Intellectual Property Rights and Biotechnology: An Overview

Read this article to learn about the intellectual property rights of biotechnology. The intellectual property is divided into two categories:

(1) Industrial Property, which includes inventions (patents), trademarks, industrial designs, and geographic indications of source and (2) Copyright, which includes literary and artistic works such as novels, poems and plays, films, musical works, artistic works such as drawings, paintings, photographs and sculptures, and architectural designs.

Introduction:

Intellectual property refers to creations of the mind: inventions, literary and artistic works, and symbols, names, images, and designs used in commerce. Intellectual property is divided into two categories: Industrial property, which includes inventions (patents), trademarks, industrial designs, and geographic indications of source; and Copyright, which includes literary and artistic works such as novels, poems and plays, films, musical works, artistic works such as drawings, paintings, photographs and sculptures, and architectural designs.

Rights related to copyright include those of performing artists in their performances, producers of phonograms in their recordings, and those of broadcasters in their radio and television programs. In recent years, instruments enforcing intellectual property rights (IPRs), such as patents and trade secrets, have received attention as mechanisms by which biodiversity resources may be maintained while promoting sustainable development and a more equitable distribution of the resulting benefits among nations.

Most of the world’s biodiversity-rich countries are underdeveloped and lack the necessary technologies to transform biological resources into products yielding significant measurable benefits. With little or insignificant in situ market value, biodiversity-rich wild lands may be expected to succumb to pressure from development activities (e.g., conversion to cropland, inundation of forest lands due to hydroelectric and flood-control projects, etc.).

One way to prevent the destruction of wild lands (and, in turn, biodiversity loss) is to promote biodiversity prospecting which creates new markets for biological resources and generates incentives for their conservation. However, biodiversity prospectors generally are multinational corporations from developed countries. These corporations are reluctant to invest in biotechnologies discovered in developing countries due to poorly defined and enforced intellectual property laws.

Several scientists currently are addressing this deficiency in IPR protection. Nations which have become signatories of two major international agreements in recent years: the 1992 Convention on Biological Diversity (CBD) (UNEP, 1992) and the 1993 Trade-Related Intellectual Property Rights (TRIPS) (UN, 1993). These agreements call for establishing a set of suitable intellectual property laws in each nation, depending on the type of intellectual material in question and the economic and technological background of the nation itself.

CBD establishes a formal framework for the reciprocal transfer of biological resources and knowledge (technology) between nations. The convention promotes the idea of biodiversity as a global common heritage, which, therefore, requires biodiversity-rich countries to allow access to biological resources to other countries on ‘mutually agreed terms’ (UN, 1993). CBD requires technology-rich nations-generally, developed nations to encourage transfer of technology to biodiversity-rich, underdeveloped countries. Thus, the Convention promotes the exchange of biological resources for technology to facilitate biodiversity prospecting, which benefits all nations in the world.

Even though the resource-technology reciprocity and IPR provisions of these agreements have strong economic justification, their use at the global level raises issues concerning the transfer of wealth and respect for national and cultural sovereignty. These issues may become pressing in situations where the resource consumption associated with a patented biotechnology comes in direct conflict with traditional uses of a region’s biological resources.

Conflict may take different forms. First, the developer of a new biotechnology who normally has greater financial strength- might out-compete traditional users for raw biological material in the input market by paying higher prices.

However, the products produced by the new commercial user and traditional users may not compete with each other in the output market. Second, the commercial product developed may have intellectual similarity with traditional products.

Then, conferring IPR to a new product/ technology may limit or prevent traditional consumers from continuing their use of biological resources. Third, the new commercial product may become a substitute for a traditional product and available at a cheaper price. The lower output market price may drive the traditional producers out of business. Such conflicts can alter the underlying market incentives of competing resource users, with likely adverse implications for biodiversity.

Intellectual Property Protection of Plant Biotechnology Inventions:

It is becoming more and more difficult to obtain broad claims in patents and the strength of broad claims in issued patents is weakening. A recent example of this is a case in the USA, in which claims to a diagnostic assay – to differentiate one genus of bacteria from other were invalidated.

Trips:

The standard for intellectual property rights is outlined in the global intellectual property treaty agreement of Trade-Related Aspects of Intellectual Property Rights (TRIPS). Member countries that have signed this agreement must ensure that the requirements stated in TRIPS are met in their own legislation. TRIPS states that ‘patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application’.

Although seemingly simple and consistent with the requirements for obtaining a patent in most developed countries, this statement is at the heart of most of the controversy relating to biotechnology patenting. An additional paragraph in TRIPS permits several grounds for exclusion in granting patent protection, including exclusion on moral grounds; or diagnostic, therapeutic and surgical methods for the treatment of humans or animals, life forms other than microorganisms and processes for the production of plants or animals. However, these exclusions are optional and vary from country to country.

For example, the European Patent Convention (EPC) provides limited moral grounds for exclusion, yet no such grounds are defined in the Patent Acts in Canada, Australia, the USA or Japan.

TRIPS also state that if protection of plants is not available by patent, then member countries need to provide protection in some other way. A standard method for such alternative protection is plant variety protection, as set out under Union International pour la Protection des Obtentions Vegetables, known more simply as UPOV.

