j

 
  p



 





p



 


Copyright © 2007, Vivek Mittal

    




 


 
 j

 
  p



 





6ational patent laws have a history of over 500 years beginning with the
Venetian Patent Law in 1474. The first international agreement, the Paris
Convention was agreed upon in 1883. Throughout the last five centuries the
guiding principle first put in place in the Venetian Law, which placed public
interests before commercial interests in patent law, was strictly adhered to.

The Paris Convention gave member states considerable flexibility in enacting

their national legislation on intellectual property rights (IPRs). Both developed
and developing countries used the provisions in the Paris Convention to enact
their national legislations on patents to serve as policy instruments for
developing and strengthening their pharmaceutical industry.

Cont«.
Copyright © 2007, Vivek Mittal

    




 


 
 j

 
  p



 




  !
In India , intellectual property rights (IPR) fall under item 49 of list - the union list
of the 7th Schedule to the Constitution. The items read - patents, inventions and
designs; copyright; trademark; and merchandise marks. Patent are thus is a
Union subject. Patent protection was first introduced in 18th century. Formal
patent protection in Indian was introduced by Patent Act, 1911.
Patent law stipulate broad categories of what can and cannot be patented and in
the words of the statute, any person who "invents or discovers any new and
useful process, machine, manufacture, composition or matter or any new and
useful improvement thereof, may obtain a patent."
•
 " 

!


 



       
  


1. Process
2. Machine
3. Manufacture
4. Composition of Matter Copyright © 2007, Vivek Mittal

    




 


 
 j

 
  p



 


Ú



Ú  

   

  


 

 

 A utility patent is granted for a new product process
machine method of manufacturing and composition of matter. This category
excludes most botanical creations related to plant and agricultural use.
  

 Design patents are granted for any new or original
ornamental design for an article of manufacture. A design patent protects
only the appearance of the article and not the article itself. An inventor can
easily register both a utility patent and a design patent.
  


 In botanical terms, any new variety of plant that has been
asexually reproduced can be granted a plant patent. The new plant must not
exist in nature or in an uncultivated state. Therefore new plants, mutants,
hybrids, and seedlings may be patented provided the inventor can satisfy
the Patent Office that the new plant did not evolve from nature.
Cont«.
Copyright © 2007, Vivek Mittal

 #   




 


 
 j

 
  p



 





 



Patentee means the person for the time being entered in Register of Patent as
the guarantor or proprietor or patent [Section 2(1) (p)]. A patentee has the
following rights:

a. Where the patent is for an article or substance the patentee enjoys the
exclusive right for himself, his agents or licensees to make use, exercise,
sell or distribute such articles or substances in India.

b. Where the patent is for the method or process of manufacturing an article or

substance, the patentee enjoys the exclusive right for himself, his agents or
licensees to use or exercise the method or process in India [Section 48 (2)].

Cont«.
Copyright © 2007, Vivek Mittal

 $   




 


 
 j

 
  p



 


& 




The patentee can assign, licence, mortgage or create other interests in his rights
in favour of any other person. Such an assignment must be in writing.
Besides, Patent IPR (Intellectual Property Rights) includes the following things:
' Ú ! 
' 
 

a. Artistic Work
b. Dramatic Work
c. Literary Work
d. Computer Programme
e. Musical Work
f. Cinematograph Film
g. Sound Recording
' (


p
 
!  

#' Ú ! ) 
  ! * !
! p



$' +
  p !


%' &



  
  


 (  Copyright © 2007, Vivek Mittal

 %   




 


 
 j

 
  p



 


6- 

(- .

/& !
0 1 !  2 33$4

India has allowed its pharmaceuticals makers to copy drugs patented abroad
since the early 1970s as long as they use different manufacturing processes.
The rise to helped a few drug as Ranbaxy, Cipla, Kopran, etc., to rise into
global challenges and made medications cheaper for the poorer masses who
often need them. Most multinationals such as Glaxo-Smithkline Plc, Pfizer Inc.,
6ovartis AG and Aventis, who have been forced to watch Indian firms eat into
their market share await the new environment with cautious optimism.
But following January 2005 and with the amendment of Indian Patent Act 1970
through a midnight ordinance on December 31, 2004, India entered in a new
phase of product patents.
According to WIPO (World Intellectual Property Organization) among individual
corporations, Dutch manufacturer Philips Electronics 6V is leading the way with
9,778 applications filed between 1995-2003. Siemens AG of Germany is in
second place with 8,981, followed by Robert Bosch GmbH with 6,069 and P&G
Co of the US with 5,841. Cont«. Copyright © 2007, Vivek Mittal

