Biotechnology is a technology that involves living organisms as a whole or their parts to develop new products that can have industrial applications and can be used for large scale productions. Biotechnology includes invention of new products by ways such as genetic engineering, gene editing or genetic modifications. These products are granted legal patent rights under the Patents Act, 1970, on the basis of the three basic tests; novelty, invention and industrial applicability. The idea of patenting advanced after the TRIPS agreement came into force in 1995. Animal cloning can also be done through genetic engineering but they are not considered to be patents by Courts. Patents are also used in the pharmaceutical industry but it allows the companies gain monopoly in the market and sell these patented product at higher prices.
Criteria for Patent rights
In Monsanto Technology Pvt. Ltd. v. Nuziveedu Seeds, the dispute was an agreement between the plaintiff and the defendant. It was claimed by the plaintiff that their chemical product, NAS (Nucleotide Acid Sequence) is patentable as it’s an invention. NAS is a product which consists of Basillus thrungensis genes (BT genes) which when inserted into the cotton seeds shows pesticidal characters to kill cotton eating ball warms. Nuziveedu seeds contended that, since NAS could not reproduce on its own, it was merely a chemical composition and not a micro-organism, thus, it was outside the purview of patent protection under Section 3 (j). It was held by the division bench of the Delhi HC that this product is within the exclusion mentioned in section 3(j) of the patents Act, 1970, and is not patentable but Monsanto can apply for registration under the Plant Variety and Farmers’ Rights Act, 2001. This case was later appealed to the SC. The SC reverted the matter to the single bench holding the decision of the Delhi HC to be wrong. It also held that the matter cannot be decided on the basis of some previous examination as the matter consists of mixed questions of facts and law and has to be dealt considering expert advice. This matter is yet pending in the Delhi HC.
The SC should have considered this as a window of opportunity to grant patent to the NAS product so that a major question of law could have been settled.
Patenting of microorganisms
Since ages microorganisms is being commercially used for production of antibiotics and vaccines, in bakeries, breweries etc. These kinds of living organisms were considered as the products of nature and not inventions so they were not considered patentable. The scenario gradually changed across the world after the pronouncement of the landmark judgment by the Supreme Court of USA in Diamond v. Chakraborty in 1980. Prior to this judgment, Patent right were only granted based on micro biological processes and not living organisms as they were considered to be naturally existing.
In Diamond v. Chakraborty, a genetically engineered organism was granted patent wich was able to degrade crude oil into multiple components. Chakraborty filed for the claim of the patent of the microorganism in the United States but was not allowed as living organisms cannot be patentable under the law. Later on the U.S Supreme Court overturned the decision and decided in favour of Cakraborthy. I was held that, “A live, human-made microorganism is patentable subject matter.” Under 35 USC § 101: Statutory Requirements and Four Categories of Invention the modified microorganisms constitute a ‘manufacture’ or ‘composition of matter’.
In accordance with TRIPS, the changes were made which recognised microorganisms to be patentable and it was added to the Patents Act, 1970, by an amendment in 2002.
Earlier in Dimminaco A.G. v. Controller of Patents & Designs, prior to the 2002 amendment, the Calcutta HC delivered a landmark Judgment. The court held that there is no statutory bar that a patent cannot be granted to a product if its end result is a new living organism and a new invention which is useful. This case was concerned with the production of vaccine for protection against Bursitis infection in poultry fowls.
The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure (Budapest Treaty)
Is an international treaty signed in Budapest, Hungary, on 28th April 1977. This treaty is administered and regulated by the World Intellectual Property Organisation. India is a party to this treaty. It allows ‘deposits of microorganisms at an international depositary authority to be recognized for the purposes of patent procedure’. The Budapest Treaty ensures that an applicant, that is a person who applies for a patent, need not deposit the biological material in all countries where he/she wants to obtain a patent. The applicant needs to only deposit the biological material at one recognized institution and this deposit will be recognized in all countries party to the Budapest Treaty.
To wipe out the need to deposit a microorganism in every country in which patent protection is sought, the Budapest Treaty provides that the deposit of a microorganism with any International Depository Authority (IDA) suffices for the purposes of patent procedure at national patent offices of all contracting states, and before any regional patent office that recognizes the effects of the treaty.
