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Wang, Mei-hua Director General

Intellectual Property Office MOEA, Taiwan

June 2011

Pharmaceutical Issues in Patent Act Amendment in Taiwan

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

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

Basis for the Draft AmendmentBasis for the Draft Amendment

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Making Amendments

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Comprehensive AmendmentComprehensive Amendment

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 :

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.

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.

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

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 》

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)

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.

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

Conditions for Patent Term Conditions for Patent Term ExtensionExtension

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Regulatory approvalRegulatory approval

approvapproval1al1

approvapproval2al2

approvapproval3al3

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.