In order to more extensively protect pharmaceutical products and to encourage the development of pharmaceutical industry, the current legal system provides two specific patent related protections to pharmaceutical products that have obtained regulatory approval. One is patent linkage system (similar to “Orange Book” in the U.S.A.) introduced into the Pharmaceutical Affairs Act implemented since August 2019 and the other is patent extension system that has been in operation for many years.
I. Patent Linkage System
Brand drug companies may submit, within 45 days from receipt of the marketing approval of a new drug, to Taiwan FDA a list of patents associated with the new drug and relating to inventions of compounds, compositions or formulations, or medical uses of the new drug, if any. Taiwan FDA will publish in a patent linkage system information regarding the patents associated with the new drug for public inspection. It is a new effective administrative measure taken by Taiwan’s government to prevent generic drug companies from infringing pharmaceutical related patents.
“New drugs”, according to Article 7 of the Pharmaceutical Affairs Act and its enforcement rules, may refer to one of the followings that has been verified and recognized by Taiwan FDA:
(i) preparations having a new compound/ingredient;
(ii) new therapeutic applications or a new formulation: “new therapeutic applications” refers to the preparations having reduced side effects, improved medical effect, or improved treatment period or involving the change of dosage; and “new formulation” refers to a composition composed of two or more drugs that has better medical effect than each drug that has single ingredient; and
(iii) a drug that has a new route of administration.
It is not to be asked whether the drugs are micromolecular chemical preparations or macromolecular biological preparations, which is at very variance with the US practice under which micromolecule chemical preparations and macromolecule biologic preparations are respectively registered in Orange Book and Purple Book (a resource listing innovator biological products, as well as any biosimilar and interchangeable biological products licensed by US FDA under the Public Health Service Act.) In addition, while “biological preparations” is not defined in the current Pharmaceutical Affairs Act, Taiwan FDA attempted to define “chemical drugs” and “generic drugs”, the correlation of chemical drugs and generic drugs, and the correlation between biological products and biosimilar drugs in the Amendment to the Pharmaceutical Affairs Act proposed two years ago but the Draft Amendment is still at the legislative stage. In the meantime, it is clearly stated in the Draft Amendment that “biological preparations” refers to the preparations approved by Taiwan FDA, whose effective ingredients are manufactured from biological sources, including toxins, toxoids, allergens, vaccines, genetically engineered products, blood-derived products, cell therapy products or gene therapy products.
In addition, only those patents relating to the substance, composition or formulation, or the medical use referred to on the certificates of marketing approval are allowed to be registered in the patent linkage system.
Taiwan FDA does not conduct a substantive examination as to whether the registration content is correct or not. However, if a third finds out that any information as published is incorrect, he is able to submit to Taiwan FDA a statement pointing out the incorrectness of the information, reasons and evidence. A written reply from the holder of the certificate of marketing approval of the new drug needs to be filed with Taiwan FDA within 45 days from receiving the official notice regarding the third party’s statement.
II. Patent Term Extension
A request for patent term extension can be filed within three months from obtaining the first certificate of marketing approval for a new drug. A patent term extension can be obtained for a patent only with respect to the claims that correspond to the items specified on the first certificate of marketing approval obtained for the related product and the use of the product. For example: (i) for a product patent, the extension will be granted only with respect to the claims directed to a specific product that corresponds to the effective component as specified on the certificate of marketing approval and the approved use of the effective component; (ii) for a use patent, the extension will be granted only with respect to the claims directed to a specific use that corresponds to the use of the effective component as specified on the certificate of marketing approval ; and (iii) for a method patent, the extension will be granted only with respect to the claims directed to a method of manufacturing the effective component having a specific use as specified on the certificate of marketing approval.
The term of a patent can be extended for a period to a maximum of five years. The term is calculated by making reference to the period of time during which the patent cannot be put into practice, i.e., the time it takes to obtain a regulatory certificate of marketing approval. Moreover, a patent can be extended once. Thus, if a plurality of the compounds covered by the patent receives respective certificates of marketing approval, only one of said plurality of the compounds can be extended based on said patent. Likewise, one certificate can serve as a basis for obtaining one patent extension.
When it comes that the patent holder and the holder of the certificate of approval are not one and the same person, when applying for a time extension, a document showing direct or indirect authority relationship between the two parties need be submitted. The application for a patent term extension will be examined in a substantive manner especially in terms of the period of time during which the patent cannot be put into practice.
A comparison between the two systems is summarized in the following table for your ready reference:
||Patent linkage system
||Patent extension system
| Legal basis
||Pharmaceutical Affairs Act
||holder of the certificate of marketing approval
| Time Limit to file
||within 45 days from issuance of the certificate of marketing approval
||within 3 months from issuance of the certificate of marketing approval
| Qualified inventions
||drug-related inventions, including substances, compositions or formulations or medical uses
||drug-related inventions, including compounds or compositions/formulations, medical uses, or methods of manufacturing a specific component of a drug
|What if the patent holder and the certificate holder are not one and the same party
||A letter of consent from the patent holder is required.
|A document showing direct or indirect authority relationship between the two parties is required.
| Substantive examination
No. However, any person can file a statement pointing out that the information as published is incorrect.
The certificate holder needs to file a reply within 45 days from receipt of the official notice.
|Substantive examination is to be conducted.
In conclusion, brand drug companies are advised to seek the opinion of their legal counsels, at the very first opportunity, to figure out the best strategy to obtain the maximum protection to the new drugs that have obtained regulatory approval.