"Protectable subject matters, Protection in biotechnology, Protection of other biological materials, Ownership and period of protection" slides by SACHIN R KONDAGURI.pptx

Protectable subject matters, Protection in biotechnology, Protection of other biological materials, Ownership and period of protection

1. WELCOME

2. UNIVERSITY OF AGRICULTURAL SCIENCES, BANGALORE COLLEGE OF AGRICULTURE,V C FARM,MANDYA CMC 503 (1+0) “Protectable subject matters, Protection in biotechnology, Protection of other biological materials, Ownership and period of protection” COURSE TITLE : Intellectual property and its management in agriculture SUBMITTED BY: SACHIN R KONDAGURI M.Sc. Plant Pathology

3. IP refers to the creations of human mind like inventions, literary and artistic works, and symbols, names, images and designs used in commerce. IPR’s protect the interest of creators by giving them property rights over there creations. A Venetian law of 1474 made the first systematic attempt to protect inventions by a form of patent, which granted and exclusive right to an individual for the first time. In the same century ,the invention of movable type and printing press by Johannes Gutenberg around 1450 contributed to the origin of the first copyright system in the world . Intellectual property

4. Importance and the role of the IP protection has been crystallized in the trade related intellectual property systems (TRIPS) agreement it was negotiated at the end of the Uruguay round of the general agreement on tariffs and trade (GATT) treaty in 1994. It addresses applicability of general GATT principles as well as the provisions in international agreement on IP. It establishes standards for availability, scope ,use ,enforcement, acquisition and maintenance of IPR, it addresses related dispute prevention and settlement mechanisms.

5. Copyright and related rights ( i.e., the rights of performers, producers of sound recordings and broadcasting organisations) Trademarks including service marks Geographical indications Industrial designs Patents including protection of new varieties of plants Layout designs( topographies ) of integrated circuits undisclosed information including trade secrets and test data Areas of the IP that it covers are :-

6. Paris Convention for the protection of industrial property in 1883 and the Berne convention for the protection of literary and artistic works in 1886. Convention establishing the World Intellectual Property Organisation ( 1967). Protection against unfair competition and all other rights resulting from intellectual activity in the industrial, scientific, literary or artistic fields. Subject matter protected by IPR’s

7. Copyright is a right given by the law to the creators of literary, dramatic, musical and artistic works and producers of cinematograph films and sound recordings. Creator of copyrighted work has right to control or prevent unauthorised copying or reproduction of the work by others for a certain time period, after the said work will enter in the public domain. The protection of copyright varies according to the national legislations and type of work . The Indian law extended copyright protection for the work made by an individual for lifetime of the author plus 60. Copyright

8. Matters not covered under copyrights: Ideas Facts Recipes Work lacking originally(the phone book) Names title or a short phrases Copyright is provided automatically to the author of any original work covered by law has soon as the work is created. Registration is not mandatory, but provides for protection of ownership in case of dispute. Supreme advantages of copyright: Protection is available in several countries across the world, by reason of India being member of Berne Convention.

9. Infringement constitutes: Any reproduction, use, distribution, performance etc,. of the work without the permission of owner. An identical or substantial similar reproduction is also covered. Remedies for copyright infringement: A suit can lie in the district court or in High Court of the copyright act, 1957. Punishable with imprisonment up to 3 years and fined as per the claims.

10. Trademark is the most valuable asset owned by a business. Businesses with particularly successful products or services spend considerable amount of time, effort and money creating, establishing and promoting their unique identities. In India Trademark registration is valid for period of 10 years the same may be renew it from time to time for additional period of 10 years. Trademark

11. International protection for trademarks Application has to be filed in each and every country where one wants protection. Application also has to be made in relevant class of goods or services over which the mark is used. Two different ways: First option is to file application individually in each and every country where the applicant wants protection for their trademark Second option is to file application for Trademark protection through regional conventions which provide for registration in multiple countries by single application process.

12. Geographical indications GI’s refers to indication which identifies a good as originating in the territory of a member, or a region or locality in that territory, where a given quality, reputation or other characteristics of the good is essential attributable to its geographical origin. In India, GI may initially be registered for period of 10 years and it can be renewable from time to time for further periods of 10 years. Indian laws certain restrictions in that registered GI is not a subject matter of assignment, transmission ,licensing, pledge mortgage or any such other agreement.

