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IPR: Drug Innovation through Better Enforcement
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Drug Innovation through Better Enforcement

IP Protection in the Pharmaceutical Industry

体育用品热销、健身房火爆……我国居民的种种日常生活变化都表明大家对健康与身体的关注度越来越高。大众健康意识也提升了人们对药物或补品药物的选择与消费。我国专利知识产权制度的完善也更加刺激了国内制药业的创新发展。对于外来企业而言,我国设立各类研发中心以及当地低成本和优惠税率等优惠条件都是吸引外企来华设厂的良好条件。下面我们就来介绍一下药企在华发展需要注意哪些方面。


首先,在专利方面,中国专利保护活性药物成分、药物制剂等制备工艺以及已知药物和医疗器械等的技术创新。大多数药品创新可以受到20年发明专利的保护。新药研发风险高、耗费大、在展开研发活动前,一定要进行“自由实施”(FTO)专利研究,确保没有侵犯其他企业专利权。在自然界中发现存在于其自然状态的物质是无法获得专利的。然而如果物质可以首先从自然界中分离或提取出来,并且其物理或化学参数在现有技术中是未知状态,那么获取物质的过程可以被授予专利权。例如获得植物提取物的方法在我国可以申请专利。


其次,在中国商标局注册商标可以是新创商标或英文的中文音译商标名。药品名称包括通用名称与商品名称。但是通用药名不可以注册为商标。商品名称则应尽可能独特并避免被误认为通用药名。


最后,保护好自己的药品研发商业机密非常重要,参与项目员工需要签署保密协议,企业也应制定相关内部规定与合同,以防未经授权使用专利或是被披露商业机密。


制药行业发展迅速,专利法也在发生变化,这也将为欧洲企业带来更好的保护和更稳定的贸易环境。

BT 201706 IPR 01
China is one of the largest pharmaceutical markets in the world. Its development is high on the government's reform agenda as they seek to provide stimulus and intensify research and development (R&D) activity. This, coupled with enhanced health awareness among a rapidly growing patient pool, makes the country an increasingly attractive market for foreign business. The China IPR SME Helpdesk explains the current intellectual property regime in China and says that better enforcement will create a more secure environment that can attract more R&D and stimulate higher levels of innovation in China's pharmaceutical industry.


The level of intellectual property (IP) enforcement in China has constrained pharmaceutical companies' efforts in carrying out R&D activities in the country. However, China's Patent Law is soon due to be revised and is expected to foster greater innovation and slow down the proliferation of counterfeit drugs. A growing number of companies have become increasingly attracted to having an R&D centre in China, as a local presence provides generally lower cost base and favorable tax rates.


Patents


China's Patent Law protects technological innovations for active pharmaceutical ingredients, drug combinations, pharmaceutical formulations, preparation processes of pharmaceutical products, new medical indications of a known drug and medical devices among others. Most pharmaceutical innovations are protected by invention patents which provide 20 years' protection.

BT 201706 IPR 02
A pharmaceutical company must continuously monitor the patent status of related subjects of its own products and design its R&D strategy based on filing a series of patent applications around its own innovations. It seems that the antibody drug Genetech could be a good example of an effective monitoring strategy with over 60 Chinese patents/applications protecting its preparation processes and its combination with other drugs not to mention innovations.


Research and development for new drugs is risk-intensive and costly. Before carrying out R&D in China, companies should conduct 'freedom to operate' (FTO) patent research to ensure that there is no risk of infringing another party's patent rights or ongoing patent application.

hl ipr01
To assess novelty and inventiveness, companies must perform a patent search before filing the application through a local patent agency. A patent search should be exhaustive, covering all scientific and chemical aspects and possible variants. This typically includes a drug's Chinese general name and trade name, structure of the compound, possible variants in structure, corresponding general formula, medical use, combination use and preparatory method.


Patentable subject matter includes the general formula of a compound, its composition with a combination of two agents, its release control formulation, sequences of amino acids and sequences of DNA/RNA preparation processes. However, treatment/diagnostic methods of diseases and first medical use are un-patentable in China.


