Development of Patent in Bio Technology: Brief Study from Patent in Micro- organisms to Cereals

This article is written by Vishal Vijayvargiya.

Abstract: Cereals like rice and wheat are an important protein source. However, they are not nutritionally very efficient as they have very low concentrations of several essential amino acids, like tryptophan and lysine. Legumes like peas also have low concentrations of sulphur-containing amino acids. These amino acids are considered
essential because the body cannot synthesise them by it. (Image taken from here.)

With the advent of recombinant DNA technology, the protein content of these legumes and cereals can be enhanced, improving their nutritional quality. Genes can be obtained from any source. But I thought it to be more appropriate to isolate a seed protein gene, as this was unlikely to create problems when incorporated into cereals or legumes using genetic engineering techniques. To do this, I chose the Amaranthus plant, because its seeds contain reasonably high quantities of the essential amino acids.

In India, The Indian Patent office guidelines with regard to Biotech related patents can be best described as inconsistent and grossly inadequate. The word gene or DNA does not appear anywhere in the Indian Patent Act nor there is any special directive issued by GOI for according legal protection to Biotechnology related inventions. The only reference for the same can be found in the Examination Manual Chapter 8 which deals with Examination and Grant of Patent applications. The Manual is currently in its third edition and has undergone substantial changes since the time it was introduced. The manual is not a binding document as it is not issued under any provisions of the Patent Act, but serves as an informal written guidance for the Examiners at the Patent office. The current as well as the 2008 edition of the Manual regards claims to ‘genetically modified Gene Sequence/ Amino Acid Sequence, a method of expressing the sequence, an antibody against that protein / sequence, a kit containing such antibody / sequence’ as having a single inventive concept and capable of being granted a patent. The above text can be found under the explanation for section 10(5) Unity of Invention. The Patent office indeed does consider claims to genetically modified sequences for grant of Patent, something which I can confirm from the experience of handling prosecution of numerous patent applications claiming DNA and protein sequences. The term ‘Genetically Modified Sequence’ however restricts smooth prosecution of only those inventions which relate to modifying known genes sequences or synthesis of a completely new gene sequence in the lab. To meet the novelty and inventive criteria, the modified gene sequence should not have existed in nature or should differ in at least one aspect from its identical copy in the nature. The difference can be a change of a single base pair which could provide new function, property or configuration to the protein molecule encoded by the gene sequence.

INTRODUCTION

The biotechnology areas have immensely showing the institutionalization in science and genetic application as the enhanced research of cereal gene patenting has been the main focus in the field of it. Continuous and ongoing researches in cereal gene project identifying specific target genes and their respective response and functional activities, as to seething, scathing & searing improvement in the quality of the product.

Cereals like rice and wheat are an important protein source. However, they are not nutritionally very efficient as they have very low concentrations of several essential amino acids, like tryptophan and lysine. Legumes like peas also have low concentrations of sulphur-containing amino acids. These amino acids are considered essential because the body cannot synthesis them by it, with the advent of recombinant DNA technology, the protein content of these legumes and cereals can be enhanced, improving their nutritional quality. Genes can be obtained from any source. But it has been thought that it to be more appropriate to isolate a seed protein gene, as this was unlikely to create problems when incorporated into cereals or legumes using genetic engineering techniques. To do this, it has been instrumental to choose the Amaranthus plant, because its seeds contain reasonably high quantities of the essential amino acids. The isolation has been done of this gene and the results were published in U.S. Journal in December 1992. Seeing the commercial potential of this discovery, the department of biotechnology (DBT), agreed to for the patent right. Using this gene in a gene transfer technique, scientists can now produce several valuable transgenic crops.

When the founding fathers penned down the patent provision of the U.S. Constitution, they probably pictured devices and not the stuff of human heredity as patent fodder. Today, with the human genome project spawning discoveries weekly, the U.S. Patent and Trademark Office (PTO) is buried in applications for inventions that include DNA sequences. The existing law on patents is that they are to be granted only on human inventions, not on discoveries. Existing living organisms, like plants and animals as well as their genes, are of course no-one’s invention and should therefore, by definition, never be patented and put under private control. But, patents now have been extended in a number of countries to various life forms, including plants, animals and micro- organisms. The first patent for a human product was granted on March 20, 1906 for a purified form of adrenaline. It was challenged and upheld in Parke-Davis v. Mulford. Judge Hand argued that natural substances when they are purified are more useful than the original natural substances. (Image taken from here.)

