2004년 11월 28일 – 30일 동안 말레이시아 쿠알람푸르에서 WTO/TRIPs 와 의약품 접근권 관련 제 2차 워크샵이 열립니다. 관련하여 우리쪽 발제문입니다.
발표는 김주연 국제연대 국장님과 남희섭 변리사님이 합니다.
SECOND ASIAN REGIONAL WORKSHOP ON THE WTO-TRIPS AGREEMENT AND ACCESS TO MEDICINES:
APPROPRIATE NATIONAL POLICY RESPONSES,
The Republic of Korea
Nam Hee Seob, Patent Attorney
Kim Joo Yeon, M.D., Ph.D.
Korean Federation of Medical Groups for Health Right (KFHR)
28-30 November, 2004
Kuala Lumpur, Malaysia
I. Patent Act and Related Regulations to Public Health
A. Government Use
Government can expropriate a patent right and work the patented invention, by itself or through a contractor. However, the government use provision is applicable only for national defense in time of war or other similar emergency.
B. Compulsory License
- No or insufficient working.
- Public interest. (Requirement would be changed from “non-commercial working” to “particular necessity” by the Draft Bill described below)
- Anti-competitive practice.
- Dependent patent
- National emergency and other extreme urgency (Added in the Draft Bill described below).
- Exporting for implementing Para 6 Solution (Added in the Draft Bill described below).
- Importing for addressing public health problems due to no or insufficient capacity to domestically produce medicine (Added in the Draft Bill described below).
- Just three cases and no grant of compulsory license.
C. Parallel Import
There is no provision in Patent Act related to the parallel import and few cases. In 1982, a Seoul District Court hold that if the patent holder is the same or can be viewed as the same identity and there is no production by the patent holder in Korea, the patent holder can not prevent a parallel import by any third party (81GaHap466, Seoul District Court, July 30, 1982).
D. Exceptions to the Patent
Patent infringement occurs only when the unauthorized working of patented invention is made commercially and industrially (Article 94 saying “a patentee has an exclusive right to work a patented invention both commercially and industrially). Therefore, individual use and research or experimental use of patented product does not constitute the patent infringement.
Other exceptions to the patent include: acts of dispensing medicines under the Pharmaceutical Affairs Act or medicines manufactured by such acts; and prior use of invention.
E. Personal Import of Medicine
Patent Act does not prevent the personal or individual import of patented medicine. Further, Foreign Trade Act allows the personal import of medicine if the goods to be imported are self-treatment drugs for a patient and the patient obtains a recommendation from the Commissioner of the Korea Food & Drug Administration (KFDA) (Article 14(2) of Foreign Trade Act, Article 27 of Presidential Decree of Foreign Trade Act, and Article 7-3 of Foreign Trade Administration Rule (Public Notice No. 2001-137 of the MCIE)).
Actually, leukemia patients has directly imported generic version of Glivec (“Veenat”) from Natco Pharma in India after they failed to obtain a compulsory license for a patent right owned by Novartis AG on Glivec.
F. Custom Act
According to Article 235 of the Custom Act, an owner of copyright or a registered trademark may request the Commissioner of the Korea Custom Service (www.customs.go.kr) to withhold the custom clearance of any allegedly infringing goods. However, the Custom Act has no such provision applicable to patent infringing goods. According to the official position of the KCS, the Commissioner does not permit the withholding of customs clearance based on a claim by a patentee that a certain shipment of goods entering Korea infringes such patentee’s patent rights. The reason for such different treatment is that unlike copyright or trademark infringement cases, it is not readily determinable whether a good infringes a patent. Therefore, to stop customs clearance of allegedly patent infringing goods, the patentee can only rely on formal court proceedings for the issuance of an injunction.
2. Bill for Amending Korean Patent Act
A. Compulsory License for Public Interest
Current law requires that the working of patented invention by a licensee should be made non-commercially. As a patent right relates to commercial and industrial use, it would follow that a “non-commercial working” falls outside such right. Thus, this requirement becomes absurd and illogical. It seems that the requirement of “non-commercial working” stems from misunderstanding of “public non-commercial use” in TRIPS Article 31. The Bill deletes the word “non-commercially” and adds “particular necessity” requirement. The addition of the particular necessity is the result of negotiation with the KIPO.
