Denied Patent Term Extension for Novartis' Exelon® Patch in Korea

Novartis' Exelon® Patch has been used to treat mild to moderate dementia of the Alzheimer's type and mild to moderate dementia associated with Parkinson's disease. The active ingredient is rivastigmine.

Novartis obtained the first MA for Exelon® Capsule and the second MA for Exelon® Patch in Korea. Exelon® Patch uses a new formulation that allows rivastigmine to be administered in a transdermal therapeutic system (TTS).

Novartis listed two patents in the Green List (http://medipatent.kfda.go.kr) of KFDA pursuant to the linkage system of patent and market approval. The first patent is Korean Patent No. 133,686 that claims chemical compounds including rivastigmine, its pharmaceutical use. The term of the compound patent expired on December 23, 2012. The second patent is Korean Patent No. 569,051 that claims inventions of TTS formulation. The second patent will expire on January 8, 2019.

Novartis has another patent in issue that claims rivastigmine compound for transdermal administration and compositions for them. The patent in issue is Korean Patent No. 121,596 that has actually lmost the same scope of protection that of the basic compound patent of Korean Patent No. 133,686. The background between two patents is somewhat complicated because Korean Patent No. 121,596 stems from transient measure in 1987.

The Patentee and NDA holder, Novartis filed a petition for patent term extension of the basic compound patent on April 23, 2012. In Korea, the patent term extension system was first introduced on July 1, 1987. Under the 1987 Act that applied to the patent in issue, a petition for patent term extension may be filed only during the last three (3) years of the original term of the patent. Upon filing a PTE request, the term of the subject patent shall be extended automatically and shall be terminated on the expiry date retroactively in case the petition has been denied.

KIPO denied Novartis’ petition. Novartis appealed to the Seoul Administrative Court. On September 26, 2013, the court rejected Novartis’ arguments and denied PTE for Exelon Patch patent. The Patentee and NDA holder, Novartis appealed the lower court decision to the Seoul High Court again. The current PTE system has been based on 1990 amendment and the first PTE regulations of 1987 are quite different from those of the current PTE regulations. The PTE regulations of 1987 that must applied to Exelon Patch case had much more narrow scope than those of the current regulations in subject patents and gourds for PTE. Exelon Patch falls in such unfortunate cases during transient period between 1987 and 1990.

Patent Term Extension (PTE) Based on MA for Drug Inventions in Korea

1. History of Changes

The patent term extension system was first introduced in Korea on July 1, 1987. Under the 1987 Act, a petition for patent term extension may be filed only during the last three (3) years of the original term of the patent. Under the new 1990 Act, however, a petition for patent term extension may be filed within three (3) months from the date of the approval and six (6) months prior to the expiration date. The current law is basically the same as that of 1990.

Some Changes to the current patent term extension system went into effect on April 3, 2013. The key change to the current system is limiting the number of PTE instances from multiple available chances to only one. Under the current PTE system in Korea, PTE may be available only to the "first" regulatory approval for "a new chemical entity."

2. Subject Patent and Procedures

A patent is eligible for term extension if the patent is related to an approved medicinal or agricultural product, if the patent was unable to be practiced after grant due to pharmaceutical or agricultural regulatory approval requirements. Such a patent should claim a compound, composition indicating use, process of manufacturing, formulation for (1) an invention relating to a drug which requires a product approval under the Pharmaceutical Affairs Act ("PAA"); or (2) an invention relating to an agrochemical which must be registered under the Agrochemical Management Act ("AMA"),

Only registered patentee may apply for patent term extension to KIPO. If the patent right is jointly owned, all the patentees must jointly apply for an extension of the term.

An application for patent term extension must be submitted within three months from the date of the approval under the PAA or from the date of the registration under the AMA. The application, however, may not be submitted less than six months prior to the expiration of the original patent term. Also, a petition for patent term extension may not be filed after the expiration of the patent term. An application for patent term extension should be supported with evidence to show the reason for the extension.

3. Period and Number of Patent Term Extensions

The term of a patent can be extended only once. In case a product approval (or registration) is sought for multiple patents, the term is extended for each patent. However, in case multiple product approvals (or registrations) are sought for a single patent, the term is extended only for the first approval (or registration).

Prior to the current law, even an approval for a combination product whose components had been previously approved by KFDA could be the basis for PTE. In addition, the approval for a second use of an approved drug could also be the basis for PTE, since the approval was regarded as the "first" approval for the new use. Further, in some cases, even an approval for a new formulation comprising an approved active ingredient could be the basis for PTE, if the new formulation was not simply different in the dose of the active ingredient but was a different administration form compared to the previously approved drug (e.g., injection vs. tablet). However, under the current PTE regulation, PTE may be available only to the "first" regulatory approval for "a new chemical entity."

The period of PTE shall be the total length of non-working time to obtain authorization or registration under provisions of the PAA or AMA to work a patented invention. For example, for drugs, the period commencing from either the approval of a protocol for clinical testing from the government authority after obtaining a conditional approval to manufacture for clinical testing or the date the patent is registered, whichever is later; to the date that the final approval to market.

The maximum patent term extension obtainable is five (5) years regardless of whether the actual period of non-working caused by the statutory requirements under the relevant Act exceeds five years.

4. Appeal to the IPT and the Patent Court

If an examiner of KIPO rejects the petition or application for patent term extension, the applicant or petitioner may appeal to the IPT of KIPO. The appeal must be filed within thirty days from the date a certified copy of the rejection is served to the applicant or his agent. On the other hand, a 3rd party may challenge PTE through Invalidation Trial at the IPT of KIPO. If a losing party in the IPT proceedings wants to appeal against the decision of IPT, the party may bring a lawsuit to revoke the IPT decision to the Patent Court within thirty days from the date of receiving the decision.