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Patent, trademark, copyright - we hear these three terms very frequently. Many don’t know that

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

there is a distinct difference between filing for a patent and filing for a trademark. Same wit

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

Examples of combination products may in

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

tent

When can you file for a patent? If you have a novel and unobvious invention, or a nov

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

l and unobvious improvement to an existing invention, you can file for a patent. A patent can b

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

Combination pro

e of different types. To see the different types of patents, see our previous article here: Dif

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

erent types of patents.

Filing a patent usually gives you protection for 14 to 20 years, depen

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

ding on the type of patent. Filing a patent is an expensive proposition, and it should be done

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

nly if you are sure of the market value of the invention.

Trademark

A trademark, to ex

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

plain simply, is a brand name. A trademark is something which forms part of a product or its pa

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

kaging, and is used to distinguish it from others in the market. It can be a word or a symbol.

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

Following aspects would a

Copyright

A copyright is a right given to the creator to exclude others from copying or

dd to the challenges in developing combination products:

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

publishing or reproducing his or her works. A copyright is applicable to music, movies, drama,

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

software, paintings, and many other fields.

One point to note is that even if there is a copyr

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

ight, it cannot cover the entire subject matter. Let us take the example of a copyrighted book.

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

You cannot copy specific wordings from the book, but you are free to read the book, understand

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

Professional from academic institutions, pharmaceutical industries, health care indust

it, and publish any of the ideas or concepts in your own words.

So, the bottom line is, one si

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

e does not fit all. There are situations where a simple copyright will protect your work. At so

.

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

me other times, you may need a trademark to protect your USP. And, if you have just invented th

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

Companies that provide selfless information through particip

t “killer product”, it certainly makes sense to go for the additional expenses for patenting it

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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