The Taiwan Intellectual Property Office (TIPO) has amended the Patent Examination Guidelines Regarding Patent Term Extension Matters (“old Guidelines”). The amended Guidelines took effect on 1 April 2018. Provided as below is a summary of the amendments to the Guidelines ("the amended Guidelines").

I.  First Market Approval Holder

The old Guidelines provide that if the market approval holder is not the patentee, a license agreement from the patentee to the market approval holder should be recorded with the TIPO.

According to the amended Guidelines, the first market approval holder can be the patentee, an exclusive licensee or a non-exclusive licensee. If the first market approval holder is not the patentee, the PTE applicant should submit documentation evidencing whether the patentee and the first market approval holder belong to the same legal entity. If the first market approval holder is a licensee, license recordation with the TIPO is unnecessary. However, the PTE applicant should submit documentation evidencing the fact that the patent has been licensed at the time when the PTE is filed.

II.   Determination of First Market Approval

The old Guidelines provide that the regulatory approval that can be used for extension must be the first regulatory approval. The first regulatory approval is determined on the basis of the active ingredient and use identified in the approval. As long as either the active ingredient or the use in the approval is different from that stated in any other previously disclosed market approval, the approval is regarded as the "first regulatory approval."

The amended Guidelines indicate that the so-called "first market approval" refers to the market approval first approved for the designated active ingredient(s) and indication(s). Generally, for a salt, ester or hydrate that is approved later and is different from a previously approved free form of a chemical moiety, salt, ester or hydrate, the market approval for the later approved salt, ester or hydrate is regarded as the "first market approval." For example, for a patent with a claim directed to compound A or its salt, if the applicant obtains two approvals directed to formate and phosphate of compound A, respectively, for the same indication, each of the two market approvals is regarded as a "first market approval" and the applicant can select one to file for a PTE application.

III.   Correlation between Claims and First Market Approval

The old Guidelines require that the claims of a patent correspond to the first market approval, while in the amended Guidelines it is required that the claims cover the first market approval. For a product patent, the amended Guidelines require that at least one claim should cover the active ingredient(s) in the market approval. The amended Guidelines provide the following explanatory examples.

(1)Example A

[Claims]

Claim 1: Compound "A."

Claim 2: The compound of Claim 1, which is "a" ("a" is covered by "A").

[Specification]

The specification indicates that Compound "A" has a medical use.

[First market approval]

Active ingredient: Besylate of Compound "a."

Indication: Pain relief.

[Explanation]

Since Claims 1 and 2 do not describe a salt of Compound "A," Compound "a" besylate stated in the market approval cannot be covered by Claims 1 and 2. The claims do not correspond to the market approval and the patent is not eligible for PTE.

(2)Example B

[Claims]

Claim 1: Compound "B" and a salt thereof.

[Specification]

The specification indicates that Compound "B" and a salt thereof have a medical use.

[First market approval]

Active ingredient: Compound "b"

Indication: Compound "b" in combination with other anti-cancer agent for use in the treatment of breast cancer.

[Explanation]

Although the indication stated in the market approval involves a combination use with another anti-cancer agent, since the active ingredient is Compound "b," Compound "b" should be compared with Compound "B" of Claim 1. Upon comparison, Compound "b" is covered by Claim 1 and the specification indicates that Compound “B” and a salt thereof A have a medical use. Therefore, the claim corresponds to the market approval and the patent is eligible for PTE.

(3)Example C

[Claims]

Claim 1: Compound "A" and a pharmaceutically acceptable salt thereof.

Claim 2: The compound of Claim 1 and a pharmaceutically acceptable salt thereof, wherein Compound "A" is Compound "a."

[Specification]

The specification indicates that Compound "A" and a pharmaceutically acceptable salt thereof have a medical use.

[First market approval]

Active ingredient: Formic acid salt of Compound "a."

Indication: Pain relief

[Explanation]

Since the active ingredient stated in the market approval is a formic acid salt of Compound "a" and the formic acid salt is a pharmaceutically acceptable salt, the formic acid salt of Compound "a" is covered by Claims 1 and 2. Moreover, the specification indicates that Compound "A" has a medical use. Therefore, the claims correspond to the market approval and the patent is eligible for PTE.

(4)Example D

[Claims]

Claim 1: An anti-cancer composition, comprising Compound "A" and Compound "B."

[First market approval]

Active ingredient: Compound "a" and Compound "b."

Indication:Bone cancer

[Explanation]

The active ingredients of the market approval are Compounds "a" and "b" and the indication is treatment of bone cancer. The enantiomer of Amisulpride is not specified in Claim 1, so it is interpreted as racemate; thus, the claim corresponds to the market approval and the patent is not eligible for PTE.

(5)Example E

[Claims]

Claim 1: Use of Compound "E" in the manufacture of a medicament against tumor.

Claim 2: The use of Claim 1, wherein Compound "E" is Compound "e. "

[First market approval]

Active ingredient: Compound "e."

Indication:Urinary incontinence.

[Explanation]

The active ingredient of the market approval is Compound "c," which is covered by Claim 1. However, urinary incontinence as stated in the indication of the market approval is different from the anti-tumor use stated in the claims, so the claims do not correspond to the market approval and the patent is not eligible for PTE.

IV.   Clinical Trial Periods

The old Guidelines provide that the period of a foreign clinical trial is calculated from the first dosing date to the last dosing date stated in the clinical trial report (i.e., clinical trial period). The period of the domestic clinical trial is calculated from the issuance date of the TFDA’s notification approving the domestic clinical trial to the issuance date of the TFDA’s notification approving the domestic clinical trial report.

The amended Guidelines further specify that the period of a foreign clinical trial is calculated from the study initiation date to the study completion date stated in the clinical trial report that meets the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The determination of the domestic clinical trial period in the amended Guidelines remains unchanged.

V.   Restorable Time

For pharmaceutical-related patents, the eligible period for PTE is the sum of the following periods that occur after the publication of the patent to be extended:

(a) the period of foreign clinical trials;

(b) the period of domestic clinical trials for regulatory purposes conducted in the ROC; and

(c) the period of regulatory review by the TFDA.

However, the following periods should be subtracted:

(i)the overlap between period a) and period b) mentioned above;

(ii)the overlap between period b) and period c) mentioned above; and

(iii)the period during which the applicant failed to properly act as required for obtaining the related regulatory approval.

The old Guidelines include the following two periods in item (iii) above: (p) delay due to late-submission of documents required for filing a market approval and (q) the time between the issuance date of the notification informing the applicant to collect a market approval and the date the market approval is actually collected.

The amended Guidelines change the above-mentioned item (p) to "delay due to late-submission of documents required to approve a market approval."