Patentability of Living Organism and Genetic Material (3).pptx

PATENTIBILYU OF LIVING ORGANISM AND GENETIC MATERIAL

1. Patentability of Living Organism and Genetic Material Punyashlok Dash

2. What is Patent? grant of exclusive right Only for an invention which is --- new or novel ; Contains inventive step and; Has some industrial application Patent Represents “ quid pro quo” . It is a “give and take” relationship

3. PATENT It refers to a grant of some privileges or authority made by the Govt. or the Sovereign of the country to one or more individuals. The instrument by which such grant is made is known as Patent Section 2(m) Patentee

4. Conceptual Analysis Living organisms and genetic materials are considered to be a part of nature and thus, patenting inventions related to it raises the question of novelty.

5. BIOTECHNOGY Any technological application which uses biological system and living organisms and derivatives thereof, to make or modify products or process for specific purposes.

6. What living organisms include… Microorganisms Plants Animals Naturally occurring substances such as.. DNA & proteins Cloning

7. International Provisions TRIPS —Article 27—Patentable Subject Matter Article 27(2 ) – members may exclude from patentability inventions, the prevention within their territory of commercial exploitation of which is necessary to protect order public , or morality , including to protect human , animal or plant life or health or to avoid serious prejudice to the environment , provided that such exclusion is not merely because the exploitation is prohibited by their law. Article 27(3)  (b)   -  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 . However, Members shall provide for the protection of plant varieties either by patents or by an effective  sui generis  system or by any combination thereof.

8. Contd. European Patent Convention expressly mentions through Articles 52 and 53 what are patentable and what are non-patentable inventions. Article 53(a ) - Biotechnological inventions and innovations are generally patentable but patents are not granted for any invention which would be contrary to public order or morality. Article 53 ( b) - Plant and animal varieties and Biological processes for the production of plants and animals are non-patentable.

9. National Provisions The Patent Act, 1970 – Section 3 (j) – “Plants and animals in whole or any part thereof other than micro-organisms but including seeds varieties and species, and essentially, biological processes for productions or propagation of plants and animals are not patentable.”

10. Microorganism Diamond v. Chakrabarty : “ Anything which involves human intelligence and is proved to be man-made can be patented .” After Chakrabarty , biotech invention are within the scope of patent law generally. EPO and JPO also started granting patents on microorganisms after US Court decision on Chakrabarty Case. In India microorganisms can be patented provided the strain (variety of an microorganism with a distinct form) is ‘novel’. Before , Sec 5 (now repealed by 2005 amendment), only allowed patent for methods or process and not for subject matter produced by it .

11. Diamond v. Chakrabarty Ananda Chakrabarty is a microbiologist employed by General Electric Corporation. During the course of Dr. Chakrabarty's research, he and an associate discovered plasmids that were capable of degrading camphor and octane, the two components of crude oil. Chakrabarty discovered a process by which four different plasmids, capable of degrading four different oil components, could be transferred and maintained stably in a single bacteria. Dr. Chakrabarty sought a patent on this process, making the following claims in his application: "first, process claims for the method of producing the bacteria; second, claims for an innoculum comprised of a carrier material floating on water and the new bacteria; and third, claims to the bacteria themselves." All of the above claims dealt in some way with so-called "genetic engineering. '

12. Respondent filed a patent application relating to his invention of a human-made, genetically engineered bacterium capable of breaking down crude oil, a property which is possessed by no naturally occurring bacteria. The first two claims were method claims regarding the method of making the bacterium and the application of the bacteria to oil.  Both were approved.  The third claim was for the bacterium itself  A patent examiner's rejection of the patent application's claims for the new bacteria was affirmed by the Patent Office Board of Appeals on the ground that living things are not patentable subject matter under 101.

13. Is the creation of a live, human-made organism patentable

14. A live, human-made micro-organism is patentable subject matter  While laws of nature, physical phenomena, and abstract ideas are not patentable, respondent's claim is not to a hitherto unknown natural phenomenon, but to a non-naturally occurring manufacture or composition of matter -- a product of human ingenuity "having a distinctive name, character and use. The creation of a bacterium that is not found anywhere in nature, constitutes a patentable "manufacture" or "composition of matter" under Section 101. Moreover, the bacterium's man-made ability to break down crude oil makes it very useful.

15. Microorganism Contd.. But now after 2005 amendment subject matter prepared by chemical processes are also claim patentability.

