Zhao Zhe,Sheng Mengdi,Fan Junyan,Liu Yanwen,Dong Li

(School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China)

Abstract Objective To analyze the current situation of pharmaceutical patents in Liaoning Province with the background of increasing emphasis on intellectual property rights in the pharmaceutical industry and the application of pharmaceutical-related patents having taken shape in Liaoning Province.Methods The invention patent information applied by Liaoning pharmaceutical manufacturers before December 31,2018 was obtained from Qixinbao APP,and then the retrieval data was also obtained through detailed search on patent information inquiry websites in China and other countries.The types of drug patents were separately extracted by Excel.Data analysis was carried out according to drug category,applicant type,legal status and transfer situation.Results and Conclusion A thorough discussion on the current situation of patent applications in pharmaceutical industry of Liaoning Province reveals that the number of patent applications is large but they are lack of creativity.Meanwhile,few patent applications are made by individual.Besides,there are fewer international patent applications for pharmaceutical patents in Liaoning Province.The problems in patent applications include the followings,such as insufficient patent applications and unbalanced proportion of patent applications.In order to promote the stable development of pharmaceutical market in Liaoning Province,some suggestions are raised.

Keywords:Liaoning Province;pharmacy;patent application

In the contemporary era,intellectual property has the value and potential to obtain great benefits.In China,more attention has been paid to it by all walks of life,including pharmaceutical industry.Pharmaceutical patents play an important role in the protection of intellectual property of drugs.The number of patents owned by a pharmaceutical enterprise shows its competitiveness in pharmaceutical market.Liaoning Province,one of China's heavy industry bases,has abundant medical resources,and the development of pharmaceutical industry has formed a certain scale.However,there are still some problems in the application of pharmaceutical patents,which inevitably causes great losses in the protection of patents in the later period.This paper mainly elaborates the status quo of pharmaceutical patent applications in Liaoning Province,pointing out the problems in pharmaceutical related patent applications and giving some suggestions for the current pharmaceutical patent work in Liaoning Province.

1 Patent search of pharmaceutical enterprises in Liaoning Province

1.1 Definition and classification of pharmaceutical patents

Drug patents,are patents applied for drugs,including patents for pharmaceutical products,pharmaceutical preparation processes,and pharmaceutical uses[1].According to Article 2 of the Patent Law of China (hereinafter referred to as the Patent Law),there are three types of drug patents:(1)invention patents,(2)utility model patents,(3)design patents.In pharmaceutical patents,the latter two kinds of patent pharmacy specialties have lower technical content and less quantity.Drug invention patents also include three types:product patents,method patents and use patents.

1.2 Sources of retrieval data

This paper mainly uses Qixinbao APP to collect 788 invention patents applied by pharmaceutical manufacturers in Liaoning Province.The data are collected through the patent retrieval and analysis platform of the State Intellectual Property Office,and then the data are sorted out,counted and analyzed.Enterprise name is used to inquire patent information in Qixinbao APP,and then application number is applied to query patent examination information in China and other countries.For example,if you want to inquire about the enterprise information and patent information of Shenyang Shide Pharmaceutical Co.,Ltd.,Dongyao Pharmaceutical Group,you can get the information needed through the production address,production scope,IPC classification number,applicant,inventor,and application number in Qixinbao APP.Then the information on the legal status of patents can be retrieved.The retrieval time is as of December 31,2018.

1.3 Analytical methods

By using Excel to make statistical analysis,the detailed information of 788 drug invention patents in Liaoning Province was obtained.

2 Analysis of patent retrieval results of pharmaceutical enterprises in Liaoning Province

Patents for invention in pharmaceutical industry mainly refer to a kind of intellectual property related to medicine which is protected by national law.Like other intellectual property rights,patent for invention can be regarded as an intangible asset.According to the above retrieval methods,the status quo of pharmaceutical patent application in pharmaceutical manufacturing enterprises of Liaoning Province is retrieved as follows.