A substance found in nature and existing in its natural state is also not patentable. However, if a substance can be isolated or extracted from nature for the first time where the physical or chemical parameters are unknown in the prior art and can be precisely characterised and it has industrial value, both the substance and the process for obtaining it will be patentable. For example, obtaining a plant extract and the process of extraction is patentable in China.


Concerning infringement cases, the plaintiff carries the burden of proof unless the patent concerned is a method patent, in which case the burden is transferred to the defendant. According to China's Patent Law where a dispute arises from an alleged infringement of the patent right, the patentee or any interested party may institute legal proceedings in the people's court or request the local Patent Administration Department (PAD) to handle the matter. If the PAD decides that there has been an infringement, it may order the infringer to stop the infringing act immediately.

BT 201706 IPR 03
Trademarks


A pharmaceutical trademark is a mark registered with the Chinese Trademark Office and can be a newly created mark or a Chinese transliteration of a trademark. The drug name of pharmaceuticals includes the common name and trade name. The common name refers to the drug's legal name approved by the Pharmacopoeia Commission of the Ministry of Health. The Trademark Law prevents common names from being registered. For instance, Paracetamol is a common name of a pharmaceutical drug meant for curing fever and therefore cannot be registered. In fact, different manufacturers often use the same common name on pharmaceutical products with the same prescription or the same variety of drugs.


BT 201706 IPR 06Trade name of pharmaceuticals is decided by the manufacturers of the drugs themselves and can be applied for as a trade mark. Under a same common name, the drugs could have different trade names. Trade names distinguish different providers of the same pharmaceutical products. For instance, Motrin and Tylenol are both trade names of pharmaceuticals for curing fever. They share the same common name but by bearing different trade names, consumers can distinguish between the two.


It is important to avoid using the trade name a common name. A classic example is the case of Aspirin where consumers became accustomed to ascribing Aspirin, a trade name at the time, to all pharmaceuticals treating arthritis, rendering it a common name in practice. As a result, the rights owner, Bayer, lost its trademark in many countries due to its failure to clarify Aspirin's status as a trade name. The following actions should thus be considered to avoid generalisation of trade names of pharmaceutical products:


A trade name should be as distinctive as possible. It is important to avoid using a name related to the features or functions of the pharmaceutical product. For instance, Motrin is translated as MEI LIN in China without literal meaning. It does not include any descriptive nature of the drug. Thus, it is not easy for Motrin to be mistaken for a common name.


The owner of pharmaceuticals in China should not claim the trade name if a trade name is listed in the pharmaceutical nomenclature. The mark will likely be regarded as a common name and can consequently be used by any party.


If any competitor uses a trade name as a common name, timely action should be taken, such as sending a cease and desist letter to the infringer and publicising the infringement in newspapers and magazines among other channels.


Trade Secrets


BT 201706 IPR 04The complexity of R&D processes concerning new drugs makes protection of trade secrets critical to pharmaceutical companies. High employee turnover in the industry makes it very important to sign a confidentiality agreement before employee participation in any R&D project. Furthermore, companies should set up relevant internal rules and physical technological and contractual measures to prevent unauthorised use of and disclosure of trade secrets.


Inspection of computer hard drives and monitoring emails of employees with access to technical secrets and know-how is also critical. A robust monitoring system of disclosure in the public domain can disincentivise unlawful actions on part of current and former employees. Once an ex-employee has shared a secret with the third party or has filed a patent application, in practice, it is advised to first attempt a settlement through negotiation with the infringer before pursuing a long and costly lawsuit.


Most disputes between business partners often relate to misuse of the involved technology secrets by the patent licensee. Once there is a dispute, be sure to collect evidence to demonstrate unauthorised access to the involved technical secrets and similarity of the alleged know-how and the involved technical secrets before commencing litigation. Be sure to protect the technology secret during litigation by asking for a closed hearing. Collecting evidence on trade secret theft is difficult and borne by the plaintiff. It is therefore advisable to seek the court's assistance in issuing an investigation order or evidence preservation during litigation by submitting a reasonable requirement.


The pharmaceutical sector is rapidly developing under the current reform agenda, with impending changes to the Patent Law expected to safeguard R&D activities. This will hopefully result in better protection and stronger enforcement mechanisms for technological innovations and a more stable operating environment for European businesses.


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