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Ratification of Patent Co-operation Treaty and the Bangladesh pharmaceutical industry http://www.theindependentbd.com/printversion/details/241218 Bangladesh may ratify the Madrid Convention as this is identical to the Paris Convention M S Siddiqui Bangladesh government has decided to endorse the Madrid convention or Patent Co-operation Treaty (PCT) but Bangladesh Association of Pharmaceutical Industries opposing the decision. WIPO developed a global patent system known as the Madrid Protocol, the Patent Co- operation Treaty (PCT) in 1978. PCT is to provide a more effective and financially viable means for patent protection in several countries with a single patent application. Under the PCT, the inventor must file a single application known as an international application with a prescribed fee (reduced 90% for LDCs) in one language having effect in each of the country party to the PCT by indicating the names of the countries where he/she desires protection. This system also provides formal examination of the international application by a single office and international search on the prior art. “Prior art” consists of everything which has been made available to the public anywhere in the world by means of written disclosure (including drawings and other illustrations); it is “relevant” in respect of the international application if it can help determine whether or not the claimed invention is new, whether or not it involves an inventive step (in other words, whether it is or is not obvious), and whether the making available to the public occurred prior to the international filing date (Rule 33). A PCT application initially requires the filing of only one application, in English or French, notwithstanding the language of the designated countries. Translations and all other formal requirements of individual countries are postponed to a future date. The filing is carried out by a single patent agent, and government fees are paid to a single authority.

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Bangladesh may ratify the Madrid Convention as this is identical to Paris Convention. The only advantage is single application system for all members of this convention. The filing of application does not mean mandatory obligation of approval like Paris convention and mailbox provision will apply. The local phama manufacturers should avail the service a lower cost application of their products rather than opposing the ratification of PCT.

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Page 1: shah@banglachemical.com

Ratification of Patent Co-operation Treaty and the

Bangladesh pharmaceutical industry

http://www.theindependentbd.com/printversion/details/241218

Bangladesh may ratify the Madrid Convention as this is identical to the Paris

Convention M S Siddiqui

Bangladesh government has decided to endorse the Madrid convention or Patent Co-operation Treaty (PCT) but Bangladesh Association of Pharmaceutical Industries opposing the decision. WIPO developed a global patent system known as the Madrid Protocol, the Patent Co-operation Treaty (PCT) in 1978. PCT is to provide a more effective and financially viable means for patent protection in several countries with a single patent application. Under the PCT, the inventor must file a single application known as an international application with a prescribed fee (reduced 90% for LDCs) in one language having effect in each of the country party to the PCT by indicating the names of the countries where he/she desires protection. This system also provides formal examination of the international application by a single office and international search on the prior art. “Prior art” consists of everything which has been made available to the public anywhere in the world by means of written disclosure (including drawings and other illustrations); it is “relevant” in respect of the international application if it can help determine whether or not the claimed invention is new, whether or not it involves an inventive step (in other words, whether it is or is not obvious), and whether the making available to the public occurred prior to the international filing date (Rule 33).

A PCT application initially requires the filing of only one application, in English or French, notwithstanding the language of the designated countries. Translations and all other formal requirements of individual countries are postponed to a future date. The filing is carried out by a single patent agent, and government fees are paid to a single authority.

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PCT provides a kind of one-stop solution for registering and managing trademarks worldwide by filing one application in one language and paying one set of fees to protect one's mark in 114 countries. The PCT is a convention between countries that consolidates the initial filing procedures of an application to be filed in more than one country into the filing of a single "international" patent application. Such an application may be transformed into national patent applications within 30 months of the priority date or the PCT filing date.

Bangladesh is at present party to Paris Convention which deal with application of patent rights under national law. The Paris Convention provides certain common rules that are either required or permitted to be implemented under national legislation. In the field of patents, they include the right of the inventor to be mentioned in the patents (Article 4ter), Article 4 A. (2) Any filing that is equivalent to a regular national filing under the domestic legislation of any country of the Union or under bilateral or multilateral treaties concluded between countries of the Union shall be recognized as giving rise to the right of priority. Again, Article 6 on Marks: Conditions of Registration; Independence of Protection of Same Mark in Different Countries(1) The conditions for the filing and registration of trademarks shall be determined in each country of the Union by its domestic legislation.

The implementation of the Paris Convention that members enjoy was derived from the application of the principle of national treatment, as established in Article 2(1) of the Convention, which reads: “Nationals of any country of the Union shall, as regards the protection of industrial property, enjoy in all the other countries of the Union the advantages that their respective laws now grant, or may hereafter grant, to nationals; all without prejudice to the rights specially provided for by this Convention...”

