Bindu Sharma

Origiin IP Solutions LLP

Bangalore

Email: bindu@origiin.com

Phone: 9845693459

IPR Protection Procedure with reference to

Biotechnology

Bindu SharmaOrigiin IP SolutionsBangalorePhone: +919845693459, +918025830363Website: www.origiin.comEmail: bindu@origiin.com, origiin2010@gmail.com

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.”

Indian constitution has no mention of IP but just the word “property”

Freedom to acquire, hold and dispose off property - Article 19

Protection from deprivation of property – Article 31

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

• 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

A structured education

system from ancient times

• 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

The birthplace

of immense knowledge

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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

In Texas, RiceTecpatented

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

Monetization of traditional knowledge by countries Champagne from Champagne district in France Scotch whiskey from Scotland Havana cigars from Cuba Colombian coffee from Colombia

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 to advance our Indian economy. Source : Annual reports of the Indian Patent Office

Why IP is ignored in India?

Vidya daan is greatest daan

There was strong funding support by Indian kings to promote education

Free education was imparted to students in gurukuls

There is subsidized higher education even today –only recently, there has been an attempt by the government to cut subsidy amidst great opposition

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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

Knowing IP is necessary

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Some facts

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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

In Chicago, unauthorized use of Trademark, Nike resulted 43-year old man in confinement

Intel to pay AMD $1.25 billion to settle IP disputes

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

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

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Brief history

In Venice, first patent was granted to a Germen engineer in 1323 for model grain mill, which could cater storage needs of entire Venice

In United States the first patent was granted in 1787 for specially designed grain elevator

In India first patent statute was passed in 1857

Patent act, 1970

landmark in industrial development in India

encourage inventions

inventions must be commercialized without undue delay

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A punkah pulling machine (February 28, 1856)

George Alfred DePenning

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

Common myths

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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

Example

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

In 1959 he came up with a new copying system and took it to IBM for evaluation

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

Carlson’s invention was the xerography process, the company founded on the system is Xerox

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Other reasons

Lack of awareness and don't know how to go about it

Funds

Lack of experts around

Tedious and complex process

Breaking trend is tough

Hesitation to approach law firms

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Simple inventions do get protection

Gillette Mach 3 is protected by 35 patents, which cover

Blade design

Razor design

Manufacturing processes

Post-it

Rubber band

Over 400 patents for improvements in paper clips have been filed till date

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

No prior use/claim/ publication

Capable of being made or

used in industry & reproduced

with the same characteristics as many times as necessary

Industrial utility

Should be non-obvious to a person skilled in the art

-Technical advancement

-Economic significance

Non-obviousnessNovel

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Novelty

Fomento v Mentmore

Improved nib for ball point pen

Continuous and uniform flow of ink

Published

Novelty was lost

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

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Non-obviousness/inventive step

Question of law based heavily on underlying issues of fact

Scope and contents of the prior art

Level of ordinary skill in the art

Differences between the claimed invention and the prior art

Evaluating evidence of secondary considerations

Final gate keeper of the patent system

Technical advancement

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

Prior failure of other inventors

Long felt need

Unexpected results

Licenses

Commercial success

EPO- Problem solution method

Japanese-identify person having ordinary skill in the art

Case-laws

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Issues in biotechnology

All involve biological processes not under the direct control of the 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

Raw material is in public domain

Usually product of nature

Research is based on pre-existing biological material

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

American Fruit Growers v Brogdex

Patent was denied to oranges coated with preservative on the ground that oranges are “products of nature”

Funk Brothers Seed co v Kalo Inoculant Co

Mixture of non-inhibiting nitrogen fixing bacteria

Patent was denied as patentee did not create new bacteria as bacteria in mixed culture are “products of nature”

Merck & Co v Olin Mathieson Chemical Corp

Purified Vitamin B12 isolated from fermentation materials which is cheap, abundant, free from toxins

Vitamin B12 naturally found in minute quantity in liver of cattle and certain microbes

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

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

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:

Genetic engineering techniques to construct bacteria that could digest oil

It involved a process by which four different plasmids could be transferred by genetic engineering techniques and be maintained stably by Pseudomonas bacterium

By breaking down multiple components of oil, microbe promised efficient and rapid oil-spill treatment

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ProceedingsPatent claimed:

[1] process of producing a bacterial organism (inoculum and medium)[2] method of using a bacterial organism[3] the bacterial organism itselfExaminer 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

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

Rights of patent owner

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

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

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

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

Infringement of patent rights

Civil remedies - Injunction, Damages, Account of profit

Criminal remedies - Imprisonment (upto 6 months), Fine (1 to 5 lakh rupees) or Both

