Success in the Emerging Asian Markets (EAMs) requires medical device companies to ensure superior product and patent protection for both their products and related methods of use, given the ease with which devices can be copied by competitors.
In China, India, Indonesia, Korea, Malaysia, the Philippines, Taiwan, Thailand, Mongolia, Pakistan, Sri Lanka and Vietnam - the countries that can be grouped together as the Emerging Asian Markets (EAMs) - securing patent protection is critical.
Once in possession of a patent, a medical device company will be able to create legal barriers to entry for competing devices by preventing others from copying, selling or manufacturing the patented device. It will also be able to license the patented device to generate revenues.
Furthermore, the value of the medical device company can be enhanced via the equity and asset building associated with the patent, which in turn may attract further investment.
EAM patents applicants need to be aware of current and future business development objectives, market specifics and how local competitors could design around the patented devices of the company. Filing in multiple countries can be prohibitively expensive, but mechanisms to control fees and costs include international application/PCT applications, or concepts such as the newly launched ASEAN Patent Examination Cooperation program. All EAM countries observe a "first- to-file" rule in granting patents, which, in cases where two different entities apply for a patent, it is the first one to file an application that will obtain the patent if the invention is patentable. The US adopted this law in 2013. What is patentable and what is not can be something of a minefield, with different EAMs applying different criteria to patentable matter, so the regulations of each country require careful scrutiny. FIVE FACTORS TO FORESTALL FAILURE
But early in the pathway leading to an EAM launch of a medical de- vice, there are five factors that a company needs to consider or act on, centering around:
Core Technology Assessments And Tailoring Patent Portfolios To Individual EAMs
Medical device companies interested in not-fully-developed patent markets, such as the EAMs, should develop a product patent portfolio that is tailored to the needs of each respective emerging market. The first stage for the medical device company is to assess the core technology and file patent applications that are designed to provide the broadest possible coverage of the core technology.
The company must consider: its current and future business development objectives; the ways that local competitors could design around its patented devices; the specific needs of the markets targeted - the Chinese vascular or ultrasound scan market or the Indian orthopedic market, say - and the way the patented technology could affect them; and whether to file national, regional or PCT (patent cooperation treaty) applications. Broad patent coverage, when and where applicable, should be directed to the entire medical device, it sub- components, methods of manufacturing, methods of use and treatment, therapeutic uses and any other aspects of the...