November 2017 – As biomedical research and development thrives in Taiwan, the government of Taiwan has not only enlisted biopharmaceutical industry in one of the five innovative industries policies, but also set to position Taiwan as “Asia-Pacific Hub for Biomedical R&D”. For an innovative and technology-intensive industry such as the biomedical industry, cross-border IP deployment and operation are indispensable roles for ensuring and improving revenue.
Biomedicines for treating or alleviating human diseases can be classified into three categories:
1. small-molecule drugs composed of chemically-synthesized compounds;
2. large molecule drugs composed of proteins, peptides or nucleic acids;
3. botanical drug extracted from plants grown in specific locations and of specific strains. A new chemical entity drug (NCE) may take many years and a significant amount of investment to step from the laboratory to the market.
Biomedicines for treating or alleviating human diseases can be classified into three categories:
1. small-molecule drugs composed of chemically-synthesized compounds;
2. large molecule drugs composed of proteins, peptides or nucleic acids;
3. botanical drug extracted from plants grown in specific locations and of specific strains. A new chemical entity drug (NCE) may take many years and a significant amount of investment to step from the laboratory to the market.
The NCE will need to go through various stages of R&D, including: basic research, technological hypothesis, preliminary verification, preclinical trial, Phase I clinical trial, Phase II clinical trial, Phase III clinical trial and post-market surveillance. These R&D stages would require the cooperation between the academia, the research institutions and the industry sector. The birth of new drug product would need interdisciplinary collaborations on resources and professional knowledge. Take the academia or research institutions in Taiwan as an example, investors or strategic partners would often participate in the drug development by spin-off, start-up, licensing, technology transfer, acquisitions and joint ventures when the research outcome and intellectual property are ripe and ready.
Thus, collaborated research and development practice would be vital to the biomedical research outcomes. Leveraging professional methodologies, tools, systems, platforms and databases, and collaborating with professional third-parties would create opportunities for the research outcome to live up with its full potential.
In order to perform the collaborated research and development practice for new drug development, I suggest the academia, research institutions and the industry sector in Taiwan should firstly conduct big data analyses on the industry, the academia and the patent landscape. In this regard, the big data analysis would provide one with insights on research strategy, technical solutions and arrangement of R&D resources. With the above industry and technical intelligence, one would be capable to initiate cooperative development, contract development, licensing, technology transfer, investment, acquisition and merger with potential partners around the globe. Cross-border IP deployment and Freedom to Operate (FTO) management are two important approaches in the collaborated research and development practice for new drug development.
Cross-border IP deployment is vital in preliminary stages of R&D for biomedical research. The following steps should be considered: 1. Define the position and extent of the research outcome via product, technology and effect structures; 2. Plan appropriate types of intellectual property protections: one or more types of intellectual property may be combined into an intellectual property cluster; 3. Plan adequate intellectual property portfolio, family and deployment territories. If the research outcome is protected by patent, a complete and comprehensive technology disclosure would be necessary. A prior art analysis should be conducted after the technology disclosure, and subsequent patent claim deployment should be based on the product, technology and effect structure. The patent claim deployment ensures maximum coverage to the proposed product and potential infringer; 4. The patent prosecution should be based on patent regulations, Manual of Patent Examination Procedure and patent practices of the U.S., wherein the deployment of patent to other territories should be planned according to the proposed area or countries of sales and production focus.
Subsequently, the biomedical research may then step into the clinical trial. Before conducting clinical trials, Freedom to Operate (FTO) management should be considered. Specifically, FTO management should include the following steps:
1. Establish patent database that is relevant with the new drug candidate, and the patent database should include areas or countries of sales and production focus;
2. According to the above patent database and industry intelligence, identify specific patent(s) and its’ patent family that are relevant with and pose risk to the new drug candidate;
3. For the above identified patent, construct the patent claims and conduct infringement analysis. Another option would be conducting validity analysis and enforceability analysis after the claim construction;
4. Initiate patent invalidation procedures in different countries to make sure freedom to operate in the target market(s);
5. If the identified patent(s) is unable to be invalidated, conduct product design around with IP professionals;
6. If the identified patent(s) is unable to be invalidated and to design around, an assessment for purchasing or licensing the patent should be considered. It would be also plausible to evade patent risk by adjusting areas of sales and production focus, or by switching clients.
It is expected for the industry, academia and research institutions in Taiwan to leverage the collaborated research and development practice, in order to establish a solid basis for commoditization, spin-off, licensing, technology transfer, investment, sale, acquisition and infringement assertion of the biomedical research. By utilizing above methodology and steps, a “unicorn” of bioindustry that competes in the global arena would be born in Taiwan.
