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IP High Court, Tokyo Japan decided to overturn the trial decision of the JPO with respect to Patent Term Extension (PTE) in Japan, wherein the judges pointed out that in the current Examination Guidelines, the conditions for acceptance of the patent term extension application are too much restricted over the conditions mentioned in the decision of the Supreme Court (Takeda Case).

           In said Examination Guidelines, when a preceding marketing approval covers a drug having the same active ingredient and the same use as the newly approved drug subjected to the PTE application, even though the newly approved drug and the previously approved drug are different in the usage/dosage of the drug, the PTE application is rejected when the patent claim does not define the usage/dosage and is inclusive also the previously approved drug.

           The IP High Court denied the standard of the Examination Guideline and admitted the patentability of the PTE application regardless the patent claim includes or not the previously approved drug, as long as a new marketing approval is required for the new drug.

New Court Decision:

           IP High Court decision, Genentech Inc. v. The Commissioner of

           JPO; Heisei 25-(Gyo-Ke)-10195[1], decided on May 30, 2014

           (en banc)；

           IP High Court decided to overturn the decision of the Trial Board of the JPO rejecting PTE application which follows to the current Examination Guidelines.

           The JPO, Trial Board decided to affirm the rejection of a PTE application by Examining Division where the Examiner rejected the PTE application by the reasons that the invention as claimed in the claims covering the approved drug in question has already been workable by the preceding approval which was concerned with a drug of the same active ingredient and the same use being inclusive within the scope of the patent subjected to the PTE application, though there is difference in the usage/dosage thereof, and hence the application shall be rejected under Patent Law, Art. 67^ter.

           The IP High Court overturned this JPO’s decision because the approval should be obtained for working the patented invention notwithstanding the claim of the patent defines or not the usage/dosage of the approved product.

Examination Guidelines:

           According to the current Examination Guidelines, which was revised at the end of 2011 so as to be consistent with the decision of the Supreme Court of Japan (Heisei-21-(Gyo-Hi)-326 decided on April 28, 2011 (Takeda Case)), even if there exists a former approval of a drug having the same active ingredient and the same use (efficacy/effect) as those of the drug in a later approval, where the drug of the former approval is not inclusive in the claims of the patent to be subjected to the PTE application, the later approved drug is applicable to the PTE application.

           Thus, it is stated in the revised Examination Guidelines that a PTE can be applied to a drug approved in a later approval even when a drug having the same active ingredient and the same use has been approved in a former approval unless the drug approved by the former approval is inclusive in the claim of the patent subjected to the PTE application, but it is further stated in said Examination Guidelines that a PTE application shall be rejected under Patent Law, Art. 67^ter in either one of the following cases because it would be unnecessary to obtain a disposition as provided for in Cabinet Order referred to in Patent Law, Art. 67(2) for working of the patented invention:

           (i) where the manufacture and selling of the drug approved by the marketing approval in question do not correspond to the working of the patented invention to be subjected to the PTE application (that is, the approved drug is not inclusive within the scope of claims of said patent),

           (ii) where among the patented invention, the invention as claimed in claim which covers the approved drug (as well as use thereof when the claim includes the use) has already been workable by the preceding marketing approval (that is, the drug approved in the preceding approval is also inclusive in the claim covering the approved drug to be subjected to the PTE application).  

Approved drugs in the instant approval and in the preceding approval

and the claims of patent subjected to the instant PTE application:

           In the instant case, the approved drug subjected to the PTE application is as follows:

           the drug to be subjected to the disposition (approval):

                       the trade name: “avastin intravenous drip 100 mg/4 ml”

                       the active ingredient: general name, “bevacizumab”

                 use (efficacy/effect) of the drug:

                       treatment of unresectable advanced/recurred colorectal cancer in

                       combination chemotherapy with other anti-malignant tumor agent by

                       intravenously dripping bevacizumab in a dose of 7.5 mg/kg (body

                       weight) per once in adult at an interval of 3 weeks or more

           The instant marketing approval is a partial change of the preceding approval in the usage/dosage.  That is, the approved drug in the preceding approval is the same active ingredient and the same use and is different in the usage/dosage.  That is, the approved drug in the preceding approval is as follows:

           the active ingredient: general name, “bevacizumab”

           use (efficacy/effect): treatment of unresectable advanced/recur­

               red colorectal cancer

           usage/dosage: in combination chemotherapy with other anti-

               malignant tumor agent by intravenously dripping

               bevacizumab in a dose of 5.0 mg/kg (body weight) or 10.0

               mg/mg (body weight) per once in adult at an interval of 2

               weeks or more

           Thus, the approved drug subjected to the instant PTE application is different from that of the preceding approval merely in the usage/dosage (the active ingredient and the use thereof are the same), but the patent claims subjected to the PTE application do not define any usage/dosage as follows: 

           Claim 1:  A composition for the treatment of cancer comprising a therapeutically effective amount of a hVEGF antagonist which is an anti-VEGF antibody.

