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Do you have an idea or an invention that you would like to get patented? Are you confused or unsure of what to do to obtain an inven

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

tion patent? The best place to go to get patent information is through the U.S. Patent Office. This patent information is available o

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

Examples of combination products may in

line at their website at uspto.gov. Here's a step by step guide to how the patent process unfolds.

The first step to filing your pat

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

nt is to determine what kind of patent you need. There are 3 types of patents. The first is a utility patent. A utility patent protec

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

s how the new article is used and how it works. The next is a design patent. A design patent protects the way the new article looks.

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

Combination pro

he third is a plant patent which is used to protect asexually reproducing plants that have been invented or discovered.

Once you hav

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

e determined what kind of patent you need, you then start the application process. The application must be filed with the U.S. Paten

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

Office. The application describes the invention and it must state how to make use of the invention. It should also include why this

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

nvention should be protected by a patent. Documents, drawings, and testimonies should be included, along with the application fees.

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

he second step is when the patent examiner does a patent search to be sure your invention is truly new and not a copy of someone else

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

s patent. The patent examiner will communicate with the inventor or the inventor's patent attorney if any questions arise. This part

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

Following aspects would a

of the patent application process can take some time.

The third step is for the patent examiner to decide if the invention is truly

dd to the challenges in developing combination products:

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

nique and therefore in need of a patent. If your invention is unique, you receive a patent. If not, your claim will be rejected and y

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

u will have to argue against it.

You may go through a patent attorney or submit your patent application yourself. Patent attorneys c

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

n be found online or in your local telephone book. You may submit applications online electronically at the U.S. Patent Office's webs

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

te at uspto.gov.

Once you have obtained your patent, it will be good for a number of years. Even so, it is possible for other invent

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

Professional from academic institutions, pharmaceutical industries, health care indust

ors to try to copy your patented idea. Your patent protection is of no use if it isn't enforced. To help ensure enforcement, you may

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

wish to get the help of an Invention Development Organization (IDO). They will help you to keep your invention safe and to market you

.

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

product.

That's it! There's really not much involved in filing your patent. For resources and other questions you may have see http

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

Companies that provide selfless information through particip

//patent101.com. With some tenacity and a clever idea, you should be able to get a patent for your invention in just a matter of time

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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