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Getting a patent is one of the most necessary things to be accomplished once you have conceptualized a

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 innovative idea. A patent confirms that the idea is original, and also secures that the creator’s id

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

Examples of combination products may in

a will not be infringed in any manner. However, before acquiring a patent, the creator has to find out

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

whether the concept has been patented before.

In America, the US Patent Office takes on the responsib

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

lity of granting patents for new ideas. The USPTO is an extremely busy office receiving more than 350,

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

Combination pro

00 patents per year. It may sometimes take a long time to grant a patent. In order to shorten the proc

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

ss, the USPTO encourages people with new concepts to conduct the patent search themselves at website w

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

w.uspto.gov. Patent hunters can use the search toolbar to type in related keywords, and check whether

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

he idea is already patented. The USPTO lists all patents from 1970 onwards, and earlier patents can be

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

obtained on demand.

Patent attorneys specialize in searching patents and giving patent-related advice

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

They are consulted if a web-based patent search yields no results. Patent attorneys are also helpful

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

Following aspects would a

in arguing a client’s case, when the USPTO has rejected an earlier patent demand. At such times, modif

dd to the challenges in developing combination products:

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

cations and alterations can be done in the original design, and it can be reapplied for.

A rough pate

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

t search done through professional attorneys consist of investigating whether the general concept has

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

een patented. The cost for a patent search is a few hundred dollars, depending on the nature of the id

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 and the province. A person can opt to have a comprehensive patent search done costing around a thous

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd dollars.

In most cases, a patent search yields negative results meaning a creative idea, no matter

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

how novel, might already have been patented earlier in some form. Therefore, it is necessary to conduc

.

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

a patent search before attempting to build a workable model of the concept. If a similar idea has bee

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

Companies that provide selfless information through particip

patented, the creator is able to decide where to make innovations in order to make the product unique

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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