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On November 17, 2015, the Supreme Court issued a decision on Patent Term Extension in Japan.  The decision is contrary to the current JPO’s examination policy.  In response, the JPO announced that the current Examination Guidelines will be revised and the Revised Guidelines will be issued at around the coming spring.

Supreme Court Case Summary:2014-(Gyo-Hi)-356:

                                                                              November 20, 2015

                                                                              Aoyama & Partners

In May 2014, IP High Court, Tokyo Japan decided to overturn the trial decision of the JPO with respect to Patent Term Extension (PTE) in Japan (Genentech case), wherein the judges pointed out that the Examination Guidelines are wrong in that the PTE application based on the newly approved drug was rejected by the reason that the newly approved drug was inclusive within the claim of the patent for the preceding marketing approval and hence it was not necessary to obtain the new approval for manufacturing and selling of the drug to be subjected to the PTE.

Against the decision of the IP High Court, the JPO has appealed to the Supreme Court, and on November 17, 2015, the Supreme Court dismissed the appeal and supported the position of the IP High Court, unanimously by five Judges.

Background:

For helping your understanding the situation of PTE system in Japan until now, some court decisions regarding to PTE examination are briefly explained.

In April 2011, the Supreme Court decided to affirm the decision of IP High Court that overturned the trial decision of the JPO regarding PTE (decided on May 29, 2009) (“Takeda case”).  The JPO had taken the old Examination Guidelines for long years, wherein it is mentioned that PTE is acceptable only based on the first approval as long as the same active ingredient with the same use is concerned and further the substance to be subjected to PTE is “active ingredient” of the approved drug, but not “approved drug” per se.  IP High Court denied the old Examination Guidelines taken by the JPO, and decided to be acceptable the PTE based on a second approval as to the same active ingredient and the same use as those of the drug in the preceding (first) approval, as long as the drug in the first approval is not inclusive within the scope of claims of the patent of which PTE application is filed.  The Supreme Court affirmed this decision of the IP High Court.

https://www.aoyamapat.gr.jp/en/news/1338

Due to the decision of the Supreme Court in Takeda case, the JPO revised Examination Guidelines.  It is stated in the Revised Examination Guidelines that PTE can be applied to a drug approved in a later (second) approval even when a drug having the same active ingredient and the same use has been approved in a former (first) approval unless the drug approved by the first approval is inclusive in the claim of the patent subjected to the PTE application, but it is further stated in said Revised Examination Guidelines that a PTE application shall be rejected where the approved drug to be subjected to the latter PTE application is inclusive within the claim of the patent subjected to the former PTE as to the approved drug of the first approval, because the patent in said former PTE include the drug of the second approval and hence it is not necessary to obtain newly an approval for working of the patented invention.

Under said Revised Examination Guidelines, the PTE application by Genentech was rejected. Against the trial decision of rejection of the PTE application, Genentech appealed to IP High Court.

Then, the IP High Court decided to deny the trial decision of the JPO and to affirm granting the PTE application of Genentech, wherein the IP High Court pointed out that the PTE application shall be accepted regardless the drug of the second approval is included or not in the claim of patent subjected to the PTE of the preceding (first) approved drug, and the Revised Examination Guidelines contrary to the above is wrong.

https://www.aoyamapat.gr.jp/en/news/1367

New decision of the Supreme Court in Genentech case:

The Supreme Court decided to affirm the position of the IP High Court as mentioned above.  In said new decision of the Supreme Court, the judges said that the drug for the new approval referred to in the PTE is not included in the conditions (usage and dosage) of the drug of the preceding approval and the marketing approval should have newly been obtained, and hence, it is affirmed the decision of the IP High Court which denied the trial decision of the JPO rejecting the PTE because of no necessity of the new approval for working the drug.

In more detail, the Supreme Court mentions as follows:

“In case of existing a preceding marketing approval in addition to the new marketing approval, the necessity of the marketing approval shall be determined by comparing both of the preceding approval and the new approval with respect to the matters relating directly to the substantial identification of the drugs in the light of the kinds and subjective matters of the patent to be subjected to the PTE, and when the manufacturing and selling of the drug approved by the preceding approval cover the features of manufacturing and selling of the newly approved drug, it shall be considered that there is no necessity of obtaining the new approval.

The instant case is studied from this viewpoint, and it is concluded that the conditions (usage and dosage) of the newly approved drug are not included in those of the drug of the preceding approval, and hence, the new approval shall be obtained for working the newly approved drug and the decision of the JPO denying the necessity of the new approval is wrong.  Thus, the decision of the IP High Court is affirmed.

As mentioned above, in Genentech case, the Supreme Court decided to reconfirm the position of the IP High Court which states the patentability of the PTE application with respect to the second approved drug, comprising the same active ingredient and the same use as the first approved drug and being different merely in the dosage from the first approved drug, and further states that even when the second approved drug is inclusive in the claim of the patent subjected to the PTE of the first approved drug, it was necessary to obtain a marketing approval for the drug having different dosage from that of the drug of the first approval, and hence it could not be said that it is not necessary to obtain a marketing approval for working the patented invention.

Due to the decision of the Supreme Court, the JPO announced that the current Examination Guidelines will be revised and the Revised Examination Guidelines will be issued at around the coming Spring.

Full English translation of the decision is added on December 4, 2015.

https://www.aoyamapat.gr.jp/contents/corporate/aocpcd/wp-content/uploads/2018/06/English-Translation-2014Gyo-Hi3561.pdf