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Patenting in Biotech & Pharma

Industry An Industry Perspective

Presentation by

Sandeep K. Rathod,Head: Corporate & Formulations IP,

Matrix Laboratories Limited

[Subsidiary of Mylan Laboratories Inc.]

At:

NGM College, Pollachi, Coimbatore.


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OBJECTIVES/

Contents for the day1. Understand basic IPR concepts; and

their usage to our Industry.

2. Basics of a Patent and underlying concepts

within the Indian law;

and finally

3. Understand patenting in the Pharmaceutical and

Biotech arena, within the framework of Patents

Act, 1970 [India]


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Intellectual Property:An introduction

The property or product of ones

mind or intellect.

Difference between intellectual property and

other forms of property:

Intellectual property is intangible i.e. it cannot

be defined or identified by physical parametersbut it needs to be expressed in somediscernible way to be protected

In business terms - proprietary knowledge


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Intellectual Property

& its TypesIP can be traded/ protected/enforced using legal means.

Types of Intellectual Property inIndia:

Trademarks [including geog.

indications] Patents

Copyrights

Designs Undisclosed Information


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IPR Laws in India

The Patents Act, 1970

[Act last amended in 2005]The Designs Act, 2000.

The Copyright Act, 1957

Trade & Merchandise Marks Act, 1999The Geographical Indications of Goods Act, 1999


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Patent

A patent is:

a grant of a limited time monopolyby the State to an inventor to stop others from

use, sell, distribute, license of his invention

in return of its full disclosure which can be

used by the public after the expiry of its term.

A patent provides protection for the invention

to the owner of the patent for a limited period.

Duration: 20 years.


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Copyright

The right of a person over an original work of art

is called as Copyright.For e.g. Books/ Paintings etc.

Duration: Life of author + 60 years.


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Design

Copyright in the external shape of an

object is protected by Design Rights.The shape must be novel and possess

artistic merit.

Duration: 14 years


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Undisclosed Information

Information that is kept and used as a

secret by a person and not open topublic is undisclosed information. Eg.

Coca-Cola Formula.

Duration: Till the information is kept asecret.


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TrademarksThe name by which an

entity sells a good ordelivers a service is

called Trade-mark.

Duration:

Continuous protection

till the proprietor uses

the same.


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Geographical IndicationsSimply put, a GI is similar to a trade mark.

Just like a TM indicates origin, a GI too assures abuyer that the particular product has come froma particular region [i.e. indicates origin].

But unlike a TM which is owned by one person/company, a GI is usually owned by the Govt. or asociety/ group of producers.


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Comprehensive Approach to the

Protection of Intellectual Property

Suppose you invent a pen, then the possibilities

are:A Patent for any new technology underlying it,

Design for the appearance,

Trade Mark for its brand &Copyright for the accompanying literature.

Now you will be in a position to

comprehensively cover your product by IPrights.


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Understanding Patent basics

EQUALSINVENTIVE STEP

CAPABLE OF

INDUSTRIALAPPLICATION

INVENTION

INVENTIONS NOTPATENTABLE

NEW INVENTION

plus

GIVES

LESSGETSPATENT


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Patent Basics: Indian perspective [1]

Inventive step

means a feature that involves technicaladvance [1] as compared to the existing

knowledge

or having economic significance [2]orboth

and that makes the invention not obvious [3]

to a person skilled in the art.


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Obviousness details [1] Based on sum total of knowledge

available on the relevant field

Whether the "Invention" in question

will be obvious to a "Person Skilled inthe Art


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Obviousness details [2] An invention will not be obvious:

Even if it does not solve a particularproblemBUT

results in unexpected advantages.

An invention will also not be obvious:

a) If there existed a long-felt problem

b) There was no known previous solution

c) Previous attempts to solve theproblem were unsuccessful


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Capable of industrial application

in relation to an invention means that theinvention is capable of being made or used in

an industry.

Invention

means a new product [1] or process [2]

involving an inventive step [3] and capable ofindustrial application [4].


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KINDS OF INVENTIONS

PROCESSES/METHODS

ARTICLES

DEVICES

SUBSTANCES


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New Invention

Means any invention or technology whichhas notbeen anticipatedby publication inany document or used in the country orelsewhere in the world before the date offiling of patent application with complete

specification, i.e. the subject matter has notfallen in public domain or that it does notform part of the state of the art.

PatentMeans a patent for any invention grantedunder the Patents Act.


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Improvements: Invention?Is an Improvement an invention?

Inventiveness is a question of degree.

Simplest improvements may be inventive andpatentable.

Where the product is an improvement over a knownproduct.

