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Top Adding - Why Patent? Part I
If you've wondered why you need a patent, this section will help you understand
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
that.
The purpose of a patent is to protect the intellectual property of the in
The purpose of a patent is to protect the intellectual property of the in
; 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
ventor. Patents prohibit anyone other than the patent holder from making or sell
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ing the patented item (or using the business method, or planting the new plant,
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
in the case of those patent types) without the permission of the patent holder.
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
Some patent seekers intend to manufacture and sell the patented item themselves,
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
while others intend to license the patent to others – in effect, selling the ri
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
ght to produce the invention while retaining ownership of the idea for a period
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
of time.
Protecting Yourself
Protecting your ownership of an invention is the
Protecting Yourself
Protecting your ownership of an invention is the
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
main reason why you should consider getting a patent. When you want to hold the
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
wnership rights for an invention, it is imperative that you file for a patent as
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
soon as possible. As the owner of the item it is very important to establish yo
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
ur rights.
Preventing Other People
The second main reason for obtaining a pate
Preventing Other People
The second main reason for obtaining a pate
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
nt would be to prevent others from stealing from you. Without a patent, anyone c
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
an make, market and sell your product without you receiving any compensation. Th
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
is is especially important in situations where your invention will end up becomi
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
ng popular, possibly making a lot of money.
By preventing others from distribut
By preventing others from distribut
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ing, selling, or manufacturing your invention, you preserve your right to earn p
.
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
rofits from the invention. This is usually the reason why large companies quickl
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
y seek patents for a new product idea, especially in the pharmaceutical industry
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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