In july this year, our 15-year protection period for joining wto expired. The pharmaceutical industry is an innovative and intensive industry, with relatively concentrated patents on inventions, and it is imperative to respond to changes in the protection of pharmaceutical intellectual property rights -
The supreme people's court, after a re-examination, ruled on the medical intellectual property case of changzhou's 3d industrial technological research institute ltd., which became the first case of domestic pharmaceutical intellectual property at the current rate of $1. 01 billion. This case is very exemplary for intellectual property protection in the pharmaceutical industry. The pharmaceutical industry is an innovation-intensive industry with relatively centralized intellectual property rights, which are relevant to everyone, and the protection of its innovations is particularly important. In july of this year, our 15-year protection period for joining the wto expired and, for many enterprises, may be facing a new cycle of card shuffles。
Behind a billion dollars of intellectual property
The patent act was enacted in 1984, at which time no patents were granted for chemical medicines, and the amendment of the patent act in 1992 was important in the context of accession. There is now a consensus to intensify the fight against violations, both administrative and judicial
After eight years of development, the institute and the shanghai long march hospital of the second military medical university developed the first new drug in the country in 2000 that was successfully used for the dialysis of urinary dialysis. In order to start production as soon as possible, the r & d unit authorized the production of the drug to changzhou lancheng pharmaceuticals ltd. And entered into a technical cooperation contract with the express agreement that all intellectual property rights over the drug, including registered trademarks, would be owned by the r & d unit. After 10 years of cooperation, the standard of quality of medicines has reached an international lead, entering the national catalogue of basic health insurance and increasing market occupancy, the name of the drug and the registered trademark “reca” are considered to be the first brand of the chinese market, zocanitis. When the products were receiving significant revenues, lancheng, in breach of its cooperation contract, and in breach of its obligations with the associated shanghai mainland pharmaceuticals company ltd., made a loss of 1. 01 billion yuan to r & d. In order to defend their legitimate rights and interests, the three-dimensional institute, among others, has brought the drug production and sale enterprise before the courts. In 2014, the jiangsu provincial high people's court rendered a final judgement in this case and found the technical cooperation contract valid. In 2015, the supreme people's court handed down a new decision upholding the final judgement of the jiangsu higher people's court。
Cases of intellectual property rights over medicines such as changju are not an example. “the biggest problem in the protection of intellectual property rights in medicine is the insufficiency of penalties for infringers and the risk of abuse for some.” the chairman of the 3d board of directors of changzhou said。
Drug regulatory law is a very important body of law for the protection of pharmaceutical intellectual property rights, and while it focuses on ensuring the quality and safety of medicines, it can more rationally create more conditions for technological innovation in the field of medicine, particularly technology conversion. The deputy director of the centre for the development of practical intellectual property rights in beijing, han won-sheng, stated that, for r & d units, since it was necessary to find a manufacturer to obtain a production symbol in order to register and market the product, it was extremely easy for the manufacturer to take possession of the product and make a profit。
“drugs are a special commodity, firstly the production of which requires authorization, authorization and transfer from intellectual property rights holders, and secondly, the ability of enterprises to recognize their qualifications in the form of the issuance of drug approval symbols. In the case of pharmaceutical regulation, its fundamental purpose is recognition of productive capacity, not recognition of production rights.” it was explained by yuan jianjun, head of the policy and regulations division of the national food and drug control authority. He hoped that, in the future, the interests of intellectual property owners would be better protected by the establishment of a publicly listed licensor system. In developed countries such as europe and the united states of america, the holders of licences to market medicines can set up their own production systems or entrust production entirely to other producers with the conditions for production, which can tie down the development and production of medicines and separate the licences and permits for listing and production, in effect guaranteeing the rights of intellectual property owners。
Inadequate protection and inadequate punishment are changing. Li sun-de, a researcher at the institute of law of the chinese academy of social sciences, described medicine as a special area within patent protection. The patent act was enacted in 1984, at which time no patents were granted for chemical medicines, and the amendment of the patent act in 1992 was important in the context of accession. There is now a consensus to intensify the fight against violations, both administrative and judicial. “for example, the trademarks act, amended in 2013, includes punitive damages, which were paid in accordance with the original civil law, i. E., the amount of the damages, but which can now be doubled as a penalty.” this is also the policy context in which changzhou has access to substantial compensation。