But it is 1980 which is a landmark year in the history of the development of life patents. The United States Supreme Court accepted the patentability of artificially created life forms, thereby paving the way for the rapid development of the genetic engineering industry. The decision in Diamond v. Chakrabarthy triggered one of the most significant changes in the patent regime in recent times. The decision was a true game changer so patent claims could include life forms The Court was presented with the novel case of the invention of artificially created life forms. The patent was granted on the basis that genetically modified bacteria used to clean up oil spills didn’t occur in nature. It analyzed the case from point of the distinction between an invention and a discovery. Hence, the Chakrabarthy decision opened door to the patentability of micro- organisms in the US.

While the patentability of micro- organisms led to pressure on the courts to accept the patentability of plants and animals, it also led to significant debates concerning the patentability of genes. A gene is a molecular unit of heredity in a living organism. It is transferred from a parent to offspring and is held to determine some characteristic of the offspring. Technically, it is a name given to some stretches of DNA and RNA that code for a type of protein or for an RNA chain that has a function in the organism. The genes are encoded on long strands of DNA in most of the living organisms. DNA (deoxyribonucleic acid) consists of a chain made from four types of nucleotide subunits, a phosphate group, and one of the four bases: adenine (A), cytosine (C), guanine (G), and thymine (T). The different combinations of these four bases have the capability of carrying the code of a certain characteristic which can be hereditarily transferred to the next generation which is called a gene.

Development of the changing standards of GMO in India; Grant of Patent:

The Indian Patent office guidelines with regard to Biotech related patents can be best described as inconsistent and grossly inadequate. The word gene or DNA does not appear anywhere in the Indian Patent Act nor there is any special directive issued by GOI for according legal protection to Biotechnology related inventions. The only reference for the same can be found in the Examination Manual Chapter 8 which deals with Examination and Grant of Patent applications. The Manual is currently in its third edition and has undergone substantial changes since the time it was introduced. The manual is not a binding document as it is not issued under any provisions of the Patent Act, but serves as an informal written guidance for the Examiners at the Patent office. The current as well as the 2008 edition of the Manual regards claims to ‘genetically modified Gene Sequence/ Amino Acid Sequence, a method of expressing the sequence, an antibody against that protein / sequence, a kit containing such antibody / sequence’ as having a single inventive concept and capable of being granted a patent. The above text can be found under the explanation for section 10(5) Unity of Invention. The Patent office indeed does consider claims to genetically modified sequences for grant of Patent, something which I can confirm from the experience of handling prosecution of numerous patent applications claiming DNA and protein sequences. The term ‘Genetically Modified Sequence’ however restricts smooth prosecution of only those inventions which relate to modifying known genes sequences or synthesis of a completely new gene sequence in the lab. To meet the novelty and inventive criteria, the modified gene sequence should not have existed in nature or should differ in at least one aspect from its identical copy in the nature. The difference can be a change of a single base pair which could provide new function, property or configuration to the protein molecule encoded by the gene sequence.

The manual issued in 2005 however spoke a different story altogether. For analysis, excerpts from the Manual of 2005 relating to Unity of Invention and inventive step requirements for gene patents is produced below;

• Explanation to section 10(5): “New gene sequence A •A method of expressing sequence A •an antibody made to the protein of sequence A •A kit made from the antibody to sequence A; All of these claims are linked by the inventive concept that sequence A is new and inventive.”
• Inventive step requirement for Biotechnology related invention: “Gene sequences, DNA sequences without having disclosed their functions are not patentable for lack of inventive step and industrial application.”

According to the 2005 guidelines a new gene sequence modified or unmodified was considered as novel invention, and providing the function of the gene sequence was sufficient to meet the inventive step and industrial applicability requirement for such inventions. The word genetically modified is not present in the explanation to section 10(5) and grant of patents was not restricted to only those inventions which claimed genetically modified sequences.

Moving image of DNA

Though the text of the Patent office Manual is not binding and only serves as a guiding principle for Examiner, it nevertheless leads to major delays in the prosecuting Biotechnology related applications e.g. inventions claiming cDNA sequences. A cDNA sequence is formed from an mRNA sequence using a reverse transcriptase enzyme, a DNA polymerase enzyme and a PCR machine. A cDNA sequence is an identical copy of chromosomal gene sequence minus the introns. Thus they cannot be regarded as truly existing in nature but nevertheless cover the complete functional gene sequence when claimed in a patent. (Image taken from here.)

With India being promoted as a hub for clinical research, contract manufacturing and basic R&D in Biotechnology led drug development, there is an immediate need for legislation and concrete guidelines for biotechnology related inventions else delays and road blocks will be a major issues working against the Government efforts of promoting Research & Development in this industry.

Monsanto Wheat: Dispute in Patent

Basmati Rice

This is a new gene-grab story. After basmati and neem, Indian wheat has attracted foreign companies on the prowl for money-spinning genes and American seeds giant, Monsanto, has patented wheat invented by crossing a traditional Indian variety with another wheat line. The wheat variety in question is Nap Hal, a primitive Indian land race. Monsanto say dough from its new wheat will be ideal for making bakery products like biscuits, crackers, wafers and crisps. (Image taken from here.)

