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You know that feeling when lightning strikes? Not literally, of course, but that instant of Eureka! An idea so brilliant that you just know this is your one way ticket to easy street. Now, 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

ll you have to do is produce and sell your idea. Should be just a hop, skip and a jump to the good life, right?

Unfortunately, it is not that easy, in fact, it can be down right complex. It

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

Examples of combination products may in

is a very risky thing to turn your idea into reality. With competitors lurking around every corner, you have to take care to protect your budding idea.

What you really want to do is make su

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

e you do not have competitors at all. You know how when you go to the store and see a product from company A under the name "Great Idea" and then Company B has a similar product under the na

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

e "Wonderful Idea" ...that is what you want to avoid. You have to try to make sure there is not a Company B.

Trademarking your product is also very important for an entrepreneur. This symbo

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

Combination pro

next to your company name or logo tells the world that this is your idea and company. You will need to register your trademark to protect your company from others illegally using yours. Thi

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

k of it as your companies identity. If you don't protect it, it is out there for the world to use.

So, now that you know you have to protect your idea and company from being copied, the nex

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

t question is how. Here is where the lawyers get their cut. You will be able to find lawyers who specialize in patents and copyright law.

By patenting your products, getting the copyright o

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

the necessary documents and registering your trademark, you will make it illegal for any other company to sell your product or use the trademark without asking your permission to do so firs

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

.

The process of obtaining a patent and registering your trademark can be very expensive, and then add to that the attorney fees and filing fees and possible time off work and the bottom li

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

e gets bigger and bigger. That is why you need to do your market research to be sure that the idea you have is worth all the expense.

You have to give due diligence to analyzing your idea t

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

Following aspects would a

make sure there is a spot for it in the market place. After all, you could pay thousands only to find out later that not everybody thinks the idea was as wonderful as you did.

After you ha

dd to the challenges in developing combination products:

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

e made the decision to go ahead and spend your time and money on the next big thing, it is time to find yourself a good attorney. You may have to talk to several lawyers before you find one

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

ou like and feel you can trust. But do not forget to make sure they know what they are doing as well. After all, a guy can be nice and incompetent at the same time.

You may be tempted to n

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

ot hire an attorney and just file the paperwork yourself. It can’t be that difficult, right?

Wrong!

An attorney will be able to navigate the maze of the US Patent Office. Not only will the

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

take care of all the paperwork necessary, but it will be filled out correctly and to the correct office. How much will you be wishing you had hired an attorney if the paperwork missed a ver

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

Professional from academic institutions, pharmaceutical industries, health care indust

important deadline and your idea got pulled out from under you and the fortune that was suppose to be yours goes to the guy that didn’t decide to save the money?

There are requirements tha

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

the patent lawyer will know about. They have the experience to help you through the process. They have done this several times before and chances are, this will be your first time. So, do n

.

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

t skip this step.

These are just a couple of the items to keep in mind after your 'light bulb' moment when making the decision whether or not to patent your idea. By knowing what you need t

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

Companies that provide selfless information through particip

do to make your idea takes off, you can make a better and more informed decision before you spend even one penny. Think of it as dipping your toe in a pool before you jump in with both feet

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 and Trademark Attorney: What They Do and Why You Need One

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