Thursday, December 10, 2009

Generic Tamiflu Approved

According to some local news stories, the Korea FDA approved, on December 9, a generic drug of Tamiflu (Tamivir Capsule manufactured by Chong Gun Dang) for the first time in Korea. For instance, see http://www.arirang.co.kr/Player/Player_Script.asp?vSeq=51913&code=News or http://www.ytn.co.kr/_ln/0103_200912091015149083.

Around 10 additional local pharmaceutical companies have applied for an approval for their generic drugs and are likely to be approved soon. However the approval does not mean actual distribution of the off-patent drugs. Without getting a license from Gilead Science (a patent holder of Tamiflu), the local companies can not put their products on the market.

Friday, November 27, 2009

Notes from the Meeting between Civil Society Organization Members and Korean Government (MCST)

Notes from the Meeting between Civil Society Organization Members and Korean Government (MCST)

November 27, 2009

MCST: Why national civil society groups are interested in the proposed WIPO Treaty? What makes CSO members take part in such a movement?

CSO: Although Korean domestic laws already have provisions similar to the proposed WIPO Treaty, access to foreign works can be enhanced by the proposed WIPO Treaty. Our participation is also vital for the shared aims of people with reading disabilities all over the world.

MCST: Korean delegation is "supportive" of the proposed WIPO Treaty and hopes the proposal will become an international treaty as proposed, rather than weakened. One of the concerns is that some delegations =96 including that of the US =96 worry that the proposed WIPO Treaty may encourage copyright infringements, which are already prevalent. If such concern is not relaxed, entering into a treaty is to be delayed. Furthermore, since the WIPO Internet Treaty of 1996 we have not seen any other treaty concluded within the WIPO (e.g. the broadcasting treaty); getting agreement on such a treaty for people with reading disabilities is also difficult. But the text of a treaty is already on the table and this is a good start.

MCST: Concerning the "alternative ways" to which the Korean delegation referred at the WIPO meeting, the MCST has no clear ideas about what exactly these =93alternative ways=94 are, and the Korean delegation is not in a position to oppose the proposed WIPO Treaty. When the WIPO discusses a treaty, any urgent efforts by the WIPO necessary for helping people with reading disabilities are likely to be halted because the WIPO is an intergovernmental organization with limited resources. [On the other hand, according to a local news story (mediaus.co.kr), the "alternative ways" may include "recommendations" which are easier to agree on than a treaty that may take more than 10 years, says an official of the MCST.

CSO: Our concern is that many industrialized countries have indirectly expressed their opposition and that the Korean government has frequently followed the U.S. position. So the statement on "alternative ways" seems to be no different from such indirect opposition. Nonetheless, we welcome if the MCST is in a supportive position and demand a clear expression of support from the Korean delegation at the next session of the SCCR.

MCST: Concerning domestic policy on people with reading disabilities, publishers still oppose the recently revised provisions in the Copyright Act regarding copyright limitation for such people. Thus the MCST focuses more on practical issues such as how to ensure the prevention of copyright infringement in the process of converting copyrighted works into an accessible format for people with reading disabilities.

Wednesday, November 04, 2009

Open Letter to the Korean Government Concerning the Proposed WIPO Treaty for People with Reading Disabilities

Open Letter to the Korean Government Concerning the Proposed WIPO Treaty for People with Reading Disabilities

The 18th session of the Standing Committee on Copyright and Related Rights (SCCR) of the World Intellectual Property Organization (WIPO) was held on 25 to 29 May 2009. During this session, Brazil, Ecuador and Paraguay proposed official discussions on the WIPO Treaty for Improved Access for Blind, Visually Impaired and Other Persons with Reading Disabilities (the proposed WIPO Treaty), which was presented by the World Blind Union last year.

It is widely accepted that a number of people with reading disabilities throughout the world have suffered from restriction in self-development and social participation due to limited access to copyrighted works. Constructing social conditions in which people with reading disabilities can equally participate in the cultural life and enjoy scientific advancement and its benefits is not only a legitimate right of these people, but also an obligation of the state. As a way of fulfilling this obligation, South Korea has tried, like some other states, to ensure rights of people with reading disabilities through the provision of limitations on copyright in the Copyright Act. Yet copyright provisions differ from one country to the next, and efforts to protect people's right to access in different countries has been constrained. It is therefore necessary to establish an internationally applied rule regarding minimum standards on copyright limitations for people with reading disabilities. This is also vital for striking a fair balance between the protection of copyright and the fair use of copyrighted works, which is inherent and essential in a copyright system.

Considering this, we ask the following questions on the position of the Ministry of Culture, Sports and Tourism (MCST) in connection with the proposed WIPO Treaty.

