Many infringers of antibiotic drug patents were sealed up

——— Infringement of intellectual property rights

Special correspondent: Weihua reporter recently learned from Guangzhou Wellman Pharmaceutical Co., Ltd. (Willman Pharmaceuticals) that at the opening of the 53rd National Pharmaceutical Fair, when all manufacturers were making inquiries, Xiamen Intellectual Property Office, Xiamen City A team of more than 10 people from the Notary Office and Hunan Changde Intellectual Property Office sealed off the antibiotics distributed by Shandong Ruiyang Pharmaceutical Co., Ltd. and Guangzhou Baiyunshan Pharmaceutical Technology Development Co., Ltd. (Baiyunshan Technology) on the spot at the pharmacy exhibition hall. "Baoding" (the common name for the use of paracetacil sodium sodium sulbactam for injection). The seizure was a success and the flag opened, and this opened a new round of drug patent protection. Professor Sun Mingjie, vice chairman of the Board of Directors of China Pharmaceutical University and chairman of Wellman Pharmaceuticals, told reporters that as early as in 2000, they obtained the invention entitled “anti-β-lactamase antibiotic complex” and “antibacterial combination drug”. Patents (Patent Nos. ZL97108942.6 and ZL98113282.0), which claims that the new drug products protected by them are "Piracillin Sulbactam Sodium for Injection" and "Cecilizin Sodium Sulbactam for Injection" sodium". However, they recently discovered that companies including Beijing Shuanghe, Guangzhou Baiyunshan Pharmaceutical Technology Development Co., Ltd., and Shandong Ruiyang are producing or selling products protected by this patent.

Pharmaceutical companies involved in compound antibiotic intellectual property "minefield"

In fact, it is not an accident that pharmaceutical companies have entered the "minefield" of intellectual property rights. Baiyunshan Science and Technology is far more than the sole infringing company. The reporter also learned that the infamous Pfizer “Waiaike” patent dispute has once again resorted to court. The case of Pfizer Inc. v. Patent Reexamination Board of the State Intellectual Property Office was opened in the Beijing First Intermediate People’s Court on March 30. The domestic 12 drug companies and a natural person were listed as the third party in the lawsuit. Comment: Previously, the Patent Reexamination Board of the State Intellectual Property Office had declared that Pfizer's "Waiai" patent was invalid. On July 5, 2004, the Patent Reexamination Board of the State Intellectual Property Office of the People's Republic of China was tried by law and declared that Pfizer's patent for the treatment of impotence was invalid (this case was selected for the 2004 China Intellectual Property Billboard). Several domestic pharmaceutical companies in the case subsequently announced that because the “Vagra” patent has been declared invalid and they have obtained the new drug certificate issued by the State Food and Drug Administration (SFDA) for “sildenafil citrate”, The production will be organized immediately. However, to this day it has not yet been implemented. Similarly, as early as 2004, Beijing Shuanghe Pharmaceutical Co., Ltd. obtained a new drug approval for the production of a new drug, “Piracillin Sulbactam Sodium for Injection” issued by the SFDA. It stands to reason that since production approvals have been obtained, production and sales can of course be justified. However, Beijing Shuanghe has not produced or sold this product until today. Why? Some professionals pointed out that the reason is very simple, that is, the products that these companies are preparing to produce have hidden problems that infringe the protection of intellectual property rights of Others. Comment: According to Chinese patent law, after the Patent Reexamination Board of the State Intellectual Property Office has handled the application according to the applicant's application and decided to declare the patent in question ineffective, the losing party may file a lawsuit in the People's Court within 90 days. During the lawsuit, although the patent involved in the case has been declared invalid by the Patent Reexamination Board, because it needs to be subject to judicial review, it has no enforcement power for the time being. From the objective effect point of view, before the people's court made the effective judgment, the legal effect of the patent involved in the case still exists. A third person may not be implemented without authorization. This is the reason why several domestic pharmaceutical companies, who are applicants, announced the production of sildenafil citrate, but they have to give up the important reasons for implementation. Therefore, despite the fact that Beijing Shuanghe Pharmaceutical has failed to actually produce the new product of “paracetacil sodium and sulbactam sodium for injection” after obtaining the production approval issued by the SFDA, the main reason for the declaration by Beijing Shuanghe is that It is a patent protection product applied by Wellman Pharmaceuticals. Comment: According to China's patent law, although Beijing Shuanghe has obtained the production approval issued by the SFDA, as long as actual production is objectively infringed on the patent right of Wellman Pharmaceutical. Not only does Beijing Shuanghe produce the product and constitutes infringement, but also the pharmaceutical operating companies and hospitals that sell or use the product produced by Beijing Shuanghe also constitute infringement. Professor Sun Mingjie also said that in fact, due to the weak awareness of intellectual property protection in Chinese pharmaceutical companies, this aspect has experienced blood lessons. For example, he said that in the 1970s, Chinese medical scientists successfully developed new chemical drugs called artemisinin after more than 10 years of hard work. However, due to various reasons, this high-tech technological achievement did not eventually apply for a patent. Shortly after the publication of this research paper on technological achievements, foreign companies applied for patent protection on a slight change, resulting in an export loss of nearly 500 million U.S. dollars a year. Even more ridiculous is the fact that China's vitamin C two-step fermentation process preparation technology with the internationally leading level, because the awareness of intellectual property protection is not strong, resulting in multi-million-dollar technological achievements are only spent less than 1 million yuan by foreign companies The renminbi was bought. In the following years, a large number of foreign vitamin C dumped at domestic low prices, causing some domestic production companies to be in trouble once.

