CDIP/7/3
Annex I, page1
(1) PROVISIONS OF LAW ON TRANSITION PERIODS
ARGENTINA: Sections 100 and 101 of the Law No. 24.481 of 23/05/1995 on Patents and Utility Models (as last amended by Law No. 24.572)
100.Inventions relating to pharmaceutical products shall not be patentable until five years have elapsed following the publication of this Law in the Official Gazette. Until that date, none of the Articles contained in this Law that provide for the patentability of inventions of pharmaceutical products shall have effect, neither shall any other provisions that are inseparably related to such patentability.
101. Without prejudice to the provisions of the foregoing Article, patent applications may be filed for pharmaceutical products in the form and under the conditions laid down in this Law, provided that the patents shall be granted as from five years following publication of this Law in the Official Gazette.
The term of the patents mentioned above shall be that arising from the application of Article35.
The owner of the patent shall have exclusive rights in his invention as from five years following the publication of this Law in the Official Gazette, except where the third party or parties making use of his invention without his authorization guarantee that the domestic market will be fully supplied at the same actual prices.
In such case the owner of the patent shall have the right only to collect fair and reasonable remuneration from the said third parties who are making the use from the time of the patent grant until the expiration thereof. If there is no agreement between the parties, the National Institute of Industrial Property shall set the remuneration in accordance with Article 46. The provisions of this paragraph shall apply unless the amendment thereof is required to implement decisions of the World Trade Organization adopted by virtue of the TRIPS Agreement, compliance with which decisions shall be mandatory for the ArgentineRepublic.
BURUNDI: Article 17 of the Law No. 1/13 of 28/072009 on Industrial Property
Article 17
Sont exclus de la protection par brevet:
- les produits pharmaceutiques, jusqu'au 1er janvier 2016.
CAMBODIA: Articles 4 (iv) and 136 of theLaw on Patents, Utility Models and Industrial Designs of 22/01/2003
Article 4
The following inventions, shall be excluded from patent protection:
(iv) pharmaceutical products as provided in Article 136 of this Law;
Article 136
The pharmaceutical products mentioned in the Article 4 of this Law shall be excluded from patent protection until January 01, 2016, according to the Declaration on Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health of the Ministerial Conference of World Trade Organization dated November 14, 2001 in Doha of Qatar.
EGYPT: Articles 43 and 44 of the Law on the Protection of Intellectual Property Rights No 82 of 03/06/2002
Article 43
The Patent Office shall receive patent applications with regard to food-related agrochemical products and to pharmaceuticals, and shall maintain such applications, along with applications relating to the same products and filed as of 1st January 1995, pending their examination as of 1st January 2005.
In the case of a patent granted for the inventions relating to the products mentioned in the preceding paragraph, the protection shall begin from the date of granting the patent until the end of the period provided for in Article 9, calculated from the date of application.
Article 44
Without prejudice to the date set for the examination of patent applications relating to the products mentioned in Article 43, the applicant shall be entitled to request from the competent public authority to be granted exclusive marketing rights for his product in Egypt, provided that:
(1) the applicant has submitted an application for this product to the Patent Office in Egypt as of 1st of January 1995;
(2) the same product was patented in a country member of the World Trade Organization on the basis of an application submitted in that country as of 1st January 1995;
(3) the applicant has obtained the approval for the circulation of that product in the same country where he was granted the patent as of 1st January 1995;
(4) the applicant has obtained the approval of the competent ministry for the circulation of that product within Egypt;
The Patent Office in Egypt shall grant an exclusive marketing right certificate upon the approval of a ministerial committee established for this purpose by a decision of the Prime Minister.
The exclusive marketing right shall not be granted when it is clear, prima facie, from the papers submitted to the Patent Office to obtain the exclusive marketing right, that the patent application has been filed with the Office was already published one year prior to the date of filing the request.
Where an exclusive marketing rights have been granted by the competent public authority, the applicant shall enjoy such rights for his product until a decision is rendered by the Egyptian Patent Office on the patent application, or for a period of five years as from the date of approval to grant him such rights, whichever comes first.
A previously granted exclusive marketing right shall be revoked by a decision of the competent ministry which has approved the circulation or where the owner of such right abuses its exercise.
INDIA: Sections 5 and 24A, 24B and 24D of the Patent Act No. 39 of 1970 as last amended by Act No. 15 of 2005
[5. Inventions where only methods or processes of manufacture patentable
(1) In the case of inventions
a) claiming substances intended for use, or capable of being used, as food or as medicine or drug, or
b) relating to substances prepared or produced by chemical processes (including alloys, optical glass, semi-conductors and inter-metallic compounds);
no patent shall be granted in respect of claims for the substances them selves, but claims for the methods or processes of manufacture shall be patentable.
[(2) Notwithstanding anything contained in sub-section (1), a claim for patent of an invention for a substance itself intended for use, or capable of being used, as medicine or drug, except the medicine or drug specified under sub-clause (v) of clause (1) of sub-section (1) of section 2, may be made and shall be dealt, without prejudice to the other provisions of this Act, in the manner provided in Chapter IVA.]