2.1 Basic situation of pharmaceutical invention patents in pharmaceutical enterprises

According to the overall publicity and authorization of invention patents,449 out of 788 invention patents were disclosed,accounting for 56.98% of the search information.And 339 drug invention patents were authorized,accounting for 43.02% of the search information.The number of authorizations for pharmaceutical invention patents is less than the number of publications,which is directly related to the strengthening of the drug registration management system.Because of the revision of the Patent Law and its implementation rules,the patent system will be further improved.

2.2 Types of pharmaceutical invention patents

According to the content of patent application for pharmaceutical invention,pharmaceutical invention patents can be divided into product invention,method invention,use invention,product+method invention,product+use invention,method+use invention,and product+method+use invention,etc.

In total,788 patents for drug invention in Liaoning pharmaceutical enterprises are mainly method invention and product+method invention,the numbers are 291 and 313 respectively,accounting for 36.93% and 39.72% of the total patents for invention.This indicates that Liaoning pharmaceutical enterprises start to pay attention to product development.There are 100 patents for product inventions with high degree of technological innovation,accounting for 12.69% of the total number of patients for drug inventions.At the same time,the proportion of patents for utility invention,product+use invention,method+use invention,product+method+use invention and patent for drug invention is relatively low,all of which are about 3%.

2.3 Classification of pharmaceutical invention patents

China's Pharmaceutical Patent divides the patent application into four fields:chemical pharmacy,traditional medicine and natural medicine,biological products and biochemical drugs as well as the treatment and comprehensive utilization of three wastes.This time only three fields are analyzed which include chemical pharmacy,biological pharmacy and traditional medicine.Among 788 pharmaceutical invention patents of Liaoning pharmaceutical enterprises,traditional pharmaceuticals are the major ones,totaling 353,accounting for 44.80% of the total patents,followed by chemical pharmaceuticals,with 300,accounting for 38.07%.While biopharmaceuticals,as an important part of the seven strategic emerging industries,have only 135,accounting for 17.13% of the total patents.The new seven industries refer to the seven areas identified by the national strategic industries planning and the supporting policies of the central and local governments.The new seven areas are energy conservation and environmental protection,information industry,biological industry,new energy,new energy vehicles,high-end equipment manufacturing industry and new materials[2].

2.4 Types of applicants for pharmaceutical invention patents

Patent application is a necessary procedure for obtaining patent right.For the acquisition of patent rights,the applicant shall submit an application to the State Patent Office,which shall approve and issue a certificate[3].

Among 788 patent applications of pharmaceutical enterprises in Liaoning Province,enterprises are the mainstream,accounting for 96.57% of the total invention patents,761 of which are patent applicants for pharmaceutical invention.Individuals are relatively rare as patent applicants for pharmaceutical invention,with only 27 patents,accounting for 3.43%.It shows that pharmaceutical enterprises in Liaoning Province are the backbone of drug research and development,and their technology,capital and talents have laid a good foundation for pharmaceutical development in Liaoning Province.

2.5 Legal status of drug invention patents

According to the time sequence,the legal status of patents can be divided into two stages:before authorization (in the trial stage)and after authorization (in the valid or invalid stage).From the submission of a patent application,it first goes through the stage of examination (invention includes public and substantive examination;utility model and design include preliminary examination).After the examination procedure,it enters the stage of validity or invalidity (including authorization,rights restoration and invalidity)[4](See Figure 1).

Fig.1 Stage diagram of patent legal status

Among 788 pharmaceutical invention patents of Liaoning pharmaceutical enterprises,there are 322 invention patents,accounting for 40.86% of the total.295 patents are invalid,accounting for 37.44% of the total patents.Only 21.7% of pharmaceutical invention patents are in the stage of examination.Generally speaking,the inefficiency of pharmaceutical invention patents in Liaoning Province is relatively high,largely due to the voluntary abandonment of patentees.First reason is the cost of patent maintenance is relatively high but the economic benefits of patents are relatively low.Second reason is that patents have no prospect of market commercialization and the holders are unwilling to pay maintenance costs.The third reason is that some researchers ignore the prospects of commercialization of patents while doing the research and these patents do not have the value of industrialization (See Figure 2).

