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Top Adding - Patent Debates
Patents perform an essential role in stimulating inventions by providing an incentive for
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
expensive investments and long-term research. Patents also contribute to society by gath
; 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
ering and making available human endeavor and knowledge. The Patent Cooperation Treaty (P
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
CT) was signed between countries in 1970 and last modified in 1984. This treaty seeks pat
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nt protection simultaneously in the signatory countries after conducting an international
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
search through the national and international offices.
A recent article by an internati
A recent article by an internati
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
onal business professor, C. Gopinath speaks of an American patent for a cardboard sleeve
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
sed to hold hot paper cups in restaurants. The author feels that patents of this kind hav
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
e very little value addition. Such patent licenses are practically 'permission to use a p
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
iece of cardboard around their paper cups'. Do patents of this kind make sense? In anothe
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
case a French firm Polypap was taken to court by the US firm Southpac on grounds of 'Pat
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
ent infringement'. Both companies manufacture flower holders as substitutes for vases.
F
F
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
iling patents is a costly process and defending them, equally costly. Patent rules should
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
perhaps pay more attention to the nature of the patented product or service. Patented pr
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
ducts and services should be those, which add value and not frivolous matters, which ofte
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
n are of little value to anybody but the patentee who makes a quick buck. World Intellect
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
ual Property Organisation (WIPO) talks of patents as 'enriching the total body of technic
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
l knowledge' and 'furthering creativity and innovation'. Patents like the above do neithe
.
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.
While patents protect the individual creator, the public interest needs to be kept in
While patents protect the individual creator, the public interest needs to be kept in
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
view. The new Indian Patent Rules have been facing objections from international sources
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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