data set forth in the first paragraph of this Article except: (1) for the need of public interests; or (2) where steps are taken to ensure that the data are protected against unfair commercial use. 13

14 Undisclosed Date Protection in China Provisions for Drug Registration Article 20 In accordance with the provisions in Article 35 of the Regulations for Implementation of the Drug Administration Law, where a manufacturer or distributor submits undisclosed drug experimental and other data which are independently acquired in order to obtain approval for production or marketing of the drug in question which contains any new chemical entity, the State Food and Drug Administration shall, within six years from the approval date of the drug, reject any application made by any other applicants by using the undisclosed data of the drug in question without permission of the original applicant who has obtained the drug approval, unless the data submitted are independently acquired by the applicants other than the original one. 14

15 Undisclosed Date Protection in China Undisclosed data about new chemical entities should be protected: against disclosure against unfair commercial use NOT data exclusivity 15

16 Undisclosed Date Protection in China NCE Definition TRIPS NCE left undefined in TRIPS; countries have freedom in adopting definition China New Chemical Entity refers to new chemical molecular structure. Exclude products with non-chemical substance, such as biological products, natural products or bio-chemicals. 16

17 Relevant IPR Articles in the Provisions for Drug Registration Article 18 An applicant shall provide the information on patent and its ownership of the applicant or other parties in China, in respect of the drug applied for registration, its formula, manufacturing processes and/or uses, etc. Where another party owns the patent in China, the applicant shall provide a statement of noninfringement. The drug regulatory department shall publish the information or the statement submitted by the applicant on its official website. Where a patent dispute occurs in the process of drug registration, it shall be settled in accordance with relevant laws and regulations on patent. 17

18 18

19 Relevant IPR Articles in the Provisions for Drug Registration Article 19 For a drug patented in China, applicants other than the patentee may submit the application for registration two years prior to the expiry date of the patent. The State Food and Drug Administration shall review the drug application in accordance with the Provisions, and after the expiry date of the patent, check and issue the drug approval number, Import Drug License or a Pharmaceutical Product License if the application conforms with the provisions. 19

20 Conclusions China has established a relatively comprehensive legal system for the protection of IPR. China's IPR protection system aims at achieving world dimension and world standards. Different government agencies are responsible for IPR policy formulation and implementation in China. Use the TRIPS flexibilities to protect health Pay more attention to the special policy related to pharmaceuticals and medicine devices. 20

21 Contact US Tel: Fax: Website: 21

22 THANK YOU! We Dedicate to Pharmaceutical Intellectual Property and Regulatory affairs

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