Survey on Actual States in Foreign Countries Related to Intellectual Property System or the like over
Biopharmaceuticals (Summary)
1. Purpose
In the prescription pharmaceutical market, while biopharmaceuticals are the mainstream ofsales and new products are successively placed on the market, there is a present state that patentdisputes between original biopharmaceutical companies are being observed. In order to encourage
the planning of the pharmaceutical industry promotion policy and the international development ofpharmaceutical companies, it is important to know well the actual state of patent disputes in respective
countries and the system to prevent patent disputes beforehand.
Therefore, in the survey, it is aimed to gather information that could be future basic materials
for the promotion of the pharmaceutical industry developing globally.
2. Overview
In the survey, literature and field survey or the like were carried out with regard to patentdisputes on biopharmaceuticals, outline and operation of patent linkage system, and system to prevent
disputes beforehand, etc., and the information obtained in the survey was organized and compiled
into a survey report.
3. Countries surveyedThe countries surveyed are Japan, the United States, China, South Korea, European Union
member states.
4. Survey method
The information was gathered through literature and website survey, inquiries for respective
countries, and field survey. The field survey was carried out in South Korea as the target in such amanner that the question items were selected mainly from the items that were found insufficient as aresult of analyzing the information in the literature or the like gathered in advance, and questionnaire
was prepared.
The 12 entities in total surveyed in South Korea were 4 public institutions, 1 industryorganization, 4 companies, 1 local Japanese organization, 1 academic expert, and 1 law firm. Further,additional survey was carried out for 2 industries organizations through written correspondences.
5 . Structure of the report
The report was complied basic information, mainly on the following items for respective- 1 -countries surveyed.
Besides, specific collateral measures of international treaties such as economic partnershipagreements or the like were described separately as they relate to respective countries surveyed.
(1) Industrial policy concerning pharmaceuticals(2) Outline of the overall system concerning the intellectual property over pharmaceutical products"doctrine of experimental or research use exception", "setting of compulsory license (arbitrarylicense)", "data protection of pharmaceuticals (re-examination system)", "patent term extension
system", "patent linkage system", etc.
(3) Patent disputes on pharmaceuticals"Cases of lawsuits concerning pharmaceuticals", "setting administrative compulsory license(arbitrary license)", "number of disputes", etc.
(4) System or the like concerning adjustment of the pharmaceutical affairs system and patent system
The system operated in respective countryies and provisions related thereto, etc.
(5) Field survey (South Korea only)
The survey was carried out mainly on items judged insufficient as a result of analysis of
information from literature or the like gathered in advance, 1) national policy on biopharmaceuticals,2) patent linkage system, 3) measures to avoide patent disputes in advance, 4) measures to avoid
discountinuing the sales of drugs due to patent disputes, 5) actual state of patent disputes, 6) system
specific to biopharmaceutical, and the situation, or the like, 7) situation of discussions, and 8) treaty,etc.
6 . National system of respective countries
Outline of the intellectual property systems relating to pharmaceutical in respective countries,
which were surveyed and organized in the survey are as follows.

- 2 -- New active ingredientdrugs: 5 years- Biopharmaceuticals: 12years- Medicines for rarediseases: 7 years- Pediatric indication: 0.5
years addition[Re-examination System]- New active ingredientdrugs: principle 8 years- Orphan drung: muximum
10 years- Pediatric indication:maximum 10 years

3) Dataprotection
ofpharmace
uticalsy license- No general clause- Government use (28 USC§1498)- March-in rights (35 USC §203)[Arbitrary license]- where not worked (Art. 83of Patent Act)- Relationship to work own
patented invention (Art. 92of Patent Act)
· Public interest (Art. 93 ofPatent Act)

2)Settingcompulsor

use is non-infringement(Art. 69, Para. 1 of PatentAct)- No general clause- Experiment for
application for approval is
non-infringement (35 USC§ 271 (e) (1))- Submission of an
application for approval isinfringement (35 USC §271 (e) (2))- Experimental or research1)
Experime
ntal orresearch
exception

U.S.A.

