Newsletter
Development of Nanomaterials in Biomedical Technology and Applications of the Patent Technology
Nanotechnology has been developed vigorously over the past 60 years in various scientific fields since it was first proposed by American physicist Richard Phillips Feynman in 1959, and nowadays it is still one of the research topics that numerous countries are dedicated to and invest in. The significance of nanotechnology lies in the fact that materials can exhibit completely different properties than before when their sizes are drastically reduced to the nanoscale. In this way, the nanomaterials can overcome the bottlenecks and predicament faced in the past research and development, and provide methods and products with better performance, such as nanoscale etching techniques for semiconductor materials in the electronics industry, nanofiber membranes for wastewater filtration in the environmental industry, and graphene batteries for energy storage in the energy industry. Amongst all the applications, the most eye-catching one is the application in the biomedical industry.
As the basic research of biotechnology becomes more and more comprehensive, the applications in the biomedical field are also evolving. Nanotechnology can be found everywhere in prevention, diagnosis and treatment of diseases. For example, magnetic nanoparticles are used as contrast agents for MRI analysis to be specifically bound with specific target cells to enhance the contrast effect; nanobiochips and nanobiosensors are used to detect the concentrations of nucleic acid or DNA molecules, the results of which can be obtained quickly and accurately with a small amount of specimen or reagent; nano-drug delivery systems can overcome the past limitations, allowing the drugs to reach the target location and release themselves correctly to enhance the stability of the drugs. All these research results have brought excellent advances and contributions to medical care.
In recent years, the number of patents regarding nanotechnology in biomedical applications has increased year by year along with a rapid progress in the development of the abovementioned technologies. Over the past five years, statistics from the five largest intellectual property offices in the world (USPTO, SIPO, WIPO, EPO, JPO) show that the number of patent publications in the field of nanobiomedicine has grown at a steady pace. The United States (USPTO) lead the number of patent publications in the early stage while China (SIPO) has the largest number of patent publications at present. In contrast, WIPO, EPO and JPO have not shown a significant increase or decrease. In terms of applications, the relevant patents can be broadly divided into the fields of nano-drug delivery, nano-inspection, nano-optics, nano-magnetism, nano-materials and the like, among which nano-drug delivery and nano-materials occupy the largest share.
IQVIA, a US clinical research firm, estimated in March 2020 that global drug spending will continue to grow at an average annual rate of 2-5% and will exceed US$1.1 trillion by 2024i. Such a huge market demand attracts major pharmaceutical companies one after another to invest in their relevant R&D projects. In addition, according to the “Biotechnology Industry in Taiwan” white paper issued by Taiwan’s Ministry of Economic Affairs in July 2020, there were up to six biologic drugs in 2019ii in comparison with the 2009 top 10 global best-selling prescription drugs which were all traditional synthetic small molecule drugs. It is therefore clear that new drug development is moving towards structurally sophisticated protein-based drugs, and nanotechnology is playing a critical role here. Unlike previous drug delivery systems, which have low selectivity, many side effects and poor delivery efficiency, drug delivery systems using nanotechnology can effectively deliver drugs to the target location. Common nanocarriers, including nanoparticles, liposomes, micelles and the like, can be used to deliver drugs precisely to specific target through special modifications on the surface layers to enhance selectivity and reduce the risk of drug degradation en route, with significant therapeutic and palliative effects in cancer, Alzheimer's disease and other rare diseases.
Over the past 20 years, the U.S. FDA has approved more than 50 nanodrugs for clinical therapiesiii, among which Alnylam Pharmaceuticals' ONPATTRO, approved for marketing in 2018, is the first FDA-approved RNA interference nanodrug with a total of 21 related patents. ONPATTRO uses lipid nanoparticles to encapsulate siRNA and deliver it directly to liver for release via infusion. The siRNA induces interference that degrades the corresponding RNA without transcribing the disease-causing transthyretin, which in turn inhibits hereditary amyloidotic polyneuropathy and helps alleviate symptoms such as limb pain or sensory loss in patients with rare diseases. In addition, there are up to 29 cancer nanodrugs in clinical trialsiv in 2020 and these nanodrugs will be available on the market in the near future, bringing silver linings to cancer patients.
In addition to utilizing the properties of nanocarriers to enhance the efficacy of drugs, other technologies can be used in clinical settings to overcome barriers in drug development. To cite an instance, the technique in the patent application (US 2019201326) filed by Johns Hopkins University combines focused ultrasound with nanodrug to inject a nanocarrier containing a neuromodulatory drug intravenously. Upon the injection, the naocarrier will be guided by focused ultrasound to release the drug in the target brain area, thereby controlling the area and time of the drug’s action because the surface of the nanocarrier is modified with ultrasound-sensitive compounds. In addition to being an aid to the drug delivery system, focused ultrasound can also be combined with MRI technology to provide a non-invasive therapeutic method: MRI-guided Focus Ultrasound. This therapeutic method combines MRI technology with novel magnetic nanoparticles as a contrast agent (e.g. the patent (US 10667716 B2) filed by University of California), wherein the nanoparticles further improves the resolution of MRI so that the tumor area can be identified more precisely. Also, by focusing multi-frequency ultrasound on the tumor area and causing an instant temperature increase, the protein in the tumor tissue is then denatured, coagulated and necrotized so as to alleviate patients’ symptoms.
In the midst of the accelerated development of biomedical industry in the world, the reform of relevant regulations and the adjustment in health insurance system will affect relevant enterprises’ evaluation toward the market of every country. It will in turn lead to the changes of the patent portfolio with respect to the needs in each country. Accordingly, the question how to balance the needs of patients and to maintain the benefits of the industry with the rapid advancement of technology will be an issue worth exploring in modern society today.