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Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
Patent Term Extension Case Law In Japan
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Patent Term Extension Case Law In Japan

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AIPLA 2009 Annual Meeting …

AIPLA 2009 Annual Meeting
IP Practice in Japan Committee - Premeeting
October 13-14, 2009

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  • 1. YUASA AND HARA<br />LAW, PATENT, TRADEMARK &amp; DESIGN and ACCOUNTING<br />TRADEMARK <br />&amp; DESIGN<br />DIVISION<br />ACCOUNTING <br />&amp; AUDITING<br />DIVISION<br />LAW <br />DIVISION<br />PATENT <br />DIVISION<br />Patent Term Extension:<br />Case Law in Japan<br />YUASA AND HARA<br />LAW, PATENT, TRADEMARK &amp; DESIGN and ACCOUNTING<br />AIPLA 2009 Annual Meeting<br />IP Practice in Japan Committee - Pre-meetingOctober 14, 2009 <br />TRADEMARK <br />&amp; DESIGN<br />DIVISION<br />ACCOUNTING <br />&amp; AUDITING<br />DIVISION<br />LAW <br />DIVISION<br />PATENT <br />DIVISION<br />Koji Hirayama<br />YUASA and HARA<br />hirayama-ch@yuasa-hara.co.jp<br />1<br />
  • 2. 2<br />Life Cycle Management of Drugs<br />Introductory Period<br />Growth Period<br />Maturation Period<br />Declining Period<br />Perform sales promotion activity<br />Sales decrease due to a drop in market share and price<br />Sales start<br />Hit the market<br />Sales expand<br />Acquire profits to recoup research and development costs<br />Patent Term<br />Entry of Generic Drugs<br />sales<br />Sales Authorization by Government<br />Profitability point<br />time<br />
  • 3. 3<br />Life Cycle Management of Drugs (cont’d)<br />Introductory Period<br />Growth Period<br />Maturation Period<br />Declining Period<br />Authorization by Government<br />Entry of Generic Drugs<br />“Gross Sales”<br />“Gross Sales”<br />Patent Term Extension<br />Expediting authorization<br /><ul><li>How to Maximize “Gross Sales” ?
  • 4. Accelerate the start of sales by expediting authorization from government
  • 5. Delay the entry of generic drugs by “patent term extension”</li></li></ul><li>4<br />Concept of Patent Term Extension<br /><ul><li>If the patented invention could not be worked for the necessity of obtaining a marketing approval provided under legal regulations designed for ensuring product safety</li></ul> Ex. Drug, Pesticide (Japan)<br /><ul><li>Benefit of exclusive rights cannot be enjoyed despite the validity of patent rights.
  • 6. Such situations pose problems affecting the basis of the patent system, and a measure of extending the patent terms is necessary in order to resolve the situation.</li></li></ul><li>5<br />Patent Term Extension System<br />Patent Term<br />extension<br />period<br />registration<br />date<br />filing date<br />clinical<br />trial<br />starting<br />date<br />20 years<br />from<br />filing date<br />approval by government<br />whichever<br />is later<br />0 < extension period ≦ 5 years<br />working of the patent right prohibited<br />extension<br />period<br />
  • 7. 6<br />Brief Comparison – US v. JP<br />*1 35 USC §§155-156 *2 Japanese patent law §67bis<br />
  • 8. 7<br />“Multiple patents” corresponding to one approval<br />patent term expires<br />extension period<br />chemical substance patent<br />patent term expires<br />extension period<br />medical use A patent<br />patent term expires<br />extension period<br />production process patent<br />All the patents individually extendible as long as there is a necessity to obtain an approval for the working of each of the patented inventions<br />filing<br />date<br />filing<br />date<br />filing<br />date<br />time<br />
  • 9. 8<br />Brief Comparison – US v. JP<br />*1 35 USC §§155-156 *2 Japanese patent law §67bis<br />8<br />
  • 10. 9<br />“Multiple approvals” corresponding to one patent<br />patent term expires<br />extension period<br />5 years maximum<br />patent term<br />20 years<br />extension period<br />for medical use A<br />extension period for medical use B<br />Chemical substance patent<br />Extension may be granted for each of the different medical uses<br />filing<br />date<br />time<br />
  • 11. 10<br />Brief Comparison – US v. JP<br />*1 35 USC §§155-156 *2 Japanese patent law §67bis<br />10<br />
  • 12. 11<br />Statutory Requirements<br /><ul><li>[T]here is a period during which the patented invention is unable to be worked because […] “[a] disposition designated by Cabinet Order” […] is necessary to obtain for the working of the patented invention… Section 67(2)
  • 13. Marketing approval for drugs and pesticides
  • 14. What acts are covered by “the working of the patented invention” ?</li></li></ul><li>12<br />JPO’s Interpretation of Statutory Law<br /><ul><li>In judging requirements for registration for extension, JPO considers “the scope of a patent right to be extended.”
  • 15. [An extended] 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 approval […] (where the specific use of the product is prescribed by the disposition, the product used for that “use”). Section 68-2.
  • 16. JPO’s Interpretation:
  • 17. “product” “an active ingredient”
  • 18. “use” “efficacy / effect”</li></li></ul><li>13<br />JPO’s Practice and Court’s Precedents<br /><ul><li>JPO’s Practice:
