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Various companies, in strive to achieve higher market shares and widespread popularity tend to ignore the importance of trademark registration. Getting a

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

trademark registration, though not a legal mandate, is as crucial as thinking of a name itself. The overall brand management and associated marketing effo

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

Examples of combination products may in

ts could go down the drain if the trademark is not registered. The registration of a trademark with the concerned authorities makes you the unique owner o

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

f a particular name or design and hence reduces possibilities of falsification or duplication in name.

Check Before You Invest: It is suggested to under

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

ake an assiduous search before thinking or launching a brand name to affirm if somebody else has already registered the specific name. A preliminary searc

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

Combination pro

can be undertaken on the various websites offering such services free of cost, however for an extensive search it is suggested to hire a professional i.e

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

. private firm involved in such researches or an attorney.

Registration Alternatives: The trademark can be registered either as a state or as federal tr

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

demark. The option to be selected from the stated depends upon the area of operation. In the case product is restricted to one state, the state trademark

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

ould be fine however, in the case the operations would be spread across at least two states, and federal trademark is considered appropriate.

Additionall

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

y trademarks can be filed in three situations i.e.: based on the use, based on a bonafide intention to use or for an application outside the country.

Reg

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

stration Process: Depending upon the alternative selected, you can download the respective application as available online. The applications must be depo

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

Following aspects would a

ited along with the requisite registration fee and mentioned information:

• The legal name of the applicant (often a corporate name);

• The state of inc

dd to the challenges in developing combination products:

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

orporation (for a corporation) or the country of citizenship (for an individual);

• The exact form of the mark;

• The use details

• A description of go

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

ds or services with which the mark will be used; and

• The international classification(s) for the goods and services

The applications are carefully scr

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

tinized by the respective departments. A unique number indicating the acknowledgement is sent out to the applicant. This number is used in future correspo

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

ndence. After about 4 months of filling, the applications are reviewed and corrections or objections are outlined which must be catered to by the applican

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

Professional from academic institutions, pharmaceutical industries, health care indust

within 6 months. In case the objections are still not clarified, the application could be abandoned. However, in spite of the applicant’s clarifications,

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

there are situations when the authorities are not satisfied and can reject the application. The applicant in such eventuality can appeal to Trademark Tria

.

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

l or Appeal board.

One can register a trademark all by one self however considering the implicit legal proceedings and requirements it is suggested to op

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

Companies that provide selfless information through particip

for professional help. There are firms or agents who deal in such related activities and have complete expertise of the procedures and anticipated issues

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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