Rodney D. Ryder Kochhar & Co Intellectual Property Best Practices: Concept to Commercialisation™ Rodney D. Ryder

Introduction - Structure Rodney D. Ryder Kochhar & Co Part I - <Legal Solutions and Strategy> The knowledge revolution of our times IP Best Practices – Copyright, Trademark[s] and Patent[s] Biotechnology and Patent Law Part II - <Strategies>: Legal procedure and IP enforcement John Doe Orders and the ‘Skylarov Example’

Part I - <Legal Solutions and Strategy>

The knowledge revolution of our times

IP Best Practices – Copyright, Trademark[s] and Patent[s]

Biotechnology and Patent Law

Part II - <Strategies>: Legal procedure and IP enforcement

John Doe Orders and the ‘Skylarov Example’

Managing Legal Strategy Rodney D. Ryder Kochhar & Co Issues in Intellectual Property Management

Intellectual Property: Concept to Commercialisation™ Rodney D. Ryder Kochhar & Co Technology Development Idea Creation Intellectual Property Protection Technology Exploitation [Commercialisation]

Rodney D. Ryder Kochhar & Co MANAGE CREATE PROTECT 1 2 3 4 IP Ecosystem or Value Chain EXPLOIT COMPETITIVE ADVANTAGE PROFIT GROWTH

Rodney D. Ryder Kochhar & Co Strategic IP Roadmap II III Strategize Define challenges, issues Market analysis Portfolio analysis Financial analysis Develop strategic plans Innovate Product & process Technology Intelligence Map to strategic business goals Comply with legal reqt Execute Develop processes Develop structures Develop metrics Set targets with timeline Review INTEGRATED, HOLISTIC, STRUCTURED

Strategize

Define challenges, issues

Market analysis

Portfolio analysis

Financial analysis

Develop strategic plans

Innovate

Product & process

Technology Intelligence

Map to strategic business goals

Comply with legal reqt

Execute

Develop processes

Develop structures

Develop metrics

Set targets with timeline

Review

Intellectual Property: Activity Mapping Rodney D. Ryder Kochhar & Co CREATE PROTECT MANAGE FINANCE EXPLOIT R&D Audit Integrate Corporate Strategy Valuation Licensing IP Development Registration (national & international) IP Portfolio analysis Collateralize Assignment IP Acquisition IP or technology intelligence Develop Strategic Plans Securitize Divestment Build new IP capability IP Litigation or Arbitration Develop risk management framework Capitalize (paid up capital) Replicate/ Manufacture Productize/ Test-bedding Alliances

The [basic] uses of Intellectual Property Defensive: Creation and protection of Intellectual Property to improve market position Income creating: With the need to increase profits, most large companies have come to realize that a defensive posture, while important, is not always sufficient. To obtain the maximum value from their assets, they need to develop licensing strategies that provide additional income Strategic: Truly creative companies use IP as a business tool to leverage their entrance into a new product and geographic areas and as a bargaining chip in business deals Rodney D. Ryder Kochhar & Co

Defensive: Creation and protection of Intellectual Property to improve market position

Income creating: With the need to increase profits, most large companies have come to realize that a defensive posture, while important, is not always sufficient. To obtain the maximum value from their assets, they need to develop licensing strategies that provide additional income

Strategic: Truly creative companies use IP as a business tool to leverage their entrance into a new product and geographic areas and as a bargaining chip in business deals

Copyright: Law and the Creative Process What can be protected? Copyright: understanding the protection accorded to the author/creator Moral rights and the creator [paternity and integrity – droit moral ] Moral rights and financial reward [ droit de suite ] Rodney D. Ryder Kochhar & Co

What can be protected?

Copyright: understanding the protection accorded to the author/creator

Moral rights and the creator [paternity and integrity – droit moral ]

Moral rights and financial reward [ droit de suite ]

Copyright, Journalism and the ‘new medium’: Jonathan Tassini v. The New York Times Freelance authors agreed to write for print publications like TIME Their articles placed in electronic databases by publishers (e.g. in LEXIS NEXIS) Publisher could use article as part of the ‘original work’ but not as stand alone article or in new collective work Rights in New Medium would vest with author, unless assigned Rodney D. Ryder Kochhar & Co

Freelance authors agreed to write for print publications like TIME

Their articles placed in electronic databases by publishers (e.g. in LEXIS NEXIS)

Publisher could use article as part of the ‘original work’ but not as stand alone article or in new collective work

Rights in New Medium would vest with author, unless assigned

‘ Da Vinci Code’ and ‘Holy Blood, Holy Grail’ Rodney D. Ryder Kochhar & Co

What is “trademarkable”? Rodney D. Ryder Kochhar & Co Trademarks: must be distinctive Generic Bread for Bread Descriptive “ washbright” for detergent Suggestive Lux for Beauty Soap Arbitrary Apple for Computers Invented Exxon /Kodak Low Medium High Distinctiveness

Patents: Evolving a Strategy Rodney D. Ryder Kochhar & Co

Evolving a Patent Strategy Polaroid v. Kodak - Instant Camera Story Polaroid inventor of instant camera : broad patents obtained in 60’s K started developing own technology to beat P’s patents & introduced their version of the instant camera P sued K. for infringement of 12 patents - won the suit and awarded more than US$ 1 Billion drove K out of instant picture business for 15 years! Kodak v. Fuji - Single Use Camera Story K prepared broad patent base in US though Fuji was first in the technology K established dominant business in US Fuji’s late entry compelled it to compete with 28 others!! Rodney D. Ryder Kochhar & Co

Polaroid v. Kodak - Instant Camera Story

Polaroid inventor of instant camera : broad patents obtained in 60’s

K started developing own technology to beat P’s patents & introduced their version of the instant camera

P sued K. for infringement of 12 patents - won the suit and awarded more than US$ 1 Billion

drove K out of instant picture business for 15 years!