Introduction of national emergency and other extreme urgency
B. Export of Patented Medicine (Implementing Para 6 of Doha Declaration)
(1) Any one who intends to export pharmaceutical product to eligible importing country may request a compulsory license to the Commissioner of the KIPO.
(2) Eligible importing country includes: LDCs designated by the UN; non-LDC WTO member country; and non-WTO member country. The applicant seeking for a compulsory license must submit documents showing that importing country has given notice to the Council for TRIPS or government of Korea the name and expected quantities of the pharmaceutical product needed and the importing country has granted or intends to grant a compulsory license where the pharmaceutical product has been patented in the importing country. In case of non-LDC country, the applicant has to submit documents showing that the importing country has insufficient or no capacity for the production of the pharmaceutical country.
(3) Prior negotiation is exempted where: (i) prior negotiation has been failed in importing country; (ii) 30 days have passed after asking negotiation with no agreement; and (iii) national emergency, public non-commercial use or anti-competitive act in importing country.
(4) Mandatory: If the importing country is eligible importing country and necessary documents are submitted, the Commissioner shall grant a compulsory license. The decision shall be made within 60 days from the filing of the request.
The remuneration to be paid by the licensee to the patentee is determined by the following formula: (quantity) x (sale price) x (contribution rate) x (basic rate). “sale price” means an amount which equals the sum of the cost of production and the costs incurred for implementing the compulsory license, “contribution rate” is the ratio of the patent used in the manufacture of the product, and “basic rate” is 4%. The basic rate may be adjusted within plus or minus 2% in consideration of the innovative nature of the patent and economic value in the importing country. When the remuneration cannot be determined by the formula, the Commissioner can determine the comparable remuneration based on its consideration of the economic value of the patent, prices of the importing country and the international humanitarian interest.
(6) The compulsory licensee can ask modification of the web site address and package or labeling.
C. Positions of the KIPO to the Bill
(1) Premature to amend the Patent Act. The KIPO argues that we have to wait until the Article 31(f) of TRIPS is finally revised by reflecting the Decision of August 30, 2003.
(2) No need to specifically regulate the process and document in Patent Act. The KIPO wants to have regulation in the form of Presidential Decree that may be prepared by the KIPO without review of National Assembly.
(3) Objections to the mandatory proceeding and specific rule for the remuneration.
II. Health Issues Related to Patent
A. HIV/AIDS, Malaria, and Tuberculosis in Korea
In South Korea, the number of PWAs is reported to be about 2,258 in 2003, but the actual number would be several folds of this, and it is rising in a steep curve.
Initial regimen and laboratory follow up are provided to the patients for free. But PWAs must pay the out-of pocket portion for the treatment of opportunistic infection and second-line anti-retroviral agents.
South Korean government didn’t issue the compulsory license of the anti-retroviral agent, and the government pays the full price to the pharmaceutical companies.
When a PWA is reported, an official of the public health center monitors the status of the patient regularly, which threatens the social life of the individual.
There are many other opportunities to break the anonymity of the PWAs in the process of governmental regulation, and the PWAs tend to hide from the public medical support, which results in deprivation of chance for treatment and additional spread of the disease.
* South Korea
The number of new case decreased from 52,735 in 1991 to 19,692 in 2000. The number of death due to tuberculosis was 1,257 in 1991, and 220 in 2000, which is showing steady decrease.
The patients are notified and treated at the public health center, and the government pays for the medicine. The dates for treatment of tuberculosis are not counted by the NHI.
* North Korea
Infectious diseases had been well contained in North Korea until the 1980s, but the health system has deteriorated during the 1990s because of the economic crisis and a series of natural disasters.
North Korean government officially reports the number of new case to be around 10,000 a year, but the WHO assumes that there would be 22,000-44,000 new cases per year. The mortality rate is around 50% due to lack of treatment, resulting in about 18,000 deaths per year.
Recently, the BCG inoculation rate has recovered from 63.9% in 1997 to 88.3% in 2002.