Plant Variety Protection:

UPOV is a global agreement setting out a minimum standard for the protection of plant varieties, similar to that of TRIPS. Member states that have signed the UPOV Convention must ensure that these standards are met within their own legislation (Table 20.1). The two versions of UPOV that are currently in force are set out in the UPOV Conventions of 1978 and 1991 and are similar in that they provide protection to a plant variety that is distinct from existing known varieties and that is uniform, stable and novel.

However, there are several significant changes in the 1991 Act. For example, the definition of propagating material has been tightened and provisions relating to farmers’ rights (or privilege) the rights that permit a farmer to replant seed for personal use have been defined.

Although plant variety protection meeting the standard set out under UPOV is accepted in 50 countries, such protection has not been uniformly accepted and many countries with strong histories of farmers’ privilege have yet to accede to the convention. A rigorous debate also continues over the effect of plant variety protection and associate Material Transfer Agreements, on sharing and developing new germplasm.

UPOV 1978 provides an exclusive right to produce and offer for sale propagating materials of a plant variety but not the harvested end product, for example a fruit. Furthermore, the right pertains only to a commercial end product and not to non-commercial uses. As a result, replanting seed is implicitly allowed under UPOV 1978, leading to farmers’ privilege.

Also provided in the 1978 convention was a breeders’ exemption permitting the use of protected varieties as a germplasm source to develop new plant varieties. The 1991 Act introduced several significant amendments. The number of plant genera and species that could be protected under UPOV was increased from the select list of plants in UPOV 1978 to all plants.

Furthermore, the 1991 Act provides the option to protect all aspects of the production and reproduction of a plant variety, thereby removing farmers’ privilege. However, the application of this provision is discretionary for each member state of UPOV and a country can provide an exemption in its laws to permit farmers’ privilege, if desired. Another important change pertains to providing protection to plant varieties that are ‘essentially derived’ from a protected variety.

An ‘essentially derived’ plant is one that comprises the properties of the protected variety along with only a minor change. The introduction of a gene using recombinant techniques into a protected plant variety might not be sufficient to exceed the ‘essentially derived’ criteria unless the gene alters the variety in a significant manner.

On 3 November 2001, the International Treaty on Plant Genetic Resources was adopted by 116 countries; there were two abstentions (the USA and Japan). Before the Treaty comes into effect 40 countries must ratify it. This Treaty pertains to ensuring that the raw materials used to develop new crop varieties remain publicly available.

In so doing, the Treaty promotes the conservation of plant genetic resources for food and agriculture. The aim of the Treaty is to ensure farmers’ privilege and to develop a multilateral system comprising an aggregate of genetic material from the member countries, so that, after paying a fee, members can have access to the genetic material.

The preface to the Treaty indicates that ‘nothing in this Treaty shall be interpreted as implying in any way a change in the rights and obligations of the Contracting Parties under other international agreements’. However, there is an active debate as to whether the Treaty will remain subordinate to TRIPS and UPOV. The USA abstained from signing this treaty partly because of the lack of clarity in the intellectual property provisions.

GATT (General Agreement on Tariffs and Trade):

During Urugway conference, WTO (World Trade Organization) was created. General Agreement on Tariffs and Trade (GATT) was framed by WTO in 1948 and was meant to be a temporary arranged to settle amicably, among countries, disrupts regarding who gets what share of world trade. This is achieved by determining both tariff rates and quantitative restrictions on imports and exports globally. In 1994, about 100 countries signed this agreement including the then president of USA, Mr. Bill Clinton. This was to be effective from 1-1-95 in phases. Its new quarter is in Geneva, Switzerland.

Although GATT has made the world a better place to do business by allowing more free and fruitful flow of goods and services, this benefit has unfortunately gone mainly to developed countries to the disadvantage of the countries in the third world.

US Plant Patents:

Another way to protect plant-related subject matter includes a ‘plant patent’, a unique form of protection offered in the USA. A US plant patent is available for a plant that reproduces through asexual reproduction but it does not include a tuber-propagated plant. Although not a common form of plant protection, it is used to protect ornamental and fruit-producing trees, roses, poinsettias, strawberries and other plants that reproduce asexually. A plant patent is different from a regular utility patent.

In the autumn of 2000, the USPTO (United States Patent and Trademark Office) began rejecting plant patents with a UPOV-based certificate that had been issued before filing for the corresponding plant patent application if the UPOV-based application had been >1 year before the plant patent application had been filed.

This interpretation of a UPOV-based disclosure had not been made previously because it was not considered ‘enabling’, that is, the disclosure of a plant variety within a Plant Breeder Right’s certificate did not provide enough information to enable someone ‘one of skill in the art’ – to produce the plant variety.

The position taken by the USPTO is in direct opposition to that decided in re LeGrice but the USPTO argued that rejection on these grounds is consistent with Ex parte Thomson. However, it should be noted that the only public disclosure made in re LeGrice was a notice in a publication, which is arguably a non-enabling disclosure, whereas in ex parte Thomson, seeds were made publicly available for >1 year before application for a plant patent, clearly placing one of skill in the art in possession of the invention.