Fig.2 Distribution of pharmaceutical patent legal status of pharmaceutical enterprises in Liaoning Province

2.6 International patent applications for pharmaceutical invention patents

Among 788 pharmaceutical invention patents of Liaoning pharmaceutical enterprises,99.62% did not apply for international patents,while only 3 patents applied for international patents,accounting for 0.38% of the total patents.That is to say,they almost completely abandoned the international market.It shows that the patent applicants of pharmaceutical inventions in Liaoning Province have weak awareness of international patent protection.Therefore,they have voluntarily abandoned the promising international market.It also reflects the low scientific and technological quality of patent applications for pharmaceutical inventions in Liaoning Province.The following factors such as the low investment in scientific research,the imperfect international application services,and the insufficient policy support from the government limit the international application of pharmaceutical invention patents in Liaoning Province to a certain extent[5].

2.7 Transfer case of pharmaceutical invention patents

388 patents of 788 pharmaceutical invention patents owned by pharmaceutical manufacturers in Liaoning Province have been transferred,accounting for 42.89% of the total patents.However,450 pharmaceutical invention patents have not been transferred,accounting for 57.11%.

3 Analysis of the current situation of patent application of pharmaceutical enterprises in Liaoning Province

3.1 The number of patent applications of pharmaceutical enterprises in Liaoning Province is large but lack of creativity

In Liaoning Province,the number of patent applications for traditional Chinese medicines is relatively high,while the number of patent applications for biopharmaceuticals and chemical medicines is relatively low.This shows that the theory of traditional Chinese medicine becomes more mature,the patent protection system of traditional Chinese medicines is increasingly perfect,and China has great advantages in the utilization of traditional Chinese medicines resources.On the other hand,it also shows the problem of low creativity.The main factors leading to the lack of creativity in pharmaceutical patent application include the lack of advanced technology,unreasonable industrial structure and the imperfect development environment.

Due to the lack of innovation and repetition of patent applications among different enterprises,pharmaceutical enterprises in Liaoning Province have wasted production resources and technology,which hinders the development of pharmaceutical industry in Liaoning Province.

3.2 The amount of patent applications filed by enterprises is more than that filed by individuals in Liaoning Province

In this retrieval of medical enterprises in Liaoning Province,the total number of medical patent applications is 788.But the number of individual applications is only 27,accounting for 3.4% of the total number of applications.Most of them are traditional Chinese medicine patent applications.Both the number of applications and authorized patent applications are small.

This phenomenon is mainly due to the fact that in the fierce market competition,it is the best choice for enterprises to apply for their own patents inventions.By applying for patents,enterprises can not only protect their patents by law,but also quickly occupy the market and establish competitive advantages in the market,which is more conducive to enterprises' publicity and sales of products.Therefore,their demand for patent applications is very strong.But at the same time,it is also one of the reasons that lead to the high repeatability,low technology and poor innovation of pharmaceutical patent applications in Liaoning Province.

On the contrary,insufficient awareness of individual patent application and many problems in the protection of patent rights becomes obstacles for the development of intellectual property rights in Liaoning Province,which will further hinder the implementation of China's patent strategy and the grand goal of building an innovative country.

3.3 Small number of international patent applications for medical patents

Relevant data show that China accounts for only 5% of the $30 billion international market for traditional Chinese medicine,and about 70% of the 5% market is herbals.The number of international patent applications of pharmaceutical enterprises in Liaoning Province is even less.Besides,Chinese patent medicines with high technology added value are not only exported in small quantities,but also face the danger of being imitated in international trade.

