Patenting Biotechnological Inventions

Patenting Biotechnological Inventions - microorganisms, plants, animals and other biological processes and products

Patent laws of most countries are solely based on non-biological objects and inventions. Since biotechnology involves application of technology on biological organisms, viz., microorganisms, plant and animals and biological material of DNA, RNA and proteins, patenting of biotechnological inventions and processes for the development or manufacture of a product or solution is a real world problem. Whether living organisms, such as, microorganisms, plants or animals, or naturally occurring substances, such as DNA and proteins, cloning and bioinformatics can be regarded as an invention is very controversial.

Concept of Novelty in Biotechnological Inventions

In the case of biotechnological inventions, the assessment of novelty is carried out in the same manner as for other inventions. For the purpose of ascertaining novelty during the examination, the prior art is to be considered.

According to Section 2 (1) (j) of the Act, an "invention" means a new product or process involving an inventive step and capable of industrial application. An invention will be patentable only if it is new in the light of prior art, or is not anticipated by prior art. The prior art includes all information and knowledge relating to the invention, which is available in any publication before the date of the patent application.

Concept of Inventive Step in Biotechnological Inventions

The Manual of Patent Office Practice & Procedure has set out the guidelines for assessment of Inventive Step of inventions. An invention should possess an inventive step in order to be eligible for patent protection. As per the Patents Act, an invention will have inventive step if the invention involves (a) technically advanced as compared to existing knowledge or (b) having economic significance or (c) both, and that makes the invention not-obvious to a person skilled in the art.

Concept of Industrial application in Biotechnological Inventions

To be patentable an invention must be useful and capable of industrial application. As per Section 2(1) (ac) of the Act, the expression “capable of industrial application”, means that the invention is capable of being made or used in an industry”. The application should disclose the usefulness and industrial applicability of an invention in a distinct and credible manner.

Patenting Microorganisms

For over 200 years living organisms were excluded from patent laws; life forms were considered a ‘product of nature,’ not a human invention.  Before 1980, Patents were given for inventions based on microbiological processes. No patent was given for the living entities, which were considered to be the products of nature. First patent based on microorganisms was made by Louis Pasteur on 28 January 1873, for the process of fermenting beer. Louis Pasteur received US Patent on 22 July 1873, for ‘yeast, free from organic germs of disease, as an article of manufacture’.

The products of nature doctrine prohibited patentability of materials existing in nature, including living matter. So one could secure patents for fermentation processes and purification of naturally occurring chemical or biological compounds as well as patents for microorganisms as a culture or in combination with a carrier. The product claims for microorganisms were not patentable because they comprised of living materials. The non-patentable status of living organisms changed with the landmark decision of the Supreme Court, USA, in Diamond v. Chakraborty in 1980. Ananda Chakrabarty’s invention of a new Pseudomonas bacterium genetically engineered to degrade crude oil was rejected by US Patent Office, but the Supreme Court decision went in favour of Chakrabarty in a landmark case, Diamond (USPTO commissioner) v Chakrabarty (inventor). Chakrabarty’s Pseudomonas bacterium was a manipulated version that contained four plasmids controlling the breakdown of hydrocarbons and thus was ‘a new bacterium with markedly different characteristics from any found in nature’. The Supreme Court stated that new microorganisms not found in nature were either ‘manufactured’ or ‘composition of matter’ and thus patentable. Thus it was not a ‘product of nature’ and can be patentable.

Following Chakrabarty case, European Patent Office (EPO) and the Japanese Patent Office (JPO) also started granting patent protection for microorganisms in 1981. The Government of India permitted patenting of microorganisms in India under the Patents (Second Amendment) Bill, 2002 and the microorganisms and microbiological inventions can be patented in India provided the strain is new.

Inventor has to deposit the new strain in any recognized international depository as per the Budapest Treaty.  The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, or Budapest Treaty, is an international treaty signed in Budapest, Hungary, on 1977. The treaty is administered by the World Intellectual Property Organization. The treaty allows ‘deposits of microorganisms at an international depositary authority to be recognized for the purposes of patent procedure’.

