AMMENDMENTS IN PATENT ACT- 1999,2002 AND 2005- OVERVIEW AND COMPARISON

About Authors:
Krunal Parikh1*, Mr. Maheshkumar Kataria2
(assistant professor, Department of pharmaceutics)
Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*Krunal_2922@yahoo.in

ABSTARCT :
The word Patent originated from the Latin Word "Patene" which means 'to open'. A patent  is a set of exclusive rights granted by a state (national government) to an inventor or their assignee for a limited period of time in exchange for a public disclosure of an invention.

Under the World Trade Organization's (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights, patents should be available in WTO member states for any inventions, in all fields of technology, and the term of protection available should be the minimum twenty years. Different types of patents may have varying patent terms(i.e., durations).After 1972  The Act remained in force for about 24 years without any change till December 1994. An ordinance effecting certain changes in the Act was issued on 31 st December 1994, which ceased to operate after six months. Subsequently, another ordinance was issued in 1999. This ordinance was subsequently replaced by the Patents (Amendment) Act, 1999 that was brought into force retrospectively from 1st January, 1995. The amended Act provided for filing of applications for product patents in the areas of drugs, pharmaceuticals and agro chemicals though such patents were not allowed. However, such applications were to be examined only after 31-12-2004. Meanwhile, the applicants could be allowed Exclusive Marketing Rights (EMR) to sell or distribute these products in India, subject to full filment of certain conditions.

Reference Id: PHARMATUTOR-ART-1487

INTRODUCTION
The word Patent originated from the Latin Word "Patene" which means 'to open'. A patent  is a set of exclusive rights granted by a state (national government) to an inventor or their assignee for a limited period of time in exchange for a public disclosure of an invention.

Under the World Trade Organization's (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights, patents should be available in WTO member states for any inventions, in all fields of technology, and the term of protection available should be the minimum twenty years. Different types of patents may have varying patent terms (i.e., durations).

If a person makes, what he thinks is an invention, he or if he works for an entity, that entity can ask the Government, by filing an application with the Patent Office to give him a certificate in which it is stated what the invention is and that he is the owner of it. Such a right conferred upon the inventor is called 'Patent' by which the inventor, more properly called as the Patentee, can make exclusive use of his invention.

Thus a patent is a monopoly right granted to a person who has invented a new and useful article or a new process of making an article.

History of indian patent system


1856

The act vi of 1856 on protection of inventions based on the british patent law of 1852. Certain exclusive privileges granted to inventors of new manufacturers for a period of 14 years.

1859

The act modified as act xv; patent monopolies called exclusive privileges (making. Selling and using inventions in india and authorizing others to do so for 14 years from date of filing specification).

1872

The patents & designs protection act.

1883

The protection of inventions act.

1888

Consolidated as the inventions & designs act.

1911

The indian patents & designs act.

1972

The patents act (act 39 of 1970) came into force on 20th  april, 1972.

1999

On march 26, 1999 patents (amendment) act, (1999) came into force from 01-01-1995.

2002

The patents (amendment) act 2002 came into force from 20th  may 2003

2005

The patents (amendment) act 2005 effective from 1st  january 2005

In India the Law relating to Patents is governed by the Patents Act 1970 along with the recent Amendment . The Indian Patents Act defines an invention as follows:

Invention means any new and useful:
i)                   
Art, process, method or manner of manufacture,
ii)                 
 Machine, apparatus or other article,
iii)               
Substance produced by manufacture and includes any new & useful improvement of any of them and an alleged invention.Therefore, in order to be patentable, an invention must possess the following characteristics:
a)     
It should relate to a manner of manufacture.
b)    
The manner of manufacture should be novel.
c)     
It should be the outcome of inventive activity.
d)    
It should have utility.
e)     
It should not be contrary to law and morality.