 ,   




 


 
 j

 
  p



 


ô
 
 


 
   

  

 


   

' 

" )"6




'  
 &


'   
  
/ 0

#' 

 ( 

$'     

+ 
1



Copyright © 2007, Vivek Mittal

 5   




 


 
 j

 
  p



 


p


" p
 


 
 

(-
Ú  


 

 
 

    
  
a. Conditional grant of patent (Section 47)
b. Revocation of patent in public interest (section 66)
c. Grant of compulsory license (Section 82 to 94)
d. Use of invention for the purpose of government (Section 100&101)
e. Acquisition of Invention and Patent for Public purpose (Section 102)
f. Bolar Provision [Section 107 (A) (a)]
g. Parallel Import [Section 107 (A) (b)]

Copyright © 2007, Vivek Mittal

 7   




 


 
 j

 
  p



 


)
8
 

 Ú ! & !



 


(-
 Extension of product patent protection to all fields of technology (i.e., drugs,
food, and chemicals).
 Deletion of the provisions relating to Exclusive Marketing Rights (EMR) and
introduction of a transitional provision for safeguarding EMRs already
granted.
 Modification in the provision relating to opposition procedures with a view to
streamlining the system by having both pre-grant and post-grant opposition
in the patent office.
 The government has the power to acquire a patent for national requirement.
 Polymorphs new forms of older drugs are patentable.
 Parallel imports are allowed.
 Local production is mandatory.
 The earlier provision of 'new use' criteria is modified to 'mere new use'.
 Transfer of cases from High Courts to the Appellate Board (S.117G.)
Copyright © 2007, Vivek Mittal

 3   




 


 
 j

 
  p



 


p


  

      ! Incrementally Modified
Drugs (IMDs) include new formulations, new combinations of active
ingredients or new salts or esters of approved compound. In the US brand
manufacturers have flooded the market with IMDs, which "in 85% of the
cases, do not provide significant improvement over currently marketed
therapies" (6ational Institute for Health Care Management, Changing
Patterns of Pharmaceutical innovation: A Research Report, May 2002, p5).
 "#    The hike in cost because of patent will depend on how
much more can the patentee charge of his patented drug. To develop and
clinically test a new drug, it costs around $500-600mn and about 12 to13
years for any M6C.
 
  $
   Compulsory licences in the new
patent bill are not very effective. According to it, with the exception of
national emergency, extreme emergency or public non-commercial use, a
compulsory license is available only after three years from the date of grant
of the patent. Copyright © 2007, Vivek Mittal

    




 


 
 j

 
  p



 


1

 
9  


 6- 


The new patent bill is a sea of opportunities. It brought numerous business
opportunities for the Indian pharmaceutical industry and the industry reaping
benefits from it. When India joined the WTO eleven years ago, its
pharmaceutical exports were less than Rs 4,000 crore. A decade later, its
exports went up to worth rupees 14,000 crore. There are ample opportunities
now because over the next few years, drugs worth $ 60 billion are going off
patent and one can grab a lion's share of these off patent drugs. The list below
shows patent status of 10 block buster drugs:
ë. Research and Development
2. Bulk Drug Supply
3. Generic
4. Contract Manufacturing
5. Strategic Alliances
Cont«.
6. Consolidation, Mergers and Acquisitions Copyright © 2007, Vivek Mittal

    




 


 
 j

 
  p



 


  : p



3itromax 2005 Pfizer
Prevacid 2006 Takeda
3ocor 2006 Merck
Pravachol 2006 Bristol Myers Squibb
3oloft 2006 Pfizer
Paxil 2006 GlaxoSmithkline
6orvasc 2007 Pfizer
Risperdal 2007 J&J
Effexor 2008 Wyeth
Lipitor 2010 Pfizer

Copyright © 2007, Vivek Mittal