Usually, in order to meet the sufficiency of disclosure, patent applications must disclose the subject-matter of the invention in a sufficiently clear and complete manner to be carried out by the person skilled in the art.  Regarding any invention involving microorganisms, it is impossible to describe it completely. As a result, in the cases of inventions involving microorganisms, a deposit of biological material must be made in a recognized institution. The Budapest Treaty ensures that a patent applicant need not deposit the biological material in all countries where he / she wants to obtain a patent, instead, needs to deposit the biological material only at one recognized institution and this deposit will be recognized in all countries obliging the Budapest Treaty.  Such institution is recognized as International Depositary Authority (IDA).  The range of materials that can be deposited under the Budapest Treaty includes: cells (such as bacteria, fungi, eucaryotic cell lines, spores), genetic vectors (plasmids or bacteriophage vectors or viruses) containing a gene or DNA fragments, organisms used for expression of a gene.

There are 34 International depositories for deposition of microbial cultures. In India, Microbial Type Culture Collection and Gene Bank (MTCC) at the Institute of Microbial Technology (IMTECH), Chandigarh, is a recognized international depository of microorganisms.

Patenting Plants

The US Plant Patent Act (PPA), enacted in 1930, allowed patenting of asexually propagated plants.  Over 6,500 of such plant patents have been granted for ornamental and fruit trees. In 1985, the US Board of Patent Appeals allowed patent protection for asexually, sexually or in vitro propagated plants. Following the principle established in the Chakrabarty case, it was decided that US utility patents could be granted for genetically modified plants also. Among transgenic plants, herbicide- resistant cotton, canola, soybean and insect-resistant potato, cotton, maize, etc. are patented.

In Japan also plant patents are allowed.  Plant patents have been granted by European Patent Office from 1989. 

Life forms of plants and animals except microorganisms are not patentable in India. Also a method or process of agriculture and horticulture is non-patentable. However, methods for rendering plants free of diseases or putting an additive value to a plant can be patented.

India and many other countries do not protect plants by strict patenting system. But there is a mandate in the TRIPS Agreement that plant varieties must be protected. Thus India has enacted ‘Protection of Plant Varieties and Farmers’ Rights’ (PPVFR) Act, 2001, a sui generis system of plant variety protection.

The model for this was the UPOV Act, an International Convention of the Union for the Protection of New Varieties of Plants for the protection of new varieties of plants in Paris in 1961 and came into force in 1968. Under the UPOV, a plant variety qualifies for protection when it meets three essential criteria, (i) distinctiveness, (ii) uniformity and (iii) stability, and the variety should be new in commercial sense. Application for its protection can be filed in the country where developed or in any other UPOV member country. 

The Indian PPVFR Act is in place but yet to be enforced. This act tends to provide a balance between the rights of breeders and farmers. Plant variety protection (PVP) may be provided to new varieties, extant varieties (already in cultivation or of common knowledge) or farmers’ varieties. The essential features are same as distinctiveness, uniformity, stability for extant and farmer’s varieties, but novelty feature is included in the newly developed variety. It will provide maximum protection for 18 years to trees and vines and 15 years to other crop varieties.

Patenting Animals

In 1980s, US Patent Office examined whether multicellular animals could be patented. In 1987, patent application for a products-by- process patent on a method of inducing polyploidy in oysters as well as the resulting oysters was rejected by USPTO.  On 1988, USPTO issued the first patent on transgenic non-human animal ‘Harvard Mouse’ developed by Philip Leder and Timothy Stewart. The ‘Harvard Mouse’ was created through a genetic engineering technique of microinjection. To the fertilized egg, a gene known to cause breast cancer was injected and then this egg was surgically implanted into the mother. The resulting transgenic mice were extremely prone to breast cancer. European patent was issued in 1992. By 2002, more than 300 patent applications for transgenic animals have been filed but so far few have been granted by EPO.

EPC, Rule 23c states that inventions concerning biological materials, such as DNA, microbiological process, plants, and animals are patentable only if ‘the technical feasibility of the invention is not confined to a particular plant or animal variety’. EPC has stated that certain inventions are excluded from patentability whose exploitation is contrary to ordre public or morality.  They are processes for cloning human beings; processes for modifying the germ line genetic identity of human beings; use of human embryos for industrial or commercial purposes; and processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

In Japan, animals became patentable after 1988 when the ‘Harvard Mouse’ patent was issued by USPTO. By the end of 1998, nineteen animal patents were issued by JPO, majority of them the products of genetic engineering.