Why is it difficult to enforce the law properly
We are now at an international level with respect to pharmaceutical intellectual property legislation, which is quite robust in terms of patents, trademarks, drug data protection, and administrative protection of medicines, and inadequate protection is mainly due to enforcement
Data show that 90 per cent of the domestic market consists of generic drugs and that the market share of innovative drugs is small. Although there is still much room for innovation in the field of medicine, this does not mean that our pharmaceutical industry has stalled. When the new china was founded, the most important drugs, penicillin and penicillin, were in the hands of only a few western countries. We are now the world's first major producer of penicillin. By the 1990s, my country had been able to produce 24 major classes of thousands of medicines, with remarkable achievements. It should be noted that imitation is not a counterfeit drug, that imitation has intellectual property rights, and that the united states, which has the capacity to create new drugs, is also the world's largest imitator。
In contrast to the rapid growth of our pharmaceutical industry, our country does not produce many patents in this area, which, according to chen, is linked to our long-standing form of public ownership by the deputy director-general of the medical intellectual property research committee of the chinese pharmaceutical society. Lee sun-dee told journalists that we now have almost international standards on pharmaceutical intellectual property legislation, be it patents, trademarks, drug data protection, drug administrative protection, etc., which are quite robust and are largely inadequate in law enforcement。
With regard to enforcement difficulties, the director of the planning and development unit of the centre for intellectual property development studies of the national intellectual property agency (inip) revealed that the national intellectual property agency was taking two measures to address them: first, the establishment of a blacklist system for torts, in addition to court decisions, would involve the creation of links between the intellectual property administration and the business sector。
Lack of intellectual property awareness is also an important reason for inadequate protection. “ipr awareness includes public awareness, including mutual respect between enterprises and competitors, respect for the intellectual property of others, and protection of one's own intellectual property.” according to former ki, deputy director of the trademarks review and coordination centre of the national directorate of commerce and industry, some of the violations are more common, such as the conflict between the name and the trademark of the new drug, and when a new drug emerges, the new name and trademark will be confused with those of the trade and used as a generic trademark. In response, the revised trademarks act makes greater adjustments to the trademark registration and regulatory regime in terms of facilitating trademark applicants, maintaining a fair competition market order, increasing the protection of trademark patent rights and regulating trademark agents。
Promoting innovation through institutional design
The country invested a lot of money in research and development, but it could not industrialize
“i think 2015 is the worst year since 1991, 1992.” “in july of this year, the 15-year buffer period for our accession to the wto ended, most of the products would fall to near-zero levels, international products would rush in, and production and competition in the same way would hardly reflect advantage. At the same time, the great stick of intellectual property rights will be swinging over your head, and some of our small businesses are likely to be destroyed.”
“we have many systems from abroad that, if not accompanied by corresponding policies, may be incomplete and raise questions, mainly in terms of the fact that the distribution of rights is not necessarily scientific and that there is no basis for the identification of some rights.” both trademark law, patent law and other relevant laws and regulations have been amended in this context。
How can enterprises better protect intellectual property rights? He believes that there should be developmental protection. In an era of “internet+”, the costs of financing and information asymmetries were gradually being eliminated, and “grain” investors could well be involved in the early stages of intellectual property development。
There is a consensus among industry that intellectual property rights related to medicines should accelerate industrialization and benefit the population as soon as possible. But there's always been a big contradiction in the development of drugs. The country has invested a great deal of money in research and development without being able to industrialize。
How can this outstanding contradiction be resolved? The “pharmaceuticals” of hinhantine are innovations in business models, with four “boundaryless” at their core: an unbridled investment model that allows intellectual property rights to absorb social capital in a securitized manner, by transforming intellectual property rights into capital and not just into re-marketing products; an unbridled process of productization, by refining securitization intellectual property rights through product engineers; the use of networks to fully market; and an investment fund on intellectual property to promote the development and utilization of intellectual property rights. Failure to adopt such rapid development and utilization will lead to a devaluation of the value of knowledge. "can't wait for all laws and regulations, including enforcement, to be fully implemented, and we can do a lot now."
