The Scope of Examination for the Extension of the patent period by Supreme Court of Japan – ‘Bevacizumab’ case (H26 (Gyo-Hi) NO.356)
The registration of an extension of the patent period is an exception in the Japanese Patent Law only applied to drug patents. Even when a drug patent is granted, the pharmaceutical companies have to obtain an approval for launching their patented drugs into market. Due to periods for the preparation of patent granting and launching new drugs, effective patent period shortens. In order to compensate for the shortened patent protection and to treat the patent right holders fairly, an extended period for protecting patent rights is accepted in many countries.
The Japan Patent Law stipulates in Article 67ter paragraph (1) item (i) that extension should be allowed where the approval is necessary to obtain for the implementation of the patented invention. When there is another approval prior to the approval, according to the examination guideline, the extension is refused, if the drug products of the prior approval include drug products of the present approval. This is decided by comparing ‘the examination matters related directly to substantial identity’ of the two drug products in the light of the type and subject of the patented inventions. In this Japanese practice, the term ‘the examination matters related directly to substantial identity’ has been unclear.
Recently, the Japan Supreme Court decided that ‘the examination matters related directly to substantial identity’ are ‘ingredient, dose, dosage, administration, efficacy and effect of drug products.’
The patented invention in question is ‘vascular endothelial cell growth factor (VEGF) antagonists,’ especially, ‘a composition for treatment of a tumor comprising a therapeutically effective amount of a hVEGF antagonist,’ registered as JP3398382 (‘382) on 14.2 2003. VEGF is a chemical signal that stimulates angiogenesis in a variety of diseases, especially in cancer. The patented drug, Bevacizumab, is a recombinant humanized monoclonal antibody, slowing the growth of new blood vessels and blocking angiogenesis by inhibiting VEGF.
Bevacizumab has been sold under the trade name Avastin and the proprietor, and the appellee of this case, Genentech Inc. (Genentech) obtained an approval (the present approval) under the Drug and Medical Equipment Law 14(ix) for their drug ‘Avastin Injection 100 mg/4 mL (the present medicine)’ on 18.9.2009. The active ingredient of the drug is (genetically recombinated) Bevacizumab of which efficacy and effect are for incurable or unresectable advanced or recurrent colorectal cancer.
Prior to the present approval, Genentech had obtained another approval (prior approval) for a drug, which had identical active ingredient, efficacy, and effect to the present drug. The usage of the former approval is intravenously infused to adults at a dose of 5 mg/kg or 10 mg/kg of body weight and the dosage thereof is an interval of at least 2 weeks. Bevacizumab of the present approval is used with other anticancer drugs and intravenously infused to adults at a dose of 7.5 mg/kg of body weight and the dosage thereof is an interval of at least 3 weeks.
Manufacturing and selling both the present and prior drugs are within the scope of the above patent right. However, the combination usage and different dosage of the identical drug from the prior approval was accepted for the first time.
Procedure and Ground for Action
Genentech filed an application requesting the extension of the patent period for the drug relating to the present approval on 17.12.2009. However, the Japan Patent Office (JPO) rejected the request because the scope defined by ‘all appropriate matters specifying the patented invention (emphasis added)’ was implemented by the prior approval and the present approval was not necessary for the implementation of the patented invention.
Genentech filed an appeal against the JPO commissioner to the IP High Court. The IP High Court held the Grand Panel and reversed the JPO’s decision.
Grounds for Appeal to Supreme Court and the Decision
JPO filed the final appeal to the Supreme Court. The Supreme Court found by comparing the present approval with the prior one that when the manufacture and sale of a medicine of the prior approval includes those of a medicine of the present approval, the protection period of the patent relating to the present approval shall not be extended. However, the necessity of the present approval for the implementation of the patented invention should be decided not by ‘all appropriate matters specifying the patented invention’, but by comparing the present approval with the prior approval on the ‘items directly related to the medicine’s substantial identity in light of the type and subject matter of the patented invention (emphasis added).’ Moreover, it was stated that the ‘items directly related to the medicine’s substantial identity’ are ingredients, amounts, usage, dosage, efficacy, and effects of the medicine.
As described in the ‘Background,’ difference of both approvals is the usage and dosage and the patented medicine for the combination treatment of the Bevacizumab and XELOX could be manufactured and sold for the first time by the present approval. In conclusion, the Supreme Court decided that the implementation of the medicine of the prior approval does not include that of the present approval and affirmed the decision of the IP High Court.
Evaluation and Discussion
In accordance with the above decision, JPO revised their examination guideline that when a present approval and a prior approval fall under a same patented invention, the examination is carried out by comparing ingredients, amounts, usage, dosage, efficacy, and effects of the medicine of both approvals.
Regarding this case, the IP High Court further commented the effect of the extended patent right that the scope of the extended patent right should only be restricted to the scope identical with ‘the matters related directly to substantial identity’ of the present approval.
After the decision of the IP High Court, the IP Committee of the Japan Pharmaceutical Manufacturers Association has expressed concern about the restricted effect of the extended patent right. This is because of the possible risk that the scope of the extended patent right should be restricted, and as a result, it possibly inhibits the development of the pharmaceutical industry. Moreover, if there are some different approvals relating to the same patent right, the scope of the patent right and the length of the extension period could be different. In such a case, since the burden of monitoring the bundle of the extended patent rights increases for the applicants and third parties, it becomes difficult for the patent holders and the third parties to estimate their business strategies.
The Supreme Court’s decision did not mention this issue, and the scope of effect for the extended patent right therefore covers the whole patent right for the meantime.
Ryoko Oshikamo
LL.M., PhD researcher
University of Helsinki
Professorr Rainer Oesch, University of Helsinki, is sincerely appreciated for his supervising.
Read more about the case: 17.11.2015 H26 (Gyo-Hi) 356 (in Japanese)
