If the patent is deemed to be invalid, then it has always been invalid, but was mistakenly granted. Skip to main content. Search catalogues. Order material. Deposit material.
Knowledge center. What is a patent? May micro-organisms be patented? Frequently Asked Questions What may be patented? How unique does an organism have to be to be patented?
For instance if a strain is isolated from the wild, given a strain name or number and without modification, is this patentable? A strain isolated from in situ conditions is found having a specific useful characteristic. May it be patented? A strain purchased from ex situ for instance provided by a culture collection is found having a specific useful characteristic.
A strain has been described in scientific literature for a specific useful characteristic. May it still be patented for this characteristic? A strain having been described in scientific literature for a particular use is found to have another new useful feature. May this strain be patented for this new feature? Is a sequence of a gene from a microbe eligible to be patented?
May a protein found in a micro-organism be patented? Are compounds or metabolites isolated from micro-organisms or naturally produced by a micro-organisms eligible to be patented?
When a micro-organism is used in biotechnological processes or for the production of products, is it eligible to be patented? Is the biotechnological process eligible to be patented?
Is a naturally occurring microbial resource traditionally in use by indigenous peoples eligible to be patented? When a strain is isolated from a mixture known in traditional knowledge and that this strain is found to produce an active compound: May the strain be patented?
May the compound be patented? May the mixture be patented? The known mixture: The answer is the same as for question 10 What kind of tangible or intangible rights may be claimed on microbial genetic resources MGR? When a user purchases a strain from a culture collection. The Biodiversity Convention changed the ownership regime for all biological materials, and provides that the national states have full sovereignty to all biological material within their borders.
When someone isolated a strain from in situ. In that case you should buy the protease from the patentee, or get his permission to produce it for your purpose if you want to use it privately in your kitchen that is an allowed private use - not research or commercial 1 Legal terminology to designate a living human being, as opposed to a legal entity such as a legal person. May a depositor of a strain made publicly available in a culture collection and listed in a published catalogue still claim any kind of ownership or IPR on this strain?
When a strain is patented, does the patent prevent others than the patent's owner to use it? Yes, if the use is commercial. How long does an intellectual property rights protection last?
How long is a patent valid? Patent deposit. A useful question to ask is: have you discovered something which is beneficial enough for someone to want to copy it? This could be a simple product improvement, but nonetheless it may be patentable. A patent is granted for inventions which are useful, and new and inventive over everything else that has gone before. The Espacenet website run by the European Patent Office EPO is a fantastic starting point to search for similar, previously filed patent applications which might have an impact on the assessment of novelty and inventiveness.
Once a patent is granted, renewal fees have to be paid to keep it in force, and to enforce your patent against infringers, you need the money to fund a potential court action.
However, this does involve risks that the patent may not be sufficiently robust and could be exploited by competitors. Patent attorneys train for many years to be able to draft good applications which not only maximise protection for inventions, but also minimise the risk of others circumventing the patent.
They can also guide your application through to grant of the patent and help you file applications abroad. An application comprising a description of and the claims covering the new inventon must be submitted. The description is similar to a scientific publication in that the background, methods and results are described.
The claims are statements which set out the boundaries of the protection you want. It is possible to make applications in individual countries, collectively in Europe or to make an international application. Pre-existing phenomena and creations of nature are non-patentable, but non-naturally occurring organisms constructed using biotechnology are patentable. For example, human cloning, modification of the human genome and commercial uses of human embryos are not patentable.
However, human genes, stem cells, and micro-organisms themselves, such as bacteria, yeast, fungi, algae, protozoa and human, animal and plant cells can all be patented. Patents can also be obtained for products produced by micro-organisms, such as antibiotics or enzymes, and processes involving micro-organisms.
Micro-organisms freely occurring in nature are not patentable as such, but they could be if isolated from their environment or produced by a technical process. There are also unique considerations when filing biotech patent applications such as making a deposit of a micro-organism and filing sequence listings for nucleotides and amino acids.
Chakrabarty 1 in s, opened gates for the patentability of microorganisms, wherein the claim of a Micro-biologist Dr. In this case, the controller of patents of the United States denied the claim for patenting the bacterium per se, stating that, microorganism are product of nature and hence are non-patentable according to the US patents regime, which was reversed by the United States Court of Customs and Patent Appeals. Diamond, the commissioner of Patents and trademarks appealed to the US Supreme court 2 which again went in favour of Chakrabarty by establishing that a human made, genetically engineered bacteria was capable of treating oil spills and thus was an invention accompanied by novelty, usefulness, utility, non-obviousness and industrial applicability 3 , which a naturally occurring microorganism was incapable of.
Chakrabarty, Patent protection was not granted to microorganisms as product claims, but only to the process claims in which microorganisms was used as a medium in inventions. Article 27 3 b of the TRIPS , further established that microorganisms and non-biological and microbiological processes are patentable by stating that, "Members may also exclude from patentability, plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes.
Further, since the disclosure of details in written description w. According to Section 3 j of the Patents Act, , a plant, animal, seeds and biological processes, apart from microorganisms are not patentable. Therefore, section 3 j of the Indian patents act, allows patentability of microorganisms. The landmark judgment of the Calcutta High court in the case of Dimminaco A. The court in this case reversed the decision of the Assistant controller and held that, the process of preparing a vendible commodity containing a living substance is not excluded from the purview of the word, 'manufacture' and that the controller erred in denying patent protection to the vaccine just because it contained a live virus.
Furthermore, the end product was novel, capable of industrial application and was useful for protecting poultry against contagious Bursitis infection, thus making the process an invention.
Nuziveedu Seeds 6 , The plaintiff claimed that their patent in the man-made, chemical product called NAS Nucleotide Acid Sequence containing the gene Bacillus thuringiensis Bt gene , capable of killing bollworms when inserted in cotton, was not an infringement under section 3 j of the patents act, , as held by the Division bench of the Delhi High Court. Nuziveedu's claim was that, NAS was merely a chemical composition in-capable of reproduction and not a man-made inventive microorganism, capable of industrial application 7.
The Supreme Court in this case set aside the order of the division bench and restored the order of the single bench and reverted back the matter back to the single bench of the Delhi High Court to be decided on the basis of expert advice and evidence, who had held that, the claims on NAS was rightly entertained by the Indian Patent office and that the parties shall remain bound to their sub-lease agreement.
Thus, the current scenario in India w. The micro-organisms with human interventions, accompanied by novelty, utility and industrial applicability are patentable. The technological advancements in the field of micro-biology, genetics, etc.
Therefore, scientific aspects and legal drafting of the invention should be done with due precaution and consideration. Further even though, the issues involved in the Monsanto's case was highly technical, The Supreme Court missed its opportunity in deciding upon the facts in issue 8.
BL Wadehra. Law Relating to Intellectual Property A World Health Organization resource. Monsanto v. The content of this article is intended to provide a general guide to the subject matter.
Specialist advice should be sought about your specific circumstances. All Rights Reserved.
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