In general, a patent linkage system provides for an early resolution of drug patent disputes that links the drug marketing applications to registered patents to resolve patent disputes and infringement risks prior to the marketing of a drug. Many countries with a patent linkage system have established a patent information registry platform to disclose patent information relating to original drugs. The generic applicants are also required to make a patent declaration or notify the patentee of their intended launch before marketing. For generic applications that are challenged by the patentee, countries may have different waiting periods and suspend generic marketing approval pending dispute resolution. In essence, patent linkage systems provide early notice of possible patent infringement arising out of the planned launch of generic drugs, so as to balance the relationship between the original drug and generic drugs. Follow the main article below where we give an introduction to the current situation regarding the patent linkage systems in several Asia-Pacific countries, including Australia, China, India, Indonesia, Japan, Korea, Singapore, Thailand and Vietnam.
Drug patent disputes have been a long-term challenge. On the one hand originator companies are challenged by the size of investments, long lead times, high risks of failure, and the difficulty of achieving innovations in the drug research and development (R&D) process. On the other hand, generic companies are faced with patent protection policies that contribute to prolonged market domination of innovator drugs. As a result, tension between the interests of innovator drug companies and generic drug companies is particularly evident in the patent field.
In order to encourage drug R&D and reduce drug prices, policies in various countries and regions on market access for drugs have given rise to different patent dispute resolution mechanisms, of which the patent linkage system is the most representative. The patent linkage system originated with the Hatch-Waxman Act introduced in the US in 1984, which established a link between the drug marketing approval process and the patent dispute resolution process through the division of labour between the drug administrative approval department (US Food and Drug Administration, FDA), the patent examination department (US Patent and Trademark Office, USPTO) and the courts. The system finely regulates the balance between generic approval for marketing and patent protection for innovator drugs through specific institutional tools such as the abbreviated new drug application process (ANDA), patent declarations, the Bolar Exception and data protection periods for innovator drugs, patent registration and the patent protection period.
The patent linkage system has played an important role in promoting the development of generic drugs, safeguarding the legitimate rights and interests of drug patentees and reducing the risk of post-marketing litigation with respect to drugs. Countries like Canada, Japan, South Korea and Australia have successively introduced patent linkage systems through free trade agreements with the US, but the practices and policies vary from country to country. This article provides an introduction to the current situation regarding the patent linkage systems in several Asia-Pacific countries including Australia, China, India, Indonesia, Japan, Korea, Singapore, Thailand and Vietnam.
Development of patent linkage systems in APAC countries
Among the nine APAC jurisdictions we studied, four countries have a patent linkage system. They include Singapore, Japan, Korea and China. The five countries that do not presently have a patent linkage system are Australia, India, Indonesia, Thailand and Vietnam.
For the four countries that have established patent linkage systems (i.e. Singapore, Japan, Korea and China), their systems reveal some commonalities. As mentioned above, the countries have generally established a patent information registry platform to disclose patent information relating to original drugs. The generic applicants are also required to make a patent declaration or notify the patentee of their intended launch before marketing. For generic applications that are challenged by the patentee, countries may have different waiting periods and suspend generic marketing approval for dispute resolution.
At the same time, in addition to the high-level similarities of the systems, there are unsurprisingly significant differences in specific regulations among the countries. In general, the patent linkage systems in these countries differ in the level of protection afforded to patentees. One of the most important differences is the duration of the waiting period. After the patentee has been informed of the details of the marketing application for a generic drug, the patentee has the right to file an opposition if it believes that the generic drug is infringing its patent rights. Once the relevant court/administrative authority receives this opposition filing, it will suspend the marketing approval of the generic drug for a specified period of time to permit the patentee to seek an injunction. In China (see Annex 2) and Korea (Annex 6) this period is nine months, while in Singapore (Annex 7) this period is 30 months. The difference in the waiting period reflects the different levels of protection of drug patents in different countries.
Among all the countries with patent linkage systems, the system in Japan is the most unique. The Japanese patent linkage system (Annex 5) is not based on any written or statutory laws or regulations. Rather the legal basis of this system is the Ministry of Health, Labour and Welfare’s administrative directive. Any disagreement or dispute concerning the infringement of a patent for an originator drug in Japan must be resolved through consultation between the parties. For example, after approval of a generic drug and prior to its listing on the National Health Insurance drug price list, the original drug manufacturer and the generic drug manufacturer discuss whether there are any patent issues with the approved generic drug and report the results of this discussion. In other words, some of the prevailing court procedures or administrative procedures in other countries are replaced by prior coordination in Japan. As a result, the commonalities of patent linkage systems in different countries discussed above, such as the waiting period, do not apply in Japan either.
A number of the countries that do not have a patent linkage system (i.e. Australia, India, Indonesia, Thailand and Vietnam) have made attempts to balance the relationship between the original drugs and the generic drugs without a linkage system. In Australia, explained in Annex 1, the onus is instead placed on the patentee to prevent market entry by seeking (and obtaining) a preliminary injunction. In Vietnam (Annex 9), prior to the marketing of any generic drug, the authorities must provide information or notify the original drug’s patent holder of the generic drug’s MA. In Indonesia, there are similar provisions like Bolar exemptions. The Patent Law in Indonesia (Annex 4) includes a provision that provides an exemption to patent infringement for production of drugs protected under a valid patent within five years prior to the expiration of the relevant patent for the purpose of obtaining the relevant distribution permit, which will then be distributed after the expiration date of the relevant patent. Due to the rapid development of the generic drug industry and the strong protection of generic drugs, India (Annex 3) and Thailand (Annex 8) have no mature patent linkage systems at present.
For ease of comparison, the reference table below contains the main elements of a patent linkage system, with “Y” indicating that the country has a corresponding provision and “N” indicating that no provision has been established. The US is also included as a standard since it was the first country to establish a patent linkage system and currently has the most mature patent linkage system.
Note that a Patent declaration means a generic applicant’s declaration or statement identifying the relationship between the patent listed by the brand-name company in the Orange Book or other similar patent listing system, and the drug for which an ANDA is submitted. Also, the Bolar exception means a statutory exemption under which a person is allowed to use a patented invention for the sole purpose of developing and obtaining marketing approval of a pharmaceutical product.
Further details on the specific Patent Linkage System for the listed APC jurisdictions can be found in the annexes here.
For more information on patent linkage systems in APAC, contact the LAN group contact or local experts in your jurisdictions.