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Recently, the Japan Patent Office (JPO) has revised the Examination Guidelines for Patent Term Extension (PTE) applications, following the revision in 2011.  According to the new Examination Guidelines (“2016 Guidelines”), when a pharmaceutical product subjected to a later marketing approval is different from a pharmaceutical product subjected to an earlier marketing approval in terms of its dosage, administration, formulation, or the like, an application for PTE based on the later approval shall be allowed even though the former and the latter products fall within the scope of the patent at issue. 

1) Background

In principle, when a marketing approval is granted for a pharmaceutical product covered by the patent, the patentee can file a PTE application requesting an extension of a patent term for a period of time (not exceeding five years) where the exploitation of the patent was prevented until the marketing approval was obtained.

Under the old Examination Guidelines for PTE (“old Guidelines”) effective before December 2011, a PTE application was allowed on the first marketing approval, but not allowed on any later marketing approval when the active ingredient and the use of the pharmaceutical product subjected to the later approval are the same as those of the pharmaceutical product subjected to the first approval.

2) 2011 Guidelines

In December 2011, the JPO had revised the old Guidelines in conformity with the decision of Supreme Court of Japan, 2009-(Gyo-Hi)-326 in 2011: “Takeda”.  In the the 2011 Guidelines, the conditions for allowing a PTE application based on a later marketing approval are expanded to include dosage, administration, formulation, etc. in addition to active ingredient and use (efficacy or effect).

According to the 2011 Guidelines, a PTE application was basically allowed on a pharmaceutical product subjected to a later marketing approval, which is different from a pharmaceutical product subjected to an earlier marketing approval in dosage, administration, formulation, or the like.  Nevertheless, if the former and the latter products fall within the scope of the patent at issue, a PTE application based on the later approval was rejected.

3) 2016 Guidelines

According to the new decision of Supreme Court of Japan, 2014-(Gyo-Hi)-356 decided on November 17, 2015: “Genentech”, the JPO has revised the 2011 Guidelines.  The new 2016 Guidelines are applicable to PTE applications pending on and after April 1, 2016.

Under the 2016 Guidelines, if a pharmaceutical product subjected to a later marketing approval is different from a pharmaceutical product subjected to an earlier marketing approval in dosage, administration, formulation, or the like, a PTE application based on the later approval shall be allowed even though the former and the latter products fall within the scope of the patent at issue.

4) Example

The 2016 Guidelines will be explained by the following simplified case example.

i) Claims of the patent

The patent includes only one claim as follows:

　　　[Claim 1]  An analgesic comprising an active ingredient A.

Claim 1 defines neither dosage nor administration of the analgesic.

ii) Approved pharmaceutical products

The patentee obtained the first marketing approval (“earlier approval”) for a pharmaceutical product wherein the “active ingredient” is A, the “use” is pain relief, and the “dosage and administration” is 3 mg/dose (see “Earlier-approved pharmaceutical product” in Table below).

The patentee has later obtained the second marketing approval (“later approval”) for a pharmaceutical product wherein the “active ingredient” is A, the “use” is pain relief, and the “dosage and administration” is 30 mg/dose (see “Later-approved pharmaceutical product” in Table below).

iii) PTE application based on the later approval

a) Under the 2011 Guidelines, the PTE application would be rejected because the pharmaceutical product subjected to the later approval is the same as the pharmaceutical product subjected to the earlier approval in terms of features of claim 1 of the patent, i.e., active ingredient and use, and the former and the latter products fall within the scope of the patent.

b) Under the 2016 guidelines, the PTE application will be allowed because the pharmaceutical product subjected to the later approval is different from the pharmaceutical product subjected to the earlier approval in “dosage and administration” (i.e., 3 mg/dose vs. 30 mg/dose in the above example).

5) Our comments

The Supreme Court’s decisions in Takeda and Genentech as well as the Examination Guidelines are silent on the protection provided by PTE.  Further court’s decisions are needed to elucidate the scope of the extended patent rights.

In this regard, the first instance decision by IP High Court in Genentech suggests that the scope of the extended patent rights should be construed to cover only the embodiments defined by ingredients (including the active ingredient), use, dosage and administration as defined in the marketing approval of the pharmaceutical product.

What is suggested by the IP High Court decision could be interpreted to mean that the patent extended on the basis of an earlier marketing approval covers only the pharmaceutical product subjected to the earlier approval.  It is thus highly recommended to file a new PTE application whenever a new later marketing approval is obtained on a pharmaceutical product covered by the patent in order to ensure the protection of every newly-approved product, even though PTEs of the patent have already been granted based on the earlier approvals.

Should you have any questions, please feel free to contact us.

Full text of new Examination Guidelines for PTE:

http://www.jpo.go.jp/tetuzuki_e/t_tokkyo_e/files_guidelines_e/09_0100_e.pdf

Full text of case examples relating to PTE in new Examination Handbook:

http://www.jpo.go.jp/tetuzuki_e/t_tokkyo_e/files_handbook_sinsa_e/app_a9_e.pdf

(Ko Ochiai)