Patenting the Cloning of Animals
Over the years, it has been a topic of debate around the globe that whether cloning of animals can be granted patentability or not. On 5th July, 1996, through the technique known as ‘somatic cell nuclear transfer technology’ the very first mammal was cloned. It was a sheep which is still popularly known as “Dolly”. The inventers applied for its patentability but their application was rejected giving the reason that its subject matter does not qualify the patenting criteria.
Later in 2014, the United States Court of Appeals for the Federal Circuit issued an opinion, In re Roslin Institute, rejecting patent claims to mammals cloned from somatic cells. The patent at issue covered animals and the cloned sheep, Dolly. The Federal Circuit panel held that such a cloned mammal was not sufficiently inventive to constitute patentable subject matter because of her genetic identity with a progenitor animal, Dolly was deemed a patent ineligible product of nature.
The Paris Convention
The Paris Convention is one of the oldest conventions with regard to the protection of ‘industrial property’. It entered into force on July 7, 1884. It includes both patent and trademarks.
Its most important provision is Article 2 which requires each member state to accord to the nationals of other parties the same level of protection that it accords to its own nationals and by imposing a requirement of national treatment, the convention creates a level playing field: Goods compete on price and quality, not on the scope of exclusivity afforded to their right holders. Article 4 further enhances the availability of patents requiring each member state to award a foreign patent application a priority date based on the date on which the application was filed in the applicant’s home country, provided that the foreign application is not filed more than one year after the original filing. Article 4 states that the respective national patents are independent of one another even if the home country patent is invalidated, foreign patents that relied on the home country’s priority remain in force if they comply with the states of registration.
According to Article 11(1) of the Paris Convention requires that the Countries of the Union “grant temporary protection to patentable inventions, utility models, industrial designs, and trademarks, in respect of goods exhibited at official or officially recognized international exhibitions held in the territory of any of them”. The Paris Convention requires inventor to be named in the patent and it creates a grace period for the payment of fees. In certain ways it has made procedures easier and convenient.
Genetically Modified Crops and its Socio-economic Effects
Genetically modified crops have its pros and cons. It is a great scientific invention but at the same time it has ramifications too. Studies suggest that for a certain time span it would be protected from pests due to its pesticidal features but later the pests would get resistant to it. The Genetically modified crops are believed to have considerably low nutritional value than their existing natural/organic varieties.
One important area of consideration regarding genetically modified foods is their direct financial impact: on consumers in developed countries, on consumers in developing countries, on farmers, and on international trade. There have been prolonged debates across the world on its economic effects. Their increased efficiency would help their agricultural industry and so aid their economy in general. The other advantage is that mentioned for developed countries: those countries that adopt new technology are helped in the long run.
Trade agreements notwithstanding, the effect of genetically modified crops upon a developing country depends on whether the country is an exporter or an importer. If the country imports the cheaper genetically modified food, it is at an advantage; however, if it exports genetically modified food, it may run into various import bans.
Criteria for Patentability
There are three general tests of patentability which are applied to check the patentable qualities of an invention.
Novelty- The invention should be new and not revealed or communicated to anyone in the world in any form through any means.
Inventive Step- The invention should not be obvious to the person specialized in that specific area of technology and the invention should have distinguished characteristics to that which has already been invented.
Industrial applicability- The product or technology which has been invented should qualify for it industrial use and it must show economic significance.
There are certain inventions which are exempted from the criteria of patents under Section 3 and 4 of the Patents Act, 1970.
Patenting of Inventions Relating to Stem Cells
Section 3(j) of the Patents Act 1970 states that “plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals” are not inventions as per the act, therefore, not patentable.
Stem cells are considered to fall under the phrase “any part thereof” and hence are excluded from patentability. However, in vitro methods of differentiating, isolating/purifying and culturing of stem cells may qualify as patentable subject matter, provided that the method is novel, involves an inventive step and has industrial applicability.
In addition, inventions with regard to stem cells may be opposed under Section 3(b) of the Act, which prohibits the grant of patent to:
an invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment.
The patent act must be narrowed down to lay down clear patenting criteria for living organisms. There must not be any judicial overreach and the patent protection shall only extend to the extent intended by the legislature. As we can see an exponential increase complicated research and advancement in technology each day, the Judges must interpret the statute as much broadly as possible so that none can be deprived of their patent rights.
By Areeb Sadaf ,3rd Year, B.A.LL.B (Hons), Jamia Millia Islamia University, New Delhi