(1) At the 18th session of the SCCR, the Korean delegation, while admitting the importance of enhancing access to copyrighted works by people with reading disabilities, supported "alternative ways", rather than negotiating a treaty. What does the MCST actually mean by "alternative ways" that can enhance the right to access of people with reading disabilities in an effective and sustainable manner, as
opposed to temporary assistance for these people?

(2) What is the reason for the position of the MCST and the Korean delegation supporting "alternative ways" rather than a treaty?

(3) Has the MCST, as an executive branch in charge of copyright policies, conducted a detailed review of the proposed WIPO Treaty? We ask that any review be made public.

(4) Does the MCST consider the proposed WIPO Treaty to be in conflict with any provisions of the Korea Copyright Act?

(5) We believe that the proposed WIPO Treaty can be negotiated in parallel with any efforts seeking to enhance access to information for people with reading disabilities. International efforts to improve access to information for people with reading disabilities started several years ago, and relevant discussions within the WIPO began in 2003. We hardly see any reason to delay discussions on an international treaty for that purpose.

We would like to know if the MCST and the Korean delegation to the WIPO intend to clearly express strong support for the proposed WIPO Treaty.

November 4, 2009

Disability Discrimination Act of Solidarity in Korea (DDASK) IPLeft (Intellectual Property Left)

Tuesday, May 26, 2009

Copyright L&E for Libraries

Bill No. 4389 to Amend the Korea Copyright Act Introduced on April 2, 2009 by Ten Congressmen (Lead by Congressman Choi, Munsoon)

1. Current Provision on Copyright L&E for Libraries

Article 31(Reproduction, etc. in Libraries, etc.)
(1)Libraries under the Libraries and Reading Promotion Act and the facilities (including the heads of the relevant facilities hereinafter referred to as "libraries, etc.") as prescribed by Presidential Decree among those facilities which provide books, documents, records and other materials (hereinafter referred to as "books, etc.") for public use may reproduce the works by utilizing books, etc. held by the libraries, etc. (in the case of Subparagraph 1, including the books, etc. reproduced by or interactively transmitted to the libraries, etc. in accordance with the provision of Paragraph 3 hereof) in any of the following cases: provided that in the case of Subparagraphs 1 and 3, the works may not be reproduced in digital format.
1. Where, at the request of a user and for the purpose of research and study, a single copy of a part of books, etc. already made public is provided to him
2. Where it is necessary for libraries, etc. to reproduce books, etc. for the purpose of preserving such books, etc. and
3. Where libraries, etc. provide other libraries etc. with a reproduction of books, etc. that are out of print or scarcely available for similar reasons at the request of other libraries etc. for their collection purpose.
(2) Libraries, etc. may reproduce or interactively transmit their books, etc. to allow users to peruse them in such libraries, etc. by using devices capable of information processing such as computers, etc. In such case, the number of users who may peruse them at the same time shall not exceed the number of copies of such books, etc. held by the libraries, etc. or authorized to be used by the persons with copyrights or other rights protected according to this Act.
(3) Libraries, etc. may reproduce or interactively transmit their books, etc. to allow users in other libraries, etc. to peruse them by using computers, etc.; provided that, in those cases where all or a part of the books, etc. have been published for sale, such books, etc. shall not be reproduced or interactively transmitted unless a period of five years has elapsed since the publication date of such books, etc.
(4) In reproducing books, etc. pursuant to Subparagraph 2 of Paragraph (1), Paragraph (2) or Paragraph (3), libraries, etc. shall not reproduce such books, etc. in digital format if they are being sold in digital format.
(5) In reproducing books, etc. in digital format pursuant to Subparagraph 1 of Paragraph (1), or reproducing or interactively transmitting books, etc. for the purpose of allowing perusal inside other libraries, etc. pursuant to Paragraph (3), libraries, etc. shall pay the owners of authors' property rights compensation in accordance with the standards determined and published by the Minister of Culture provided that said provision shall not apply to books, etc. (excluding those books, etc. which are, in part or in whole, published for a sales purpose) regarding which the state, local governments or schools as provided in Article 2 of the Higher Education Act hold authors' property rights.
(6) The regulation regarding compensation in Paragraph 5 to Paragraph 9 of Article 25, shall apply mutatis mutandis to foregoing Paragraph 5 with regard to distribution of compensation, etc.
(7) If books, etc. are reproduced or interactively transmitted in digital format pursuant to the foregoing Paragraphs (1) through (3), libraries, etc. shall take necessary measures as provided by Presidential Decree such as reproduction prevention measures in order to prevent infringement of copyrights and other rights protected under this Act.

