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In marketing, there is a particular strategy known as branding. In many ways, trademarks are designed to protect your brand from use

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

by others.

An Introduction to Trademarks

A trademark is a form of intellectual property. Intellectual property is owned by the pers

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

Examples of combination products may in

n or business creating it. With practically all forms of intellectual property, however, you have to take steps to formally notify th

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

world of your property and protect it.

A trademark is a distinctive mark used to identify a product, company, service or device. Wh

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

n you think about it, you are very familiar with trademarks. At the risk of being sued to the high heavens, the following are tradema

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

Combination pro

ks: Coca Cola, Pepsi, Google, EBay and Toyota. Each of these words mean something to you and are readily identifiable with a product

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

r service in your mind. When you think of EBay, you immediately think of an online auction site that was originally created so the ow

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

er’s girlfriend could trade Pez dispensers [true]. When you think of Toyota, you think of cars. This is the power of brand recognitio

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

and trademarks are used to protect them.

A trademark is a powerful thing when it comes to the law. If you obtain a trademark, it is

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

binding nationwide and others are not allowed to infringe upon it in an effort to swipe your customers or confuse the public. With yo

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

r mark, you can sue to stop the infringement and recover monetary damages suffered. Basically, a trademark is a hammer for stopping n

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

Following aspects would a

farious conduct cold.

To obtain a trademark, you must have patience, patience and more patience. The mark is obtained through the Pa

dd to the challenges in developing combination products:

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

ent and Trademark Office. It is a very slow process. You or your attorney do a search to make sure are not in conflict with any previ

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

us marks. You then file an application and begin waiting. Within 8 weeks, the Patent and Trademark Office will send you a notificatio

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

indicating they acknowledge receiving your application. Just receiving it! You will then wait another 6 months or so to hear if 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

pplication is accepted. Often you will receive correspondence asking for clarification or raising a problem. You then provide a respo

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

Professional from academic institutions, pharmaceutical industries, health care indust

se and wait. Months will pass. Eventually, the back and forth will come to final result. If your trademark application is accepted, i

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

will be published and you are protected. The process is so lengthy that it is not uncommon for it take well over a year for the appl

.

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

cation to be approved. In short, you are going to need a lot of patience.

While obtaining a trademark can take forever, it is well w

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

Companies that provide selfless information through particip

rth the effort. Once you have it, you can keep competitors and others from using the trademarked term you worked so hard to establish

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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