The Indian Patents Act also lays down some norms as to which inventions are not patentable. Following inventions are not patentable:
a)     
An invention which is frivolous or which claims anything obvious or contrary to well established natural laws.
b)    
An invention, the primary or intended use of which would be contrary to any law or morality or injurious to public health.
c)     
The mere discovery of a scientific principle or the formulation of an abstract theory.
d)    
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 atleast one new reactant.
]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 rearrangement or duplication of known devices each functioning independently of one another in a known way.
g)     
A method or process of testing applicable during the process of manufacture for rendering the machine, apparatus or other equipment more efficient or for the improvement or restoration of the existing machine, apparatus or other equipment or for the improvement or control of manufacture.
h)    
A method of agriculture or horticulture.
i)       
A process for the medical, surgical, curative, prophylactic or other treatment of human beings or any process for a similar treatment of animals or plants to render them free of disease or to increase their economic value or that of their products.
j)      
An invention relating to atomic energy.

Brief about Indian Patent System
After 1972  The Act remained in force for about 24 years without any change till December 1994. An ordinance effecting certain changes in the Act was issued on 31 st December 1994, which ceased to operate after six months. Subsequently, another ordinance was issued in 1999. This ordinance was subsequently replaced by the Patents (Amendment) Act, 1999 that was brought into force retrospectively from 1st January, 1995. The amended Act provided for filing of applications for product patents in the areas of drugs, pharmaceuticals and agro chemicals though such patents were not allowed. However, such applications were to be examined only after 31-12-2004. Meanwhile, the applicants could be allowed Exclusive Marketing Rights (EMR) to sell or distribute these products in India, subject to full filment of certain conditions.

The second amendment to the 1970 Act was made through the Patents (Amendment) Act, 2002 (Act 38 0f 2002). This Act came into force on 20th May 2003 with the introduction of the new Patent Rules, 2003 by replacing the earlier Patents Rules, 1972

The third amendment to the Patents Act 1970 was introduced through the Patents (Amendment) Ordinance, 2004 w.e.f. 1st January, 2005. This Ordinance was later replaced by the Patents (Amendment) Act 2005 (Act 15 Of 2005 ) on 4th  April, 2005 which was brought into force from 1-1-2005.

THE PATENTS (AMENDMENT) ACT 1999.
The Patents Amendment Act 1999 was passed in March 1999 to confirm with these international obligations and has retrospective effect from 1st January 1995. This act was published in The Gazette of India, on Friday, March 26, 1999. As “ The Patent (Amendment) Act 1999, (No. 17 of 1999).
The main features of the amendments are as follows:

1. SHORT TITLE AND COMMENCEMENT.-
(1) This Act may be called the Patents (Amendment) Act, 1999.
(2) It shall be deemed to have come into force on the 1st day of January, 1995.

2. AMENDMENT OF SECTION 5.-
Section 5 of the Patents Act, 1970 (39 of 1970)(hereinafter referred to as the principal Act) shall be renumbered as sub-section (1) thereof and after sub-section (1) as so renumbered, the following sub-section shall be inserted, namely:-"(2) Not withstanding anything contained in sub-section (1), a claim for patent of an invention for a substance itself intended for use, or capable of being used, as medicine or drug, except the medicine or drug specified under sub-clause (v) of clause (l) of sub-section (1) of section 2, may be made and shall be dealt, without prejudice to the other provisions of this Act, in the manner provided in Chapter IVA.". 

3. INSERTION OF NEW CHAPTER IVA.-
After Chapter IV of the principal Act, the following Chapter shall be inserted, namely:
CHAPTER IVA- EXCLUSIVE MARKETING RIGHTS

24A. Application for grant of exclusive rights.-
(1)
Notwithstanding anything contained in sub-section (1) of section 12, the Controller shall not, under that sub-section, refer an application in respect of a claim for a patent covered under sub-section (2) of section 5 to an examiner for making a report till the 31st day of December, 2004 and shall, where an application for grant of exclusive right to sell or distribute the article or substance in India has been made in the prescribed form and manner and on payment of prescribed fee, refer the application for patent, to an examiner for making a report to him as to whether the invention is not an invention within the meaning of this Act in terms of section 3 or the invention is an invention for which no patent can be granted in terms of section 4.