From 2002, with the support of the United Nations Global Fund , DOTS program (directly observed treatment short course program) has been launched nationwide.
* South Korea
South Korea had been announced as malaria- free area in 1979. However, in 1992, two soldiers serving near the DMZ(de-militarized zone) were reported to be infected with Plasmodium vivax. Since then, malaria expanded exponentially each year, with more than 4,000 patients diagnosed in 2000.
With aggressive effort for eradication of mosquitoes and prophylactic chemotherapy of the risk groups, the number of patients started to decrease from 2001.
* North Korea
The resurgence of malaria occurred at the same time in the northern part of Korea.
The incidence is reported to be 200,000 in 2000, and 300,000 in 2001, but this seems to be an over-diagnosis. Due to the lack of diagnostic equipments, patients with fever from other origins are likely to be counted as malaria. The actual number of patients is assumed to be about 50% of the reported number.
From 2002, WHO started the mass chemoprophylaxis program in the epidemic area, resulting in 90% decrease of the epidemic.
4) Compulsory license for export
The draft bill for the review of the patent law contains the compulsory license for export. We hope that this could be a measure to help the North some day.
B. Problems Caused by Patents in Relation to Access to Medicine
1) Glivec (imatinib)
Glivec(imatinib) is a newly developed innovative drug for treatment of CML(chronic myelocytic leukemia), which emerged in the market in 2001 by Novartis. Based on the exclusive patent right, Novartis settled the price of Glivec as 25,000 won(about 20 US dollars) per tablet, and it is adhering to the worldwide single price policy.
The patients and their families, who were compelled to spend 2,000-5,000 US dollars every month to buy Glivec, started to ask Novartis and S. Korean authority to lower the price of Glivec.
Progressive medical professionals and NGOs formed the ‘Glivec Coalition’ to cope with the issue of Glivec and to enhance the access to medicines. The Glivec Coalition asked the S. Korean government to approve the compulsory license, which was rejected. The Glivec Coalition and Leukemia Patients’ Association organized series of demonstrations, sit-in strikes, and signature-collecting campaigns.
The Minister of Health and Welfare who attempted to lower the price of Glivec had to resign because of the pressure from the foreign channels.
After two years of struggle, the S. Korean government reduced the out-of-pocket portion from 30% to 20%, and Novartis agreed to pay back 10% of the price of Glivec. Now Glivec is available for about 200-400 US dollars per month, but this is still expensive for some patients.
In September 2002, the Glivec Coalition and the Association of Leukemia Patients started to import a generic product of imatinib named Veenat from India. India is the only country that is producing the generic product of imatinib, and Korean patients who cannot afford Glivec are importing this product for individual use at 1/10 of the price of Glivec. But recently, the Industrial Property Office of India approved the exclusive right to sell Glivec in India, even though it is against the patent law of India itself.
2) Iressa (gefitinib)
Iressa is a product of AstraZeneca that is approved for use as monotherapy for the treatment of patients with advanced non-small-cell lung cancer.
The launching of Iressa to Korean market followed the similar course with Glivec.
The price based on the A7 was too high for most patients, costing about 60 US dollars per tablet, and 1800 US dollars per month, but it was unchanged despite of the protest of the patients.
3) Norvasc(amlodipine besylate)
Norvasc(amlodipine besylate) is a block buster calcium channel blocker, produced by Pfizer, which is the most commonly prescribed product in the world.
The patent of amlodipine besylate is expected to expire in 2007, but several pharmaceutical companies acquired the patent right of amlodipine by attaching camsylate or mesylate as salt.
Even though Pfizar won the suit against Dr. Reddy’s Laboratories (a major Indian company that applied for the right to a patent on amlodipine maleate), production of amlodipine maleate and camsylate is approved by KFDA.
C. Matters of Pricing
1) Matters of Expense
At present, the medical insurance is provided mainly by the NHI(National Health Insurance) in S Korea.
The Korean government had encouraged the pharmaceutical industry by allowing relatively high price on generic product and negative-list policy, which allows introduction of most medicines to the NHI prescription list with several defined exceptions.
As a result, as of 2002, 16,665 products are listed on the NHI prescription list, which is several times compared to other countries.
