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Answers - Intellectual Property-Exclusive Rights
The term “intellectual property” denotes the specific legal rights which authors, inventors and other pro
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
perty holders may hold and exercise, and not the intellectual work itself. The laws confer a bundle of ex
; 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
lusive rights in relation to the particular form or manner in which ideas or information are expressed or
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
manifested, and not in relation to the ideas or concepts themselves.
They are designed to protect diffe
They are designed to protect diffe
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ent forms of subject matter. Copyright may subsist in creative and artistic works (e.g. books, poems, mov
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ies, music, paintings, photographs, databases, and software) and give a copyright holder the exclusive ri
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
ht to control reproduction or adaptation of such works for a certain period of time.
A patent may be gra
A patent may be gra
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
nted for a new, useful, and non-obvious invention, and gives the patent holder an exclusive right to comm
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
rcially exploit the invention for a certain period of time (typically 20 years from the filing date of a
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
patent application).
A trademark is a distinctive sign which is used to distinguish the products or serv
A trademark is a distinctive sign which is used to distinguish the products or serv
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ces of differentbusiness.
An industrial design right protects the form of appearance, style or design of
An industrial design right protects the form of appearance, style or design of
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
an industrial object (e.g. spare parts, furniture, or textiles).
A trade secret (which is sometimes eit
A trade secret (which is sometimes eit
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
er equated with, or a subset of, “confidential information”) is secret, non-public information concerning
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
the commercial practices or proprietary knowledge of a business, public disclosure of which may sometime
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
be illegal.
Patents, trademarks, and designs rights are sometimes collectively known as industrial prop
Patents, trademarks, and designs rights are sometimes collectively known as industrial prop
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
erty, as they are typically created and used for industrial or commercial purposes.
The protection of in
The protection of in
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
ellectual property is that the laws facilitate and encourage the pursuit and disclosure of innovation int
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
o the public domain for the common good, by granting authors and inventors exclusive rights to exploit th
.
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
ir works and invention for a limited period. From the perspective of economics, intellectual property is
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
a temporary monopoly
in the use or exploitation of that good, supported by legal enforcement mechanisms
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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