There are misunderstandings in drug declaration and production

The reporter learned that some pharmaceutical companies in China have a few misunderstandings in the process of drug declaration and production in addition to the weak sense of intellectual property protection. First, provide false ownership certificates and promises to swindle production approvals. Article 11 of the "Administrative Measures for Registration of Drugs (Trial)" stipulates that an applicant shall provide proof of patents and their ownership in China and submit patents to others if they apply for registered drugs or prescriptions and processes used. Infringement guarantee. In practice, since the law does not require the SFDA to conduct substantive examination of the above-mentioned applicant's certificates and guarantees, some drug companies know that the products they declare are protected by intellectual property rights, because the SFDA only conducts formal inspections and finally passes the trial. Commentary, in the reporting process, Yan submitted false information in order to get through. Comment: It is reported that in order to implement the new "Administrative Licensing Law" promulgated and implemented, the regulatory and policy department of the SFDA is drafting an approach to objection hearings for drug registration. In the future, not only will the SFDA be able to initiate a review of the filing materials submitted by applicants for drug registration, including the above-mentioned ownership certificates and guarantees, the applicants will be required to submit further certification materials, and interested parties (such as patentees) and third parties. If it is found that the applicant’s filing information is false or may infringe the legitimate rights and interests of others, the SFDA may apply for the initiative or through the application of interested parties to organize a hearing. Upon discovery that its submitted ownership certificate and promises are false, the new drug certificate will be cancelled according to law. Production approvals are given and penalties are imposed. Severe persons will be revoked production licenses. If this method is implemented, companies that want to use their brains for ownership verification and commitment will undoubtedly lift their hands on their own feet. Second, they believe that they can produce and sell pharmaceutical production approvals. The production approval documents are only the competent authorities of the industry reviewing and approving the pharmaceutical products declared by the pharmaceutical companies from the business perspective. The issuance of a production approval document does not directly imply the full legality of the applicant’s production of the declared variety. The protection of intellectual property rights includes administrative protection and judicial protection. If the applicant’s declared variety is in the patent protection of another person and fails to obtain the patent implementation permit at the same time, the pharmaceutical company as the applicant cannot actually organize the production even if it has obtained the production approval issued by the SFDA. Because, once the production will infringe on the legal rights of others, its products are also infringing products. Third, to invalidate the infringement lawsuit against others. In actual operation, some pharmaceutical companies discovered that the patented product was patented after they had obtained the production approval document. Because of the interests, they still ignored the existence of the patent to carry out production and sales. When the patentee filed an infringement lawsuit against him, the infringing company applied to the Patent Reexamination Board of the State Intellectual Property Office for declaring that the patent was invalid. In order to seek agency profits, individual legal agencies and individuals unilaterally explain China's patent legal protection provisions unilaterally. They believe that when the patentee filed an infringement lawsuit and the defendant subsequently applied for a patent invalidation, the court would suspend the trial of the infringement lawsuit. Commentary: This is a one-sided understanding. The relevant professionals pointed out that the revised patent law has made specific