16. Plants US Plant Patent Act (PPA)– separate legislation for plant Asexually or sexually or in vitro (taking place in test tube) propagated plants . In HIBBERD CASE- -- “tryptophan over producing mutant”. NAP HAL case( Indian wheat variety) (2003)– good biscuit making quality In Ciba Geigg’s case– EPO granted a patent for genetic modified plant seeds.

17. NAP HAL The wheat variety is Nap Hal, a primitive Indian land rice. Monsanto says dough from its new wheat will be ideal for making bakery products like biscuits, crackers, wafers and crisps. the European Patent Office granted a patent on Galahad 7 (Number EP 445929), a wheat variety which relied on a traditional variety from India called Nap Hal in 2003, under the plant category. Due to the low levels of gluten, Nap Hal possessed low viscoelasticity rendering the dough ideal for making chapatis and biscuits, a valued speciality .  In 2004, a writ of mandamus was filed by Vandana Shiva’s Research Foundation for Science Technology and Ecology at the Supreme Court praying that the court direct the centre to challenge the patenting of wheat before the EPO. The petitioner averred that the patent specification involved an Indian wheat variety which was a result of indigenous research over thousands of years.

18. While the Supreme Court issued notices to various government departments, a petition was filed at the EPO by a consortium involving Bharat Krishak Samaj , Navdanya and Greenpeace, Germany for revoking the patent.  The EPO withdrew the patent, agreeing with the then patent holders, who had requested a withdrawal citing no commercial viability

19. Plants contd.. In India, the protection of plant varieties through IPR has historically been denied as is reflected in the Patents Act, 1970. India has adopted sui generis system of protection for plant varieties. Many countries, including India, do not allow patents on plant varieties and animals, but allow Plant Breeders’ Rights for plant varieties. Patents on plant varieties are only allowed in the USA, Japan and Australia, and are most often used in the USA.

20. Animals According to general position under Indian patent regime, animals are not patentable. According to EPC Article 53(b) patents shall not be granted for plant or animal varieties or essentially biological processes for the production of plants or animals . The US patent office granted a patent on Oncomouse / Harvard mouse, a non natural animal, which was beneficial in cancer research. Subsequently, the European Patent Office also granted a patent on the same.

21. Harvard Oncomouse The Oncomouse , genetically modified to develop cancer for the purposes of medical research, raised complex ethical issues for patent authorities.  Researchers at Harvard Medical School in the early 1980s produced a genetically modified mouse that was highly susceptible to cancer, by introducing an oncogene that can trigger the growth of tumors. The  oncomouse was conceived as a valuable means of furthering cancer research. Harvard College sought patent protection in the United States and several other countries.

22. should patents be granted at all for animals or animal varieties , particularly for higher-order animals such as mammals, even if they do otherwise meet patentability criteria (novelty, industrial applicability/usefulness, inventive step etc.)? how should moral implications be addressed in relation to specific cases, e.g. the question of suffering caused to the transgenic animal?

23. Upjohn Pharmaceutical

24. Upjohn pharmaceutical company, was on a transgenic mouse, into which a gene had been introduced such that the mouse would lose its hair. The objective was to test products to treat human baldness and wool production techniques.

25. The United States Patent Office in 1988 granted a patent no. 4,736,866 to Harvard College claiming "a transgenic non-human mammal whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal…"

26. The Supreme Court of Canada finally ruled in 2002 that higher life forms were not patentable because they were not a " manufacture or composition of matter within the meaning of invention" of the Patent Act **. Manufacture was interpreted as a non-living mechanistic product or process . "Composition of matter" was understood as ingredients or substances that had been combined or mixed together by a person. So while microorganisms, or an oncogene-injected egg capable of maturing into an oncomouse , may be a mixture of ingredients and thus patentable under Canadian Law, the body of a mouse was not.

27. The United States Patent Office in 1988 granted a patent no. 4,736,866 to Harvard College claiming "a transgenic non-human mammal whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal…"  the EPO developed a utilitarian balancing test.  This aimed to assess the potential benefits of a claimed invention against negative aspects, in this case weighing the suffering of the  oncomice  against the expected medical benefits to humanity.  The EPO concluded that the usefulness of the  oncomouse in furthering cancer research satisfied the likelihood of substantial medical benefit, and outweighed moral concerns about suffering caused to the animal.

28. Conclusion On critical analysis of the statutory provisions and judicial pronouncements one can draw the inference that as far as the criteria of novelty, utility, non-obviousness and industrial application are being fulfilled, granting patents on living organisms and genetic materials is justified.