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ETHICAL & REGULATORY BASISINTELLECTUAL PROPERTY RIGHTSPresented by Ms. Smita Jadhav

Intellectual properties (IP) refers to creation of minds: inventions, literary, artistic works and symbols, names,

images and designs used in commerce.

Industrial Property

-Patents-Trademarks-Industrial designs-Geographical indications of source

Copyrights

-Literary-Artistic works

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Trade Secret0When the individual/organization owing an

intellectual property does not disclose the property to any one & keeps it as closely guarded secret to promote his business interests, it is called trade secrets.

0May relate to formulate ,processes or materials.0Eg. Coca Cola0 In biotechnology, include ,cell lines,

microorganisms strains,, production processes,etc.

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• Unlimited Duration• Not necessary to satisfy stringent

requirements• Costs of filing, consenting & enforcing

patents is saved• Risk of someone improving upon the

product, process, etc is minimized

Advantages

• Maintaining it is costly.• Offers no protection from

independent innovation/ invention.• Nondisclosure of the invention does

not give others a chance to improve upon the original.

• Cannot be applied to many inventions eg. Equipment designs, plant varieties, books etc.

Disadvantages

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0TrademarksA trademark is an "identifier": it should make a link between a product or service and its source, i.e. the person/institution/enterprise behind it0 It provides added value to the product or service

by projecting an expectation of quality, goodwill, uniqueness etc.

0The value of a trademark can be immense:• Coca Cola = USD 74 billion (2011)0A trademark shall be distinctive and not

descriptive:• "apple" OK for computers, but not for a fruit juice0A trademark shall not be deceptive:• "Sana-star" OK for health food, but not for cigarettes

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Some examples of trademarks

0 Word mark MIGROS

0 Device mark

0 3D-mark

0 Acoustic mark (the Nokia melody)0 Position mark

Note: trademark registrations can be renewed every 10 years

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Patent

0 A patent is the right granted by a government to an inventor to exclude others from imitating, manufacturing, using or selling the invention in question for commercial use during the specific period.

0 Patents are granted for:1. An invention(an product)2. Innovation/improvement in an invention3. The process/product of an invention4. A concept

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Patent RequirementsNovelty: Invention must be new & should not be already known to public

Inventiveness: should not be obvious & should represent an innovation.

Industrial Application & Usefulness: Subject must have industrial application either immediate/future, should be useful to society/nation.

Patentability: Subject matter must be patentable under the existing law & its current interpretation.

Disclosure: Gives an opportunity to improve upon the various features of the invention.

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0 A patent provides its proprietor with an exclusive right, i.e. a right to exclude others from making, using, selling, offering for sale, exporting or importing the patented invention.

0 A patent is directed against anyone; however, it is limited:• substantively (according to the patent claims)• temporally (according to the patent duration, usually up to 20 years)• geographically (according to country selection)0 Important:A patent does not provide any positive rights:• a patent for a pharmaceutical drug is not a permission to market the drug• a patent does not exclude the infringement* of another party'spatent* infringement of a patent = violation of patent rights

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0The patent as a contract between society and inventor

"Rewarding principle":0• The inventor discloses its knowledge to the public

(as described in the patent application)0• Society provides the inventor with a limited

monopoly (as defined by the patent claims)0The patent specification is both a technical and a

legal document!

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0Structure of patent documentsDescription (= the technical part):• Short summary of the relevant state of the art ("prior art")• Problem to be solved by the invention• Detailed technical description of the invention (US: "enablingdisclosure")

Claims (= the legal part):• Definition of the protection range• Concise and clear (legal certainty for third parties!)• Limited to one sentence (for historic reasons)

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Procedure of Patenting0An inventor files a properly prepared application with

the patent office of the concerned country.0 If application material is unsuitable, returned to the

inventor.0Can be resubmitted with modification and explanation.0 If application considered for patenting, the invention

along with the adequate details of the desired patent is published.

In India, this is done 18 months after the date of filing the application.0Patent can be challenged, four months after the

application, but if not challenged the patent is granted after the said period and sealed.

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Copyrights0“Copyright is a legal device that provides the

creator of a work of art or literature, or a work that conveys information or ideas, the right to control how the work is used." Stephen Fishman, Esq. The Copyright Handbook, 1996.

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Public Domain

The only thing you don’t have to cite is common knowledge. Something that everyone knows like who the president is.And Then There’s Copyright. (2009). NJIT Library Searchpath Tutorial 24 August 2009. http://library.njit.edu/researchhelpdesk/howto/searchpath/mod6/07-copyright.htm

16Fair Use Poster 2001. American Library Association. 24 August 2009http://www.ala.org/ala/aboutala/offices/wo/woissues/copyrightb/FairUsePoster.jpg

Fair Use the ability to use sources without seeking

permission from the copyright holder

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0 In case of Biotechnology, Copyright protection is available for DNA sequences. But one may target these protection by designing alternative sequences to encode the same protein taking advantage of genetic degeneracy

Plant variety Protection(PVP)

0 Plant varieties & Animal breeds are developed through years of painstaking & scientifically planned work.

0 It may be argued that these entities are essentially derived from naturally occurring lines, but usually represent a considerable reorganization of the existing gene combinations & skillful selection work.

Utility patents are considered to be the most powerful & the most expansive in score of their coverage; a single patent may cover several varieties, an entire species/genus, genes/proteins or technology & processes.

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Protection of Biotechnology Inventions0Biotechnology inventions are concerned with the

life forms & involve one or more of the following:1. Various methods/processes of generating useful

products.2. Various products e.g. Antibiotics, purified

vitamins, etc.3. Applications of various products/processes4. Various microorganisms, cell lines, plant/animal

lines obtained through biotechnological approaches.

5. Various DNA sequences/ proteins encoded.6. Technologies to modify the properties of various

organisms. 20

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International conventions do not permit patenting of processes/product applications concerning alleviation of human diseases.

0The European patent Office (EPO) has suggested that isolation of a substance from nature is merely a ‘discovery’ &, therefore, should not be patentable. However, the process developed is patentable.

0The processes used for genetic modification of various organisms are patentable virtually in all countries, including India.

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A] Patenting of Genes & DNA Sequences

0An artificially synthesized gene is considered patentable in all developing countries.

0But, its controversial in case of genes isolated from naturally occurring organisms.

0 In USA, patent are allowed on such genes. The patent statue (35 USC101) requires an invention to be useful for being patentable.

0 In contrast, courts in UK held that natural genes are not patentable. The protein encoded by the gene would be covered under the patent if it were considered novel.

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B] Gene Patents & Genetic Resources

0The developing countries are technology poor, but gene rich. In contrast, developed countries are technology rich and gene poor.

0Aspect of germplasm collections made from the developing nations relates to the patenting of useful genes isolated from them by the individuals/organizations of developed countries.

0The use for genetic transformation of such gene by anyone may be prohibited or, at least, would carry a suitable fee.

0Thus the country of source origin should not be charged on gene usage.

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C] Patenting of Life form0 Life forms, are not patentable in India under the

provisions of Indian Patent Act(1970).0 However, patents can be obtained for various

biotechnological processes & product applications within the limitation of international conventions.

0 In USA, microorganisms modified by using more ingenious techniques i.e. genetic engineering, are now patentable.

The first patent to a microorganism was allowed by the American Supreme Court in 1980. Soon after, in 1981,a patent was allowed in European Union for microorganism by EPO.

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0Among the higher organisms, plants were the first to be patented in USA, in 1985, a maize line overproducing tryptophan was allowed a patent.

0The biotechnology companies in Europe strongly favor the patenting of inventions based on living materials at par with USA & Japan.

0Animal materials are protected by patents. USA again was the trendsetter in this regard; the first animal patent in world was awarded in USA in 1988 to ‘oncomouse’.

0 In 1992, EPO also awarded a patent for ‘oncomouse’.

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Management of IPR0 IPR is ordinarily acquired in the anticipation

that the concerned intellectual property can be commercialized.

0A mere holding of IPR does not guarantee profit.Often R&D effort may be needed to make an intellectual property marketable.

0 IPR management involves:1. Transfer of the IPR appropriately & at

optimum value to obtain returns for expenses.2. Exploitation of collaborative linkages to

facilitate exploitation of the IPR. 3. Monitoring infringements of the IPR &

enforcing one’s right where necessary.

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4. Renewal of patents & designs periodically.5. Quantitative evaluation of factors such as R&D investments to royalty ratio will have to be done periodically.