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If you are an inventor looking at applying for your first patent, chances are you will be seeking what is known as a “utility patent.”

Also known as

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

a “full utility” patent or a “concept” patent, the utility patent represents over 85% of the approximately 3,500 patents issued by the United States P

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

Examples of combination products may in

tent and Trademark Office (USPTO) every week.

Like the other two categories of patents (design and plant), the utility patent does three basic things

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

• It requires novelty, usefulness and non-obviousness;

• It excludes anyone else from making, using or selling your invention for a cer

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

tain number of years; and

• Once it expires, it allows other parties than the patent holder to produce and sell the product.

If you are

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

Combination pro

applying for a utility patent, your invention must fit within one of four categories:

• apparatus

• method or process

• composition

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

of matter, or

• article of manufacture.

The U.S. government considers an apparatus to be a device with moving parts. Things

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

like electric pencil sharpeners, fax machines, blenders and even the infamous mousetrap fall into this category. An apparatus can be completely origin

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

l, or it can simply combine two or more existing products that result in a new use.

Are you a chemist who has invented a new chemical process or, per

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

aps, a computer professional who has written a new software program? If so, your product would fall into the method or process category which c

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

vers anything that describes a process from start to finish.

If someone asked you what a new prescription drug and cleaning solutions have in common,

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

Following aspects would a

would you know the answer?

Both fall into the composition of matter category for utility patents. Unique formulas for everything from film pr

dd to the challenges in developing combination products:

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

cessing solutions to biotechnology to lower-cholesterol butter can be protected through utility patents.

If you look around your home or office, you

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

ill quickly see many products which fall into the fourth utility patent category, article of manufacture.

Look in the silverware drawer. Knife

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

s, forks and spoons all fall into this next category. Take a look at the items on your desk. You’ll find paperclips, letter openers and the plastic co

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

er for your PDA. Visit your bathroom, and you will notice things like combs, tooth brushes and soap dishes.

So, what do all of these things have in c

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

Professional from academic institutions, pharmaceutical industries, health care indust

mmon?

None of them have moving parts. And, if you have improved or redesigned any of these items, your patent application will specify them as articl

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

es of manufacture.

Once granted, the utility patent provides you 20 years from date of application to “produce, promote and profit from your unique i

.

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

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

Companies that provide selfless information through particip

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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