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Actual - Patent Writing India - The Patent Amendment Act, 2002
The Patents (Amendment) Act, 2002 was passed by Parliament in May, 2002 and notified in June, 2003. The Act has been made effective from May, 2003 and has brought about lot of changes.
Salient Features: The salient features of the Patents (Amendment) Act 2002 are as follows:
A. Modification of term invention:
The Sec. 2 (1)(j) of Patent (Amendment) Act 2002, defines the term “invention” as "a new produ
Salient Features: The salient features of the Patents (Amendment) Act 2002 are as follows:
A. Modification of term invention:
The Sec. 2 (1)(j) of Patent (Amendment) Act 2002, defines the term “invention” as "a new produ
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
ct or process involving an inventive step and capable of industrial application" Where ”Inventive step” means a feature that makes the invention not obvious to person skilled in the art.
Earlier “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 and use
(i) Art, process, method or manner of manufacture;
(ii) Machine, apparatus or other article;
(iii) Substance produced by manufacture; and includes any new and use
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ful improvement of any of them, and an alleged invention.
B. Examination of application (Sec. 11(b)):
India has opted for a deferred examination system. This means the Controller will not initiate examination of the application. Examination of an application will now be taken up only upon request by applicant or in the Form 19 with fees of Rs.1000 for individual applicant or Rs. 3000 for legal entity oth
B. Examination of application (Sec. 11(b)):
India has opted for a deferred examination system. This means the Controller will not initiate examination of the application. Examination of an application will now be taken up only upon request by applicant or in the Form 19 with fees of Rs.1000 for individual applicant or Rs. 3000 for legal entity oth
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
er than an individual, at the appropriate office of the Patent office (Rule 24).
The request is to be made within forty-eight months from the application filing date. Where an application was filed prior to May 20, 2003 (i.e. before the commencement of the Patent (Amendment) Act 2002), a request for examination is required to be made within a period of twelve months from May 20, 2003 or forty-eight months
The request is to be made within forty-eight months from the application filing date. Where an application was filed prior to May 20, 2003 (i.e. before the commencement of the Patent (Amendment) Act 2002), a request for examination is required to be made within a period of twelve months from May 20, 2003 or forty-eight months
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
from the filing date, whichever is later. Upon failure to request examination, the application shall be treated as withdrawn by the applicant. The applicant or agents can also withdraw the application at any time (before the grant of the patent) after filing the application.
C. Publication/Notification of the Application (Sec. 11 (a)):
After the expiry of 18 months from the date of filing or the date of
C. Publication/Notification of the Application (Sec. 11 (a)):
After the expiry of 18 months from the date of filing or the date of
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
priority whichever is earlier, the Controller will notify the contents of the applications falling within the provision in the Gazette of India Part-III Sec.2 (Rule 25).
D. Term of Patent (Sec.53):
The term of patent has been enlarged to twenty years for existing patents and patents granted on pending applications. This term is calculated from the date of filing of the application.
Earlier the term of
D. Term of Patent (Sec.53):
The term of patent has been enlarged to twenty years for existing patents and patents granted on pending applications. This term is calculated from the date of filing of the application.
Earlier the term of
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
patent for method or process of manufacture of substance (e.g. food, medicines, drugs etc.) was five years from the date of the sealing of the patent, or seven years from the date of patent whichever period is shorter and in respect of any other invention, fourteen years from the date of the patent.
E. Burden of proof (Sec. 104 A):
The burden of proof in a proceeding for process patent infringement has b
E. Burden of proof (Sec. 104 A):
The burden of proof in a proceeding for process patent infringement has b
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
een reversed and imposed on Defendant.
F. Fees (First Schedule):
The fees for filing a new application for patents has been reduced from Rs. 1500 to Rs. 750 in the case of an individual applicant and from Rs. 5000 to Rs. 3000 in the case of legal entity.
G. Prohibition to apply abroad (Sec. 39):
No person shall file an application or patent for an invention without applying in India or without the writ
F. Fees (First Schedule):
The fees for filing a new application for patents has been reduced from Rs. 1500 to Rs. 750 in the case of an individual applicant and from Rs. 5000 to Rs. 3000 in the case of legal entity.
G. Prohibition to apply abroad (Sec. 39):
No person shall file an application or patent for an invention without applying in India or without the writ
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ten permission of the Central Govt. If the applicant is not interested to secure a patent in India or the invention is not patentable according to the Indian law, he has to mandatorilly file an application for the said invention and has to wait for the expiry of six weeks after filing the application and then only file the corresponding application abroad for the same invention.
H. Date of Patent (Sec. 45
H. Date of Patent (Sec. 45
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
):
The date of every patent will be the date of filing the application for patent. According to The Patent Act 1970, the date of patent was the date of filing of complete specification. The date of patent is very important to determine the term of parent.
I. Rights of patentee (sec.48):
The rights can be consider as negative because the rights of patentee, in the case of product patent, prevent third pa
The date of every patent will be the date of filing the application for patent. According to The Patent Act 1970, the date of patent was the date of filing of complete specification. The date of patent is very important to determine the term of parent.