Indian Patents Act has excluded the following from patentability

•           Section 3(j), plants and animals as a whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals

•           Section 3(i) ‘any process for medical, surgical, curative, prophylactic (diagnostic, therapeutic), or other treatment of human beings, or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products’.

In pursuance to the TRIPS Agreement, human beings or treatment procedures are neither patentable in India nor anywhere else. Modified animals are patentable in USA, Japan, Korea, Hungary, South Africa and few other countries. Patent offices of USA, Japan and Australia grant patents on human body parts such as limbs, organs and tissues. The making of human body parts is an invention since they exist in nature, but modified or isolated body parts are viewed as multicellular organisms and treated as such for patentability if they meet the statutory requirements.

Patenting other biological processes and products

Inventions arising from biological research can mean nucleic acids, proteins, kits for the manipulation or use of DNA or proteins in the laboratory or in medicine, diagnostic kits, pharmaceuticals, microarrays, pieces of software for bioinformatics analysis, or industrial-scale processes for the production of food or medicine.  Biotechnology also deals with inventions for models of  diseases and methods of drug discovery, such as the ‘Harvard Mouse’ or ‘OncoMouse’

·         Cloning

Cloning is the process of transferring nucleus of an adult multicellular organism’s cell to an unfertilized egg of the same species.  In Transgenic cloning a particular gene is added to the nucleus of an adult organism cell and then this nucleus is transferred to an unfertilized egg of the same species. Dolly, the first mammal sheep, was created in 1997 by cloning. Creation of animals by cloning is patentable in some countries. However, patenting of human cloning issue varies in different countries. Japan banned human cloning in 2001, but in July 2004, Japan Government Science Council permitted limited cloning of human embryos for scientific research. Britain and South Korea also allow cloning of human embryos for therapeutic purposes. United States prohibits human embryo cloning but allows patenting of animal cloning.

·         Biological Compounds

Biological compounds, such as DNA, RNA and proteins are naturally occurring. The ability and methods to isolate genes and produce proteins they encode has enormous commercial impact and is vital for the survival and success of biotechnology industry.

Under US patent law, DNA sequences are considered chemical compounds by USPTO and are patentable as compositions of matter. As per USPTO isolated and purified DNA molecule that has the same sequence as a naturally occurring gene is different from the naturally occurring compound as it is processed through purifying steps that separate the gene from other molecules naturally associated with it and hence eligible for patent protection. If a patent application discloses nucleic acid molecular structure only for a newly discovered gene, and no utility, the claimed invention is not patentable since one of the requirements of a patent is utility.

As per EPO, definition of biotechnological invention is invention that concerns ‘a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used’. This includes DNA- related inventions, such as an isolated DNA fragment and the gene it encodes or DNA sequence analysis protocols and its software products. The definition of biological material is ‘any material containing genetic information and capable of reproducing itself or being reproduced in a biological system’. The biological materials, such as, DNA, protein, plasmids, are patentable if the materials are isolated from its natural environment or produced by means of a technical process.

Indian Patent Act allows inventions on isolation for a substance like DNA. Gene sequences are patentable if function of the has been ascribed.

The JPO points out that since ‘the aim of the patent law is to develop industries, only inventions that are useful or having industrial applicability are patentable’.

·         Expressed sequence tags (ESTs)

An EST is part of a sequence from a cDNA molecule of expressed gene and can be used to identify and locate an expressed gene. The patenting of ESTs is highly controversial. In 1998, the first ‘EST patent’, ‘Human Kinase Homologs’ was issued to Incyte Pharmaceuticals Inc by USPTO. By 1998 patent claims for over 1.2 million DNA sequences were filed.

The patentability of ESTs and DNA fragments were studied by the Trilateral Patent Offices (USPTO, EPO, JPO) and is summarised as: Isolated and purified nucleic acid molecule-related inventions, including full-length cDNAs and SNPs, of which function or specific, substantial and credible utility is disclosed, which satisfy industrial applicability, enablement, definiteness and written description requirements would be patentable as long as there is no prior art (novelty and inventive step) or other reasons for rejection.