The WIPO Committee on Development and Intellectual Property (CDIP) prepared a paper on “Patient related Flexibilities in the Multilateral framework and their legislative implementation at the national and regional levels for 5th Session at Geneva, April 26 to 30, 2010 and clarified that, where the Paris Convention does not establish minimum mandatory standards, members of the Union are free to set those standards in their law. (sec 18). Therefore, countries are free to set their own standards of patent protection in their national laws which will also apply to other members of the Union. However, in case no protection is available to their own nationals for instance because the invention is excluded from patentability the same standard would apply for nationals of other countries. Thus, if pharmaceutical products are excluded in a given country, neither a national of that country nor of any other country, would be able to secure protection for their inventions on this type of product, without any challenge to the Paris Convention (sec 19).

Bangladesh got extension of exemption on Patent rights on pharmaceuticals for domestic and international market. The policy makers are afraid of losing this benefit with access to ICT. But the exemption on Patent rights on Pharmaceuticals has no specific relation with ICT. Under the TRIPS Agreement, specific provisions mandate patent protection for pharmaceutical and agricultural chemical products (Articles 27, 65.4 and 70.8) as well as provide for transitional periods for the implementation of this obligation. These transitional periods have lapsed, except for LDCs which enjoy an extension until 2016 and now extended up to 2031.

WTO Members must comply with Article 31 of the TRIPS Agreement regarding the conditions to be met in the grant of compulsory licenses; this document further refers to some of the possible grounds for compulsory licenses, without exhausting all possibilities. As confirmed by the Doha Declaration on the TRIPS Agreement and Public Health, each Member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.

Members are also bound by the Decision of the General Council of August 30, 2003, on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (Paragraph 6 Decision); therefore, some national laws provide specific provisions to implement that Decision. The Decision was designed to address the public health problems recognized in Paragraph 1 of the Doha Declaration on TRIPS and Public Health, which says that WTO ministers “recognize the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics.” The Decision takes the form of an interim waiver, which allows countries

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producing generic copies of patented products under compulsory licenses to export the products to eligible importing countries. The waiver would last until the WTO’s intellectual property agreement is amended. The Decision covers patented products or products made using patented processes in the pharmaceutical sector, including active ingredients and diagnostic kits.

Patent rights, like other intellectual property rights, are territorial in nature, which means that each patent provides its owner the exclusive right of exploiting the invention within the limits of the country or countries where the patent was granted. Thus, one single invention could be the object of patent protection in several countries, creating rights that are independent from each other (Article 4bis Paris Convention). Article 28 of the TRIPS Agreement (Rights Conferred) enumerates those rights. It includes among them the “right of importation” because the exclusive right derived from a patent could be affected by the importation of the patented product from another country.

The TRIP agreement has given appropriate protection of health care issues and Bangladesh enjoy the weaver of patent weaver as LDC and there is no fear of losing the status as per WIPO agreement. Moreover, as a signatory of Paris Convention, Bangladesh has obligation to receive application and treat the application under national law and other international agreement. By joining the ICT Bangladesh will receive Patent application and keep in drop box until 2031 or upto come out of LDC hopefully by 2027 as projected.

On the other hand, During the World Trade Organization (WTO) Uruguay Round multilateral negotiations (1986-1994), the European Union signed an agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Pharmaceutical patents are among the intellectual property rights the agreement is intended to protect. In the case of pharmaceutical products, developing countries that did not provide product patent protection on 1 January 1995 (when the TRIPS Agreement came into force) have up to 10 years to introduce this protection. In the meantime, they have to comply with obligations to must allow inventors to file patent applications from 1 January 1995, (It has been extended up to 1913 and again upto 2031) even though the decision on whether or not to grant any patent itself need not be taken until the end of this transition period (the "mailbox" provision).

ICT and Paris Convention have mandatory provision of receiving patent application while ICT is an automated version of receiving the application with some other facilities. Bangladesh Patent office will receive applications coming via the PCT has already been verified regarding compliance with formal requirements during the international phase. Patent office will have excess to information and can provide technical advisory services to local industry on available technologies or about research and development activities. Besides, the Patent Office can save the cost of publishing as the international application has been published in an official language of the country, they can forgo publication.

The Madrid Convention article 4 (1) held that “from the date of the registration so effected at the International Bureau in accordance with the provisions of Articles 3 and 3ter ensuring Territorial Limitation, the protection of the mark in each of the contracting countries concerned shall be the same as if the mark had been filed therein direct. The indication of classes of goods or services provided for in Article 3 shall not bind the contracting countries about the determination of the scope of the protection of the mark”. The Article 5 refusal by national office referred that ……… shall have the right to declare that protection cannot be granted to such mark in their territory.

Bangladesh may ratify the Madrid Convention as this is identical to Paris Convention. The only advantage is single application system for all members of this convention. The filing of application does not mean mandatory obligation of approval like Paris convention and mailbox provision will apply. The local phama manufacturers should avail the service a lower cost application of their products rather than opposing the ratification of PCT.

The writer is a legal economist, e-mail: [email protected]