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This article will help you get clear on getting a patent and understanding some of the ways patents work.

Before you embark

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

on the process of obtaining a patent for your idea, realize that obtaining a patent is not an overnight process. It involves

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

Examples of combination products may in

countless hours of detailing or describing how your invention works, along with thoroughly and correctly filling out the part

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

of the application form. If you have a wonderful invention, it is a good idea to have realistic expectations of what you can

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

expect to undergo during the patent process. This will save you a lot of trouble and frustration in the long run.

The first

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

Combination pro

thing you should do is read as many of the guidelines and documents that the Patent Office itself publishes as you can. The

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

atent and Trademark Office has numerous guides and publications available at

www.uspto.gov/main/definitions.htm

This page o

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

utlines the steps involved in receiving an approved patent.

By reading as much literature as possible before you submit your

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

application, you decrease the chances of filling out the application incorrectly, and will have a better understanding of th

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

various stages of submitting a patent application and having it approved.

Another aspect to consider when thinking about fi

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

ling a patent application is your reason for doing so. If you are filing the application just so you can brag to your friends

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

Following aspects would a

about having a patented product, then stop and think about the fees you will be paying for an invention that will never be m

dd to the challenges in developing combination products:

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

nufactured or sold. The patent application route can become expensive for the lone person filing an application, or for someo

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

ne who has taken a few wrong turns here and there. However, if you plan to sell your product and make back the expenses after

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

paying for the patent, then consider filing the application.

Before putting in the application for a patent, it is also rec

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

mmended that you think seriously about the invention you have. Can your invention realistically be patented? There really is

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

Professional from academic institutions, pharmaceutical industries, health care indust

no point in going through the process of obtaining a patent lawyer and filling out the paperwork only to have the Patent Offi

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

ce reject your application because you failed to consider your invention realistically based on the Patent Office criteria. E

.

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

en though it might be painful to reach this conclusion, if your invention will not fit the criteria for obtaining a patent, i

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

Companies that provide selfless information through particip

t is best not to submit an application.

Now you understand how to clearly get moving in the direction of setting up a patent

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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