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New ruling on scope of extended patent rights in japan

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This material shows the recent changes on the scope of protection of extended patent rights in Japan in the pharmaceutical field, based on an IP High Court Decision.

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New ruling on scope of extended patent rights in japan

  1. 1. Hiroshi Higuchi Allegro IP Law Firm New Ruling on Scope of Protection of Extended Patent Rights in JAPAN
  2. 2. 2 Disclaimer The materials prepared and presented here reflect the personal views of the author and do not necessarily represent any other individuals or entities. Allegro IP Law Firm does not assume any responsibility for the materials. It is understood that each case is fact specific and the materials are not intended to be a source of legal advice. These materials may or may not be relevant to any particular situation. The author, Allegro IP Law cannot be bound to the statements given in these materials. Although every attempt was made to ensure that these materials are accurate, errors or omissions may be contained therein and any liability is disclaimed.
  3. 3. 3 Contents • Patent Term Extension in Japan • Main Issues • Scope of Protection of Extended Patent Right • Key Takeaways • Related Topics
  4. 4. 4 Patent Term Extension in Japan 1. Overview  Objective:  To restore the period during which a patented invention was unable to be worked because it was necessary to obtain an “disposition” ((i) Registration related to agricultural chemicals; and (ii) Regulatory Approval related to pharmaceuticals)  Basic Limitations:  5 years at the maximum  Pharmaceuticals, in-vitro diagnostic reagents, regenerative medicine products and agrochemicals are eligible (not applied to intermediates, catalysts and manufacturing apparatus) [Patent Law Art. 67] (Duration of patent rights) (i) The duration of a patent right shall expire … 20 years from the filing date … ; and (ii) Where there is a period during which the patented invention is unable to be worked because an approval or other disposition … is necessary to be obtained for the working of the patented invention, the duration … may be extended … not exceeding 5 years.
  5. 5. 5 Patent Term Extension in Japan 2. New Drug Development Process Basic Study Non- clinical Study Clinical Trial Phase I, II, III Examination for Approval Examination Non-enforceable Protection of Product Patent Term Extension Patent Application Patent Right Sales 9 years 20 years up to 5 years IND Filing Regulatory Approval Patent Granted
  6. 6. 6 Patent Term Extension in Japan 3. Basic Requirements  Applicant Patent Holder  Timing  Before the original patent term expires  Within 3 months of regulatory approval  Disposition  Disposition was necessary to be obtained for the working of the patented invention  Patentee or Licensee obtained the disposition  Patent Term to be Extended  Start: when clinical trial is started or when patent is registered, whichever is later  End: when applicant receives regulatory approval  Official Fees  JPY 74,000
  7. 7. 7 Comparison between JP and US Practices JP US Legal Basis Patent Act Hatch-Waxman Act Maximum Extension 5 years 5 years Extendable Patent(s) per Product Plural patents Only one patent Number of Extension Time(s) per Patent Plural times Only once Eligible Pharmaceuticals, diagnostic reagents, regenerative medicines, agrochemicals Drugs, food or color additives, medical devices
  8. 8. 8 Main Issues regarding Patent Term Extension 1. Whether it was “necessary to obtain a disposition”  Pacif Supreme Court Judgment (April 28, 2011): If the earlier pharmaceutical, for which the earlier disposition was already obtained, is not included in the technical scope of the patented invention, the Patent Term Extension based on the later disposition is not denied. Examination Guidelines revised in 2011  Bevacizumab Supreme Court Judgment (November 17, 2015): If the implementation of the pharmaceutical covered by the earlier disposition includes that of the pharmaceutical covered by the later disposition, it was “not necessary to obtain a disposition”. Even if active ingredient and application of the prior and present pharmaceuticals are identical, the necessity of the later disposition should not be denied so long as dosage and administration are different. Examination Guidelines revised in 2016 (current version) 2. Scope of protection of extended patent right  Oxaliplatinum IP High Court Judgment: Debiopharm v. Towa Pharmaceutical (January 20, 2017)
  9. 9. 9 Scope of Protection of Extended Patent Right Overview of Oxaliplatinum Case  Main Issues in this case: I. Does Towa’s product fall within the scope of Debio’s patent (literally or under DoE)? II. Is Debio’s extended patent right effective against Towa’s products?  Tokyo District Court said:  Debio’s extended patent right is not effective against Towa’s products (Issue II) (no decision on Issue I)  IP High Court said:  Debio’s extended patent right is not effective against Towa’s products (Issue II)  Towa’s products do not fall within the scope of Debio’s patent (Issue I)
  10. 10. 10 Scope of Protection of Extended Patent Right Overview of the patent at issue  Japanese Patent No.: 3547755 (‘755 Patent)  Patent Holder: Debiopharm (Swiss)  International Filing Date: August 7, 1995  Original Patent Term: August 7, 2015  Extended Patent Term: January 29, 2020  Claim 1: A pharmaceutically stable preparation of oxaliplatinum for the administration by the parenteral route, consisting of a solution of oxaliplatinum in water at a concentration of 1 to 5 mg/ml and having a pH of 4.5 to 6, the oxaliplatinum content in the preparation being at least 95% of the initial content and the solution remaining clear, colorless and free of precipitate after storage for a pharmaceutically acceptable duration of time.  Summary of History:  1st Office Action Argument without amending claims Allowance  3 Invalidation Trials  7 Extensions
