Seminar Atul

.BY:- ATUL H KATEGAONKAR M.PHARM. SECOND SEM.2007-08 GUIDED BY:Prof. SWATI JAGDALE. ASST.PROFESSOR IN PHARMACEUTICS

MAEER’s MAHARASHTRA INSTITUTE OF PHARMACY KOTHRUD,PUNE-38 Nov 28, 2009

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Contents 

INDIAN PHARMACEUTICAL INDUSTRY.

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PHARMACEUTICAL INDUSTRY AND INDIAN PATENT SYSTEM.

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TRIPS.

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INTELLECTUAL PROPERTY.

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MODES OF PROTECTING INTELLECTUAL PROPERTY.

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INVENTION.

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PHARMA PATENT.

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INFRINGMENT.

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CASE STUDIES.

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CONCLUSION.

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BIBLIOGRAPHY.

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Indian Pharmaceutical Industry Global Pharmaceutical market estimated at US$ 600 bn plus About 60% from exports to about 65 countries.

Pharmaceutical Pharmaceutical Industry Industry

In terms of market ranking India ranks 4th in Volume terms, 13th in Value terms & 8th in Manufacturing capabilities terms in the world 3000 API units; 5000 Formulation units & 2000other units (intermediates,etc.). Represents less than TWO percent of the global pharmaceutical industry

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PHARMACEUTICAL

INDUSTRY AND INDIAN PATENT

SYSTEM. 

First Indian Patent Act 1856

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Patents and Design Act 1911

-Product-patents for drugs and medicines



Strong intellectual property laws

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MNCs enjoyed a complete monopoly and charged high prices

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Dominated the Indian drug market

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Controlling 80% of the market

“India ranks amongst the highest priced nations of the world “

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Indian Patents Act, 1970 was a response to the Patents Act, 1911.

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Salient Features Only process patents for food, pharmaceuticals and chemical products.

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Product and process patents in all other areas

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Term of patent – variable (7 / 14 years)

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As on date, India is fully in compliance with its international obligations under the TRIPs Agreement.

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The Patents Act 1970 3 amendments 1999, 2002 & 2005.

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The III Amendment in 2005 has major implications on Introduction of product patent protection for food, pharmaceutical and chemical inventions.  Examination The “mail box” applications, from January 01, 2005 mail box facility to accept product patent applications

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Results of Changes in the Patent System 

Pharma industry – 10 billion dollar industry

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Size of drug industry

About 20,000 manufacturing units providing employment to approximately 33 Lakhs people 

Ranked 4th in terms of volume and 13th in terms of value world wide

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India is one of the top five manufacturers of bulk drugs and among top 20 pharmaceutical exporters

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R&D expenditure over Rs.1000 crores Nov 28, 2009

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TRIPS

(Trade Related Aspects of Intellectual Property Rights)

-International agreement administered by the World Trade Organization (WTO) that sets down minimum standards for many forms of intellectual property (IP) regulation. - It was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in 1994.

“To promote access to medicines for all." Nov 28, 2009

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Indian Patent Act of 1970

TRIPS

Only process not product patents in

Process and product patents in almost

food, medicines, chemicals

all fields of technology

Term of patents 14 years; 5-7 in

Term of patents 20 years

chemicals, drugs Compulsory licensing

Limited compulsory licensing

Several areas excluded from patents

Almost all fields of technology

(method of agriculture, any process for patentable. medicinal surgical or other treatment of humans, or similar treatment of animals and plants to render them free of disease or increase economic value of products)

Government allowed to use patented

Very limited scope for governments to

invention to prevent scarcity (rare)

use patented inventions

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What is Intellectual Property ? Intellectual property Rights refers to the Right of any party to safeguard & legally prevent others from using an original brand, trade secrets or inventions. THE IPR CYCLE

Creation

Exploitation

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Protection PHARMA PATENT

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MODES OF PROTECTING INTELLECTUAL PROPERTY. Instruments

Protection

Patents

Protect

Copyrights

Protects

Trademarks

inventions which are novel, non-obvious and have commercial application etc.

™

creative output such as words, music, art,

Protects

signs or marks which distinguish product or services

Geographical

Protection

Traditional

e.g.

Design

Protection

Indications

Knowledge

Rights

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of goods that can be identified to a particular territory, region or country therapeutic benefits of turmeric, neem, etc., agricultural practices, genetic resources of external appearance of products PHARMA PATENT

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MODES OF PROTECTING INTELLECTUAL PROPERTY. contd….