(2)Where the Controller, on receipt of a report under sub-section (1) and after such other investigation as he may deem necessary, is satisfied that the invention is not an invention within the meaning of this Act in terms of section 3 or the invention is an invention for which no patent can be granted in terms of section 4, he shall reject the application for exclusive right to sell or distribute the article or substance.

(3)In a case where an application for exclusive right to sell or distribute an article or a substance is not rejected by the Controller on receipt of a report under sub-section (1) and after such other investigation, if any, made by him, he may proceed to grant exclusive right to sell or distribute the article or substance in the manner provided in section 24B.

Explanation. It is hereby clarified that for the purposes of this section, the exclusive right to sell or distribute any article or substance under this section shall not include an article or substance based on the system of Indian medicine as in clause (e) of sub-section (1) of section 2 of the Indian Medicine Central Council Act, 1970 (48 of 1970) and where such article or substance is already in the public domain.

24B. Grant of exclusive rights.-
(1)
Where a claim for patent covered under sub-section (2) of section 5 has been made and the applicant has,-
(a) where an invention has been made whether in India or in a country other than India and before filing such a claim, filed an application for the same invention claiming identical article or substance in a convention country on or after the 1st day of January, 1995 and the patent and the approval to sell or distribute the article or substance on the basis of appropriate tests conducted on or after the 1st day of January, 1995, in that country has been granted on or after the date of making a claim for patent covered under sub-section (2) of section 5; or

(b) where an invention has been made in India and before filing such a claim, made a claim for patent on or after the 1st day of January, 1995 for method or process of manufacture for that invention relating to identical article or substance and has been granted in India the patent there for on or after the date of making a claim for patent covered under sub-section (2) of section 5,

and has received the approval to sell or distribute the article or substance from the authority specified in this behalf by the Central Government, then, he shall have the exclusive right by himself, his agents or licensees to sell or distribute in India the article or the substance on and from the date of approval granted by the Controller in this behalf till a period of five years or till the date of grant of patent or the date of rejection of application for the grant of patent, whichever is earlier.

(2)Where, the specifications of an invention relatable to an article or a substance covered under sub- section (2) of section 5 have been recorded in a document or the invention has been tried or used, or, the article or the substance has been sold, by a person, before a claim for a patent of that invention is made in India or in a convention country, then, the sale or distribution of the article or substance by such person, after the claim referred to above is made, shall not be deemed to be an infringement of exclusive right to sell or distribute under sub-section (1):

Provided that nothing in this sub-section shall apply in a case where a person makes or uses an article or a substance with a view to selling or distribute the same, the details of invention relatable thereto were given by a person who was holding an exclusive right to sell or distribute the article or substance.

24C. Compulsory licenses.-
The provisions in relation to compulsory licenses in Chapter XVI shall, subject to the necessary modifications, apply in relation to an exclusive right to sell or distribute under section 24B as they apply to, and in relation to, a right under a patent to sell or distribute and for that purpose the following modifications shall be deemed to have been made to the provisions of that Chapter and all their grammatical variations and cognate expressions shall be construed accordingly, namely:

(a)throughout Chapter XVI,
(i) working of the invention shall be deemed to be selling or distributing of the article or substance;
(ii) references to "patents" shall be deemed to be references to "right to sell or distribute";
(iii) references to "patented article" shall be deemed to be references to "an article for which exclusive right to sell or distribute has been granted";

(b)three years from the date of sealing of a patent in section 84 shall be deemed to be two years from the date of approval by the Controller for exclusive right to sell or distribute under section 24B;

(c)the time which has elapsed since the sealing of a patent under section 85 shall be deemed to be the time which has elapsed since the approval by the Controller for exclusive right to sell or distribute under section 24B;

(d)clauses (d) and (e) of section 90 shall be omitted.