Explanation: for the purposes of this section “chemical processes” includes biochemical, biotechnological and microbiological processes.] (Section omitted by Patent amendment Act of 2005)
[24A. Application for grant of exclusive rights – (1) Notwithstanding anything contained in sub-section (1) of section 12, the Controller shall not, under that sub-section, refer an application in respect of a claim for a patent covered under sub-section (2) of section 5 to an Examiner for making a report till the 31st day of December, 2004 and shall, where an application for grant of exclusive right to sell or distribute the article or substance in India has been made in the prescribed form and manner and on payment of prescribed fee, refer the application for patent, to an Examiner for making a report to him as to whether the invention is not an invention within the meaning of this Act in terms of section 3 or the invention is an invention for which no patent can be granted in terms of section 4.
(2) Where the Controller, on receipt of a report under sub-section (1) and after such other investigation as he may deed necessary, is satisfied that the invention is not an invention within the meaning of this Act in terms of section 3 or the invention is an invention for which no patent can be granted in terms of section 4, he shall reject the application for exclusive right to sell or distribute the article or substance.
(3) In a case where an application for exclusive right to sell or distribute an article or a substance is not rejected by the Controller on receipt of a report under sub-section (1) and after such other investigation, if any, made by him, he may proceed to grant exclusive right to sell or distribute the article or substance in the manner provided in section 24B.
Explanation: It is hereby clarified that for the purpose of this section, exclusive right to sell or distribute any article or substance under this section shall not include an article or substance based on the system on Indian Medicine as defined in clause (e) of sub-section (1) of section 2 of he Indian Medicine Central Council Act, 1970 (48 of 1970), and where such article or substance is already in the public domain. ] (Omitted by Act No. 15 of 2005)
[24(B). Grant of exclusive of rights – (1) Where a claim for patent covered under sub-section 2 of section 5 has been made and the applicant has –
a) where an invention has been made whether in India or a country other than India and before filing search a claim, filed an application for the same invention claiming identical article or substance in a convention country on or after the 1st day of January, 1995 and the patent and the approval to sell or distribute the article or substance on the basis of appropriate tests conducted on or after the 1st day of January, 1995 in that country has been granted or after the date of making claim for patent covered under sub-section 2 of section 5; or
b) where an invention has been made in India and before filing search a claim, made a claim for patent on or after the 1st day of January, 1995 for method or a process of manufacture for that invention relating to identical article or substance and has been granted in India the patent therefore on or after the making the claim for patent covered under sub-section 2 of section 5, and has been received the approval to sell or distribute the article or substance from the authority specify in this behalf by the Central Government, then, we shall have the exclusive right by himself, his agents or licencee to sell or distribute in India the article or the substance on or from the date of approval granted by the Controller in this behalf till a period of five years or till the date of grant of patent or the date of rejection of application for the grant of patent, whichever is earlier.
(2) Where, the specifications of an invention relatable to an article or a substance covered under sub-section (2), of Section 5 have been recorded in a document or the invention has been tried or used, or, the article or the substance has been sold, by a person, before a claim for a patent of that invention is made in India or in a convention country, then, the sale or distribution of the article or substance by such person, after the claim referred to above is made shall not be deemed to be an infringement of exclusive right to sell or distribute under sub-section (1).
Provided that nothing in this sub-section shall apply in a case where a person makes or uses an article or a substance with a view to sell or distribute the same the details of invention relatable thereto were given by a person who was holding an exclusive right to sell or distribute the article or substance. ] (Omitted by Act No. 15 of 2005)
[24D. Special provision for selling or distribution
Without prejudice to the provisions of any other law for the time being in force, where, at any time after an exclusive right to sell or distribute any article or substance has been granted under sub-section 91) of Section 24B, the Central Government is satisfied that it is necessary or expedient in public interest o sell or distribute the article or substance by a person other than a person to whom exclusive right has been granted under sub-section (1) of Section 24B; it may, by itself or through any person authorized in writing by it in this behalf, sell or distribute the article or substance.
The Central Government may, by notification in the Official Gazette and at any time after an exclusive right to sell or distribute an article or a substance has been granted, direct, in the public interest and for reasons to be stated, that the said article or substance shall be sold at a price determined by an authority specified by it in this behalf. ] (Omitted by Act No. 15 of 2005)
LEBANON: Article 36 of the Law onPatents of Invention No. 32 for the Year 1999(as last amended by Law No. 71 of 2001)
Article 36
A. Patents of invention shall be granted for manufacturing and chemical processes relating to chemical products, pharmaceuticals and foodstuffs.
B. After the enforceability date of this law, it shall be permissible to file patent applications for registering inventions involving the protection of final products for chemicals relating to pharmaceuticals or medicines or foodstuffs.
C. Deciding the applications referred to in the previous paragraph (B) shall only be made after the enforceability date of this Article.
D. Without prejudice to the provisions of any other law, the Minister may grant the applicant for a patent registration the exclusive right to market the chemical products relating to medicines or pharmaceuticals or foodstuffs covered by the patent subject for five years or until the date of patent grant or rejection whichever is shorter if the following takes place after the enforceability date of this Article:
1. Filing an application for obtaining a patent of invention in the Kingdom relating to the products mentioned in this Article.