For the purpose of controlling the rise of the drug expense, several proposals such as switching of the negative-list to positive list, application of pharmacoeconomics to the calculation of drug prices, and Lowest Transaction Pricing has been made.
2) Matters of Innovative Medicines
The Korean authorities accepted to define prices of innovative medicines as the average of the prices in A7 countries(France, Germany, Italy, Japan, Switzerland, UK and US). However, there is a huge gap between the TNCs and Korean NGOs on the definition of the word ‘innovative’.
The TNCs claim that all products that are approved as new drugs by the Commissioner of the KFDA should be admitted as innovative medicines.
On the other hand, the Korean NGOs carry the point that a new product should fulfill all three conditions to become an innovative medicine, which are: 1) a newly discovered medicine with unique chemical formula; 2) must have prominent effect with less side effects compared to previous alternatives; 3) and to be proved to cost less than the pre-existing measures.
Korean NGOs also claim that it is irrational to define prices as the average of A7. The price should be compared to other countries of similar economic and social system.
III. Pharmaceutical Industry in Korea
A. The Business Performance
1) Growth of the Market
Due to the emergence of aging society, change of dietary life, and increased interest in healthy life, the Korean pharmaceutical market seems to grow constantly, in a rate of 6-7% every year.
The total output of Korean pharmaceutical manufacturers was about 6,456 billion won (5.87 billion US dollars) in year 2000, which increased to 8,013 billion won ( 7.28 billion US dollars) in 2003, resulting in 24.1% growth.
In the same duration of time, the total output of the 25 leading pharmaceutical TNCs increased from 1,264 billion won (1.15 billion US dollars) to 2,279 billion won(2.07 billion US dollars), marking 80.3% increase.
2) Development of Original and Generic Drugs
In 2003, 27 new original products were patented and launched in Korean market. Most of the patent holders were TNCs such as Rilley, GSK, Novartis, Pfizer, AstraZeneca, etc.
But number of patent applied by local pharmaceutical companies is rising, resulting in 20% of total application of pharmaceutical case in 2000.
On the other hand, domestic companies tend to focus on generic market, and recently launched simvastatin, omeprazole, cyclosporin A, ceftriaxone, amlodipine, fluoxetine, azithromycin, and itraconazole.
3) National Plan for Pharmaceutical Industry
The Korean government settled 50 goals for the development of industries related to health, especially supporting biologic high-technology, such as gene therapy. The government will introduce the ‘prompt review system’ to shorten the time for processing license of the newly developed technologies.
The MOHW appropriated 90 million dollars every year to support the R&D of new therapeutic agents, and planning to issue the “Long term Developmental Strategy for the Biotechnology and Health” by the end of this year.
4) Limiting factor of the Production of Generic Drugs
As long as the ingredient is not infringing the patent right of the others, and as long as quality is tested, production of generic drug is approved without obvious obstacles.
The success of a launch rather depends on the ability of marketing and distribution of the launching company. It is likely that several large local generic companies will survive through massive competition and merger.
B. Sustainability of Supply of Essential Medicines
1) Procurement Policy
There is no advantageous policy to the generic drugs in the procurement of governmental facilities.
Instead, doctors are reimbursed 10% of the price of some 1,552 defined essential medicines, by the NHI(National Health Insurance) to promote the prescription of those medicines.
2) Public Pharmaceutical Company
Recently, NGOs proposed to establish a public pharmaceutical company in order to ensure sustainability of supply of essential medicine, but the proposal didn’t proceed to any visible result, yet.
Rethinking of Essential Medicine
Definition of Essential Medicine (WHO essential medicines list 2002)
“Essential medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness. Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford. The implementation of the concept of essential medicines is flexible and adaptable to many different situations; exactly which medicines are regarded as essential remains a national responsibility.”
As defined above, Essential Medicine should:
- satisfy the priority health care needs,
- be intended to be available within the context of functioning health systems,
- be available at a price the individual and the community can afford,
- and be flexible and adaptable in concepts.
Most essential medicines are usually regarded as ‘basic’ medicine, but we propose that some non-basic, but life-saving medicines should also be included in the list of essential medicines.