2. Amendment

Article 31(Reproduction, etc. in Libraries, etc.)
(1) In Libraries under the Libraries and Reading Promotion Act and the facilities (hereinafter referred to as "libraries, etc.") as prescribed by Presidential Decree among those facilities which provide books, documents, records and other materials (hereinafter referred to as "books, etc.") for public use may be produced the works by utilizing books, etc. held by the libraries, etc. (in the case of Subparagraph 1, including the books, etc. reproduced by or interactively transmitted to the libraries, etc. in accordance with the provision of Paragraph 2 hereof) in any of the following cases: provided that in the case of Subparagraph 1, the works may not be reproduced in digital format.
a. Where, at the request of a user and for the purpose of research and study, a single copy of a part of books, etc. already made public is provided to him
b. Where it is necessary for libraries, etc. to reproduce books, etc. for the purpose of preserving such books, etc. and
c. Where libraries, etc. provide other libraries etc. with a reproduction of books, etc. that are out of print or scarcely available for similar reasons at the request of other libraries etc. for their collection purpose.
(2) Libraries, etc. may reproduce or interactively transmit their books, etc. to allow users to peruse them in such libraries, etc. (including an Internet address that is supported by an information telecommunication network of such libraries, etc.), in other libraries, etc., and outside of the libraries, etc. by using devices capable of information processing such as computers, etc., provided that in case where all or a part of the books, etc. have been published for sale (excluding books, etc. that are out of print or scarcely available for similar reasons), such books, etc. shall not be perused outside the libraries, etc. unless a period of five years has passed from the publication date of such books, etc.
(3) (Deleted)
(4) In reproducing books, etc. pursuant to Paragraph (2), libraries, etc. shall not reproduce such books, etc. in digital format if they are being sold in digital format.
(5) In reproducing or interactively transmitting books, etc. for inside other libraries, etc. or for outside libraries, etc., libraries, etc. shall pay the owners of authors' property rights compensation in accordance with the standards determined and published by the Minister of Culture provided that said provision shall not
apply to:
a. books, etc. (excluding those books, etc. which are, in part or in whole, published for a sales purpose) regarding which the state, local governments or schools as provided in Article 2 of the Higher Education Act hold authors' property rights;
b. books, etc. of which use is permitted free of charge by the owners of authors' property rights; and
c. those cases pursuant to Subparagraphs 2 and 3 of Paragraph 1.

(6) The regulation regarding compensation in Paragraph 5 to Paragraph 9 of Article 25, shall apply mutatis mutandis to foregoing Paragraph 5 with regard to distribution of compensation, etc. In this case the state or local governments may provide with a subsidy for libraries, etc.

(7) If books, etc. are reproduced or interactively transmitted in digital format pursuant to the foregoing Paragraphs (1) through (2), libraries, etc. shall take necessary measures as provided by Presidential Decree such as reproduction prevention measures in order to prevent infringement of copyrights and other rights protected under this Act.

3. Explanation of the Amendment

3-1. Paragraph (1)

The current provision is designed to allow "libraries" to make copies. This creates an unintended consequence: only librarians can reproduce works upon request of users. Put differently, users can not make their own copies of works held by a library even with using a self-service photocopier which is under control of the library. Therefore, librarians need to be engaged in every reproduction task and to police the activities of users.

The Amendment abolishes the division between librarian copying and copying by users and permits copying by users or agencies employed by libraries.

Further, the Amendment permits the copying of works in "digital format." Such a copy can be provided for other libraries where the works are unavailable or scarcely available due to, e.g., out-of-print.

3-2. Paragraph (2)

Expansion of "in the library"

Under the current provision, a library is defined as an establishment occupying physically the same space. Therefore, for instance, when a university has several libraries distant but connected by the same computer network, each library is separate one within the meaning of current Article 31.

The Amendment expands the concept of "in the library" by adding the phrase "including an Internet address that is supported by an information telecommunication network of such libraries, etc."

Remote Access

Under the current provision, in order to access works provided in digital format by a library, users have to visit the library. Further, in such a library, the number of users concurrently accessing the digital works is limited by the number of physical copies held by the library.

The Amendment removes these two limitations, allowing remote access to the digital works regardless of the number of the physical copies kept by the library. In consideration of concerns of and harmful impacts on the publishers, the Amendment provides that peruse by readers outside the libraries is only permitted after five years have passed from the date when the works were published for sale. Even after the elapse of five years, libraries have to pay compensation to a copyright holder for their providing for the remote use (Paragraph 5).

3-3. Paragraph (3)

Deleted in accordance with the amendment of Paragraph (2).