Top damages awarded

Polaroid V Kodak – US $ 873,200,200

Cordis V Boston Scientific –US $ 324,400,000

Cordis V Medtronic AVE – US $ 271,100,000

3M V Johnson & Johnson – US $ 107,300,000

Stac V Microsoft - $ 43,000,000 + $ 40,000,000 as investment settlement after $ 130,000,000 jury award

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Procedure of patent filing

18 months

48 months

Revocation

Post-grant opposition

Pre-grant opposition

Filing Publication Examination Grant

Provisional/Complete

Priority date

Patent Cooperation Treaty (PCT) filing

Report onpatentability

National Offices

Filing at national

office

IB Geneva ISA IPEA

International Phase National Phase

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Patenting Dos:

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.

Patenting Don'ts:

Disclose invention to third parties before filing the patent.

Offer the invention for sale before filing.

Delay the patenting process, thereby allowing others to file an application for the same invention.

Precautions

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Challenges: bioinformatics patents

Uses computers to manage biological information

Large investments of time and money

Multidisciplinary nature of the technology involved

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

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Position in US

AT &T Case - declared that algorithms are patentable, if it has a “practical approach to produce a useful result”

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

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

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

U.S. Patent No. 6,510,391 is for a computer software for analyzing gene expression data

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

Databases are not themselves patentable

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

Under Section 3 (l) of Indian Patents act, following are not patentable:

Literary work such as a book, periodical, compilation of data or 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

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

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Obviously, the highest type of efficiency is that which can utilize existing material to the best advantage.

Copyright

Inherent

Statutory rights

20th century- printing technology [prohibit the unauthorized copying and distribution of works ]

Original/creative works of authorship

Copyright notice is necessary

© 2007, Sony Music Entertainment (India) Limited. All Rights Reserved. Unauthorized copying, reproduction, hiring, lending, public performance and broadcasting prohibited.

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Legislations

Copyright Act, 1957

Compliant with most international conventions and treaties in the field of copyrights

Berne Convention of 1886 (as modified at Paris in 1971)

Universal Copyright Convention of 1951

Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement of 1995

COPYRIGHT

Fixed

Original

Expression IDEA

EXPRESSION

Literary Books, periodicals, computer programs,

databases, tables & compilation

Dramatic Recitation, scenic arrangement & work

capable of being performed by action

Musical Work consisting of music & graphical

notation of such work

Cinematographic

film and Sound

recording

Soundtrack in a film, video tapes

Artistic Painting, sculpture, drawing, photograph,

work of architecture & artistic craftsmanship

Literary Books, periodicals, computer programs,

databases, tables & compilation

Dramatic Recitation, scenic arrangement & work

capable of being performed by action

Musical Work consisting of music & graphical

notation of such work

Cinematographic

film and Sound

recording

Soundtrack in a film, video tapes

Artistic Painting, sculpture, drawing, photograph,

work of architecture & artistic craftsmanship

Literary Books, periodicals, computer programs,

databases, tables & compilation

Dramatic Recitation, scenic arrangement & work

capable of being performed by action

Musical Work consisting of music & graphical

notation of such work

Cinematographic

film and Sound

recording

Soundtrack in a film, video tapes

Artistic Painting, sculpture, drawing, photograph,

work of architecture & artistic craftsmanship

Literary Books, periodicals, computer programs,

databases, tables & compilation

Dramatic Recitation, scenic arrangement & work

capable of being performed by action

Musical Work consisting of music & graphical

notation of such work

Cinematographic

film and Sound

recording

Soundtrack in a film, video tapes

Artistic Painting, sculpture, drawing, photograph,

work of architecture & artistic craftsmanship

Literary Books, periodicals, computer programs,

databases, tables & compilation

Dramatic Recitation, scenic arrangement & work

capable of being performed by action

Musical Work consisting of music & graphical

notation of such work

Cinematographic

film and Sound

recording

Soundtrack in a film, video tapes

Artistic Painting, sculpture, drawing, photograph,

work of architecture & artistic craftsmanship

Computer program – ©

Copyright Registry, New Delhi

Source code: Literary work [Printed code, CD –3 copies]

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

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Conclusion

Understanding and awareness of IPR is essential for research/ innovation based organizations

Registration and commercialization of IPR can fetch you revenues, it’s a powerful tool

Awareness of IPR can prevent you from infringing other’s right: Remember that litigations result in huge loss of time n money.

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, Bangalorebindu@origiin.com

9845693459, 080-9880213204