·         Bioinformatics and Patenting

Bioinformatics encompasses all aspects of biological information: acquisition, processing, storage, distribution, analysis and interpretation. pPatent offices have created separate units for bioinformatics. There are three basic types of inventions on bioinformatics which can be patented.

1.         Tools of Bioinformatics

Computer software is one of the central tools of bioinformatics. In the USA, if a claim contains a mathematical algorithm, but is limited to a practical application in the technological arts, it might be patentable only if it meets patentable utility.

In Europe, EPC disqualifies computer programs from patentability. Also excluded are aesthetic creations, discoveries, scientific theories, mathematical methods and other activities that are essentially non-technical in character. Despite this, applicants obtain patents covering computer programs by not claiming computer programs ‘as such’. The computer programs are patentable as long as they are technical in nature.

2.         The Methods of Bioinformatics

Patenting of bioinformatics methods is especially relevant because classical biotechnology claims, e.g. methods for generating a tangible such as RNA, DNA or protein do not provide satisfactory protection for the true product of bioinformatics - information.

In the USA, business methods are patentable subject matter, but they are unpatentable ‘as such’ under the EPC. A patentable business method (or computer program) at EPO must have technical elements - it must be at least partly computer implemented.

3.         The Product of Bioinformatics

Bioinformatics produces information.  In Europe, information as such is unpatentable because of its abstract nature. However, EPO has allowed claims directed to data due to the technical content.  In the USA, claims have been obtained to business methods and to methods in which the resulting product is information.

The applicant must ensure that, if information is to be claimed, it is claimed in a technological nature. For example, nucleic acid and protein sequence data, which is a primary data that lack any annotation is non patentable. However, elements of information of this type can be combined with other sources of data to provide useful further information, such as the function of a gene or a polypeptide. This information is technical and may concern diagnosis of diseases, therapy, biotechnology, genetic engineering, etc and can be patented. Data can be technical if they provide functional information of any useful sort.

Under the Indian Patents Act, Section 3 (k) a mathematical or business method or a computer program per se or algorithms are not inventions and hence unpatentable.

Justification for Protection - Why consider patenting?

Our world is moving from an economy based industry to one based on information.  So protecting ideas becomes increasingly important. Ideas can be captured and passed on as information and then it can be transferred from one place to another much more easily and quickly than physical objects. The economic value of information is greatest when it relates to an idea, rather than that of a physical object, such as a manufacturing plant or commercial product. Because information about ideas is so valuable and so easy to obtain and use, protecting ideas becomes a paramount concern.  Here come the important of Intellectual Property Rights, where the ideas, inventions and information can be patented.

Legally protecting discoveries and inventions through patents provides an incentive for researchers and businesses to undertake scientific inquiry for financial benefit in return. Likewise, it results in competitors, thus bringing new products to the market rapidly. On the other hand, permitting an inventor or company to exclude others from making and using an invention can result in higher costs for consumers or a delay in advances in the field.

For companies, patenting is the more attractive choice rather than keeping it as a secret because it enables the companies to profit. Due to the tight budgets and financial accountability, pursuing patent protection for scientific discoveries and inventions is also important for academic researchers, as patents can generate prestige and income for them and also their institute.

In the present era, patenting of biological organisms, cloning, genomics, bioinformatics are highly important aspect areas and has become the core of biotech companies. During earlier periods, biotechnological inventions were interpreted by different patent offices of the world in different ways.  Now unification of ideas has emerged in some cases while differences still persist on stem cell research, human cloning, etc. Let us hope in the near future, these issues and confusions will be solved and common grounds will be laid as per the TRIPS regulations.

 

References

·         Patenting of Biological Material and Biotechnology, 2005, HS Chawla, Journal of Intellectual Property Rights, Vol 10, pp 44-51

·         Patenting inventions arising from biological research, 2004, Matthew T Latimer, Genome Biology 6:203

·         Patenting of microorganisms: Systems and concerns, 2010, Ramkumar Balachandra Nair, Pratap Chandran Ramachandranna, Journal of Commercial Biotechnology,16, 337 – 347