3-4. Paragraph (4)

It is permitted that libraries reproduce works in digital formats even when they are being sold in digital format so long as the reproduction is made for the purpose of preservation under Subparagraph 2 of Paragraph 1.

3-5. Paragraph (5)

The current compensation rule applies to any interactive transmission between libraries. The Amendment rules out the transmission of works that are non-for-sale.

3-6. Paragraph (6)

The Amendment enables the State or local government to financially assist a library having a slim budget for paying compensation to the copyright holders.

Friday, May 08, 2009

EU Wants Patent Provisions In ACTA

According to Inside US Trade, "the European Union is insisting that the Anti-Counterfeiting Trade Agreement (ACTA) cover all intellectual property rights, including patents, and not focus exclusively on copyright and counterfeit items."

While the US-Japan joint proposals focus on trademark and copyright infringement (counterfeiting and piracy in ACTA's jargon), the EU "favors greater inclusion of patent protections in the talks." But it seems that the EU "is not pushing for patent infringements to be subject to ACTA criminal enforcement."

Friday, May 01, 2009

Duke University and Trimeris in Compulsory License Case of Fuzeon

Today took place a meeting of the Dispute Settlement Committee within the Korea Patent Office to hear opinions of parties involved in a case of compulsory license of Fuzeon patent. I did not attend the meeting but obtained the material presented by Duke University and Trimeris through their Korean attorney, Kim & Chang.

Duke University and Trimeris, resting on four grounds, insisted the CL request to be dismissed. First they argued that IPLeft and KANOS who initiated this case lack the standing to request a CL because they have neither ability to manufacture nor import a pharmaceutical product covered by the Fuzeon patents. The Patent Act does not allow a licensee under the CL to be assigned to a third party. Therefore IPLeft and KANOS are not "person who intends to work the patented invention" within the meaning of Article 107.

Second, Duke University and Trimeris argued that the statutory condition of a prior negotiation was not met. Under Article 107, the condition of a prior negotiation is exempted only when the intended working of a patented invention is of non-commercial use. IPLeft and KANOS failed to establish the non-commercial working as they indicated to sell a product under the CL at a price set by government (25,746
KW).

Third ground relates to the statutory requirement of "the particular necessity for the public interest". Duke University and Trimeris took a position that granting a compulsory license is exceptional and should be subject to a strict interpretation of the statutory requirement as it imposes a restriction on property right protected under the Constitution and the Patent Act. They argued the requirement of particular necessity for the public interest can be met when there is no substitutional measure in an emergent situation. Further, the determination of the particular necessity for the public interest should be made by balance striking between "the interests of the
general public and a patentee" through the protection of a patent right and "the interests of the general public" through the exceptional limitation of patent protection.

Duke University and Trimeris went further to argue that the authorization of a CL should be considered on its individual merits according to Article 31(a) of TRIPS: individual situation of relevant state. Such factors as economic status of Korea (OECD member state, world top 14th in GDP, world top 4th in R&D investment per GDP) and technology strength of Korea (world top 4th in PCT patent applications, world top 3rd in the number of US patent applications, and R&D activities in 488 items by 45 domestic pharmaceutical companies) should be taken into account for the "individual merits" of TRIPS Art. 31(a).

According to Duke University and Trimeris, very small group of patients who needs Fuzeon indicates no emergency. IPLeft and KANOS estimated the patients being approximately 150. In contrast, Roche Korea approximated 68 patients and only two patients have called for Fuzeon which has been provided free of charge through the Korea Orphan Drug Center.

Concerning the substitutional measure and access to medicine, Duke University and Trimeris maintained that the patients can be treated by other product such as Prezista sold by Jansen and Fuzeon has been provided free of charge by Korea Orphan Drug Center since February 25, 2009.

Fourth, Duke University and Trimeris insisted that the CL is ineffective because there is no generic and manufacturing Fuzeon is technologically too difficult. Further, granting a CL on the Fuzeon patent would only produce a harmful impact: reducing incentive to develop new pharmaceutical products and in turn hampering innovation and industrial progress.

