BIOTECHNOLOGY AND PATENTS,COPYRIHTS,TRADEMARKS
--Definition of IP(Intellectual Property) and IPR(Intellectual Property Rights)
* The issues related to legal characterization and the treatment of trade related biotechnological processes and products
* These are popularly known as Intellectual Property.
* Intellectual Property includes
1.Patents
2. trade secrets
3. copyrights
4. trademarks.
* In biotechnology, the intellectual property covers the processes and products which result from the development of genetic engineering techniques through the use of restriction enzymes to create recombinant DNA.
* Restriction enzymes (is just like a scissor which) cuts the desired gene of a virus (WHICH WE WANT TO PUT IN THE HOST CELL OR MOTHER DNA) and sticks it with the help of ligase enzyme (which is like fevicol)onto the mother DNA.In this way we get the Recombinant DNA with the desired traits.
* In the above figure
* 1=host bacteria(Yellow part) in which a change has to be brought(i.e a desired trait has to be brought in)
* 2=virus has the desired trait which is the blue segment
* 3=Recombinant DNA or rDNA where the trait has been brought in.
* 1+2=3
* Intellectual Property Rights (IPR) is a collective term applied to a number of different types of legal rights granted by each country. The right to protect this property prohibits others from making, copying, using or selling the proprietary subject matter.
--- Advantages of getting a patent
1. help in encouraging and safeguarding intellectual and artistic creations.(No Piracy to your innovations)
2. to disseminate new ideas and technologies quickly and widely.
3. promote investment.
4.They help the inventor to provide the fruits and benefits of his creation and invention to the public.
5. They provide increased opportunities for the distribution of the above effects across countries in a manner proportionate to national levels of economic and industrial development (OECD, Paris, 1989)
-----What are breeders right?(PBR)
* The new crop varieties are developed and protected through plant breeders rights or PBRs. The PBRs ensures that the plant breeder who developed a particular variety gets the exclusive rights for marketing the variety.
* The following two major steps were taken in consideration of PBRs:
1. The Food and Agriculture Organisation (FAO) has an International treaty on plant genetic resources for food and agriculture. This treaty consists of a particular clauses which refers to operation of farmers rights.
2. The Plant Varietal Protection and Farmers Rights Act 2001 agrees for the right of farmers, breeders, and researchers. The protection is provided by making compulsory licensing of rights, and inhibiting the import of plant varieties consisting of genetic use of restriction technology (GURT) e.g. terminator technology of Monsanto.
* Following conditions should be fulfilled to grant protection to the new varieties:
a) the new variety must always be new i.e. it should not have ever been exploited commercially.
b) It should be biologically distinct and possess different characters.
c) The new variety of the plant must have uniform characters.
f) The distinguishing character of new variety must be stable for generations.
g) The new variety should have taxonomic validity i.e. systematic position, generic and species names etc.
-- The general layout of a patent
* A patent consists of three parts: the grant, specifications, and claims.(SCG or Syndey Cricket Ground just a mnemonic)
* The Grant- The grant is filled at the patent office which is not published. It is the actual signed document which is the agreement that grants patent rights to the inventor.
Specifications- The specifications part is narrative and describes the subject matter and explains about the process of invention. It is published as a single document which is made public at a minimum charge from the patent office.
The claim- The claim section specifically defines the scope of the invention to be protected by the patent to which the others may not practice.
* Reading a Patent
* In order to file a patent, the documents required should have a specialized structure. An applicant should first file a patent in his or her own country and then at a later stage/date files in the international office. The application is prepared with a specific, clear and concise title. A patent attorney is appointed for the legal aspects of the patent whose job also involves filling the patent in the office of the Controller of Patents.
(a) WIPO- World Intellectual Property Organisation,
(b)TRIPS- Trade related Intellectual Property rights,
(c) GM- Genetically modified,
(d) PCT- Patent Co-operation Treaty,
(e) GURT- Genetic use restriction technology.
---What do you mean by patenting live forms and examples
* The EPO has suggested to patent the genetically engineered liveforms.
* Onco mouse is one of the examples of which initially the patent claims was rejected but on appeal the previous decision was overruled.
* Genetically engineered E.coli, in which human genes for insulin, growth hormone, t-PA etc have been introduced, have been patented in the USA.
* The transgenic herbicide and bollworm resistant cotton, and insect- resistant tobacco have been granted patents.
* Several countries such as Japan, USA, Europe, etc. have modified the patent laws stating that the transgenic plants and animals can be protected through patent claims.
---- Trade secrets and Trademarks
* Trade secrets relate to private proprietary information or physical material that allows an advantage to the owner. Trade secrets in the biotechnology field includes materials like hybridization conditions, cell lines, corporate merchandise plans, customer lists etc. It is sometimes difficult to maintain trade secrets in biotechnology due to its large degree of research component.
If the trade secrets become public before the granted period, the intellectual is paid compensation and unauthorized users are punished by the Court.
* The Trademark relates to distinctive words or symbols applied to products or services by manufacturers and helps to distinguish the goods of different companies. In biotechnology, the laboratory equipments, and some of the vectors useful in recombinant research are known by their trademarks. The public makes use of these trade works in order to choose whose goods they will have to buy. Trademark laws vary in every country and through agreement it is ensured that the trademark of one country must be protected in another country.
---- Main areas of consideration for safety aspects in biotechnology
The main areas of consideration for safety aspects in biotechnology are the following:
1. How to dispose off spent microbial biomass and purify the effluents from biotechnological processes?
2. The toxicity of the allergy associated with microbial production.
3. How to deal with the increase in the number of antibiotic resistant pathogenic microorganisms?
4. How to evaluate the pathogenicity of the genetically engineered microorganisms to infect humans, plants and animals?
-- PCT and Budapest treaty.
* The Patent Co-operation Treaty(PCT) was signed in 1970 and is administered by the World Intellectual Property Organization (WIPO) based in Geneva.
* Patent applications filed under PCTs are first processed by WIPO before being formally introduced into designated national systems.
* The patents granted by PCT are treated as International patent.
* The patent applications are processed by the WIPO which processes the patent application in an International phase.
* The international phase has concerns with: (a) formal preliminaries, (b) art search, (c) publication of patent application.
* The Budapest Treaty (1980) provides for the recognition of culture collections at International Depository Authorities (IDA), in any of which a new strain of microorganism can be deposited for the purposes of a patent application in any member state.
* The strains which can serve the purpose of scientific community or society are accepted.
* These can be procured if required in future to work in Industry or research. The strains which are deposited are allocated an accession number, accession date, source of isolation and specific function.
* The purpose of convention of Budapest Treaty was to provide International Recognition of Microorganisms for the purpose of patent procedure.
--What is the role of copyright in biotechnology?
* The copyright protection is only a form of expression of ideas.
* The patents and trade secrets provide protection of only basic know how, whereas copyrights protect the expressed materials viz. materials in printed, video-recorded r taped form. In the field of biotechnology, copyright usually may cover DNA sequence data which may be published.
* Computer data bases, photomicrographs of DNA instruction manuals can also be copyrighted.
NAME-GEORGE SINHA
REFERENCES
1. http://motherboard.vice.com/blog/why-the-biotech-industry-is-rejoicing-over-the-end-of-gene-patents
2. http://en.wikipedia.org/wiki/Copyright
3. http://www.downtoearth.org.in/content/saying-no-monsanto
4. NCERT CLASS 12 biology
5. Ramesh Singh"s book on Biodiversity