Instruments

Examples

Patents

New Chemical Entity, Novel Drug Generally 20 years; Delivery System (NDDS), etc. in some countries 14 years Also process patent

Copyrights

Literary article/book, computer software, Research Papers

Not less than 50 years

Trademarks

Logos, marks, etc. e.g.

Initially for 7 years can be renewed perpetually

Geographical Indications

Scotch Whisky,Basmati rice, Darjiling Tea

Initially for 10 years can be renewed from time to time

Design Rights

Coca Cola bottle shape

Initially for 10 years, can be renewed for further 10 years

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No. of Years of Protection

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

Core, IP generating departments in pharma.       

Drug discovery & development Drug delivery Formulation Pharma research Chemical research Herbal research Biotechnology

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Inventio n Invention meansA new product or process involving an Inventive Step and capable of Industrial application 

An invention is considered to be new, if it does not form a part of the state of the art

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Capable of industrial application means- invention is capable of being made or used in any kind of industry Inventive Step means a feature of an invention that involves an technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art



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Patent :

A patent for an invention is granted by the Government to the inventor, giving the inventor the right to stop others from making, using or selling the invention without the permission of the inventor for a limited period Need for Patent System  

  

Legal protection for newly developed product & processes. To ensure commercial returns to the inventor for time & money spend in generating a new product. Provides an inducement to invest in R & D “Research is the heart of the Pharma.” Stimulant for Economic growth.

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INVENTIONS – NOT PATENTABLE

“Not Everything is Patentable” B) Primary or intended use or commercial exploitation of 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 . e.g.  Device for house-breaking,  Biological warfare material or a device,  Embryonic stem cell,  Terminator gene technology, 

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C ) Mere Discovery of a Scientific Principle  or Formulation of an Abstract Theory  or discovery of any living thing  or discovery of non–living substance occurring in nature

e.g.   

Archimedes Principle. Bohr’s Postulates etc as such – not patentable , However, An apparatus/method for technological application may be patentable

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d) The mere discovery of a new form of a known substance 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 substance OR  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. 3 d : Explanation : 

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For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixture of isomers, complexes, combinations, and other derivatives of known substances shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy. e.g. New use of Aspirin in heart ailments,

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E) A substance obtained by mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance e.g. Not patentable1) Paracetamol (Antipyretic) +Brufen (analgesic) = A drug (antipyretic & analgesic) 2) A mixture of sugar and some colorants in water to produce a soft drink is mere admixture But, a mixture resulting into synergistic properties of mixture of ingredients however, may be patentable e.g. Soap, Detergents,lubricants etc

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i)

Any process for medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or a similar treatment of animals to render them free of disease or to increase their economic value or that of their products

e.g. Removal of cancer tumor  Removal of dental plaque and carries,  Surgical processes, any process relating to therapy,  Method of vaccination However ,  Method performed on tissues or fluids permanently removed from the body  Surgical,therapeutic or diagnostic Apparatus or instrument are not excluded from patentability 

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



j) Plants & animals in whole or any part thereof other than microorganisms, but including seeds, varieties and species and essentially biological process for production or propagation of plants & animals e.g. Clones and new varieties of plants: Not patentable

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Microorganisms: Not patentable

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 PRODUCT WITHIN THE SCOPE OF PRODUCT PATENTS “ANYTHING UNDER THE SUN MADE BY MAN”    

  

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New drug molecules, Pharmaceutical preparations Synergistic combinations Combination of a new chemical entity with a known component Agrochemicals New chemical products New products resulting through bio-technological, microbiological or biochemical processes Genetically modified Micro-organisms/DNA sequence.

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PATENT GRANT PROCEDURE Filing of patent application

Early Publication

Publication after 18 months Opposition By Third Party Representation (Pre Grant Opposition) Request for examination (Form 18 with fees) Examination: Grant or Refusal

Publication of Grant of patent Opposition to the patent (Post Grant Opposition) Decision By Controller Nov 28, 2009

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PUBLICATION OF INVENTION Promptly

after 18 month from priority date Early publication Possible on request In Patent Office journal/ ipindia.nic.in No publication of Applications for which

Complete specification not filed

What is published ? Priority details Applicants details Abstract

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DOCUMENTS REQUIRED     

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  

Application Form 1 in Duplicate with Fees. Provisional or complete specification along with Drawings, if any, in Duplicate. Abstract in Duplicate Declaration as to Inventorship (If provisional specification is filed first or, in case of convention application) along with Complete Specification or within one month in F/ 5 For Convention Application- A certified copy of Complete Specification filed in the convention country Power of Attorney- If filed through a Patent Attorney Information regarding foreign filing (u/s 8) Statement and undertaking regarding foreign filing in Form 3 in duplicate.

