Source: China Daily Global

As researchers in the pharmaceutical industry seek to contain the novel coronavirus epidemic, Tao Xinliang, honorary dean of the Intellectual Property Institute of Shanghai University, shares with China Daily his insights into related patent issues.

Can a new patent be filed for an old drug due to novel use?

When it is found that a patented drug can be used for another medical use, it is a common practice worldwide to file a new patent based on the novel use. The filing is in compliance with laws and regulations.

Such applications are called second medical use patents. Under the current legal framework in China, as well as in other major countries and regions, second medical use patents can be granted when they meet certain requirements.

Globally, it is a thorny issue to provide medicine with patent protection. This is due to the lengthy research and development, heavy investment and high risks involved.

Thus the design of the patent system for the pharmaceutical industry needs to consider the balance of interests between business and the public.

Technical improvements to products and methods can be patented. According to rights claims, patents can be categorized into product inventions and method inventions. A new use patent falls into the second category.

Based on existing medicines, further research on such aspects as medicine types, dosages, production procedures and new uses are encouraged worldwide.

Legal systems in most countries provide protection for newly discovered uses of patented medicines, as they have proved to be a boost for the healthcare industry.

Novel use of medicines often comes as a surprise to pharmaceuticals companies and researchers. Aspirin is an exemplary case. The fever reducer and pain reliever has been found helpful in preventing cardiovascular and cerebrovascular diseases.

Will a second medical use patent be granted?

Filing an application is just the first step toward seeking protection under the patent system. Whether it will be granted or not depends on if it is proved to be useful, novel and non-obvious.

Out of a host of applications, only some can be granted. It is no exception with second medical use patents.

According to China's Patent Law, a filing needs to go through a series of administrative procedures, including preliminary examination and substantive examination.

At the latter stage, examiners will review whether filers have each provided a clear and complete statement of their technological solutions. They will also check the requirements of being useful, novel and non-obvious.

A filing will be rejected in the absence of sufficient details of experiment data or due to the lack of creativeness in the second medical use.

How does a second medical use patent work?

If a second medical use patent is granted, its owner needs to cross-license intellectual property to gain the authorization for the medicine's product patent.

Generally, a second medical use patent is a spinoff of its related medicine product patent. Their relationship is similar to that between basic patents and improvement patents. Gaining a new use patent does not necessarily follow that it can be used directly. The patentee needs to gain the authorization of the basic patent holder, or the owner of the medicine patent, who also needs to be authorized for the new medical use.

Facing the novel coronavirus outbreak, public safety and health are top priority. Government agencies, patentees, innovators and pharmaceuticals are being called on to join hands to advance medicine R&D and share research data.

2020-02-17