Globally, many patients with various diseases are not suffering because of the absence of medicine, but life-saving medicines are still inaccessible due to its high price, which is excessively protected by patent rights.
We are glad to be here to join you in the struggle for the accessibility to various essential medicines, and hope to be a part of this movement.
Draft Bill for Amending Korean Patent Act
Introduced in the National Assembly on November 26, 2004 by 15 Congressmen
Article 107 Adjudication for the Grant of a Nonexclusive License
(1) Where a patented invention falls under any of the following subparagraphs and consultations with the patentee or exclusive licensee is not possible or no agreement is reached at the consultation, a person who intends to work the patented invention may request the Commissioner of the Korean Intellectual Property Office to adjudicate (referred to as “an adjudication”) for the authorization of a nonexclusive license; however, in the event the working of the patented invention is for purpose of public non-commercial use and the request meets the following subparagraphs (iv) and (v), such authorization may be requested without consultation with the patentee or exclusive licensee:
(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 non-commercially is particularly 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 in case of a national emergency or other circumstances of extreme urgency; or
(vi) where working the patented invention is necessary to export a pharmaceutical product for the purpose of addressing public health problems in importing country.
(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) In adjudicating the authorization of a nonexclusive license, the Commissioner of the Korean Intellectual Property Office shall limit the use of patented inventions through the nonexclusive license predominantly to the supply of the domestic market, unless the authorization is based on a request under subparagraph (1)(iv) and (vi).
(5) In adjudicating the authorization of a nonexclusive license set forth in subparagraph (1)(i), the Commissioner of the Korean Intellectual Property Office may take into account the need to amend unfair practices in determining the amount of remuneration.
(6) For semiconductor technology, a request for adjudication may be made only in the cases set forth in subparagraph (1)(iii) (only for public non-commercial use) and (1)(iv).
(7) Where the request is made pursuant to Paragraph 1(vi), if the importing country has notified the government of Korea that one of the circumstances described in the subparagraphs below applies, or the patentee or the exclusive licensee holds the patent in the importing country and a consultation was attempted with such person pursuant to Paragraph (1) but no agreement was reached or it is not possible to proceed with such consultation, or if a consultation was made 30 days prior to the request for an adjudication but no agreement was reached or it is not possible to proceed with such consultation, then it shall be deemed that a consultation with the patentee or exclusive licensee pursuant to Paragraph (1) is not possible or no agreement has been reached at such consultation:
(i) the working of the patent is being requested due to national emergency or other circumstances of extreme urgency of the importing country;
(ii) the working of the patent is being requested for public non-commercial use by the importing country; or
(iii) the working of the patent is being requested to remedy a practice determined to constitute unfair trade practice in a judicial or administrative proceeding of the importing country.
(8) In the event that an adjudication is sought for the purpose of exporting a pharmaceutical product in accordance with Paragraph 1 (vi), the importing country of such product (hereinafter an “importing country”) shall be limited to a country that has given notice regarding each of the following matters to the Council for the Trade Related Aspect of Intellectual Property of the World Trade Organization, provided that with respect to any country not a member of the World Trade Organization, an importing country shall mean a country that has given such notice to the government of Korea.
(i) specification of the name and the expected quantity of the pharmaceutical product needed;
(ii) unless the importing country is a country designated as a least-developed country by the United Nations, an evidence of confirmation to the effect that that the importing country has insufficient or no manufacturing capacity to produce such product; and
(iii) an evidence of confirmation to the effect that where the pharmaceutical product has been patented in the importing country, that the importing country has granted or intends to grant a compulsory license.
(9) The pharmaceutical product referred to in Paragraph 1(vi) means one of the following:
(i) any patented pharmaceutical product;
(ii) any pharmaceutical product manufactured through a patented process;
(iii) any patented active ingredient needed for the manufacture of the pharmaceutical product; and
(iv) any diagnostic kits needed for the use of the pharmaceutical product.
(10) In the event that a request for adjudication is made pursuant to Paragraph 1 for working of a patented invention by importing, due to having insufficient capacity to domestically produce pharmaceutical products, from a country that has received a waiver under Article 31(f) of the Trade Related Aspect of Intellectual Property Agreement, the relevant procedures that apply to such request shall be set forth in the Presidential Decree.