  11. 11. 11 Scope of Protection of Extended Patent Right Towa’s Products: Towa Product 1 Towa Product 2 Towa Product 3 Content/Vial 10 mL 20 mL 40 mL Active Ingredient oxaliplatin 50 mg oxaliplatin 100 mg oxaliplatin 200 mg Additive conc. glycerin 50 mg conc. glycerin 100 mg conc. glycerin 200 mg Nature colorless and clear liquid pH 4.0 – 7.0 Efficacy | Effects identical with Debio’s Dosage | Administration identical with Debio’s
  12. 12. 12 Scope of Protection of Extended Patent Right [Patent Law Art. 68bis] (Effect of patent right in the case of duration extension) Where the duration of a patent right is extended …, such patent right shall not be effective against any act other than the working of the patented invention for the product which was the subject of the disposition … (where the specific usage of the product is prescribed by the disposition, the product used for that usage). Fundamental Policy The extended patent right is effective against the "working of the patented invention" for the "product" specified by the "ingredients, quantity, dosage, administration, efficacy, and effects" specified by a specific disposition. Enlargement of Scope of Extended Patent Right Extended patent right is effective … also against products which are substantially identical with said "product" as a medicine.
  13. 13. 13 Scope of Protection of Extended Patent Right • Substantially Identical? Even if there is a part that differs from the subject product …, if said part is merely a slight difference or formal difference as a whole, it is reasonable to understand that the subject product is included in the products which are substantially identical with the product … as a medicine and falls within the scope of the extended patent right. *Note: The IP High Court said that it is impossible to apply or analogically apply the five requirements of the doctrine of equivalents in determining the scope of being substantially identical.
  14. 14. 14 Scope of Protection of Extended Patent Right 4 types IP High Court ruled where the products are recognized as being substantially identical : i. where … a different ingredient (not the active ingredient) is partially added, converted, etc. based on well-known or commonly used art … in relation to a patented invention which is characterized only by the active ingredient of a medicine …; ii. where … a different ingredient is partially added, converted, etc. based on well- known or commonly used art … in relation to a patented invention pertaining to stability or dosage form, etc. of a medicine with a publicly known active ingredient, and the products are recognized as being identical with each other in the technical features and function/effect in light of the content of the patented invention; iii. … only a quantitatively meaningless difference … in terms of the "quantity" or "dosage and administration"; and iv. … differ in the "quantity" … but are recognized as being identical with each other in consideration of "dosage and administration".
  15. 15. 15 Scope of Protection of Extended Patent Right • Comparison of Debio and Towa products Towa Product 1 Towa Product 2 Towa Product 3 Content 10 mL 20 mL 40 mL Active Ingredient oxaliplatin 50 mg oxaliplatin 100 mg oxaliplatin 200 mg Additive conc. glycerin 50 mg conc. glycerin 100 mg conc. glycerin 200 mg Debio Product 1 Debio Product 2 Debio Product 3 Content 10 mL 20 mL 40 mL Active Ingredient oxaliplatin 50 mg oxaliplatin 100 mg oxaliplatin 200 mg "ingredients" include only oxaliplatin and injectable water and do not include any other ingredients "ingredients" include concentrated glycerin as an additive (stabilizer), in addition to oxaliplatin and injectable water literally different * “ingredients” are not limited to active ingredients
  16. 16. 16 Scope of Protection of Extended Patent Right • Substantially Identical? Specification of ‘755 patent recites: the purpose of the invention can be attained by using an "aqueous solution of oxaliplatinum that is free of any acidic or alkaline agent, buffer or other additive" and "this preparation is free of any other ingredients and should, in principle, not contain more than about 2% of impurities". One of the technical features of the patented invention lies in the aqueous solution of oxaliplatinum free of any additive The difference in "ingredients" between the Debio products and the Towa products cannot be considered as a slight difference or formal difference as a whole Towa products cannot be considered to be included in those that are substantially identical with the Debio products.
  17. 17. 17 Key Takeaways  Extended Patent Right is effective against “substantially identical” product  IP High Court ruled 4 types where the products are recognized as being “substantially identical”  Patent Term Extension practice in Japan Plural patents extendable based on one disposition Plural extensions available per patent
  18. 18. 18 Related Topics • Possible Revisions regarding Patent Term Extension under the TPP The TPP requires member nations to allow patent applicants to request adjustment of the patent term due to unreasonable or unnecessary delays by the Patent Office. Under the revised law, patent applicants may request adjustment (extension) of patent term if: (1) a patent takes more than five years to issue from the filing date; or (2) patent examination continues beyond three years from the date of filing the request for examination; whichever is longer.
  19. 19. 19 Hiroshi Higuchi higuchi@allegropat.com Allegro IP Law Firm Thank you for your kind attention.

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