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Top Articles - Patent- How Well Protected Are The Patent Holders?
Intellectual property laws vary from jurisdiction to jurisdiction. And it is such that the acquisitio
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
n, registration or enforcement of the rights must be pursued or obtained separately in each territory
; 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
of interest. Intellectual property in law is a general term for various legal entitlements. The hold
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 of this legal entitlement is generally entitled to exercise various exclusive rights.
Intellectua
Intellectua
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
l property laws are designed to protect different forms of subject matter, in this case a Patent. A p
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
atent may be granted for a new, useful, and non-obvious invention, and gives the patent holder an exc
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
lusive right to commercially exploit the invention for a certain period of time, typically 20 years f
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
rom the filing date of a patent application. Patents, trademarks, and designs rights are sometimes co
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
llectively known as industrial property, as they are typically created and used for industrial or com
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
mercial purposes.
Various schools of thought are critical of the term “intellectual property”. Some
Various schools of thought are critical of the term “intellectual property”. Some
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
characterise it as intellectual protectionism. From the perspective of economics, intellectual proper
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
ty is a temporary monopoly on the use or exploitation of that Patent, supported by legal enforcement
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
mechanisms.
There is a debate going on every where that intellectual property laws truly operate to
There is a debate going on every where that intellectual property laws truly operate to
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
confer the stated public benefits, and whether the protection they are said to provide is appropriate
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
in the context of innovation derived from such things as traditional knowledge and folklore, and pat
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
ents for software and business methods. Manifestations of this controversy can be seen in the way dif
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
ferent jurisdictions decide whether to grant intellectual property protection in relation to subject
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
matter of this kind, and the divide on issues of the role and scope of intellectual property laws.
M
M
.
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
ost exclusive rights are the right to sue an infringer, which has the effect that people will approac
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
h the patent holder for permission to perform the acts to which the patent holder has exclusive right
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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