E.g. An improved detergent and method for makingsuch an improved detergent having anti-static

properties


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Inventions not patentable -1

The following are not inventionswithin the meaning of the Patents Act:(a) an invention which is frivolous or which claims anything obvious

contrary to well established natural laws;

(b) an invention the primary or intended use or commercial

exploitation of which would be contrary to public order or morality or

which causes serious prejudice to human, animal or plant life orhealth or to the environment;

(e) a substance obtained by a mere admixture resulting only in the

aggregation of the properties of the components thereof or a process

for producing such substance;

(f) the mere arrangement or re-arrangement or duplication of knowndevices each functioning independently of one another in a known

way;


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Inventions not patentable - 2The following are not inventions within themeaning of the Patents Act:(k) amathematical method or a business method or a computer

programper seor algorithms

(l) a literary, dramatic, musical or artistic work or any other

aesthetic creation whatsoever including cinematographic works

and television productions;

(m) a mere scheme or rule or method of performing mental act ormethod of playing game;

(n) a presentation of information;

(o) topography of integrated circuits;

(p) an invention which, in effect, is traditional knowledge or which is

an aggregation or duplication of known properties of traditionally

known component or components.


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Inventions not patentable - 34. Inventions relating to atomic energy not

patentable

No patent shall be granted in respect of an inventionrelating to atomic energy falling within sub-section (1) of

Section 20 of the Atomic Energy Act, 1962.


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Inventions not patentable -4The following are not inventions within themeaning of the Patents Act:

(d) the mere discovery of a new form of a knownsubstance which does not result in the enhancement of

the known efficacy of that substance

or the mere discovery of any new property

or new use for a known substanceor of the mere use of a known process, machine or apparatus unless

such known process results in a new product or employs at least one

new reactant.

Explanation.For the purposes of this clause, salts, esters,ethers, polymorphs, metabolites, pure form, particle size,

isomers, mixtures of isomers, complexes, combinations andother derivatives of known substance shall be considered to be

the same substance, unless they differ significantly in

properties with regard to efficacy;


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Synergistic Compositions and S. 3d

admixtures of two or more componentscombined in a predetermined proportion

which do not chemically react with eachother, BUT

physically interact

to evince an improved or unexpectedproperty when put to use.


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Inventions not patentable - 5The following are not inventions within themeaning of the Patents Act:

(c) the mere discovery of a scientific principle or theformulation of an abstract theory or discovery of any

living thing or non-living substance occurring in nature;

(h) a method of agriculture or horticulture;

(i) any process for the medicinal, surgical, curative, prophylactic,diagnostic, therapeutic or other treatment ofhuman beings or any

process for a similar treatment of animals to render them free of

disease or to increase their economic value or that of their products.

(j) Plants and animals in whole or any part thereof other

than micro-organisms but including seeds, varieties andspecies and essentially biological processes for

production or propagation of plants and animals;


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Some ray of hope YES A METHOD FOR PREPARING A DNA CONSTRUCT WITH

GLYPHOSATE TOLERANCE

Application: 477/MAS/2001, Patent: 194265,Patentee: MONSANTO

PROCESS FOR EXTRACTION OF SUPERIOR-QUALITYPLASMID DNA

Application: 614/MAS/99, Patent: 193223,Patentee: JAWAHARLAL NEHRU CENTRE FOR ADVANCED

SCIENTIFIC RESEARCH

An in-vitro method for inserting a desired DNAApplication: 300/DEL/2002, Patent: 199927Patentee: IDEC


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Understanding Patent basics

EQUALSINVENTIVE STEP

CAPABLE OF

INDUSTRIALAPPLICATION

INVENTION

INVENTIONS NOTPATENTABLE

NEW INVENTION

plus

GIVES

LESSGETSPATENT


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Biotech patent litigation in India

INFECTIOUS BURSITIS VACCINE

Application 136/CAL/98 Invention is concerned with a vaccine which is capable

of protecting poultry against Infectious Bursitis Infections,characterized in that it contains an Infectious Bursitis

virus which has the combined properties of uponadministration to a chicken causing a reduction in thesize of the bursal size, expressed as bursa/body weightratio, of less than 55% and the capability to protectpoultry having an ELISA antibody titer of at least about500 and with viruses having the above characteristics.


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Q & AThis completes my version of todays talk.

I open the floor to Questions and Answers.

Site for Pharmaceutical news:

http://genericpharmaceuticals.blogspot.com

IP course for beginners [FREE]

http://academy.wipo.int [Check for DL 101]

Later on you could move to DL 204 [IP and biotech]

EMAIL ME AT

THANK YOU.

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