(11) The provisions relating to the documents to be submitted by a person requesting an adjudication shall be set forth in the Presidential Decree.
Article 108 Submission of Response
Where a request for an adjudication has been made, the Commissioner of the Korean Intellectual Property Office shall transmit a copy of the written request to the patentee or exclusive licensee mentioned in the request and to any other persons with a registered right related to the patent, and shall give them an opportunity to submit a response within a designated period.
Article 109 Solicitation of Opinion from the Minister of the Relevant Ministry or the Intellectual Property Rights Dispute Committee
Before adjudicating, the Commissioner of the Korean Intellectual Property Office may shall solicit an opinion from the Minister of the relevant Ministry or the Intellectual Property Rights Dispute Committee established under Article 29 of the Invention Promotion Act, provided that the foregoing shall not apply to any request for adjudication made pursuant to Article 107, Paragraph 1(vi).
Article 110 Formality of Adjudication
(1) An adjudication must be in writing and must state the reasons for the adjudication.
(2) The following matters must be specified in an adjudication under paragraph (1):
(i) the scope and duration of the nonexclusive license; and
(ii) the remuneration for the license and the method and time of payment.
(3) Any adjudication issued with respect to a request for adjudication made pursuant to Article 107, Paragraph (1)(vi) shall specify each of the following:
(i) the name and the quantity of the pharmaceutical product;
(ii) country of import;
(iii) the remuneration for the license and the method and time of payment;
(iv) packaging or labeling for identifying the pharmaceutical product from the patented product; and
(v) a website address on which the matters set forth in items (i) through (iv) may be posted
(4) The Commissioner of the Korean Intellectual Property Office shall make a determination regarding adjudication within six months from the date on which a request for adjudication is made.
(5) In the event that a request for adjudication made pursuant to Article 107, Paragraph 1(vi) falls under Article 107, Paragraph 7, 8 or 9 and all of the documents specified in Paragraph 11 of such Article have been submitted with in connection with such request, then the Commissioner of the Korean Intellectual Property Office shall grant an adjudication authorizing a nonexclusive license.
(6) The nonexclusive licensee may request a modification to the [adjudication] in the event there is a change to the packaging or labeling referred to in Paragraph 3(iv) or the website address referred to in Paragraph 3(v) by submitting documents that evidence the cause of such change. Upon such request, the Commissioner of the Korean Intellectual Property Office may solicit opinions of interested parties as deemed necessary before authorizing such modification.
(7) The Commissioner of the Korean Intellectual Property Office may designate the remuneration for the license referred to in Paragraph 3(iii) as an amount which is the product of each of the quantity, sale price, contribution percentage and the basic rate referred to below, provided if determining the remuneration in accordance with the foregoing provision is materially unreasonable, then a comparable remuneration shall be established taking into consideration of its economic value in the importing country, the price level in the importing country and the purpose of public welfare for which the products are to be used:
(i) “quantity” shall mean the quantity of pharmaceutical products specified in the request for adjudication;
(ii) “sale price” shall mean an amount which equals the sum of the cost of production and the costs incurred for implementing the adjudication;
(iii) “contribution percentage” means the percentage of contribution made by the patent in producing the pharmaceutical product; and
(iv) “basic rate” shall mean 4/100, provided that such rate may be decreased or increased within the range of 2/100 upon consideration of the excellence of the invention or its economic value in the importing country.
(8) Where an adjudication for nonexclusive license is granted in accordance with Article 107, Paragraph 1(vi), the Commissioner of the Korean Intellectual Property Office shall notify the Council for the Trade Related Aspect of Intellectual Property Rights of the World Trade Organization of such adjudication and its content.
Article 111 Transmittal of Certified Copies of Adjudication
(1) Where an adjudication is made, the Commissioner of the Korean Intellectual Property Office shall transmit a certified copy of the adjudication to the parties and to any other persons with a registered right related to the patent.
