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Even if you choose to use a patent agent or attorney to help you protect y

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

our invention, you will still have some work to do. After all, it’s your

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

Examples of combination products may in

invention. And they need you to communicate the in’s and out’s of it as b

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

est you can.

It’s not just as simple as meeting with a patent attorney, g

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

ving them a short blurb on your invention, and expecting everything to mag

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

Combination pro

ically fall into place. You will have to put in some effort here.

Obviou

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

sly, they don’t know your invention like you do. And a short little discu

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

sion on it is probably not going to put them in the know. You will likely

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

need to spend a significant amount of time conveying the intricacies of w

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

hatever you’ve invented to them. After all, the strength of your patent d

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

pends on how well you communicate your invention to your patent practition

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

Following aspects would a

er.

So here are some things you need to ponder before you start getting c

dd to the challenges in developing combination products:

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

harged by the hour…

What problem does my invention solve?

When exactly w

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

as it invented?

How can I describe my invention as specifically as possib

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

e?

What are similar or related inventions?

What makes my invention bette

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

r than these similar or related inventions?

What features have I improved

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

Professional from academic institutions, pharmaceutical industries, health care indust

upon?

In addition to answering these questions as best you can, bring an

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

drawings, photographs, or an actual prototype of your invention that 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

may have. These will only help demonstrate your invention better. They a

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

Companies that provide selfless information through particip

ren’t absolutely necessary, but may help keep the meeting running smoothly

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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