13. A patent is a form of protection that provides a person or legal entity with exclusive rights for making, using or selling a concept for invention and excludes others from doing the same, also for claiming damages from those infringe the invention. It is granted by Indian Patent office and has a term of 20 years. After expiration of this 20 year Monopoly the product \inventions will fall in public domain for any third party to use it. Ownership of patent In most countries, both natural persons and corporate entities may apply for a patent. In the United States however, only the inventor may apply for a patent although it may be assigned to corporate. In most European countries, ownership of an invention may pass from the inventor to their employer by rule of law . Patent

14. ID refers to the creation of a shape ,configuration or composition or combination of pattern or color in 3-D forms containing aesthetic value. Designs act protect only designs that are aesthetic in nature. An ID can be a two or three-dimensional pattern. Novelty and originality are important criteria for a design registration. The industrial design registration grants the proprietor the exclusive rights of selling , importing and applying the design to any product. Industrial designs

15. India has adopted the first to file system, which means that the right holder should file the application on the earliest point of time to rule out the possibility of any other person claiming for the rights of the intended designs In India, a design registration is valid for a period of 10 years , renewable for further period of 5 years

16. PROTECTION IN BIOTECHNOLOGY AND OTHER BIOLOGICAL MATERIALS

17. What are biotechnological inventions ? “Biotechnological inventions” are inventions which concern a product consisting of or containing biological material or a process by means of which biological material is produced , processed or used.

18. “ Biotechnology is an industry driven by science” “Biotechnology today is all about money."

19. Branches in Biotechnology Agricultural Biotechnology Animal Biotechnology I mmunology Diagnostic Biotechnology Pharmaceutical Biotechnology Industrial Biotechnology Recombinant Biotechnology Molecular biology Genomics P roteonomics Bioinformatics Pharmaco genomics Nanotechnology

20. Encompasses a range of research tools used by scientists to understand and manipulate the genetic make-up of organisms for use in agriculture. AGRICULTURAL BIOTECHNOLOGY

21. Overcome production constraints that are more difficult or intractable with conventional breeding. Create crops that resist pests and diseases , replacing toxic chemicals that harm the environment and human health. Provide diagnostic tools and vaccines that help control devastating animal diseases. Create new products for industrial uses Can offer both direct and indirect health benefits Major benefits of Biotechnology Research

22. Direct benefits : Improving the nutritional quality of foods (e.g. Golden Rice ) R educing the presence of toxic compounds (e.g. Cassava with less cyanide ) R educing allergens in certain foods (e.g. Groundnut ). Indirect benefits : Reduced pesticide use lower occurrence of mycotoxins

23. R & D in biotechnology is extremely time consuming and requires huge investment , granting IPR ia an effective tool to protect biotechnology inventions. Why IPR in Biotechnology ?

24. US is the world’s largest grower of GM crops. GM crop activity in EU member states is minimal, partly because the EU only ended a six-year moratorium on growing GM crops in 2003 Individual applications to import GM seeds into the EU need the approval of all 25 member states. Some EU member states such as Austria , Germany and Italy, remain strongly opposed to growing GM crops The EU/US Dispute

25. Europe’s approach is based on the precautionary principle. Though commercial GM crops are banned, processed food in the EU is allowed to contain GM ingredients , but any food product whose GM content exceeds 0.9 per cent needs to be labelled. This is because of another principle underlying EU policy – that the general public should be able to choose whether to consume GM food or not . Many large European supermarkets have chosen to remove GM ingredients from their products. Campaigners in Europe want even stronger legislation to ensure that GM produce should kept separate from non-GM produce at every stage of production

26. US policy-makers believe that the precautionary principle is a hindrance to technology development and ultimately to trade. They claim that the EU ban is a barrier to trade, costing US farmers several hundred million dollars a year in potential exports to Europe; that it has no scientific basis.

