Advice Pool - Legal

The scope and nature of “Intellectual Property” has expanded. It is an umbrella term 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

most various legal entitlements. The product of “intellect” or mind is termed as the inte

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

lectual property. It inspired the extension of laws to new types of subject matter such a

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

s databases. Also it regulates new categories of activity in respect of subject matter al

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

eady protected. It helps the increase of terms of protection, in the removal of restricti

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ons and limitations on exclusive rights, and in an expansion of the definition of "author

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

to include corporations as the legitimate creators and owners of works. The holder of th

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

is legal entitlement is generally entitled to exercise various exclusive rights in relati

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

n to the subject matter of the intellectual property. And its rights may be protected at

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

law in the same way as any other form of property.

Intellectual property laws vary from

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

urisdiction to jurisdiction, such that the acquisition, registration or enforcement of IP

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

rights must be pursued or obtained separately in each territory of interest. However, the

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

se laws are becoming increasingly harmonised through The effects of international treatie

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

such as the 1994 World Trade Oraganization or WTO and TRIPs have enabled the laws to har

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

monise, while other treaties may facilitate registration in more than one jurisdiction at

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

a time.

The rights conferred by intellectual property laws can generally be transferred,

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

with or without consideration, licensed or rented, or mortgaged to third parties. Like o

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

her forms of property, intellectual property or rather the exclusive rights which subsist

.

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

, can be transferred, with or without consideration or licensed to third parties. In some

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

jurisdictions it may also be possible to use intellectual property as security for a loan

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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