* Relevant provisions of Patent Act:

Article 107 Adjudication for the Grant of a Nonexclusive License (1) Where a patented invention falls under any of the following subparagraphs, a person who intends to work the patented invention may request the Commissioner of the Korean Intellectual Property Office to make an adjudication (referred to as "an adjudication") for the establishment of a nonexclusive license, provided no agreement is reached despite having a consultation (referred to as "a consultation" in this Article) under reasonable conditions with the patentee or exclusive licensee on the grant of a nonexclusive license for the patented invention or a consultation is impossible to arrange; however, the person may request an adjudication even in the absence of a consultation if the patented invention is to be worked noncommercially for the public interest or in any case that falls under subparagraph (iv):
(i) where the patented invention has not been worked for more than three consecutive years in the Republic of Korea, except for natural disasters, unavoidable circumstances or other justifiable reasons prescribed by Presidential Decree;
(ii) where the patented invention has not continuously been worked commercially or industrially in the Republic of Korea on a substantial scale during a period of three years or more without justification, or where the domestic demand for the patented invention has not been satisfied to an appropriate extent and under reasonable conditions;
(iii) where working the patented invention noncommercially is necessary for the interests of the public; or
(iv) where working the patented invention is necessary to remedy a practice determined to be unfair after the judicial or administrative process
(v) where working the patented invention is necessary for the export of medicine to a country (referred to as "an importing country") that intends to import the medicine (including effective ingredients that are necessary for the production of the medicine and diagnostic kits necessary for the use of the medicine) in order to treat diseases that threaten the health of the majority of its citizens.
(2) Paragraph (1)(i) and (ii) of this Article does not apply unless a period of four years has elapsed after the filing date of the application for the patented invention.
(3) In adjudicating the authorization of a nonexclusive license, the Commissioner of the Korean Intellectual Property Office shall consider the necessity of each request.
(4) When the Commissioner of the Korean Intellectual Property Office makes an adjudication under subparagraphs (i) to (iii) or (v) of paragraph (1), the following conditions apply to the person for whom the adjudication was made:
(i) where the adjudication is made under subparagraphs (i) to (iii) of paragraph (1), the nonexclusive license must be implemented for the primary purpose of meeting domestic demand; and
(ii) where the adjudication is made under subparagraph (v) of paragraph (1), all the medicine produced under the terms of the adjudication must be exported to importing countries.
(5) The Commissioner of the Korean Intellectual Property Office shall ensure that reasonable consideration is given to every adjudication. When making an adjudication under subparagraph (iv) or (v) of paragraph (1), the Commissioner of the Korean Intellectual Property Office may consider the factors in each of the following subparagraphs:
(i) where an adjudication is made under subparagraph (iv) of paragraph (1), the need to rectify unfair transactions; and
(ii) where an adjudication is made under subparagraph (v) of paragraph (1), the economic value generated in importing countries by the working of the patented invention.
(6) For semiconductor technology, a request for adjudication may be made only in the
cases set forth in subparagraph (1)(iii) (where the noncommercial working of the patented invention is permitted in a limited way for the interests of the public) and (1)(iv).

Article 109 Solicitation of Opinion from the Intellectual Property Rights Dispute
Committee and the Heads of Relevant Authorities Before adjudicating, the Commissioner of the Korean Intellectual Property Office may solicit an opinion from the Intellectual Property Rights Dispute Committee established under Article 41 of the Invention Promotion Act and the heads of relevant authorities and seek assistance from relevant administrative authorities or interested parties.

Korean Government on the Production of Tamiflu and Relenza through Compulsory license

According to a report of Yunhap News, an official in the Minister of Health and Welfare said yesterday "when Tamiflu and Relenza runs short of domestic supply, a compulsory license of patents will be issued to make possible domestic production." He added, reportedly, that upon the request of civil society groups asking to amend a compulsory license provisions of the Patent Act, they reviewed the relevant provisions and concluded that the domestic production of necessary medicines is possible by the decision of Patent Office to issue a compulsory license. In this case, 3% of sales price would be given to the patentees as a royalty.

I'm not sure this is an official position of Korean government. For the original text which is in Korean, refer to http://news.naver.com/main/read.nhn?mode=3DLSD&mid=3Dsec&sid1=3D101&oid=3D0=01&aid=3D0002636646.

Another news report on the same date, also in Korean, says that the scenario of issuing a compulsory license is just a principle story and Korean government has not specifically considered it. See http://news.naver.com/main/read.nhn?mode=3DLSD&mid=3Dsec&sid1=3D100&oid=3D2=77&aid=3D0002149279.

At the moment, the stockpile of Tamiflu and Relenza in Korea covers only 5% of population. Government plans to increase the stock to 10% by the end of this year. On the other hand, more than ten Korean pharmaceutical companies announced they had a sfficient ability to produce pharmaceutical products equivalent to Tamiflu and Relenza. It was 2005. So far only one company, Yuhan Corporation, is chosen by Roche Holdings AG, a sole and exclusive licensee of Tamiflu patent which is owned by Gilead Science, Inc. as one of the producers of Tamiflu. In reality, however, Yuhan is simply allowed to take part a portion of production of Tamiflu, which means that Yuhan has no contractual power to produce Tamiflu for the domestic supply.