provisions on this matter, such as the temporary injunction before litigation, and the decision to stop production while ruling on the suspension of litigation. Moreover, the risk that the infringer bears is extremely high. Once the patent is still valid and its infringement is established, the patentee may demand huge compensation. The longer the infringement is, the greater the compensation will be, and the closure of the production plant and sales company will force the hospital to stop the infringement. product. Fourth, direct production of infringing products is illegal, but sales of infringing products are not illegal. Relevant professionals stated that Article 11 of the newly revised Patent Law stipulates that after a patent right for an invention and a utility model is granted, no unit or individual may obtain permission from the patent owner unless otherwise specified in this Law. The implementation of its patents means that it may not manufacture, use, promise to sell, sell or import its patented products for production or business purposes, or use its patented methods and use, promise sales, sales, or import products directly obtained according to the patented method. It can be seen that selling infringing products or using infringing products is also an infringement of the law. Experts said that the statistics on the number of patent applications filed by the global pharmaceutical industry in 2004 also showed that there were 44,246 in the United States and only 1,784 in China. This indicates that over 96% of China's pharmaceutical products are imitation products. On the other hand, it also reflects that the awareness of intellectual property protection of Chinese pharmaceutical companies needs to be improved. Some small drug research and technology companies knowing that their products have been protected by patents, they still deceived SFDA to obtain new drug certificates and production approvals through various channels and channels, concealed the infringement facts and defrauded the production companies for technology transfer fees, and passed the huge risks to production. Corporate and sales pharmaceutical companies. A considerable number of companies accept commissioned production of infringing products without knowing the truth. For example, Shandong Ruiyang Pharmaceutical Co., Ltd. stated that when it was commissioned by Baiyunshan Technology to produce “Baiding”, it did not disclose any infringement risk. As a market entity, pharmaceutical companies must gradually understand the serious consequences that must be borne by infringing the intellectual property rights of others in the process of full marketization. Commentary: With the transition from traditional economy to knowledge economy, knowledge has become an intrinsic core factor of economic growth. Intellectual property rights are not only an important civil rights, but also an intangible capital and primary wealth that are difficult to substitute. From the perspective of the market It is a powerful means of competition that determines the structure and space of the company's core competitiveness and profit. Experts remind that Chinese companies should learn to swim and create their own intellectual property products. The “crisis of industrial technology hollowing out” is not an alarmist, and there is no way out without innovation. It is meaningless to infringe other people’s intellectual property rights, and spend 5 to 8 years or more. It takes no financial, human, or material resources to legally file a patent lawsuit, such as in the case of “Waick” patent litigation. The third party in the litigation --- of the 12 domestic pharmaceutical companies, many companies have completely suspended production, plant equipment is vacant, and workers are laid off. Not only that, but also a lot of capital has been dumped for patent litigation. This is not as good as a new drug. At the beginning of R&D, it established its own intellectual property strategy, and did not rush to copy or circumvent the coverage of existing domestic and foreign patents, put human, financial, material, and time on its own innovation, and promote social, scientific and technological progress, and corporate development. It is more meaningful to improve the level of science and technology