Answers - Legal

Protecting your logo and so on with a trademark is a smart move. Ah, but what about protecting it in the United

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

States AND internationally?

Filling for a trademark is a smart move for practically any business. Although the

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

Examples of combination products may in

process can be lengthy, the final approval gives you the ability to stop competitors from using your mark to con

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

fuse consumers and perhaps steal them.

To obtain a trademark, one has to file an application with the Patent an

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

d Trademark Office. The application sets out the areas, known as classes, you wish the mark to apply to. Once th

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

Combination pro

e “PTO” approves your application, it is published for comment. Assuming no objections are raised, your trademar

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

k is approved. It is important to understand, however, the mark only applies to the United States.

If you want

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

to gain international protection for your trademark, you need to understand the Madrid Protocol. The protocol wa

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

s created to deal with problems where two marks were registered in different countries and conflicts then result

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

ed. The idea is to create a clearinghouse where a trademark in one country automatically applies to the other co

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

untries signing on to the Protocol. The United States signed on to the Madrid Protocol in 2003. 80 others have

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

Following aspects would a

signed on as well, including most major economic countries.

To apply for an international trademark, one files

dd to the challenges in developing combination products:

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

a form with the Patent and Trademark Office. The application must perfectly match the national mark you are seek

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

ing. Once filed, it is forwarded by the Patent and Trademark Office to the International Bureau in Switzerland w

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

here the application is run against an international database and approved or rejected.

The cost for filing 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

international application is $100 per class you wish the mark to apply to, although there are exceptions where

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

Professional from academic institutions, pharmaceutical industries, health care indust

$150 is the cost. If approved, the registration will last for a period of 10 years. You can renew the registrati

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

on for subsequent 10 year periods as necessary.

Filing an international trademark is a smart move if you envisi

.

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

on your business entering international transactions. A question of cost effectiveness, however, certainly needs

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

Companies that provide selfless information through particip

to be considered for most small businesses. Simply put, your money may be spent more effectively in other areas

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 - International Trademarks and the Madrid Protocol

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