But gene-scientists and farmers here say this is a clear case of theft with the potential to stymie further breeding of high-quality varieties utilising this heritage wheat seed. Monsanto Technology was granted the patent last month by the European Patent Office based in Munich. The patent has been given both for the biscuits, flour, and dough produced from the wheat, as well as the plant itself. By owning this kind of patent, Monsanto could, in the future, potentially take legal action not only against farmers and scientists trying to breed wheat varieties with similar genetic traits, but also bakeries, confectioners and supermarkets if they produce or sell biscuits and other foods made from patented wheat.

The Monsanto India office confirmed the patent, but had nothing more to add. International NGO Greenpeace, however, has much to say. In a statement on its website it says, "Monsanto is targeting and stealing from Indian farmers who have cultured this specific variety of wheat for centuries. This patent demonstrates the urgent need for a general legal ban on the patenting of genes, live organisms and seeds." Greenpeace intends to file an objection to the patent over the coming weeks.

Coming to the patent itself, Monsanto produced a new wheat variety by crossing a commonly grown soft wheat variety 'Galahad' with a 'Sicco' line containing the Indian 'Nap Hal' variety. Monsanto christened the new variety Galahad 7 and patented it.

The seeds major has stated in its patent application that samples of Nap Hal are freely available from several public germplasm collections. "For example, it is available under Accession No 1362 from the AFRC Institute of Plant Science Research, Norwich, UK. As Nap Hal is a land race, it is genetically mixed and it’s therefore necessary to purify the sample to homogeneity by selection,”

The technical details of the new patent are as follows. Monsanto has created a soft-milling wheat variety, with the unique genetic characteristic of a Glu-D1 double null. All soft-milling wheat varieties having this essential characteristic are covered by the patent. The patent also encompasses the use of a wheat line exhibiting the Glu-D1 double null trait in the production, i.e. by breeding or genetic engineering, of soft-milling wheat.

Monsato: "Control the food supply
and you control the people"

For Monsanto, the patent has tremendous scope for enhancing its profits because it gives flour sufficient inelasticity to produce perfect semi-sweet biscuits and non-fermented crackers without any chemical treatment. The new variety also has a grain protein which is soluble, to prevent lumpiness in the batter made from it. "This is particularly important in wafer manufacture," says Monsanto in its patent claims. The patent also encompasses dough made from the flour and all edible products made by cooking such dough. (Image taken from here.)

Conclusion:

The protection conferred by a patent on a biological material extends to any biological material derived from that biotechnologically invented material through propagation or multiplication and possessing the same characteristics. The protection conferred by a patent on a product containing the genetic information extends to all material in which the product is incorporated.

However the protection does not extend to plant-propagating material or breeding stock sold to a farmer by the holder of the patent or with his consent, provided that the farmer uses the biological material or livestock for his own agricultural purposes.

Where a breeder cannot acquire or exploit a plant variety right without infringing a prior patent, he can apply for a compulsory license for non-exclusive use of the invention protected by this patent, subject to payment of royalty.

Though there are certain questions that are raised as related to the Patenting of Gene in Sectors like Cereal & other food products like, what is the potential of genetic engineering in meeting India's food needs? In India, only about 15 to 20 per cent of seed sales are in the formal sector, and farmers mostly sell seeds to one another informally. Would the patenting of this gene and its commercial exploitation at a later stage make life more difficult for small farmers? There is a debate and a certain degree of fear in the West about genetic engineering. On the one hand, people are worried that the manipulation of genes could have serious environmental fallout; on the other, they are concerned about the ethical aspect of genetic manipulation, what is the stand of India where still majority is living in rural areas? Though these are the questions that need to answer before the implementation of Patent in food sectors as otherwise the dispute which arose from the Monsanto will continue & consistent & the changes would rather be a far-fetched destiny. 

This article is written by Vishal Vijayvargiya.

Vishal Vijayvargiya is a Fourth Year Law Student from Amity Law School, Delhi. He is currently the College Manager for Lawctopus, a one stop resource for law students in India. He was also the Joint Secretary for Eco Needs Foundation, Delhi, which worked for the creation of Environment awareness in India. He is also the member of the legal service cell in his college in which we worked for the upliftment of the legal education & legal awareness via campaigning for the underprivileged in NCT. He is highly interested in pursuing a career in IPR.

Also see the articles on Geographical Indications in India, Game Changer in the Generic Industry and the Enercon Patent Case.

Keywords: basmati, bio-patent, biotechnology and patent law, cereals, gene patenting, genetically modified sequence, gmo, greenpeace, india, micro-organisms, Monsato patents, neem, patent, Vishal Vijayvargiya, wheat, 

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