Knowing the facts about patent term extension and data exclusivity will ensure you are not missing out on the protection your pharmaceutical product is entitled to, thereby maximising the commercial life of and revenue gained from your product.
As the extension of term and data exclusivity provisions vary considerably between Australia, New Zealand and key Asian countries; including Singapore, China, Japan, India, South Korea, Thailand, Vietnam and Hong Kong, an understanding of the specific requirements in each jurisdiction is necessary.
Patent Term Extension
Those in the pharmaceutical and biotechnology industries appreciate that it can take as long as 15 years to successfully develop and market a product containing a new active ingredient. But do you know which countries offer an extension of patent term to offset the loss of term brought about by the delay in obtaining regulatory approval for a product?
Data exclusivity refers to a period of protection for data provided by an innovator company to a regulatory agency to prove the safety and efficacy of a new pharmaceutical product. The period of protection prevents a competitor from relying on the innovator’s data when seeking approval of a generic version of the same pharmaceutical product with the same regulatory agency.
Which countries have extension of term and data exclusivity provisions?
This fact sheet provides you with the information you need on patent term extension and data exclusivity in Australia, New Zealand and key Asian countries.
Australia provides for patent term extensions of up to 5 years. To obtain an extension of the term the first regulatory approval for goods that contain, or consist of the pharmaceutical substance(s) which is "in substance disclosed" in the patent, and falls within the scope of at least one claim of the granted patent, must have occurred more than 5 years after the filing date of the patent application.
An application for an extension of term must be made within 6 months after the latest of:
- the date the patent was granted; and
- the date of the first regulatory approval.
Australia provides an automatic 5 year data exclusivity period for new products containing pharmaceutical actives. Data exclusivity is not provided for new dosage forms, routes of administration, indications or combinations with other active ingredients.
Patent term extensions are not available in New Zealand.
New Zealand provides a data exclusivity period of 5 years for new products. Data exclusivity is not available for data relating to new uses or new formulations of known active ingredients.
Of all the countries in Southeast Asia, only Singapore and Brunei provide for patent term extensions, in each case of up to 5 years.
Singapore permits an extension of term for a “pharmaceutical product” which is defined as:
a medicinal product which is a substance used wholly or mainly by being administered to a human being for the purpose of treating or preventing disease…
There are a number of exclusions from the extension provisions, including a substance which occurs naturally in a plant, animal or mineral; and traditional or homeopathic medicines, quasi-medicinal products, medicated oils or balms, foods, food additives, and food supplements.
The deadline for making an application for an extension of patent term is the later of six months from the grant of the patent or six months from obtaining marketing approval for the pharmaceutical product by Singapore’s Health Services Authority. In order to be eligible to make an application, the time between filing for marketing approval and the date marketing approval was obtained must be at least two years.
Singapore provides a 5 year data exclusivity period which commences on the date that a product licence is granted.
Patent term extensions are not available in China.
China provides a data exclusivity period of 6 years for new chemical entities, which commences from the date that marketing approval is granted.
In Japan, patent term extensions of up to 5 years are available for pharmaceuticals and agrochemicals. An application for an extension of term must be filed within three months of the first regulatory approval of the product. An early patent grant is also advantageous for maximising the term of the extension because time lost in the regulatory process while the patent application is still pending does not count towards the extension of term. Notably, in Japan subsequent approval for the same active ingredient for a second indication may serve as a basis for an additional extension.
The Japanese regulatory authority re-examines the safety and efficacy of new chemical entities and drugs approved for new indications. The re-examination period lasts from 4 to 10 years during which time data is protected.
There are currently no provisions in India for obtaining an extension of term of a patent or for the protection of data submitted to a regulatory authority.
South Korea provides patent term extensions of up to 5 years for pharmaceuticals and agrochemicals. An application for an extension of term must be filed within three months of the first regulatory approval of a product comprising a new chemical entity and within six months of the expiry date of the patent.
South Korea provides a 5 year data exclusivity period for new chemical entities which commences from the date on which a product licence is granted.
Patent term extensions are not available in Thailand.
Thailand provides a 5 year protection period that ensures the data provided in respect of a new drug application remains confidential.
Patent term extensions are not available in Vietnam.
Vietnam provides a 5 data exclusivity period which commences from the date on which a product licence is granted.
There are currently no provisions in Hong Kong for obtaining an extension of term of a patent or for the protection of data submitted to a regulatory authority.
More far reaching extension of patent term provisions to come?
It is worth noting that whilst the most readily available form of additional protection in the key countries discussed is data exclusivity; it is possible that the Trans-Pacific Partnership agreement will provide more far reaching extension of patent term provisions as well as potentially increasing the length of time that data exclusivity will be available.