I. Rights of patentee (sec.48):
The rights can be consider as negative because the rights of patentee, in the case of product patent, prevent third pa
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ties without the consent of the patentee, from making, using, offering for sale, selling or importing into India and the rights in the case of process patent, prevent third parties without the consent of the patentee, from the act of using that process and offering for sale or selling in India or importing for those purposes the product obtain directly by that process, provided that the product obtained is
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
not patentable under the Act.
J. The Powers of the Branch Office (Rule 4):
The branch offices of the Patent office have been vested with more powers. Under Sec. 68 the actions such as making a request of sealing of patents, registration of assignment (under Sec. 68) etc has to be made in the appropriate Branch offices of the Patent office and not at the Head Office as the case earlier.
K. Appellate Boa
J. The Powers of the Branch Office (Rule 4):
The branch offices of the Patent office have been vested with more powers. Under Sec. 68 the actions such as making a request of sealing of patents, registration of assignment (under Sec. 68) etc has to be made in the appropriate Branch offices of the Patent office and not at the Head Office as the case earlier.
K. Appellate Boa
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
rd (Sec. 2 (1a)):
Appeal Board appointed under the Trade and Merchandise Marks Act 1999 shall be the Appeal Board for purposes of Patents Act. This Appellate Board hears and decides appeals from the decision of the controller. The Head Quarter of the Appeal Board is to be in Chennai.
It is clear that the definition of term invention in Patent Act, 2002 has enlarged the scope of protection. The controller
Appeal Board appointed under the Trade and Merchandise Marks Act 1999 shall be the Appeal Board for purposes of Patents Act. This Appellate Board hears and decides appeals from the decision of the controller. The Head Quarter of the Appeal Board is to be in Chennai.
It is clear that the definition of term invention in Patent Act, 2002 has enlarged the scope of protection. The controller
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
has also been vested with the power to consider the question of obviousness of the invention disclosed while conducting the examination of application for considering the grant of a patent for the invention. In this context it should be noted that in the Patent Act, 1970 the Controller has no direct power to consider the question of obviousness. The power is only for the opponents while opposing the draft
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
of patents under Sec. 25 of the Patent Act, 1970. The effect of this amendment is that it may not be possible to get a patent for trivial modifications.
L. Time for placing the application in order for acceptance (Sec. 21): The time frame for putting an application in order for acceptance subsequent to its first examination has been shortened to 12 months (non-extendible) from the date of First Examinat
L. Time for placing the application in order for acceptance (Sec. 21): The time frame for putting an application in order for acceptance subsequent to its first examination has been shortened to 12 months (non-extendible) from the date of First Examinat
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
ion Report (FER). The first reply to the first examination report is required to be made within 4 months of the date of its issuance.
M. Unity of Invention (Sec. 10(5)):
The concept of 'unity of invention' has been broadened to include a group of inventions linked so as to form a single inventive concept. The claims in a specification should relate to a single invention or a group of invention linked so
M. Unity of Invention (Sec. 10(5)):
The concept of 'unity of invention' has been broadened to include a group of inventions linked so as to form a single inventive concept. The claims in a specification should relate to a single invention or a group of invention linked so
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
as to form a single inventive concept. Now, by this amendment it may be possible to claim more than one process in a single application if these processes fall under one group and are closely linked.
N. Electronic Communication (Rule 6):
The documents can also be filed by electronic transmission duly authenticated. In that event the document should be clear, properly addressed and mailed and its original
N. Electronic Communication (Rule 6):
The documents can also be filed by electronic transmission duly authenticated. In that event the document should be clear, properly addressed and mailed and its original
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
has to be submitted within fifteen days from the date of receipt of communication. The drawings can also be filed electronically.
O. Statement and Undertaking (Rule 12(4)):
For filing the Statement and Undertaking on Form 3 a provision has been provided to seek extension beyond three months.
P. Declaration of inventor-ship (Rule13 (6)):
The declaration of inventor ship on Form 5 should be filed along
O. Statement and Undertaking (Rule 12(4)):
For filing the Statement and Undertaking on Form 3 a provision has been provided to seek extension beyond three months.
P. Declaration of inventor-ship (Rule13 (6)):
The declaration of inventor ship on Form 5 should be filed along
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
with the complete specification. An extension of one month beyond this period can be secured by filing a request on Form 4 with the fees Rs. 250/- pm if the applicant is an individual or Rs. 1000/- pm if the applicant is a legal entity.
Q. Abstract (Rule 13 (a) to (d)):
While filing the application accompanied with a complete specification, an abstract of the invention maximum 150 words have to be filed.
Q. Abstract (Rule 13 (a) to (d)):
While filing the application accompanied with a complete specification, an abstract of the invention maximum 150 words have to be filed.
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
R. Application (Rule 20 (1)):
An application for patent corresponding to International application (PCT application) has to be filed on Form 1 A.
S. Licenses of right (Sec. 86 to 88):
The Provisions relating to "licenses of right" deleted.
T. Restoration of lapsed patent (Sec. 60):
The time for filing the request for restoration of the lapsed patent has been extended from one year to eighteen months
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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