Intellectual Property Protection in biotechnology

 

Intellectual Property Protection in biotechnology

Biotechnology is a broad area of biology, involving the use of living systems and organisms to develop or make products. It is a technology that utilizes biological systems, living organisms or parts of this to develop or create different products.  

This branch of science began with the studies on the improvement of hereditary material (DNA) during 1970s, and grew quickly thereafter.  Today, biotechnology plays an important role in the fields of medicine, food, fertilizer, energy, and protection of the environment. Biotechnology concerns living organisms, such as plants, animals and micro-organisms, as well as non-living biological material, such as seed, cells, enzymes, plasmids, etc. 

Intellectual Property Rights & Biotechnology

Intellectual property rights help to protect one’s innovation. In biotechnology the inventor can protect his/her rights if the novelty and innovation of the particular product could be proved.  Intellectual property rights in biotechnology help to protect claim and ownership of inventions through common law, state law or federal law.

There are some controversies over intellectual property rights in biotechnology. Those who are in favor argue that IPR provide a key incentive for developers to innovate because these protections make them financially rewarded for successful innovations. Those opposed to the strict IPR enforcement argue if broader sharing of information is there it would reduce prices and increase access especially in developing countries.

There are currently two main systems of protection for biotechnology: rights in plant varieties, and patents. Both systems provide exclusive, time-limited rights.

·         Biotechnological Trade secret can be a valuable form of protection. However, this form of protection is lost when it is used commercially.  Trade secrets in the area of biotechnology may include material like Hybridization conditions, Cell lines, Corporate merchandising plan or Customer lists.  Trade secrets have unlimited duration, however if a trade secret becomes public knowledge by independent discovering or other means, it is no longer protectable.

·         Copyright could also afford some protection for biotechnology. Genetic code is analogous to computer program code and are incorporated into the copyright systems of most industrialized countries. However, this route to protection is troubled with practical and conceptual difficulties and there is no recorded case of biotechnologists claiming copyright in their inventions.  Trademarks are also not of much use in protecting biotechnological inventions.  They may be used while marketing products, processes or services.

·         Rights in plant varieties

Prior to 1960s only a few countries like Germany and USA gave any intellectual property protection to plant varieties. In the early-1960s due to pressure from their plant breeding industries, 10 western European countries entered and culminated in the formation of an International Union for the Protection of New Varieties of plants (UPOV) and the signing of a Convention (the UPOV Convention 1961). Since that time a number of other countries also became parties to the UPOV Convention. Amendments were made to the UPOV Convention in 1978.

A plant variety is protectable or is "a protectable variety" under the UPOV system if it is distinct, uniform, stable (DUS) and satisfies a novelty requirement. Satisfaction of the DUS criteria is conducted by the national authority, usually by growing the variety over at least two seasons. Another important requirement is that the variety be maintained throughout the duration of protection. Amongst the UPOV members there is still some inconsistency in protection.

Duration of protection depends on national legislation and on the plant species, but is generally for 20-30 years. Grant of plant variety rights provides certain exclusive rights on the holder, and it includes the exclusive right to sell the reproductive material such as seed, cuttings, whole plants, etc of the protected variety. The rights do not extend to consumption material (e.g., fruit, wheat grown for milling into flour).

Plant breeders were not satisfied with the protection provided by the UPOV system and UPOV Convention was substantially revised in 1991.  The new 1991 decision provide far greater protection, all member countries apply the convention to all genera and species, the exclusive rights are extended to include harvested material (e.g., fruit, wheat grown for milling into flour) and by allowing enforcement against farm-saved seed (where a farmer produces further seed of the protected variety from the previous year's crop). However, until the national governments ratify the new convention the system will continue to be based on the 1978 UPOV text.

·         Patents for biotechnology

A patent is a grant of exclusive rights for a limited time in respect of a new and useful invention. The exact requirements for grant of a patent, the scope of protection it provides and its duration differs depending on national legislation and country.

Generally, the invention must be of patentable subject matter, novel (new), non-obvious (inventive), of industrial application and sufficiently disclosed. A patent will provide a wide range of legal rights, including the right to possess, use, transfer by sale or gift, and to exclude others from similar rights. Duration will be for around 20 years (although for only 17 years in the USA).

These rights are generally territorial and thus an inventor wishing to protect the invention in a number of countries will need to seek separate patents in each of those countries. Whilst the majority of countries provide patent protection, only a few provide patent protection for biotechnology and they are Australia, Bulgaria, Canada, Czechoslovakia, Hungary, Romania, Japan, the Soviet Union and the parties to the European Patent Convention. The reasons for this varies, but generally it is due to that biotechnology has been thought inappropriate for patent protection, either because the system was originally designed for mechanical inventions, or for technical or practical reasons, or for one or more ethical, religious or social concerns. In all the National Patent Offices where patents are granted for biotechnology there is a considerable backlog of pending applications.

Patents were granted for plants since 1930 in the USA, under The Plant Patent Act.  Prior to 1980, the US Patent Office were not granting utility patents to living matter because it deemed products of nature not to be within the terms of the utility patent statute. Then came the landmark decision of the US Supreme Court in Diamond v Chakrabarty (where it was quoted "anything under the sun that is made by man" can be patented).  Here a particular genetically engineered bacterium was statutory subject matter for a utility patent. This decision has been the basis upon which patents are granted for higher life forms. Later it was decided that a utility patent may be granted for plants and a patent can be granted for an animal. US Patent No.3,736,866, was issued in respect of a "transgenic nonhuman mammal all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into the said mammal, or an ancestor of said animal, at an embryonic stage" - popularly known as the 'onco-mouse '.

While patents are granted in many countries for plants and microorganisms, issue of patents for animals remain to be controversial.

The European Patent Convention or EPC is a regional arrangement by 14 European countries for the purpose of making multiple applications for patent protection in any of the member countries through a common system. An application under the EPC is for a European patent, or Europatent, for short. If a Europatent is granted by the European Patent Office (EPO) it is like a national patent in each of the member countries designated in the application. In other words, through a single application a bundle of national patents can be obtained.

The EPC states that "plant or animal varieties or essentially biological processes for the production of plants or animals" are excluded from patent protection.  Microbiological processes and products can be patented. 

References

https://www.wipo.int/treaties/en/ip/plt/

https://www.iipta.com/role-of-ipr-in-biotechnology-industry/

https://blog.ipleaders.in/ipr-biotechnology/