With the help of popular film and television works and news events, topics such as pharmaceutical patents and generic drugs have gradually attracted public attention in recent years. As the so-called slogan reads "no patent, no new drug," the high dependence of the pharmaceutical industry on patents is self-evident. Since 2017, China Food and Drug Administration, General Office of the CPC Central Committee and General Office of the State Council have been exploring the establishment of the drug patent linkage system, as well as the reform of drug review and approval and market access systems. As a result, the patent conflicts between pharmaceutical companies and generic drug companies will no doubt intensify.
Under the new situation, how should the pharmaceutical industry and enterprises protect their innovation achievements and continue to promote research and development? How should pharmaceutical innovation protection and generic drug development address patent challenges? In order to solve the above problems, the 10th China IP International Annual Forum & 2020 Annual Conference of In-House IP Managers in China set up a special Panel, with the theme of "Patent Challenges Faced by Pharmaceutical Innovation Protection and Generic Drug Development Under the New Situation," invited representatives from the judicial, administrative and corporate circles related to the pharmaceutical industry to come together and analyze the way of innovation. The Panel was chaired by Cheng Yongshun, Director of Beijing Intellectual Property Development Center.
In his opening speech for the Panel, Director Cheng pointed out that the protection of pharmaceutical patents is a difficult issue in the field of intellectual property, which requires a high degree of legal and technical expertise and complexity. At the same time, the pharmaceutical industry has an important special status as it is closely related to the national economy and people's livelihood. Therefore, the protection of pharmaceutical innovation and the development of generic drugs have become hot topics. With regard to the protection of pharmaceutical patents, the opinions and considerations from the judicial, administrative and corporate parties will undoubtedly push the protection of pharmaceutical innovation towards a positive direction.
Liao Xiaojun, Director of Intellectual Property Department of Jiangsu Hengrui Medicine Co., Ltd., as the first keynote speaker, gave the speech on the theme of "Comparison and Thinking of the Creative Evaluation of Drug Compound Patents." He first demonstrated the high dependence of the pharmaceutical industry on patents through detailed data and specific cases and pointed out the fact that pharmaceutical companies have no incentive to invest drugs that cannot obtain patent protection in clinical trial research. Later, Liao compared and considered the creative evaluation of pharmaceutical compound patents based on the actual reviewing cases of China and the United States. He finally suggested that the creativity of a compound patent that has been approved to market should not be easily neglected, but the patent access restrictions on drugs should be appropriately relaxed so that the market can decide which is the better drug.
Xue Yaping, Deputy Director of Intellectual Property Department of HEC Pharmaceutical Co., Ltd., combined the two cases of the first generic drug lawsuit (Fingolimod, Apixaban) in the United States in 2019 sued by HEC Pharmaceutical, and made a speech with the theme of "The First Generic Drug Lawsuit in the United States and Its Reflection. " She first gave a general introduction to the US patent linking system and pointed out that the system, on the one hand, encouraged the enthusiasm for original drug innovation, on the other hand, accelerated the marketing for generic drugs. Regarding the forthcoming drug patent linkage system, Xue said that domestic pharmaceutical companies should continuously improve their innovation capabilities, rationally arrange high-value patents, do a good job of patent early-warning analysis, formulate different patent response strategies for various projects, and respond to challenges in a positive attitude.
Zhang Xiaoyu, Patent Affairs Minister of Jiangsu Hansoh Pharmaceutical, gave a speech on the theme of "The Development of the Pharmaceutical Industry and the Status Quo of Intellectual Property Work," and analyzed the development status of the entire pharmaceutical industry and the Hansoh Pharmaceutical from both macro and micro perspectives, as well as the opportunities and challenges faced under the new situation. Zhang pointed out that under the continuous influence of national policies, China’s rapid development of innovative drugs, the speeding up for generic drugs review, and the intense pressure of foreign pharmaceutical companies, competitions in China's pharmaceutical industry is becoming increasingly fierce. In combination with the status quo, Zhang further suggested that the judicial authorities should strengthen the protection of pharmaceutical intellectual property rights, prevent excessive protection, and stabilize the standards of invalid patents as much as possible, consider the status quo of technological development for patent authorization and confirmation, appropriately regulate the abuse of patent rights in the pharmaceutical field, and promote win-win cooperation among pharmaceutical companies.
From the perspective of judicial trial practice, Luo Xia, Judge of the Intellectual Property Court of the Supreme People's Court, made a speech entitled "Typical Legal Issues in Pharmaceutical Patent Disputes." Luo pointed out that for pharmaceutical patent disputes, it is necessary to convert disputes related to technical facts into legal language and conduct trials and adjudications under the protection of the patent system. Guided by this principle, Luo made a specific analysis on the pharmaceutical patents authorization and confirmation as well as the typical disputes in the infringement cases, which include examination of evidence, full disclosure of compound inventions, product claims and method claims in the same technical solution, creative judgment of new crystalline compounds, closed claims, and the impact of pharmaceutical production approvals on the establishment of the prior right defense.
Rui Songyan, Judge of the Beijing Intellectual Property Court, made the final speech on the theme of "Understanding of Markush Claim." After explaining the meaning of the Markush claim, Rui combined specific cases to discuss a focus issue in the industry, that is whether the Markush claim should be understood as a technical solution or a combination of multiple technical solutions and gave her detailed analysis. Rui pointed out that the Markush claim should be regarded as a technical solution in principle, and she believed while verifying the prior right, the entire claim should be taken as the basis of comparison instead of the specific compounds in the claim.
The keynote speeches were followed by the discussion session, guests expressed their opinions, and explored the interaction between pharmaceutical R & D innovation, the patent system and related judicial cases from different positions of judicial, administrative and pharmaceutical enterprises.
This Panel provided many useful lessons for the patent challenges brought by China's pharmaceutical innovation protection and generic drug research and development.