2. Filing an application for an invention patent in another country member of the World Trade Organization and the patent has been granted.
3. Granting a permit for marketing the product in the other country.
4. Granting a permit to register the medicine in the Kingdom by the Ministry of Health.
E.1. The provisions of paragraphs (C) & (D) of this Article shall come into force after the elapse of one month as of the Cabinet’s decision to do so, within 3 years as of the date of Jordan’s joining the World Trade Organization.
2. In case of non-issuance of the decision referred to in item (1) of this paragraph, the provisions of the said two paragraphs shall come into force under the law when the 3-year period elapses.
MADAGASCAR: Section 1. 8 (1) (v) of the Ordinance No. 89 019 Establishing Arrangements for the Protection of Industrial Property of 31/07/1989
8. (1) Subject to the specific regulations in respect of the subject matters listed below, applications for patents or inventors’ certificates shall not be admissible or shall be rejected
where they concern:
(v) pharmaceutical, veterinary, cosmetic and food products.
PAKISTAN: Section 13 (9) of the Patent Ordinance No. LXI of 2000 as last amended by Patent Ordinance No. 2(1)/2002
13. (9) An application for availing exclusive marketing rights for a patentable invention relating to pharmaceutical or agricultural chemical product shall be filed in the mailbox provided for this purpose by the Controller who may require the form and manner for submitting such application as may be prescribed.
URUGUAY: Article 127 of the Law No. 17.164 Regulating Rights and Obligations Relating to Patents, Utility Models and Industrial Designs No. 1.827*R of 02/09/1999
127. Inventions of pharmaceutical and agrochemical products may not be patented until November 1, 2001.
Without prejudice to the foregoing, a patent may be sought for these products in accordance with the provisions and requirements of this Law, but the patent shall not be granted until the date laid down in the previous paragraph.
Where patents for pharmaceutical and agrochemical products claim the priority right provided in Article 4 of the Paris Convention for the Protection of Industrial Property, the first deposit may not under any circumstances be made prior to January 1, 1994.
RWANDA: Article 18 (1) 8) of the Law No. 31/2009 of 26/10/2009 on the protection of intellectual property
The following shall be excluded from patent protection even if they constitute inventions under article 5 (7): of this Law;
8° pharmaceutical products, for the purposes of international conventions to which Rwanda is party;
(2) PROVISIONS OF LAW ON PATENTABILITY OF SUBSTANCES EXISTING IN NATURE
ALBANIA: Art.4 no.7-11, Art. 5(2) (a) and(5) and Art.6 (2) and (3) of the Industrial Property Law Nr. 9977 of 07/07/2008
Article 4
7. "Biotechnological inventions" means inventions which concern a product consistingof or containing biological material or a process by means of which biological materialis produced, processed or used;
8. "Biological material" means any material containing genetic information and capableof reproducing itself or being reproduced in a biological system;
9. "Plant variety" means any plant grouping with a single botanical taxon of the lowestknown rank, which grouping, irrespective of whether the conditions for the grant of aplant variety right are fully met, can be:
a) defined by the expression of the characteristics that result from a given genotype orcombination of genotypes;
b) distinguished from any other plant grouping by the expression of at least one of thesaid characteristics; and
c) considered as a unit with regard to its suitability for being propagated unchanged;
10. "Essentially biological process for the production of plants or animals" means aprocess consisting entirely of natural phenomena such as crossing or selection;
11. "Microbiological process" means any process involving or performed upon orresulting in microbiological material;
Articles 5 (2) (a) and(5)
2. The following in particular shall not be regarded as inventions within the meaning of paragraph 1:
a) discoveries, scientific theories and mathematical methods;
5. Biotechnological inventions shall also be patentable if they concern:
a) biological material which is isolated from its natural environment or produced bymeans of a technical process even if it previously occurred in nature;
b) plants or animals if the technical feasibility of the invention is not confined to aparticular plant or animal variety;
c) microbiological or other technical process, or a product obtained by means of such aprocess other than a plant or animal variety;
d) an element isolated from the human body or otherwise produced by means of atechnical process, including the sequence or partial sequence of a gene, may constitute apatentable invention, even if the structure of that element is identical to that of a naturalelement. The industrial application of a sequence or a partial sequence of a gene must bedisclosed in the patent application.
Article 6
Exceptions to patentability
Patents shall not be granted in respect of:
2. Plant or animal varieties or essentially biological processes for the production of plants or animals, without prejudice to the patentability of inventions which concern a microbiological or other technical process or a product obtained by means of such a process;
3. The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene.
ALGERIA: Articles 7 (1) and 8 (1) of the Ordinance No. 03-07 of 19/07/2003
7. Au sens de la présente ordonnance, ne sont pas considérés comme inventions:
1) les principes, théories et découvertes d’ordre scientifique ainsi que les méthodes mathématiques;
Article 8
- En vertu de la présente ordonnance, les brevets d’invention ne peuvent pas être obtenus pour: