Chung-Hua Shen Department of Finance National Taiwan University Yu-Li Huang
Wang, Mei-hua Director General Intellectual Property Office MOEA, Taiwan June 2011
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Transcript of Wang, Mei-hua Director General Intellectual Property Office MOEA, Taiwan June 2011
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Wang, Mei-hua Director General
Intellectual Property Office MOEA, Taiwan
June 2011
Pharmaceutical Issues in Patent Act Amendment in Taiwan
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OutlineOutline
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Number of Patent Applications for Medical Number of Patent Applications for Medical Industry(2008~2010)Industry(2008~2010)
*IPC classification related medical industry: A61B 、 A61C 、 A61F 、 A61G 、A61H 、 A61J 、 A61K 、 A61L 、 A61M 、 A61N 、 A61P 、 A61Q
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Patent Patent Applications for Medical Industry by Applications for Medical Industry by Nationality (2008-2010)Nationality (2008-2010)
*IPC classification related medical industry: A61B 、 A61C 、 A61F 、 A61G 、A61H 、 A61J 、 A61K 、 A61L 、 A61M 、 A61N 、 A61P 、 A61Q
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Basis for the Draft AmendmentBasis for the Draft Amendment
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Making Amendments
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Comprehensive AmendmentComprehensive Amendment
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Amendment TimelineAmendment Timeline
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Exceptions to Patent Rights Exceptions to Patent Rights ConferredConferred
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Article 30 of TRIPSMembers may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions :
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Research and Experimental Research and Experimental ExemptionsExemptions
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Explanation of AmendmentExplanation of Amendment
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Reference to §11(2) of German Patent Act and §60 (5)(b) of UK Patent Act, the limit on “with no profit-seeking acts ” is to be deleted.
In consideration of the ambiguity of definition of “education” and for keeping fine balance between public interest and private interest, “educational” is to be deleted.
The scope of the “[a]ctivities necessary for research or experimental purposes” shall not be broadened to beyond the purposes of research and experiment, avoiding impacting the patentees’ economic interest.
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Pharmaceutical—Research Pharmaceutical—Research and Trial and Trial ExemptionsExemptions
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expiration
Market approval issued
Clinical trial
The effects of patent right shall not extend to research, trial, and necessary acts thereof, which are conducted for the purpose of obtaining Pharmaceutical inspection and registration approval under the Pharmaceutical Act or obtaining market approval of pharmaceuticals from a foreign country.
To encourage the develop of generic drugsTo promote the develop of clinical trial industries
To encourage the develop of generic drugsTo promote the develop of clinical trial industries
Exemption for trial
Patent granted Patent term
Patentee
Generic drugs maker
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Pharmaceuticals include medicines and medical devices.
Explanation of AmendmentExplanation of Amendment
The trial exemption applies to both new drugs and generics.
Covering pre-clinical trials and clinical trials for obtaining regulatory approval. All trial acts and the direct relevant acts thereof before or after applying for the regulatory approval for the purpose of obtaining regulatory approval are exempt from liabilities. However, acts irrelevant to obtaining regulatory approval are not covered, such as test in hospitals for procurement purpose.
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Preparation of prescribed Preparation of prescribed medicinesmedicines
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Explanation of AmendmentExplanation of Amendment
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Clarify that the original meaning of “prescriptions made by
physicians” is “acts of preparing medicines in accordance
with prescriptions made by physicians”
Reference to §13(3) of German Patent Act, §69(3) of
Japan Patent Act and §96(2) of Korea Patent Act.
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Situations for Patent Compulsory Situations for Patent Compulsory Licensing—Current LawLicensing—Current Law
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Situations for Patent Compulsory Situations for Patent Compulsory Licensing—To be AmendedLicensing—To be Amended
In the event of national emergencies or other circumstances of extreme urgency
Non-commercial use of a patent for enhancement of public welfare In the event of an applicant's
failure to reach a licensing agreement with the patentee concerned under reasonable
commercial terms and conditions within a
considerable period of time
Act of restricting competition or unfair competition confirmed by court or a
decision by the Fair Trade Commission
For practicing a plant variety
For practicing a re-invention patent
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《 prerequisite 》
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Issues Concerning Public HealthIssues Concerning Public Health
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Patentee A
TaiwanTaiwangeneric drugs generic drugs
companycompany
Countries lacking Countries lacking pharmaceutical pharmaceutical
production ability production ability or with inefficient or with inefficient pharmaceutical pharmaceutical
productionproductionexport
pharmaceutical(s)
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Issues Concerning Public HealthIssues Concerning Public Health
According to TRIPS §31bis : Scope for applying for compulsory license Qualification of the importing countries Negotiating with the patentee concerned under
reasonable commercial terms and conditions in advance is required
Conditions to be observed by compulsory licensee while exporting
Amount of compensation Exemption from liability against test data
exclusivity
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Relaxing the threshold for Patent Relaxing the threshold for Patent Term ExtensionTerm Extension
Applications filed for patent term extension prior to the enactment of the amendment whose decisions have not been issued and whose patents are still in force at the time the amended act takes effect, the amended act shall govern.
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(To be amended)Deleting the minimum two-year threshold
(Current law)A patentee can only apply for a two-to-five year extension of the patent term.
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The patent term shall be deemed having been extended if the Patent Authority has not issued a decision before the original patent expiration date. However, where the Patent Authority rejects such extension request, the patent shall expire at the original expiration date.
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Effect of Filing Extension Effect of Filing Extension RequestRequest
Filing date
Expiration date
Extension request is approved
Maximum 5 years
Original patent term : 20 years
Granted date
deemed having been
extended
Request for extension
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Conditions for Patent Term Conditions for Patent Term ExtensionExtension
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Regulatory approvalRegulatory approval
approvapproval1al1
approvapproval2al2
approvapproval3al3
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Scope to be ExtendedScope to be Extended
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Scope of patent right :
a method for preparing aspirin
A method for preparing aspirin
that treats hypertension
Active ingredient: aspirin
Indication: hypertension
An application for An application for patent term extension patent term extension
is filed and grantedis filed and granted
Extension periodExtension period20 years from the filing date20 years from the filing date
The scope of a patent right, of which the patent term extension has been granted, is confined to the active ingredients and its relevant indication(s) stated in the regulatory approval concerned.
The scope of a patent right, of which the patent term extension has been granted, is confined to the active ingredients and its relevant indication(s) stated in the regulatory approval concerned.
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