JP Supreme Court (Nov. 17, 2015) Patent Term Extension based on a Second Marketing Approval Pre-Meeting AIPLA MWI La Quinta, CA: Jan.26, 2016 Hirokazu Honda, Attorney-at-Law Abe, Ikubo & Katayama

Patent Term Extension Research Pre- Clinical Trial Clinical Trial Examin ation Patent Extension Registration “Cannot practice the patent” Encroachment on Patent term Application 20 yrs 5 yrs Max. Sale!! 2

Patent Law Art. 67 “2. Where there is a period during which the patented invention is unable to be practiced because approvals prescribed by relevant Acts that are intended to ensure the safely, etc. or any other disposition designated by Cabinet Order as requiring considerable time for the proper execution of the disposition in light of the purpose, procedures, etc., of such a disposition is necessary to obtain for the practice of the patented invention, the duration of the patent right may be extended, upon the filing of a request for the registration of extension of the duration, by a period not exceeding 5 years.” In sum …  The patent term can be extended where a patentee could not practice the patented invention because it was necessary to obtain a marketing approval under the Pharmaceutical Affairs Law for such practice.  An application for registration of extension is required. 3

Case Plural Drug Approvals Patent Drug A Can be extended Drug A Drug A’ Drug A Can be extended For Drug A’ Already practiced with approval for Drug A’ ⇒ Cannot be extended For Drug A 4

Factors to be Considered? Drug XDrug Y Active IngredientAAA IndicationBBB PreparationCCCDDD FormEEEFFF Dosage & AdministrationGGGHHH Compare first drug (X) and second drug (Y) in various factors: Similar drug has been sold (=practiced), the period of waiting for approval as to the second drug cannot be considered as parent term extension. For a long time … “Active Ingredient” and “Indication” had been factors to be considered because those factors are important. 5

Amendment of Standard on Extension [Problems]  Patents with technology on preparation, etc. without any character on active ingredient or indication ex. Patents on Drug Delivery System  Refusal of extension is unreasonable only because the second drug (DDS) has the same active ingredient and indication as that of the first drug (not DDS).  The first drug is out of the scope of such DDS patent: also Unreasonable (IP High Court Decision on May 29, 2009; Sup. Court Decision on Apr 28, 2011) Amendment of Standard by JPO  Whether or not the marketing approval was necessary for practicing the patented invention should be determined by all matters that fall in the technical special features of patented invention 6

Supreme Court Case Drug XDrug Y Active Ingredientbevacizumab Indicationincurable unresectable advanced or recurrent colorectal cancer Dosage & Administration 5 or 10mg/kg body wt Interval should be 2w 7.5mg/kg body wt Interval should be 3w [Patented Invention]  a composition for treating cancer comprising effective amount of vascular endothelial growth factor antagonist [Drug]  Brand name: Avastin drip infusion  General name: bevacizumab (genetic recombination) 7

Decision of JPO Matters falling in the technical special features of patented invention  Active ingredient and Indication  Dosage and Administration is not feature of patented invention Rejected an application b/c “features” are the same. JPO Dismissed the patentee’s trial for cancellation of the rejection IP High Court Vacated the JPO’s decision Appeal by Patentee Supreme Court Affirmed High Court Decision Appeal by JPO (May 30, 2014) (Nov 17, 2015) 8

Supreme Court Decision  “… when there are a prior disposition and a subject disposition, upon comparing them, if the manufacture and sales of drug covered by the prior disposition encompasses manufacture and sales of drug covered by the subject disposition, the subject disposition is not found necessary for practicing the patented invention” Prior Drug (X): already practiced the patented invention Subject Drug (Y): approval for Y was not necessary for practicing the patented invention  “In this way, whether or not the subject disposition was necessary for practicing the patented invention should be determined by comparing the prior deposition and the subject disposition; it should not be determined by all matters that fall in the technical special features of the patented invention.” 9

Standard on “Encompassed by Prior Drug”  Comparison of both marketing approvals with regard to matters for examination directly relevant to the substantial identity as drug in light of types and subject matters of the subject patent  As a result of such comparison, where it is found that the manufacture and sales of drug covered by the prior disposition encompasses manufacture and sales of the subject drug, it is reasonable to find that the subject disposition was not necessary for practicing the patented invention That holding means that not every matter for examination is considered in comparison of both marketing approvals. Patent term extension should not be granted by comparing matters for examination which would never interfere practice of the patented invention 10

Matters for Examination in This Case [Invention directed to an ingredient of a drug] Matters for examination of both approvals which are directly relevant to the substantial identity as drug are:  Ingredients; Amount; Dosage; Administration; Indication This Case  The dosage and administration of both drugs are different.  The prior approval did not allow manufacture and sales of the drug for combination therapy of bevacizumab therapy and XELOX therapy, and it was allowed by the subject approval for the first time. The manufacture and sales of drug covered by the prior approval is not found to encompass manufacture and sales of the subject drug covered by the subject approval. 11

Effect of Patent Term Extension Patent Law Art “Where the duration of a patent right is extended …, such patent right shall not be effective against any act other than the practice of the patented invention for the product which was the subject of the disposition designated by Cabinet Order under Article 67(2) which constituted the reason for the registration of extension (where the specific usage of the product is prescribed by the disposition, the product used for that usage).”  What is “the product (the product used for that usage)” which was the subject of the approval?  Long time ago: Product specified by active ingredient and indication (Same as the standard of comparison of both marketing approvals) 12

Effect of Patent Term Extension [IP High Court (May 30, 2014)] (Not an infringement action: stated as obiter dictum)  In light of the purpose of patent term extension and of a patent infringement action,  in the case of a patented invention for an ingredient of a drug,  effective for the practice of the patented invention identified by: Ingredients (not limited to active ingredient) - as an invention pertaining to a product Indication and dosage and administration - as an invention pertaining to usage [Supreme Court] No decision. 13

Requisite and Effect Prior Drug Subject Drug [Easy to be Rejected][Wider Range of Effect] Subject Drug Prior Drug Compared by Less Matters Sup. Court Decision Prior DrugSubject Drug [Easy to be Granted][Narrower Range of Effect??] ? ? 14

Thank You!! Hirokazu Honda, Attorney-at-Law Abe, Ikubo & Katayama URL: Phone: Fax: