IPR Protection Procedure with reference to Biotechnology

Bindu Sharma Origiin IP Solutions LLP Bangalore Email: bindu@origiin.com Phone: 9845693459

Bindu Sharma Origiin IP Solutions Bangalore Phone: +919845693459, +918025830363 Website: www.origiin.com Email: bindu@origiin.com, origiin2010@gmail.com

y The U.S. Constitution authorizes Congress to protect patents (Art. 1, Sec. 8,

clause 8): Congress shall have the power to promote the progress of science and useful arts, by securing for limited times to Inventors the exclusive right to their Discoveries.
y Indian constitution has no mention of IP but just the word property
y Freedom to acquire, hold and dispose off property - Article 19 y Protection from deprivation of property

Article 31 y Property could be possessed or acquired for public purpose only by law and only on payment of compensation Article 32

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Development of IP in India A structured education system from ancient times
Known as the land of gurus and gurukuls World's first university in Takshila in the 8th century BC, where over 10,500 students from all over the world studied more than 60 subjects The University of Nalanda, built in the 4th century BC , one of the greatest achievements of ancient India

The birthplace of immense knowledge

The number system Invention of zero Ayurveda earliest schools of medicine known to mankind, invented by Charaka 2500 years ago Complicated surgeries conducted over 2600 years ago by Sushrata, regarded as the father of surgery The Indus Valley Civilization, or the Harappan Culture, known for its scientific town planning

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Hands of 20,000 worker were cut off

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invented wireless telegraphy a year before Marconi patented his invention

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In Texas, RiceTec patented modified basmati rice, traditionally grown in India & Pakistan

In US, over 150 patents on Yoga asanas which is used in India for more than 5000 years

There are 200 medicinal plants from our country on which multinationals are trying to take patents

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Non-monetization of knowledge
y Monetization of traditional knowledge by countries y Champagne from Champagne district in France y Scotch whiskey from Scotland y Havana cigars from Cuba y Colombian coffee from Colombia y Neem, turmeric, basmati

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Patent filings by the Indian applicants in every year are growing only with a rate of about 11.6%, where as foreign applicant filing growing at a rate of about 31.7%. The patent filed by the Indian firms lag behind substantially as compared to foreign counterparts. The trend in patent filing by the Indian companies is not good signal 8/9/2011 to advance our Indian economy. Source : Annual reports of the Indian Patent Office

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Why IP is ignored in India?
y Vidya daan is greatest daan y There was strong funding support by Indian kings to

promote education

y Free education was imparted to students in gurukuls y There is subsidized higher education even today

only recently, there has been an attempt by the government to cut subsidy amidst great opposition

Mr C.N. Rao, former Director Of IISc published 1,000 papers but did not file a single patent

Ryoji Noyori and Barry Sharpless (2001 Nobel Prize in Chemistry) have 38 and 20 patents, respectively

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Knowing IP is necessary

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Some facts
y Researchers at the Indian Institute of Science (IISc) missed filing a patent

regarding carbon nanotubes (with potential applications in power generation equipment), published it in Science
y In Chicago, unauthorized use of Trademark, Nike resulted 43-year old man in

confinement
y Intel to pay AMD $1.25 billion to settle IP disputes y Apple Computer Inc. resolves its patent squabble with Creative Technology

Ltd. by paying the Singapore-based company $100 million for a license to use a recently awarded patent.

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Patent
y

A patent is a statutory grant by Govt for new inventions conferring certain monopoly rights on the grantee for a defined period, subject to certain conditions Patent rights are territorial Term: 20 years from date of filing

y y

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Brief history
y In Venice, first patent was granted to a Germen engineer in

1323 for model grain mill, which could cater storage needs of entire Venice

y In United States the first patent was granted in 1787 for

specially designed grain elevator

y In India first patent statute was passed in 1857 y Patent act, 1970
ylandmark in industrial development in India yencourage inventions yinventions must be commercialized without undue delay

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A punkah pulling machine (February 28, 1856)

George Alfred DePenning

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Common myths

Invention is more complex than the problem merits Invention is not kept secret until the date of filing

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The invention isn't new Inventor hasn't fully considered the problem An invention is safer if it's kept secret Inventor has an unrealistic idea on value of invention No-one wants it

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Example
y Chester Carlson was a patent agent who tired of having to make multiple copies

of patent applications using the only duplication method available at the time: Carbon paper
y In 1959 he came up with a new copying system and took it to IBM for

evaluation
y The "experts" at IBM determined potential sales to be only 5,000 units because

people wouldn t want to use a bulky machine when they had carbon paper
y Carlson s invention was the xerography process, the company founded on the

system is Xerox

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Other reasons
y Lack of awareness and don't know how to go about it y Funds y Lack of experts around y Tedious and complex process y Breaking trend is tough y Hesitation to approach law firms

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Simple inventions do get protection
y Gillette Mach 3 is protected by 35 patents, which cover

Blade design y Razor design y Manufacturing processes
y

y Post-it y Rubber band y Over 400 patents for improvements in paper clips have been filed till date y Thousands of patents on kids toys and household items

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What is an invention?
Invention as defined in Section 2, Indian Patent Act, 1970 A new product or process involving an inventive step and capable of industrial application

Novel Novel

Industrial utility

Non-obviousness

No prior use/claim/ publication

Capable of being made or used in industry & reproduced with the same characteristics as many times as necessary

Should be non-obvious to a person skilled in the art -Technical advancement -Economic significance

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Novelty
Fomento v Mentmore
y Improved nib for ball point pen y Continuous and uniform flow of ink y Published y Novelty was lost

Van Der Lely (c.) N.V. v. Bamfords y Hay raking machine y Anticipated by photograph in a journal

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Non-obviousness/inventive step
y Question of law based heavily on underlying issues of fact y Scope and contents of the prior art y Level of ordinary skill in the art y Differences between the claimed invention and the prior art y Evaluating evidence of secondary considerations y Final gate keeper of the patent system y Technical advancement y Who is "person having ordinary skill in the art ?

Fictional person having the normal skills and knowledge in a particular technical field, without being a genius. He or she mainly serves as a reference for determining, or at least evaluating, whether an invention is non-obvious or not

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Non-obviousness/inventive step
y Prior failure of other inventors y Long felt need y Unexpected results y Licenses y Commercial success y EPO- Problem solution method y Japanese-identify person having ordinary skill in the art y Case-laws

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Issues in biotechnology
y All involve biological processes not under the direct control of the y y y y y

scientist May be hazardous to health and biodiversity There is no scientific basis to support the patenting of genes and genomes, which are discoveries at best Unethical, contrary to public order and morality Many patents involve acts of plagiarism of indigenous knowledge and biopiracy of plants (and animals) bred and used by local communities Doctrine of product of nature

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Novelty and non-obviousness in biotechnology
y Raw material is in public domain y Usually product of nature y Research is based on pre-existing biological material y Example: DNA, genes, tissues etc

NATURE AND EXTENT OF HUMAN INTERVENTION AND DEGREE OF VALUE BY SUCH INTERVENTION IS USUALLY RESORTED TO CHECK PATENTIBILITY

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Novelty in biotechnology inventions
Raw material is in public domain and usually product of nature y American Fruit Growers v Brogdex y Patent was denied to oranges coated with preservative on the ground that oranges are products of nature y Funk Brothers Seed co v Kalo Inoculant Co y Mixture of non-inhibiting nitrogen fixing bacteria y Patent was denied as patentee did not create new bacteria as bacteria in mixed culture are products of nature y Merck & Co v Olin Mathieson Chemical Corp y Purified Vitamin B12 isolated from fermentation materials which is cheap, abundant, free from toxins y Vitamin B12 naturally found in minute quantity in liver of cattle and certain microbes y Patent can be granted to products of nature provided it is a new and useful composition of matter
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Non-obviousness in biotechnology
y y

y

Discovery vs invention Exparte Erlich, the claim of the applicant was related to the use of hybridoma technology to produce monoclonal antibodies specific for human fibroblast inteferon. Rejected on the basis that the ordinary person skilled in the art would have done it with reasonable expectations of success INVENTION WAS CONSIDERED OBVIOUS TO A PERSON SKILLED IN THE ART

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Non-obviousness in biotechnology
y y y

Amgen Inc v Chugai Pharmaceutical Co Ltd Gene and DNA sequence encoding protein erythropoietin (EPO) and protein itself in a highly purified state Therapeutic potential in treating chronic anemia Cloning of EPO was able to produce recombinant EPO in quantities exceeding those of EPO purified from natural sources

Naturally occurring genes are not patentable and mere identification of same is just discovery. But purified and isolated gene sequences are different from those occurring in nature and hence patentable

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Diamond v Chakrabarty
1980, USPTO: yGenetic engineering techniques to construct bacteria that could digest oil
yIt involved a process by which four different

plasmids could be transferred by genetic engineering techniques and be maintained stably by Pseudomonas bacterium
yBy breaking down multiple components of oil,

microbe promised efficient and rapid oil-spill treatment

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Proceedings
Patent claimed: [1] process of producing a bacterial organism (inoculum and medium) [2] method of using a bacterial organism [3] the bacterial organism itself Examiner allowed [1] and [2] but not [3] because: Micro-organisms are products of nature and living organisms and hence are not patentable Whether genetically modified organism is product of nature or human-made invention??

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US Supreme Court judgment
Invention was considered Human-made invention by 5 out of a bench of 9 judges and Court made a classic judgment: anything under sun made by man is patentable This decision opened the door for patenting living organisms for the first time

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Indian scenario
y y y y y

Microorganisms are patentable provided criteria of patentability is fulfilled Budapest treaty on the international recognition of the deposit of microorganisms 1980 31 International deposit authorities in 19 countries Institute of microbial technology (IMTech), Chandigarh Patent application has to specify the conditions necessary for the cultivation, storage and testing for the availability of microorganisms

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Rights of patent owner
y If the patent is for a product, the right to prevent others from
y

Making, using, offering for sale, selling, importing the patented product

y If the patent is for a process, the right to prevent others from
y

Using the process, offering for sale, selling the product, importing the product using the process

Infringement of patent rights
y Civil remedies - Injunction, Damages, Account of

profit y Criminal remedies - Imprisonment (upto 6 months), Fine (1 to 5 lakh rupees) or Both y Top damages awarded y Polaroid V Kodak US $ 873,200,200 y Cordis V Boston Scientific US $ 324,400,000 y Cordis V Medtronic AVE US $ 271,100,000 y 3M V Johnson & Johnson US $ 107,300,000 y Stac V Microsoft - $ 43,000,000 + $ 40,000,000 as investment settlement after $ 130,000,000 jury award

Procedure of patent filing
Provisional/ Complete Priority date Pre-grant opposition Post-grant opposition

Filing

Publication

Examination

Grant

Revocation 18 months 48 months

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Patent Cooperation Treaty (PCT) filing

Filing at national office

IB Geneva

ISA

IPEA

Report on patentability

National Offices

International Phase

National Phase

Precautions
y Patenting Dos:
y y y y y

Keep accurate records and logbooks. Determine if the invention is patentable. Determine the value of the invention. Determine its alternative embodiments/applications. Disclose ALL information while patenting.

y Patenting Don'ts:

Disclose invention to third parties before filing the patent. y Offer the invention for sale before filing. y Delay the patenting process, thereby allowing others to file an application for the same invention.
y

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Challenges: bioinformatics patents
y Uses computers to manage biological

information

y Large investments of time and money y Multidisciplinary nature of the technology

involved

y Diversity of patent claim types that may be

necessary to ensure maximum patent protection

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Products of bioinformatics
Data Genomics Proteomics Clinical High-throughput assays Tools Software/hardware Collection Analysis Visualization Pattern recognition Molecular modeling Predictive

y y y y

y y y y y y y

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Position in US
y AT &T Case - declared that algorithms are patentable, if it has a

practical approach to produce a useful result

y Excel Case - all step by step processes whether they are electronic,

chemical or mechanical, which involves an algorithm and if the algorithm is an integral part of a machine or a process which as a whole produced a useful result, then the invention might be patentable.

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Examples
y The U.S. Patent No. 6,772,069, granted to the University of California -

Los Angeles, for a software which determines protein function and interaction by genome analysis

y Incyte Genomics, Inc., has been granted U.S. Patent No. 6,611,82 which

is for to a graphical user interface for displaying biomolecular sequence data expression data

y U.S. Patent No. 6,510,391 is for a computer software for analyzing gene y A study conducted by London-based firm Silico Research found that

only 50 software related patents had been issued by the USPTO between 1996 and 2001 to companies operating in the the pharmaceutical, biotechnology, and genomics research.

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Patent-databases
y Databases are not themselves patentable y Patent protection may be available for database-related inventions

which put a sort of functional utility on the data-base itself, such as new applications for databases, algorithms for extracting or mining data, and systems which include databases

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Under Section 3 (l) of Indian Patents act, following are not patentable:
y Literary work such as a book, periodical, compilation of data or y y y y

computer program code Dramatic work such as stage shows Musical work such a song and its graphical notation Artistic work such as work of sculpture or architecture Any other aesthetic creation whatsoever including cinematographic works and television productions

y However all these categories are subject matter of copyright protection and can be protected under various classes of Copyright Act.

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Copyright law

Obviously, the highest type of efficiency is that which can utilize existing material to the best advantage.
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Copyright
y Inherent y Statutory rights y 20th century- printing technology

[prohibit the unauthorized copying and distribution of works ]

y Original/creative works of authorship y Copyright notice is necessary y © 2007, Sony Music Entertainment

(India) Limited. All Rights Reserved. Unauthorized copying, reproduction, hiring, lending, public performance and broadcasting prohibited.

Legislations
y Copyright Act, 1957 y Compliant with most international conventions and treaties in the field of

copyrights
y Berne Convention of 1886 (as modified at Paris in 1971) y Universal Copyright Convention of 1951 y Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS)

Agreement of 1995

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I D E A

Expression Original

Fixed

COPYRIGHT

E X P R E S S I O N

Literary Dramatic Musical Cinematographic film and Sound recording Artistic

Books, periodicals, computer programs, databases, tables & compilation Recitation, scenic arrangement & work capable of being performed by action Work consisting of music & graphical notation of such work Soundtrack in a film, video tapes

Painting, sculpture, drawing, photograph, work of architecture & artistic craftsmanship

Literary Dramatic Musical Cinematographic film and Sound recording Artistic

Books, periodicals, computer programs, databases, tables & compilation Recitation, scenic arrangement & work capable of being performed by action Work consisting of music & graphical notation of such work Soundtrack in a film, video tapes

Painting, sculpture, drawing, photograph, work of architecture & artistic craftsmanship

Literary Dramatic Musical Cinematographic film and Sound recording Artistic

Books, periodicals, computer programs, databases, tables & compilation Recitation, scenic arrangement & work capable of being performed by action Work consisting of music & graphical notation of such work Soundtrack in a film, video tapes

Painting, sculpture, drawing, photograph, work of architecture & artistic craftsmanship

Literary Dramatic Musical Cinematographic film and Sound recording Artistic

Books, periodicals, computer programs, databases, tables & compilation Recitation, scenic arrangement & work capable of being performed by action Work consisting of music & graphical notation of such work Soundtrack in a film, video tapes

Painting, sculpture, drawing, photograph, work of architecture & artistic craftsmanship

Literary Dramatic Musical Cinematographic film and Sound recording Artistic

Books, periodicals, computer programs, databases, tables & compilation Recitation, scenic arrangement & work capable of being performed by action Work consisting of music & graphical notation of such work Soundtrack in a film, video tapes

Painting, sculpture, drawing, photograph, work of architecture & artistic craftsmanship

Computer program ©
y Copyright Registry, New Delhi y Source code: Literary work [Printed code, CD

3 copies]
y Look and Feel: Artistic work [Screen shots, CD

3 copies]

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Conclusion
y Understanding and awareness of IPR is essential for research/

innovation based organizations
y Registration and commercialization of IPR can fetch you revenues, it s a

powerful tool
y Awareness of IPR can prevent you from infringing other s right:

Remember that litigations result in huge loss of time n money.
y It s right time to start thinking about it ..

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We should do something when people say it s crazy. If people say something is good , it means that someone else is already doing it

Contact Information: Bindu Sharma

Origiin IP Solution, Bangalore
bindu@origiin.com 9845693459, 080-9880213204

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