(2) Where a certified copy of an adjudication has been transmitted to the parties under paragraph (1), a consultation on the terms as specified in the adjudication is deemed to have been held by the parties.
Article 112 Deposit of Remuneration
Under any of the following circumstances, a party obligated to pay remuneration under Article 110(2)(ii) shall deposit the remuneration:
(i) where the party entitled to receive the remuneration refuses the remuneration or is unable to receive it;
(ii) where an action under Article 190(1) has been brought concerning the remuneration; or
(iii) where the patent right or exclusive license is the subject of a pledge, unless the pledge has consented.
Article 113 Lapse of Adjudication
Where a person granted an adjudication on an authorization fails to pay or deposit the remuneration (or the first installment of the payment, if the payment is to be made periodically or by installments) under Article 110(2)(ii) by the time the payment is due, the adjudication loses its effect.
Article 114 Cancellation of an Adjudication
(1) Where a person is granted an adjudication on an authorization under either of the following circumstances, the Commissioner of the Korean Intellectual Property Office may cancel the adjudication ex officio or upon the request of any interested party. However, for subparagraph (ii), such action must protect the lawful interests of the nonexclusive license:
(i) where working the patented invention is not within the purpose of the adjudication; or
(ii) where the grounds for adjudicating the authorization of a nonexclusive license disappear and are considered unlikely to reoccur; or
(iii) where the person who has obtained an adjudication does not work the patented invention within the specifications set forth in the provisions of Article 110, Paragraph 3 without proper justification
(2) Articles 108, 109, 110(1) and 111(1) apply mutatis mutandis to paragraph (1) of this Article.
(3) A nonexclusive license is extinguished upon cancellation of the ruling under paragraph (1) of this Article.
Article 115 Restriction on Reasons for Objections to an Adjudication
Where a request for an administrative trial has been filed under Article 3(1) of the Administrative Trial Act or a revocation action has been brought under the Administration Litigation Act for an adjudication, the remuneration determined in the adjudication may not be a basis for objection.
Article 116 Cancellation of a Patent Right
(1) Where a patented invention has not been continuously worked in the Republic of Korea for a period of two years or more from the date of an adjudication under Article 107(1)(i), the Commissioner of the Korean Intellectual Property Office may cancel the patent right, ex officio, or upon the request of any interested party.
(2) Articles 108, 109, 110(1) and 111(1) apply mutatis mutandis to paragraph (1) of this Article.
(3) When a patent right under paragraph (1) of this Article is cancelled, the patent right is extinguished.
Related Provisions to the Compulsory License System
Article 2 Definitions
The definitions of terms used in this Act are as follows:
(i) ”invention” means the highly advanced creation of a technical idea using the rules of nature;
(ii) ”patented invention” means an invention for which a patent has been granted; and
(iii) ”working” means any of the following acts:
(a) acts of manufacturing, using, assigning, leasing, importing or offering for assignment or lease (including displaying for assignment or lease) an invented product;
(b) acts of using an invented process; and
(c) acts of using, assigning, leasing, importing or offering for assignment or lease a product manufactured by an invented process for manufacturing a product, in addition to the acts mentioned in subparagraph (b).
Article 26 Effects of a Treaty
Where a treaty contains a patent-related provision that differs from this Act, the treaty prevails.
Article 32 Unpatentable Inventions
Notwithstanding Article 29(1) to (2), an invention likely to contravene public order or morality or to injure public health may not be patented.
Article 96 Limitations on a Patent Right
(1) The effect of a patent right does not extend to any of the following subparagraphs:
(i) working a patented invention for research or experimental purposes;
(ii) vessels, aircraft or vehicles merely passing through the Republic of Korea, or machinery, instruments, equipment or other accessories used on the vessels, aircraft or vehicles; or
(iii) articles existing in the Republic of Korea when the patent application was filed.
(2) The effects of a patent right for the invention of products used for diagnosis, therapy, alleviation, medical treatment or prevention of human disease (referred to as “medicines”) that are manufactured by mixing two or more medicines, or for the invention of processes for manufacturing medicines by mixing two or more medicines, do not extend to acts of dispensing medicines under the Pharmaceutical Affairs Act or to medicines manufactured by such acts.