Kodak v. Fuji - Single Use Camera Story

K prepared broad patent base in US though Fuji was first in the technology

K established dominant business in US

Fuji’s late entry compelled it to compete with 28 others!!

An integrated Intellectual Property Policy Strategic Integration – Do trademarks and patents go together? They must – the context of the pharmaceutical sector – Prozac and other brands Patents as a source of revenue – IBM and Texas Instruments Improve, Innovate and Commercialise - improve blockbuster drugs patented by others - basically by removing side effects obtain patent on improvement license the improvement to owner of original drug patent and earn royalties Prozac, Claritin and Seldane - some of the “blockbuster drugs” improved Rodney D. Ryder Kochhar & Co

Strategic Integration – Do trademarks and patents go together? They must – the context of the pharmaceutical sector – Prozac and other brands

Patents as a source of revenue – IBM and Texas Instruments

Improve, Innovate and Commercialise -

improve blockbuster drugs patented by others - basically by removing side effects

obtain patent on improvement

license the improvement to owner of original drug patent and earn royalties

Prozac, Claritin and Seldane - some of the “blockbuster drugs” improved

Patents: Best Practices [Dow Chemicals] Developed Intellectual Asset Management Model (IAM) Mapped its existing patents : “weeded out” old technology Studied Competitors’ patents Built “Knowledge Tree” Build a ‘fortress of patents’ – new molecule, process, derivatives, use of derivatives, treatment, new use Key words: Assessment, Classification, Valuation, Investment & Portfolio Management Rodney D. Ryder Kochhar & Co

Developed Intellectual Asset Management Model (IAM)

Mapped its existing patents : “weeded out” old technology

Studied Competitors’ patents

Built “Knowledge Tree”

Build a ‘fortress of patents’ – new molecule, process, derivatives, use of derivatives, treatment, new use

Key words: Assessment, Classification, Valuation, Investment & Portfolio Management

Biotechnology and Patent Law [I] Mere discovery of sequence or partial sequence of gene - not patentable invention gene isolated from body…purified…or produced by technical process - patentable high standard of utility, adequate description of gene and link to specific application Biotechnology – Patent ‘term’ No patent for invention which could be “… contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment…” <Section 3(j), Patent Amendment Act, 2002> Rodney D. Ryder Kochhar & Co

Mere discovery of sequence or partial sequence of gene - not patentable invention

gene isolated from body…purified…or produced by technical process - patentable

high standard of utility, adequate description of gene and link to specific application

Biotechnology – Patent ‘term’

No patent for invention which could be “… contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment…” <Section 3(j), Patent Amendment Act, 2002>

Biotechnology and Patent Law [II] No patents granted for animals & plants No patents for essentially biological processes test is human intervention e.g. method of crossing , interbreeding say horses treatment of soil to promote growth .. essentially technical Microbiological processes patentable (Dimminaco AG case < Dimminaco AG v. Controller of Patents and Designs >, - process for preparation of infectious Bussitis vaccine) followed Diamond v. Chakrabarty [United States Supreme Court] End product <the vaccine> contained living organisms in the form of a virus. Patent granted for <process of manufacture> even though the end product contained living organisms Rodney D. Ryder Kochhar & Co

No patents granted for animals & plants

No patents for essentially biological processes

test is human intervention e.g. method of crossing , interbreeding say horses

treatment of soil to promote growth .. essentially technical

Microbiological processes patentable (Dimminaco AG case < Dimminaco AG v. Controller of Patents and Designs >, - process for preparation of infectious Bussitis vaccine) followed Diamond v. Chakrabarty [United States Supreme Court]

End product <the vaccine> contained living organisms in the form of a virus. Patent granted for <process of manufacture> even though the end product contained living organisms

Protection of Test Data: Implementing the Standards [I] Test Data – data relating to drug quality, information on the composition, chemical and physical characteristics of the product. Important issue – direct or indirect use of the data for subsequent registration of the product Implementation Standard – TRIPS Agreement [Art. 39.3] [requires member countries to establish protections for submitted test data] Requirement is narrowly drawn – substantial flexibility on implementation Rodney D. Ryder Kochhar & Co

Test Data – data relating to drug quality, information on the composition, chemical and physical characteristics of the product.

Important issue – direct or indirect use of the data for subsequent registration of the product

Implementation Standard – TRIPS Agreement [Art. 39.3] [requires member countries to establish protections for submitted test data] Requirement is narrowly drawn – substantial flexibility on implementation

Protection of Test Data: Implementing the Standards [I] Public interest – limit protect to promote competition. Ensure that data protection does not become a ‘means’ of blocking generic competitors Does not require protection to known ‘public data’ – only for new chemical entities. [Member states have considerable discretion in defining ‘new’] Art. 39.3 – requires countries to protect against ‘unfair commercial use’ of marketing approval data [discretion to define ‘fair’] No obligation to confer exclusive rights on the originator of marketing data Pharmaceutical companies – broader protection [not provided for in TRIPS] Rodney D. Ryder Kochhar & Co

Public interest – limit protect to promote competition. Ensure that data protection does not become a ‘means’ of blocking generic competitors

Does not require protection to known ‘public data’ – only for new chemical entities. [Member states have considerable discretion in defining ‘new’]

Art. 39.3 – requires countries to protect against ‘unfair commercial use’ of marketing approval data [discretion to define ‘fair’]

No obligation to confer exclusive rights on the originator of marketing data

Pharmaceutical companies – broader protection [not provided for in TRIPS]

Any questions? Rodney D. Ryder Kochhar & Co

Rodney D. Ryder [email_address] [+91] 9811013560; 97170 05813 Technology, Media and Communications