Answers - Legal

It's less of a need than a want. Registering a trademark is NOT mandatory. However, are you a b

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

usiness owner, or do you work with a business that does not currently have a trademark register

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

Examples of combination products may in

ed or pending with the USPTO? If this last statement in any way describes you, then YES, you ma

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

benefit from having a trademark. It is true that many businesses do not register a trademark w

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

ith the USPTO, but this puts the business at a great disadvantage when compared to another comp

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

Combination pro

ny that does have a trademark.

Having a trademark notifies an individual that you have

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

the corner on your market. It allows you to take court action if another business does attempt

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

o infringe upon your name. You are essentially protecting your market upon registering a tradem

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

ark by publicly individualizing your name. This protection allows a greater piece of mind for t

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

e average business owner, by ensuring that no one may interfere with your customer base by conf

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

using their business with your own. The last scenario is a common occurrence, and many individu

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

Following aspects would a

als have been forced to deal with legal repercussions because they did not take the time to tra

dd to the challenges in developing combination products:

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

emark their name, while a competing business did.

Think about it like this; if your name was T

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

om Smith and you were a hard-worker, while there was another Tom Smith who was a poor worker, y

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

u wouldn’t want to be confused with that other individual, would you? As I mentioned above, thi

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

s confusion is a common occurrence among businesses. This is why it is important to prote

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

Professional from academic institutions, pharmaceutical industries, health care indust

t your name, and your products or services! While it is ultimately up to each business

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

owner whether or not they want to protect their name, be aware of the potential ramifications t

.

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

at can come with not applying for a trademark. Whether or not your name is trademarked could

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

Companies that provide selfless information through particip

have the ability to make or break your business; so why wouldn’t you apply for a trademark?

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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Answers - Do You Need a Registered Trademark?

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