24D. Special provision for selling or distribution.-
(1)
Without prejudice to the provisions of any other law for the time being in force, where, at any time after an exclusive right to sell or distribute any article or substance has been granted under sub-section (1)of section 24B, the Central Government is satisfied that it is necessary or expedient in public interest to sell or distribute the article or substance by a person other than a person to whom exclusive right has been granted under sub-section (1) of section 24B, it may, by itself or through any person authorized in writing by it in this behalf, sell or distribute the article or substance.

(2) The Central Government may, by notification in the Official Gazette and at any time after an exclusive right to sell or distribute an article or a substance has been granted, direct, in the public interest and for reasons to be stated, that the said article or substance shall be sold at a price determined by an authority specified by it in this behalf.

24E. Suits relating to infringements.-
All suits relating to infringement of a right under section 24B shall be dealt with in the same manner as if they were suits concerning infringement of patents under Chapter XVIII.

24F. Central Government and its officers not to be liable.-
The examination and investigations required under this Chapter shall not be deemed in any way to warrant the validity of any grant of exclusive right to sell or distribute, and no liability shall be incurred by the Central Government or any officer thereof by reason of, or in connection with, any such examination or investigation or any report or other proceedings consequent thereon.''. 

4. OMISSION OF SECTION 39.-
Section 39 of the principal Act shall be omitted.

 5. AMENDMENT OF SECTION 40.-
In section 40 of the principal Act, the words and figures "or makes or causes to be made an application for the grant of a patent outside India in contravention of section 39" shall be omitted.

6. AMENDMENT OF SECTION 64.-
In section 64 of the principal Act, in sub-section (1), in clause (n), the words and figures "or made or caused to be made an application for the grant of a patent outside India in contravention of section 39" shall be omitted. 

7. AMENDMENT OF SECTION 118.-
In section 118 of the principal Act, the words and figures "or makes or causes to be made an application for the grant of a patent in contravention of section 39" shall be omitted. 

8. INSERTION OF NEW SECTION 157A.-
After section 157 of the principal Act, the following section shall be inserted, namely:-
"157A. Protection of security of India.-Notwithstanding anything contained in this Act, the Central Government shall,-
(a)
not disclose any information relating to any patentable invention or any application relating to the grant of a patent under this Act, which it considers prejudicial to the interest of security of India;

(b) take action including the revocation of any patent which it considers necessary in the interest of security of India:

Provided that the Central Government shall, before taking any action under this clause, issue a notification in the Official Gazette declaring its intention to take such action.

Explanation.- For the purposes of this section, the expression "essential security of India" means any action necessary for the security of India which-
(i) relates to fissionable materials or the materials from which they are derived; or

(ii) relates to the traffic in arms, ammunition and implements or war and to such traffic in other goods and materials as is carried on directly or indirectly for the purpose of supplying a military establishment; or

(iii) Which is taken in time of war or other emergency in matter of international relations.".

9. REPEAL AND SAVINGS.-
(1)
The Patents (Amendment) Ordinance, 1999 (Ord. 3 of 1999), is hereby repealed

(2) Notwithstanding such repeal, anything done or any action taken under the principal Act, as amended by the Patents (Amendment) Ordinance, 1994 (Ord. 13 of 1994), which ceased to operate, or under the Patents (Amendment) Ordinance, 1999 (Ord. 3 of 1999), shall be deemed to have been done or taken under the corresponding provisions of the principal Act, as amended by this Act.

(3) All applications made in respect of claims for patent of invention specified under sub-section (2) of section 5 of the principal Act, from the date of cesser of the Patents (Amendment) Ordinance, 1994 (Ord. 13 of 1994) till the date on which this Act received the assent of the President (both days includive) shall be deemed to have been validly made as if the provisions of the principal Act, as amended by this Act, had been in force at all material times.(The Patent Amendment act 1999 (No. 17 of 1999), The Gazette of India, Part-II, section-I, Ministry of law, justice and company affairs,(Legislative Department). New Delhi, 26th March, 1999.)

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