First,because the current patent system originated in the West,the patent protection system of traditional Chinese medicine formed under the Western cultural system and thinking mode is much less effective than the protection of chemical drugs,which has caused a blow to the enthusiasm of enterprises to apply for international patents.Second,the lack of familiarity with international application procedures has led to the low enthusiasm for international pharmaceutical patent applications.Thirdly,China does not have a standard system for traditional Chinese medicine which is in line with international standards and recognized by the international community.Besides,the upper limit of Chinese medicine quality standards,such as heavy metals,is lower than that of Western countries.It is difficult for such a standard system to be recognized in the international community[6].

4 Proposals

4.1 The industrial structure of internal medicine in Liaoning Province should be optimized

Since the 21st century,all countries in the world have given priority to the development of biopharmaceutical industry,increasing policy support and investment in this industry.The number of pharmaceutical patent applications in pharmaceutical enterprises of Liaoning Province is high,but most of them are patent applications for traditional Chinese medicine and essential drugs.The number of patent applications for biopharmaceutical industry is low,and the research and development of biopharmaceutical industry is falling behind as well.In view of this phenomenon,the industrial structure in Liaoning Province should be the adjusted and optimized.First,a practical and feasible development model should be made to promote the coordinated pharmaceutical economy.We should optimize the overall layout of pharmaceutical industry in Liaoning Province,and key enterprises and groups should be encouraged and cultivated to list on the market.In addition,modern pharmaceutical logistics network should be built to optimize the allocation of resources and promote the intensive development of enterprises.At the same time,small and medium-sized enterprises with competitive advantages in Liaoning's pharmaceutical industry should be actively supported to promote the development of pharmaceutical economy.

4.2 Improving patent acquisition and the protection system in pharmaceutical industry

The acquisition of patents in China requires a lot of costs,which to some extent hampers the enthusiasm of patent applicants.The application fee,examination fee and registration fee for invention patents are 3 705 yuan per piece.The validity period is 20 years.The annual fee is 900 yuan per year for 1-3 years,1 200 yuan per year for 4-6 years,2 000 yuan per year for 7-9 years,4 000 yuan per year for 10-12 years,6 000 yuan per year for 13-15 years,and 8 000 yuan per year for 16-20 years.In addition,there are loopholes in the protection system of medical patents in China,the low penalties for patent infringement and insufficient restrictions on generic drugs also affect the enthusiasm of patent applicants.

4.3 Increasing patent R&D investment and strengthening government support

In order to solve the problems of insufficient patent applications and unbalanced proportion of patent applications categories in Liaoning Province,the government should give policy support to pharmaceutical enterprises in terms of financial,technical and human resources.Pharmaceutical enterprises should purchase advanced equipment and employ excellent talents to improve patents application Liaoning Province.Meanwhile,the government can provide research and development funds for enterprises or individuals to ensure the smooth development and application of the project.Enterprise can communicate with international organizations actively so that they can apply for international patents with the international application review model.

As to the problems of low enthusiasm of patent applicants,weak consciousness and lack of innovation caused by patent application,the government should also take adequate incentives.For example,reducing the cost of patent application can motivate patent applicants.Besides,the government should increase the investment in patents and provide loans.At the initial stage when patents enter the market,the uncertain technology makes the investment risky.Therefore,increasing government investment is conducive to the transfer of patented technology.Last,the government should improve the incentive mechanism for patent applications.

4.4 Adjusting the organization security system and strengthening the construction of famous and excellent products

We should strengthen macro-control and formulate policies for the development of pharmaceutical industry in Liaoning Province.Then the reform of medical and health system can be actively and steadily promoted.The management of drug bidding and procurement should be standardized to monitor the process of drug centralized bidding and procurement strict.Besides,GMP,GSP and GAP certification must be strengthened to make pharmaceutical industry an important economic growth point in Liaoning Province.

Brand advantage should be form first.Enterprises can be encouraged to implement brand strategy to expand the overall influence and competitiveness of Liaoning pharmaceutical industry.The brand effect can be used to drive the steady development of Liaoning pharmaceutical industry.