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Before you register a patent you need to do some basic research.

Not only is it the

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

job of the United States Patent Office to issue patents, it also maintains a database

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

Examples of combination products may in

of the patents that have been granted. The majority of patents issued by the Patent

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

and Trademark Office are utility patents. With such a large amount of these patents i

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

ssued yearly, it is necessary for the inventor to research whether someone else has a

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

Combination pro

lready patented their newest invention.

A search of previous patents can be done in

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

a variety of ways. These methods include accessing the Patent and Trademark database

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

by searching online or going to the library of the USPTO and completing a patent sear

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

ch there. When visiting the USPTO, the patent database is available on microfiche, pa

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

per, and CD-ROM.

An initial search on the government patent website can show if the

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

atent has already been released for the product you plan to apply for. By doing this

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

Following aspects would a

search, you reduce the risk of wasting your time putting in an application for an ite

dd to the challenges in developing combination products:

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

m that has already been patented. Another reason to consider using the patent databas

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

e for research when submitting an application is that it can help reduce the time tak

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

en for your application to be processed. The Patent Officer looking at your applicati

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

on file will have an easier time when they search the database, and discover no other

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

Professional from academic institutions, pharmaceutical industries, health care indust

patents exist. This might speed up the approval process on your application.

Using

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

the online search tool is great if you have a patent that is easy to find. If you are

.

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

not located within driving distance of the Patent Office, it is possible to request

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

Companies that provide selfless information through particip

lists of patents be sent to your home address, though there is a fee for this service

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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Actual - Patent Research - Part I

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