Status and Implication of IPR

2.2. Status and Implication of IPR

The present day status and implications of IPR may be elaborated and expatiated under the following six points, namely :

(i) Intellectual property protection (IPP) systems are not just arbitrarily fixed but they do evolve with the passage of time. As on date, the patent system in several countries essentially comprise of parts/segments of plants, whole plants, and plant varieties.

(ii) Based upon the negotiations in the World Intellectual Property Organization (WIPO), bilat- eral consultations, and in General Agreement of Tariffs and Trade (GATT) the industrialised countries invariably strive for worldwide adaptation of IPP to the newer emerging technolo- gies. Thus, USA, Japan, and EU usually pressurize the developing countries (e.g., India) to expunge (remove) completely the provisions in their patent laws which specifically exclude from patent protection such critical matter as ‘living material’.

Besides, the prevailing plant breeder’s right (PBR) might serve as a viable alternative for patent protection for plant varieties to certain developing countries in the world ; however, GATT does not take into consideration this alternative aspect at all.

(iii) The major function of IPP in biotechnology is to promote profusely biotechnological inno- vation, application, and development. In case, the developing countries are left with no other choice than to enforce establishment of IPP for biotechnological inventions or for plant varieties, then the function of IPP shall be confined primarily to the promotion of the

* OECD : Organization for Economic Cooperation and Development, Document No : 237, 94, Paris, 1989.

REGULATORY ISSUES IN BIOTECHNOLOGY

biotechnological innovation in the industrialized countries. In other words, IPP with respect to plant material as adopted by developing countries may certainly promote innovation in agricultural research in these countries, only in a situation when the introduction of IPP is directly and intimately related to their stage of development.

Nevertheless, there may arise three distinct situations with regard to the status and implica- tions of IPR which shall be discussed briefly in the sections that follows :

Situation-I. i.e., where intellectual property protection would not be appropriate : In case, practically little breeding or biotechnological research activity, occur, it is absolute

little interest for any country to go in for either plant breeder’s right (PBR) or patent protec- tion in these fields.

Importantly, for plant brieeding systems, critically characterized by an absolute open ex- change of finished varieties, unimproved base materials, and breeding lines, there is no ne- cessity to go in for the adoption of ‘intellectual property protection (IPP)’ specifically for the plant material. It also holds good in the instance where local propogation of varieties is invariably encouraged as is the case in majority of developing nations.

Nevertheless, in the event when the component of the ‘domestic IPP’ for the plant material is absent, a nation is quite free from any restriction whatsoever to import technical know- how and varieties, to make use of the acquired knowledge abundantly, and also to propogate it freely and commercialize the ‘end material’ within the borders of that nation.

Situation-II. i.e., where plant breeder’s right (PBR) may seem to be appropriate : In this particular instance, the prevalent ‘breeding activity’ has undergone a development

much beyond its preliminary stages ; and. therefore, the implementation of a legal system pertaining to intellectual property protection (IPP) particularly for the plant material as a viable avenue of stimulating and encouraging private investment would remarkably promote local private plant breeding activities in favour of the development of market oriented agri- culture research. The much acclaimed principle of the ‘breeders exemption’ ultimately guarantees the ‘free and fair’ utilization of genetical material (without any compulsion) of the so called protected variety towards the gainful creation and legitimate commercialization of new varieties. Of course, the ‘farmers privilege’ certainly provides the farmers certain degree of freedom in order to save ample quantum of seeed essentially needed for the next crop production.

There is absolutely little doubt that the free importation of ‘foreign improved varieties’ would definitely go a long way in involving as a necessary consequence for bringing in severe cut- throat competition for those specific varieties bred by domestic breeders. Alternatively, it may give rise to a positive impact upon the well established market oriented agriculture since farmers most probably may not depend exclusively either on public or on local private breeding activities to obtain the improved varieties.

Nevertheless, the plant breeder’s right (PBR) system may prove to be effective only when the following conditionalities are fulfilled, such as : • Farmers should be able to purchase modern varieties of seeds,

• Independent ‘quality control’ and ‘testing facilities’ must be available, • Various approved channels to spread the information should always be available freely, and

PHARMACEUTICAL BIOTECHNOLOGY

• Users and holders of proprietary rights should be in a position to rely on an approved and recognized legal and technological infrastructure to protect their legitimate interests.

Situation-III. i.e., where granting of patent protection might be appropriate : Importantly, the ‘patent protection’ could be accomplished expeditiously only via an ex-

tremely superb and high level of research and development activities in ‘biotechnology’. However, the domestic entreprenuers (companies) may largely benefit from the patent abil- ity of their biotechnological inventions, whereas patent protection certainly encourages foreign organizations to enable their knowledge and wisdom duly available in the entire world.

It may be worthwhile to state here that the legitimate right of the foreign companies to a reasonable remuneration for an inventor may not be a subject of a probable controversial debate ; however, the granting of utility patents of plants involves and attracts sufficient risk that may have an access to a common pool of plant genetic resources, essential for ‘plant breeding’ may become restricted ultimately. As a result, the ultimate patent protection of plant material would cause a tremendous hinderance in the overall agricultural development across the globe.

(iv) Two vital and important aspects, namely : plant breeder’s right (PBR) on plant varieties, and patent protection for the numerous biotechnological inventions should necessarily provide the ‘public research institutes’ with substantial additional funding and also adequately pro- tect their work against free commercialization. It is, however, emphasized amply that the ‘ultimate quest’ for the strategic legal protection may not entail any delay whatsoever in providing improved plant material or technology needs for the futuristic growth. In the same vein, the availability across the national boundaries of inventions or innovations or varieties derived primarily from the on-going programmes of the prevailing international agricultural research centres (IARCs) must not be subjected to any sort of restrictions or limitations.

Importantly, whenever public institutes do lodge an application for IPP of their research product, it must be regarded that any step taken forward in the commercialization of the ensuing subsidized public research would lead to encounter possible opposition on the pri- vate sector related to their unfair trade practices.

(v) Intellectual property protection (IPP) for plant material specially in industrialized countries may adversely affect the agricultural export from developing countries.

It has been duly observed that the extension of the underlying scope of plant breeder’s right (PBR) protection as explicitely applicable to almost all material of the protected specimen, besides any prolongation of the period of protection, may have an altogether adverse conse- quences to the farmers belonging to the developing nations because of the complete block- ade of the export material of a specific variety gaining entry to a developed nation where this variety is entirely protected. Furthermore, the authorized certificate holders may prohibit this export operation :

(a) unless the farmers employed purchased seed, and (b) unless the farmers pay hefty royalties for their multiplication of seeds legally.

(vi) In a broader perspective the industrialized (i.e., developed) countries avoid exerting undue pressure upon the developing nations to protect and preserve the intellectual property em- bodied in plant material thereby ignoring, as far as possible, the consequences for the ensu-

REGULATORY ISSUES IN BIOTECHNOLOGY

the intellectual property protection (IPP) meant for plant material exclusively deserves to be adopted if it strategically promotes the much desired national agricultural development. In conclusion, one may add that the various rules and regulations, including the plant breed- er’s right (PBR) as well as the patent legislation, should be judged from that perspective

solely.