In the field of biopharmaceutical industry, top scientific research institutions (including top colleagues and top institutes) have huge advantages in many aspects such as top-level talent reserves, technology accumulation, academic atmosphere, the scale of research, management mechanism, etc. Most enterprises do not possess these advantages within a certain period of time, and even difficult to matchup.
Therefore, different from the common opinions that enterprises should play the main role in technical innovation, the author hold the view that the top scientific research institutions of China should bear the unshirkable responsibility to play the main role in innovation, transform the original scientific research achievements in life sciences into fundamental patents, and gain a foothold in the global stage of high level R&D of biopharmacy.
- The enlightment from the patent strategy of top scientific research institutions abroad
Most major breakthroughs were made by the overseas top scientific research institutions, and because of the keen awareness of IPR protection and rigorous patent management system, these heavy weighted achievements were customarily transformed into various blockbuster patents.
For example, the gene recombination technology (US4237224) which is an unprecedented contribution to biotechnology industry greatly expanded the frontier of bioindustry. Before 1997 when the patent expired, it brought more than 250 million dollars of patent license fee to Stanford University.
Also there are many other heavy weighted biological patents; some of them are shown in the following table And these patented technologies not only bring welfare to the whole human beings, but also create many brand new industries. Table 1 Incomplete List of Blockbuster Biological Patents
Click here to view table.
*One inventor was from Stanford Univ.
- The preliminary feasibility for the high level R&D of biopharmaceutical industry of China
The fundamental research in life science is the main propulsion for R&D of biopharmaceutical industry. In the current stage, the top scientific research institutions in our country have been provided with objective conditions to play a leading role, to make key breakthrough in important biological fields and to obtain fundamental patents.
- In terms of stage of development, different from some other mature technical fields, life science has not yet fully matured, so that it has a relatively larger development space. With the progress and diversification of the research means, the new achievements will emerge continuously.
- In terms of technical characteristics of life science itself, it relates to a large number of knowledge growth points and has a wide range of applications; therefore, life science is prone to produce more achievements objectively.
- In terms of research hardware, the gap between our country and developed countries is not too wide.
There are many public technology platforms in the field of life science, and compared with that of developed countries, the gap is not wide, which provides the material basis for our country to participate in the international competition in this area.
- In terms of talents and achievements, certain progresses have been made in domestic fundamental research of life science, and in some subdividing technical fields, we have reached or approached the international advanced level.
Thanks to the measures such as the introduction of top-level talents, currently in some technical field, there is a certain amount of international first-class researchers.
According to report, the Chinese researchers published 65 “CNS” papers pertaining to the fundamental research of life science, wherein 27 papers in <Cell>, 21papers in <Nature>, and 17 papers in <Science>.
- The fundamental patents desiderate a rapid growth.
- Compared with the so called “peripheral patents” or “downstream patents”, the fundamental patents occupy a key status and possess strategic significance in industry.
The importance of fundamental patents is much greater than that of peripheral patents. For example, because of the filing of a novel antigen or epitope of tumor, the numerous monoclonal antibodies and hybridoma cell lines filed later become “peripheral patents”, and the implementation of “peripheral patents” has to depend on the license of the patentee. That is not to say that “peripheral patent” is unimportant, in fact, it is an important strategy of patent application.
- The fundamental patents in the field of biopharmacy have a close correlation with the fundamental research work.
For example, the research on new drug targets, mechanisms of action, signaling pathways, regulatory factors or biomarkers, often generate original achievements. Besides the academic significance, these achievements usually contain huge potential commercial value. In addition, the conversion of uses i.e. the finding of new functions or new effects of known materials is also one kind of important inventions.
- Top scientific research institutions need to establish a highly effective and intact IP management system.
Top scientific research institutions need to convert the upstream fundamental achievements into fundamental patents. This is a systematic work in which the awareness of patent protection and perfection of system are required.
For example, one basic work is to evaluate the commercial application prospect of the research achievements, decide whether a patent should be filed and further decide the patent layout based on the importance of the achievements. Only being protected properly, the subsequent transformation or implementation will be guaranteed, because no investor will take the risk of being replicated. Such work can help to lay a solid foundation for the subsequent transformation or implementation.
- The advantages and strategies in patent transformation for research institutions
The value of a patent lies in implementation.
Contrary to the common opinions that scientific research institutions have a rigid system with low efficiency, the author holds the view that scientific research institutions have their advantages in patent transformation.
- Different from enterprises, since scientific research institutions are seldom engaged in commercial activities such as production, sale, therefore, they seldom encounter the risk of tort or being prosecuted and there is hardly any restriction of commercial interests. Because the “peripheral patents” or “downstream patents” hardly have any impact on scientific research institutions, the power of fundamental patents can be fully demonstrated.
- Because scientific research institutions do not involved in commercial competition, they have comparatively larger freedom in choosing their collaborators when their patents are licensed or transferred.
In view of the high input and slow output of biopharmaceutical industry, patent licensing or patent transfer can avoid the mass input of capital and energy as well as some uncertainty.
- For some specialized laboratories, they can concentrate on a certain field, and build the brand of the laboratory by the development and licensing of fundamental patents.
- The science parks or incubators in various regions or universities also bring convenience to the implementation of the patents. At present, a certain amount of biomedical firms have emerged based on proprietary technologies.
Scientific research institution can chose an appropriate way and strategy of patent transformation according to their own conditions and advantages. In addition, as to the issues such as patent ownership or incentive mechanism, the author believes that it will be resolved in the near future, since there has been too much discussion already.
Since the top scientific research institutions converge the optimal resources of our country, they should play the leading role in the application, layout and transformation of fundamental patents of biological pharmacy, not only in concept but also in action, to promote the high level R&D of biopharmaceutical industry of China via patent.