  • 19. [W]hen approvals are granted to pharmaceuticals with the same active ingredient (product)andthe same efficacy / effect (use) and differing only in […] dosage forms, etc., patent term extension shall be granted on basis of the earliest approval only. Examination Guidelines Part IV 3-1-1(1)
  • 20. Court’s precedents upheld JPO’s practice.</li></li></ul><li>14<br />Extension Inapplicable to Later Approval<br />patent term expires<br />extension period<br />5 years maximum<br />patent term<br />20 years<br />extension period<br />for medical use A<br />Chemical substance patent<br />extension period for medical use B<br />later approval of dosage form of medical use B<br />same active ingredient<br />same efficacy / effect<br />different dosage form<br />Extension is inapplicable to a later approval for dosage form if there is a preceding approval in which active ingredient and efficacy / effect are the same<br />filing<br />date<br />time<br />
  • 21. 15<br />IP High Court Cases<br /><ul><li>Three cases are brought before IP High Court, challenging appropriateness of JPO’s interpretation of law and Court’s precedents.</li></ul>No. 2008-10458, -10459, -10460<br />(May 29, 2009)<br />These cases are related to different patents.<br />(decided on the same day by Judge Iimura’s panel)<br />IP High Court (Tokyo High Court)<br />
  • 22. 16<br />Facts in common among 3 cases<br />JPO examiner rejects the application due to an existence of the preceding approval .<br />Patent Term<br />Extension<br />Takeda files an application for<br />patent term extension.<br />Preceding Approval<br />active ingredient A<br />efficacy / effect B<br />dosage form C<br />Later Approval<br />active ingredient A<br />efficacy / effect B<br />dosage form D<br /><ul><li>Takeda obtained two marketing approvals under the Pharmaceutical Affairs Law.</li></li></ul><li>17<br />Facts – Details of Approvals<br /><ul><li>Between preceding and later approvals,
  • 23. Same active ingredient
  • 24. Same efficacy / effect
  • 25. Different dosage form</li></li></ul><li>Issues of the Cases<br /><ul><li>Should “the scope of a patent right to be extended” be considered in judging requirements for registration for extension ?
  • 26. Should “the product” in Section 68-2 (defining the scope of a patent right to be extended) be interpreted as “an active ingredient” ?</li></ul>18<br />
  • 27. 19<br />Holding of the Cases<br />NO.<br />NO.<br /><ul><li>Should “the scope of a patent right to be extended” be considered in judging requirements for registration for extension ?
  • 28. Should “the product” in Section 68-2 (defining the scope of a patent right to be extended) be interpreted as “an active ingredient” ?</li></li></ul><li>20<br />Holding of the Cases (cont’d)<br /><ul><li>To refuse an application for patent term extension, an examiner shall prove:
  • 29. (i) that “the disposition designated by Cabinet Order” does not dissolve prohibition of working of the patented invention; or
  • 30. (ii) that acts whose prohibition is dissolved by “the disposition designated by Cabinet Order” do not fall within acts of working of the patented invention.
  • 31. “product” means a product specified by “ingredient,” “amount,” and “structure” of the drug which is the subject of the disposition.
  • 32. “use” refers to a case of a use invention.</li></li></ul><li>21<br />Effect of the Cases<br />patent term expires<br />extension period<br />5 years maximum<br />patent term<br />20 years<br />extension period<br />for medical use A<br />Chemical substance patent<br />extension period for medical use B<br />later approval of dosage form of medical use B<br /><ul><li>Patent term extension may be applicable to a later approval of dosage form.
  • 33. Pharmaceutical company can recoup more investment.</li></li></ul><li>22<br />Short Summary <br /><ul><li>IP High Court denies JPO’s interpretation of the statutory law.
  • 34. IP High Court vacates its own precedents.
  • 35. Possible effects on Patent Law Reform
  • 36. Ministry of Economy, Trade and Industry (METI) has studied on possibility of reforming patent term extension system, but now stops proceeding of the study until the decisions of these three cases become conclusive and final.</li></li></ul><li>What comes the next ?<br /><ul><li>JPO appeals to the Supreme Court
  • 37. Need to pay attention to the progress before the S. Ct.
  • 38. Whether a writ of cert is granted
  • 39. If granted, how the S. Ct. decides the cases</li></ul>OR<br />Trick or Treat !<br />Supreme Court<br />23<br />
  • 40. YUASA AND HARA<br />LAW, PATENT, TRADEMARK &amp; DESIGN and ACCOUNTING<br />TRADEMARK <br />&amp; DESIGN<br />DIVISION<br />ACCOUNTING <br />&amp; AUDITING<br />DIVISION<br />LAW <br />DIVISION<br />PATENT <br />DIVISION<br />Thank you for your attention !<br />YUASA AND HARA<br />LAW, PATENT, TRADEMARK &amp; DESIGN and ACCOUNTING<br />TRADEMARK <br />&amp; DESIGN<br />DIVISION<br />ACCOUNTING <br />&amp; AUDITING<br />DIVISION<br />LAW <br />DIVISION<br />PATENT <br />DIVISION<br />Koji Hirayama<br />YUASA and HARA<br />hirayama-ch@yuasa-hara.co.jp<br />24<br />

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