Tags |
|
|
Links |
|
|
Top Articles - India Patents
India - Patents (Amendment) Act, 2005
The Government of India has met the December 3
The Government of India has met the December 3
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
1 deadline for complying with its obligation to World Trade Organisation (WTO) under
; 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
TRIPs agreement, by promulgating an Ordinance – The Patent (Amendment) Ordinance, 200
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
4 followed by the Act – Patent (Amendment) Act, 2005.
Under TRIPS, India was require
Under TRIPS, India was require
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
d to introduce product patent where only process patent was permitted. Procedural cha
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
nges were also required to be made as per Patent Co-operation Treaty ( PCT). The new
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
Act ensures adequate safeguards against misuse of patent rights and vests enough powe
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
r with the Government to intervene and ensure that patented inventions are available
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
for the public at an affordable price.
In nutshell, the most important changes are:
In nutshell, the most important changes are:
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
Product Patent can be issued in respect of food, drugs and chemicals. Provisions of
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
'process patent' for these goods abolished.
Provisions in respect of EMR (Exclusive
Provisions in respect of EMR (Exclusive
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
Marketing Rights) abolished.
Computer software per se is not patentable, but in comb
Computer software per se is not patentable, but in comb
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
ination with or embedded in hardware is patentable.
Provision of 'acceptance of spec
Provision of 'acceptance of spec
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
ification' and its advertisement have been deleted.
Provision for pre-grant and post
Provision for pre-grant and post
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
-grant opposition to the granting of a patent.
Application for patent will be publis
Application for patent will be publis
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
hed in Official Journal. At that time opposition can be made on limited grounds but h
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
earing is not mandatory.
After grant of patent, opposition can be made within 12 mon
After grant of patent, opposition can be made within 12 mon
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ths.
Provision of sealing of patent omitted.
Provision for acquisition of patent fo
Provision of sealing of patent omitted.
Provision for acquisition of patent fo
.
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
r public health purposes.
Suit for infringement of patent cannot commence before dat
Suit for infringement of patent cannot commence before dat
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
e of publication of publication of the application.
Penalties enhanced substantially
Penalties enhanced substantially
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.toparticles.org.ua/article/130811/toparticles-India-Patents.html">India Patents</a>
BB link (for phorums):
[url=http://www.toparticles.org.ua/article/130811/toparticles-India-Patents.html]India Patents[/url]
Related Articles:
Top 3 Internet Income Method Any Newbies Must Know
Divorce - Protect Your Financial Future
Unsecured Car Loans: Don't Put Your Home At Stake
Bookmark it:
|