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The law of property is a branch of private law which regulates the relationship between p

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

ersons and things, or property. This branch of law provides rules prescribing the manner

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

Examples of combination products may in

n which someone acquires rights in property, the manner in which these rights can be tran

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

sferred, and it provides the remedies available in the event of an infringement on such r

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

ghts.

There are two main types of right that a person may hold in property, namely: real

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

Combination pro

rights and personal rights.

The only real right recognised in our law is the right of ow

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

nership. This is where a person has complete title (or control) over a thing or property.

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

It is important to note that a person may also hold a limited real right in relation to p

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

operty. This is a subcategory of real rights but an important distinction is that they ar

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

e held by a person in relation to someone else’s property. One can never have a whole rea

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

right in relation to someone else’s property.

A personal right is one against another p

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

Following aspects would a

rson for the performance of an obligation, i.e.: the other person must either do or refra

dd to the challenges in developing combination products:

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

in from doing something. These rights are usually created by contract.

Real rights are o

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

ten described as absolute rights and as such can be enforced against anyone. Personal rig

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

ts on the other hand, can only be enforced against the other party to your contract.

An

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

easier way to distinguish between real rights and personal rights is to keep in mind that

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

Professional from academic institutions, pharmaceutical industries, health care indust

real rights establish a legal relationship between a thing/property and a person, whereas

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

personal rights establish a legal relationship between two persons (the relationship betw

.

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

een the two persons could be relating to property but the rights are created in relation

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

Companies that provide selfless information through particip

o the two persons and each other, and not in relation to either of them and the property)

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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