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CONTENTS OF COMPLETE SPECIFICATION  It is a Techno-legal document         

   

Title of Invention along with form 2 Field of Invention. Use of Invention Prior Art and its drawbacks . Problem to be solved. Object of Invention(may be more than one) General statement of invention Detailed Description of Invention[ with reference. to drawings Best method /example of working of the invention known to the applicant Statement of claims. Signature with date Drawings Abstract

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LIFE OF A PATENT 

EUROPE : 20 years from date of filing.

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USA -

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Before GATT (June 08, 1995): 20 years from date of filing or 17 years from date of grant After GATT: 20 Years from date of filing.

INDIA Till May,2003 (a) Pharmaceuticals / Food 7 years from date of filing, (b) others like engineering etc 14 years from date of filing - After May, 2003: 20 years from filing date.

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A typical product life cycle

Growth

100

Year

50 0

10 Proprietary

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30 Generic

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Commodity

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Patent Applications 1999-2007 32000 30000 28882

28000 26000 24415

24000 22000 20000 18000

17466

16000 14000 12613

12000 10592

10000

11466

8503

8000 6000 4824

4000 2000 0 19992000

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2000-01

2001-02

2002-03

2003-04

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2004-05

2005-06

2006-07

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2007 2008 2009 2010 2011

14 10

Year & No. Of Drugs Going Off patent

6 9

10

Anti-cancer drugs scheduled to lose their patent protection are:

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STATUS IN 2008 

Countries in the world 200

:

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Countries having patent laws 157

:

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Country members of Patent Cooperation Treaty 130

:

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INFRINGEMENT

A patent provides the proprietor of that patent with the right to exclude others from utilizing the invention claimed in that patent. Should a person utilize that invention, without the permission of the patent proprietor, they may infringe that patent.

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CASE

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STUDIES

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1)

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REVOCATION OF TURMERIC PATENT

U.S. Patent 5401540 granted to University of Mississippi by USPTO for Turmeric Wound Healing Properties - 1995. CSIR requested for re-examination giving 32 references from Ancient Indian Literature (e.g. Ayurvedic Pharmacopoeia, The Wealth of India, Indian Home Remedies, etc.) – 1996. CSIR proved that use of turmeric is not novel and it is prior knowledge. Based on CSIR representation USPTO revokes Turmeric Patent – 1998. Nov 28, 2009

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2) 

Tarceva case-

Roche Vs Cipla

Mar 20, 2008

Patent case: HC declines to restrain Cipla Making, selling generic version of Roche’s Tarceva (lung-cancer drug)

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CONCLUSION The only thing that keeps us alive is our brilliance The only thing protecting our brilliance is our patents Edwin H. Land, 1976

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BIBLIOGRAPHY   

   

Malik K A, Zafar Y. IPR in plant biotech,Asian Biotechnology & Development Review. 2005;(8);7-43. Narayan S. Drug IPR where India must not 'trip'. BusinessLine.2007;(24);8. Dhar B, Gopakumar K.M. Post-2005 TRIPS scenario in patent protection in the pharmaceutical sector: The case of the generic pharmaceutical industry in India 2006;8. Dr.Kuchekar B S,Khadatare A M,Itkar S C, Forensic Pharmacy,Nirali Prakashan.2005;(5);15.1-16.8. Subbaram N ,What everyone should know about PATENTS?,Pharma Book Syndicate.2007;1-192. Ashiya M, TRIPS and Pharmaceutical Industry Impact on Developing Countries,The Icfai University Press.2007(1);1-230. Chakaraborty S,New patent Regime,Lessons for indian Pharma, Countries,The Icfai University Press.2006(1); 1-242.

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



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The Patent Act, 1970, Office of the Controller General of Patents, Designs, and Trademarks, Government of India. “India’s new product patent law: challenges and opportunities for local drug makers,” Pharma Market Letter, Dec. 6,2004. The Indian Pharmaceutical Industry: Collaboration for Growth, KPMG, 2006 TOI PUNE JUNE 14,2008.

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Business Daily from THE HINDU group of publications Wednesday, Apr 16, 2008

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Business Daily from THE HINDU group of publications

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Sunday, Sep 23, 2007 Business Daily from THE HINDU group of publications Wednesday, Apr 04, 2007

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http://en.wikipedia.org/wiki/Agreement_on_Trade-Related_Aspects_of_Intelle http://www.iprsonline.org/unctadictsd/description.htm http://www.uspto.gov/web/offices/ac/ido/o eip/taf/asgstca/inx_stc.htm

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E-mail :- [email protected] Nov 28, 2009

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