                  Claims 2-9: The composition depending on preceding claim(s) defining the antibody, cancer, etc.

                   Claims 10-11: The composition depending on preceding claims, wherein the medicament is used in combination with other anti-cancer drugs, or in combination with radiological treatments.  

The position of the JPO, Trial Board:

           The JPO, Trial Board pointed out that the PTE application shall be examined under the conditions as defined in patent law, and even if the conditions for obtaining a marketing approval as defined in the Pharmaceutical Affairs Law are somewhat different from the conditions for enjoying a PTE as defined in the patent law, the workability of the patented invention shall be interpreted under the provisions of Patent Law but not under the provision of the Pharmaceutical Affairs Law,

           that in the instant case, the patented invention is defined in the claims merely by the active ingredient and use for the treatment of cancer, but any usage/dosage is not defined in claims, and hence, it is reasonable to interpret the workability of the patented invention without considering the usage/dosage. 

           Accordingly, the JPO, Trial Board concluded that since the drug of the preceding approval is also inclusive in the claims of the patent for the instant PTE application, the patented invention has already been workable by the preceding approval, and hence, the instant PTE application shall be rejected under Art. 67^ter.  

The Decision of IP High Court:

           The IP High Court overturned the above-mentioned trial decision of the JPO by the reasons that the marketing approval shall be obtained under Pharmaceutical Affairs Law even for a new drug having the same active ingredient and the same use as those of the drug approved by the former approval where the new drug is different from the former approved drug in the usage and dosage, etc., otherwise, the new drug cannot be put on the market, which means that the patented invention covering the new drug cannot be worked with respect to the scope covering said new drug, accordingly, the PTE application shall also be accepted for the new drug regardless the formerly approved drug being inclusive or not within the scope of the claims subjected to the PTE application

           and that the statement with respect to the reasons of rejection under Patent Law, Art. 67^ter, based on the patent claims inclusive of the approved drug, in the current Examination Guidelines is shown by the own interpretation of the JPO over the statement of the Supreme Court, in which decision of the Supreme Court the Judges mentioned about patent claims because of mere necessity for explanation of the situation in said case (but it is not essential for determination of the workability of the patented invention).

Effects of extended patent right under Patent Law, Art. 68^bis:

           The current Examination Guidelines do not mention the effects of extended patent right under Patent Law, Art. 68^bis but entrust it to court decisions in future.  Then, the above IP High Court decision mentions about the effects of extended patent right under Patent Law, Art. 68^bis as follows:

           The effects of the extended patent right do not extend to the acts other than the working of the patented invention with respect to the product subjected to the PTE application as defined in Art. 68^bis.

           Although to what scope the effects of the extended patent right are extended may be determined in each infringement suit, it is optionally studied in this case as follows.

           When a marketing approval is obtained under the Pharmaceutical Affairs Law, Art. 14, Para. 1, it is examined with respect to “name of the drug, components, dose, usage, dosage, efficacy, effects, side effects and other factors concerning quality, effectiveness and safety of the product”.

From this viewpoint, the disposition as provided for in Cabinet Order referred to in Patent Law, Art. 67(2) shall always be examined based on the approved drug and the use (efficacy/effects) thereof, and the scope of the extended patent right shall be determined likewise and also from the viewpoint of fair positions between the patentee and the third persons. And then, the factors to be considered in the determination of the effects of the extended patent right are those taken in the examination of the marketing approval as mentioned above, among which the important factors are components, use including efficacy/effects, usage, dosage, while the name of the product, dose, side effects and other factors concerning quality, effectiveness and safety of the product are not effective on the interpretation of the effects of the extended patent right.

           Thus, it is understood that the effects of the extended patent right shall be extended to the working of the patented invention within the scope as defined by components of the approved drug (not limited to the active ingredient) and use thereof including efficacy, effects, usage and dosage, while it will, of course, be interpreted by applying the doctrine of equivalents, and the thought of being substantially the same, as usual.  

Consideration:

           Although it is not sure whether the current Examination Guidelines might be revised due to the above-mentioned decision of IP High Court, or alternatively the JPO will appeal to the Supreme Court, it may be said that according to this decision of IP High Court, when a marketing approval is obtained with respect to a new drug having an improved formulation, modified usage and dosage, the patentee will file a PTE application in order to protect the new drug for a longer period of time, even though the new drug has the same active ingredient and the same use (efficacy/effect) as those of the preceding approval which drug is inclusive within the scope of claim of the patent, while it has been considered to be unable to subject to the PTE application under the current Examination Guidelines.  Thus, the number of PTE applications will increase in future. 

           It shall also be noted that the scope of the extended patent right will be interpreted narrower than that would have usually been considered by the interpretation shown in the above decision of IP High Court.