The applicant of a US plant patent is provided with a 1 year period of grace. Strong pressure from the industry resulted in a review of USPTO’s position and the issue of a preliminary statement recanting its position  and, in May 2002, an amendment to the US Patent Act was proposed (it is still under discussion), providing a 10-year period of grace. Even so, the question as to whether a public, non-enabling disclosure of a plant is sufficient to permit one of skill in the art to be in possession of the invention, as is the case in re LeGrice, was not addressed.

Utility Patents:

Plants can also be protected using a regular (utility) patent in countries that permit patenting of plant or higher life forms (HLFs). This is a more common method for protecting whole novel plants, plant genes, methods for creating novel plants and novel applications for an existing plant.

However, the costs are greater and the process more involved than plant variety protection. Many major jurisdictions permit the patenting of non-human HLFs, including Europe, the USA, Japan and Australia. In the USA, patents have been granted to HLFs since the 1980 landmark decision in Diamond v/s Chakrabarty. The recent Supreme Court decision in the case of Pioneer Hi-Bred International, Inc., v/s J.E.M. AG Supply. Inc. et.al. Further established that such protection is valid for plants, even if protection of a plant is available through either plant variety protection or plant patent protection. This case also confirmed that plants are a composition of matter, as ruled earlier by the US Patent Board of Appeal.

The scope of protection offered by a utility patent is broader than that available under plant variety protection. As noted above, a farmer saving and replanting seed, and a breeder producing a new variety, can do so without infringing a plant variety certificate. However, if a utility patent, the patent owner, protects the plant or licensee has the right to exclude the making, using or selling of the plant or seed, making a user buy seed every year.

Gene Patenting:

Although patents have been granted on nucleotide sequences for >30 years, there has been much recent controversy surrounding the patenting of genes. Genome sequencing initiatives coupled with improved techniques for identifying and sequencing genes, has resulted in an exponential increase in the number of gene patents in the last decade.

As a result, the obscure world of gene patenting is now being scrutinized closely in many different sectors, not least because the effect of these patents is felt in everyday life, especially healthcare. For example, in Europe, a European Parliament resolution regarding the patenting of BRCA 1 and BRCA 2 (breast cancer associated) genes was passed calling on the EPO (European Patent Office) to ensure that all patent applications in Europe do not violate the principle of non-patentability of humans, their genes or cells in their natural environment.

The resolution identified two European patents related to BRCA 1 and BRCA 2 and asked that an official objection be filed against these patents. The importance of intellectual property in India is well established at all levels- statutory, administrative and judicial. India ratified the agreement establishing the World Trade Organisation (WTO). This Agreement, inter-alia, contains an Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) which came into force from 1st January 1995.

Patenting of Life Forms and GMO:

Life forms such as microorganisms, plants and animals, are not patentable in India under the provisions Indian patent Act (1970). However, patent can be obtained for various biotechnological processes and product applications within the scope of International conventions. In America, Europe and other developed countries, microorganisms isolated from nature or are obtained by simple manipulations are not patentable. But microorganisms obtained by novel techniques like genetic engineering are patentable.

The first patent of GMO (Genetically Modified Organisms) was allowed by US Supreme Court in 1980 as described in utility patent. A maize plant over producing tryptophan amino acid was patented in USA in 1985. This was beginning of patenting of high organisms for patenting. For animals, a patent was granted in 1988 for ‘oncomouse’, genetically modified mouse in USA.

In USA, non-naturally occurring non-human multi-cellular organisms are now considered patentable by US patent and trademark office. This clearly excludes humans and human parts. There is long debate about patenting of life forms including GMO and several organizations and religious groups are opposing the patenting of these life forms.

Copyrights:

India’s copyright law, laid down in the Indian Copyright Act, 1957 as amended by Copyright (Amendment) Act, 1999, fully reflects the Berne Convention on Copyrights, to which India is a party. Additionally, India is party to the Geneva Convention for the Protection of rights of Producers of Phonograms and to the Universal Copyright Convention. India is also an active member of the World Intellectual Property Organisation (WIPO), Geneva and UNESCO.

The copyright law has been amended periodically to keep pace with changing requirements. The recent amendment to the copyright law, which came into force in May 1995, has ushered in comprehensive changes and brought the copyright law in line with the developments in satellite broadcasting, computer software and digital technology. The amended law has made provisions for the first time, to protect performer’s rights as envisaged in the Rome Convention.

Trade Secrets:

Trade secrets often include private proprietary information that allows a definite advantage to the owner. This can be illustrated by the popular example of Coca-Cola brand syrup formula which is not known publically under trade-secret.

Trade secrets in the area of biotechnology may include material like:

(i) Hybridization conditions

(ii) Cell lines

(iii) Corporate merchandising plan or

(iv) Customer lists.

Unlike patents, trade secrets have an unlimited duration and therefore may not be required to satisfy the more difficult conditions laid down for patent applications. Disclosure of a trade secret and its unauthorized use can be punished by the court and the owner may be allowed compensation. However if a trade secret becomes public knowledge by independent discovering or other means, it is no longer protectable.