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I believe there is creativity in every person and so, apparently, does Simon Cowell (or maybe he knows it makes great TV!). The crazies on American Inventor aside, I believe t

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

hat people's creativity may may be suppressed, out of fear or embarrassment, or just undiscovered. But maybe you already knew that. Maybe you have a little workshop in your g

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

Examples of combination products may in

arage or in a corner of your apartment. Maybe you spend your free time tinkering around, trying to make a better mousetrap. Maybe you count yourself among the inventors, a ra

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

re breed of maverick that feels compelled to solve the most mundane of problems. And I, for one, thank you for being that kind of freak.

If you’re going to be an inventor, tho

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

ugh, it’s crucial to protect your Intellectual Property from people who might try to steal your idea and your resulting profits. There are three types of patents currently gran

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

Combination pro

ted by the U.S. Patent and Trademark Office. They are:

• Design Patents

• Utility Patents

• Plant Patents

Design and Utility Patents are the two most commonly applied for.

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

As of the time of this writing, Design Patents are issued for a period of 14 years, and protect the design of a device, machine or process. For instance, you cannot patent a

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

woman’s purse. But if you've made substantial enough changes to it in terms of its structure and overall look, you may be granted a Design Patent.

A Utility Patent is grante

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

d for a period of 20 years, and governs the way a device, machine or process might be used. If significant improvements are made to the way a process, such as yoga or physical

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

exercise, is used, it may be granted a Utility Patent.

Plant Patents protect new varieties of plants, which may be patently (sorry) obvious.

Some people choose to go through

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

a patent attorney, and that can be very helpful for newbies. But if money is an issue, Design Patents are very easy to apply for, and the services of an attorney are not requir

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

Following aspects would a

ed. The typical cost of obtaining a design patent is approximately $400, which does not include an international patent search or technical drawings. An international patent

dd to the challenges in developing combination products:

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

search is necessary to make sure someone else has not yet patented your idea or design. Patent searches can be done in patent libraries, or through a patent searcher, who is l

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

ikely to charge around $200-300 per search. Technical drawings are usually necessary, unless your product has been prototyped (at least one of them has to exist, in other word

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

s).

Applying for a patent provides “patent pending” or “patent applied for” status, usually in about six weeks. Much, if not all, of the process can be done online (http://ww

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

w.uspto.gov), or easily with PatentWizard 2.0. Doing things this way allows you to seek out venture capital, if you want to start your own business and take care of manufactur

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing, or approach a licensing agent, if you’d prefer to farm out the manufacturing in exchange for a cut of units produced and sold.

Licensing is another issue, but suffice it

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

to say that you will need a logbook to track the process of inventing your product. In the event of a challenge by the Patent Office, you need to have a record of drawings, sk

.

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

etches, ideas and random jottings that are dated along the way. Inventor’s Place has a wonderful logbook that not only gives you the space you need to keep track of your invent

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

Companies that provide selfless information through particip

ion’s progress, but also gives encouragement and valuable tips that will save you money before you fork any more over to the government.

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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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