27. IPR for biotechnology is currently in a state of flux It is used to be the case that living organisms were largely excluded from protection, but altitudes are now changing and increasingly biotechnology is receiving some form of protection. These changes have largely taken place in the USA and other industrialized countries, but as other countries wish to compete in order to protect and encourage investment in biotechnology. Indian biotech industry at present is facing great challenges of the emerging trade related aspects of intellectual property rights, Article 27.3 (b) of TRIPS excludes biological processes for the production of plants or animals as a patentable subject matter, but patent can be granted to the microorganisms and microbiological processes used in the production of plants and animals. IPR in Biotechnology

28. Civil society organizations and Non governmental organizations argue that naturally occurring organisms are gods gift and hence they are common property of mankind and its inappropriate to modify them . Biotechnological inventions fall into 3 categories Processes for the creation or modification of living organisms. Biological material, the results of such processes The use of such results.

29. There are two main systems of protection for biotechnology ; Rights in plant varieties and Patents . Keeping biotechnology trade secret can also a valuable form of protection, which will provide protection against those who steal other trade secrets unfairly. However, the problem with this form of protection is that the secret generally becomes public once the biotechnology is used commercially and thus the protection lost. When it comes to protection with copyright , It is generally unsuitable because of practical and conceptual difficulties. Until now there is no record of biotechnologist claiming copyright in their inventions. Intellectual property protection currently available

30. Trademarks are also unlikely to be of much use in protecting biotechnology, though they may of course prove important later in regards to marketing products An attempt to register the name of plant or an animal as a trademark is unlikely to be successful as public policy would prevent it. Examples of patents in biotechnology 1980- First cohen boyer recombinant DNA patent 1984- Cell line derived from human leukemia patient patented 1986- Genetically engineered corn patented ( B t Corn ) 1988- Harvard Onco mouse patent 1991- Isolated human bone marrow stem cells patent

31. There are three international intellectual property treaties which are of particular importance for the protection of biotechnology. Paris convention for the protection of industrial property ( The paris convention ); The Budapest treaty on the international recognition of the deposit of microorganisms for the purposes of patent procedure ( The deposit treaty ) The patent cooperation treaty ( PCT ) International treaties related to Biotechnology

32. Paris convention for the protection of industrial property ( The paris convention); The Paris Convention was originally signed in 1883 by just 11 countries , but now the majority of countries who have any form of intellectual property now are parties to it. The keystone to the convention is the principle of national treatment: an applicant from one convention country shall have the same rights in a second convention country as a national of that second country. The most important practical result of the convention is that, it is possible to claim priority from an application made in a convention country for all subsequent convention countries within 12 months of the original filing.

33. The Budapest treaty on the international recognition of the deposit of microorganisms for the purposes of patent procedure ( The deposit treaty); The Deposit Treaty, as the full title suggests, is concerned with the deposit of examples of microorganisms for the purposes of patent applications. Applications for patents for biotechnology often face considerable difficulties in describing the nature of the invention sufficiently. The Deposit Treaty is a vehicle for solving these problems, primarily through the setting up of a series of International Depository Authorities (IDA) and through the recognition by all member countries of a deposit in single IDA.

34. Deposit of Biological Materials India – IMTECH, Chandigarh What to deposit ?? GMO’s, bacteria, viruses, cells, Cell line, seeds, plasmids Why deposit ??? Viability - 30 years.

35. Patenting Biotechnological Inventions The Legal Basis Patentable biotechnological inventions Non Patentable biotechnological inventions

36. Patentable biotechnological inventions Biological material isolated from its natural environment or human body or produced by a technical process The industrial application / function of a genetic material ( E g : Sequence or a partial sequence of a gene) must be disclosed in the patent application

37. Non Patentable biotechnological inventions The human body, at the various stages of its formation and development , and the simple discovery of one of its elements, eg : sequence or partial sequence of a gene Plant and animal varieties

38. Gene patents: what exactly is patentable? Raw DNA sequence? NO Full length genes (cDNAs)? (with function) YES Partial seq., ESTs & SNPs? NO seq info only, no “real-life” utility ? NO w/ computer-aided “guess” of function? SOMETIMES w/ biological info showing function? YES Entire Genomes? NO

39. Types of Biotech Patents Described in terms of Eg : Gene function (e.g., codes for xxx protein) properties (e.g., purity level of known materials) structure (e.g., its nucleotide sequence) Process & Product Use a product (not in India) Method of treatment (not in India)

40. Patent protection in the past & now (after biotechnology ? Past Money, Time Natural resource Present Genetic Resources R&D, Man power Money, Time R&D, Man power Think tomorrow Think today

41. 07-09-2023 PAMM2030 Dept. of Pathology 44