JapanItems- 3 -- Use of State-owned
enterprise (Art. 14 ofPatent Law)
- Non-exploitation ormonopoly (Art. 48 ofPatent Law)
- National emergency or
public interest (Art. 49 ofPatent Law)
- Public health (Ar. 50 ofPatent Law)
- Relationship to work own
patented invention (Art. 51of Patent Law)
- New substance: 6 years- Orphan drug: No specialcase- Pediatric indication: nospecial case

- The use for the purpose ofscientific research andexperimentation, orproduction for the purposeof approval or the like is
non-infringement (Art. 69(4) and (5) of Patent Law)

China

[Arbitrary license]- Government use (Art.106
and Art. 106-2 of PatentAct)- No execution of patent(Art. 107, Nos. 1 and 2 ofPatent Act)
- Public interest (Art. 107,No. 3 of Patent Act)- rectifying unfair tradepractice (Art. 107, No. 4 ofPatent Act)- export of medicine (Art.
107, No. 5 of Patent Act)
[Re-examination System]- New drugs, etc.: 6 years- Orphan drug: 10 years
Orphan drug and pediatricindication: 11 years- Pediatric indication: nospecial case

- Research or testing(including clinical trial ofpharmaceuticals) is noninfringement (Art. 96, para.
1 of Patent Act)South Korea- New active ingredientdrugs: 10 years
8 years for ban on
application for generic
medicines
2 years for ban on
application for generic drugsales
+ 1 year for additional
breakthrough efficacy- Orphan drug: 10 years
Orphan drug and pediatricindication: 12 years- Pediatric indication: 6months addition

Europe(EU member countries)- clinical trial for approval
applications is noninfringement (Art. 10, para.
6 of Directive 2004/27/EC)- act done for experimental
purpose is non-infringement( Art. 27 (b) of theCommunity Patent
Convention (CPC)) (Not ineffect)- No provision in European
Patent Convention (EPC)
therefore, according to thenational law of the respective
Member States- Setting compulsory license(Art. 45 of CPC (Not ineffect))- lack or insufficiency ofexploitation (Art. 46 of CPC(Not in effect))- depending patents (Art. 47of CPC (Not Ain effect))- Maximum 5 years (Art.
67, para. 2 of Patent Act)

(No written rule under thelaw, but directed by thenotice [1])- In principle, "genericdrungs should not beapproved, if the active
ingredient itself cannot bemanufactured due to thepresence of the patent for
the active ingredient of theoriginal drug product"- Submission of the"pharmaceutical patent
information report sheet"by new pharmaceuticalcompanies (optional)- Pre-adjustment procedure
before drug price listing- provision of patentinformation by generic
medicines applicant- Submission of "patentee’s(of original drug
manufacturers or the like)
consent or the like" bygeneric drug applicant

5) PatentlinkagesystemJapan4) Patent
term
Extension

Items- Maximum 5 years.
However, it does notexceed 14 years from theapproval date (35 USC §156)[Abbreviated New Drug
Application: ANDA](Federal Food, Drug, andCosmetic Act (FDCA)- The first applicant thatmeets certain requirements(Paragraph IV drug
application) is given theexclusive right for 180
days.
[abbreviated Biologics
License Application:aBLA] ("Biologic Price
Competition andInnovation Act" (BPCIA))- Patent dance

U.S.A.

- 4 -- Applicant for medicinal
products (regardless of newdrugs or generic drugs)
shall provide thedocuments explaining thepatent situation in China
concerning his own patent.
The regulatory authority(CFDA) shall publish thepatent situation on thewebsite.
- Where another party
owns the patent in China,
the applicant for the
medical product shallprovide a statement of noninfringement. (Art. 18 ofProvisions for Drug
Registration (enforcementof 2007))―(No institution)

China- Arts. 50-2 through 50-10
of Pharmaceutical Affairs
Act- In order to file anapplication for registrationof the patent information ofa drug in the patent list
relating to approval of thedrug (revised approval ofthe drug), the applicant
shall file an application forregistration within 30 days
from the date of marketing
approval or revised
approval or file anapplication for registration
within 30 days from thedate of registration of thepatent, if there is no patent
for registration at the timeof approval and the patent
was subsequentlyregistered. (Art.50-2, para.
2 of Pharmaceutical AffairsAct)- only once up to 5 years(Art. 89 of Patent Act)South Korea(No institution)―Europe(EU member countries)[Supplementary Protection
Certificate System]- maximum 5 years