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Patents had been long identified as most valuable informational source of the technical and competitive informati

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

ons. During the last few years these have gained a lot more attention. Due to increase in the globalization and c

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

Examples of combination products may in

ompetition, it is very important for the companies to protect their innovations and also make their R&D activitie

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

s more efficient. India is well recognized as a knowledge hub, due to it’s highly talent pool. A lots of IP servi

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

ces providers; emerge in India during the last few years. Most of them have are being started by 2-3 people with

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

Combination pro

their contacts in mostly in US. Now these firms are become the giant in providing specialized IP services. Lots o

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

f Indian law professional and law firms are also now trying to enter into the market to provide the highest quali

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

ty analysis and research services.

Most of these companies are located in the Bombay, Delhi, Hyderabad and B

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

angalore cities, with well developed infrastructures and internet access. Almost all firms are claiming to provid

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 the following different types of IP services :

1. Novelty search
2. Infringement search
3.

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

State-of -art search
4. Patent validation
5. Patent drafting

There are lot more very specialized o

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

Following aspects would a

ther services also.

All these services include three basic crucial steps:

1. Patent and non-patent search<

dd to the challenges in developing combination products:

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

br> 2. Mining/analysis of Patent and non-patent documents for information specific to project needs
3. Repr

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

esentation of gathered information in nice visual and easy to understand format

Most of the professional and

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

firm are using the very general and conventional methods for all three section mentioned above. There are a lot

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

of chances for the improvement in these areas to generate more quality technical reports. Dolcera is one of the

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

Professional from academic institutions, pharmaceutical industries, health care indust

US based firm at Hyderabad, had done a lots of research in all these important area and has implemented new ways

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

and method for patent searching analysis and mapping to provide world class IP services. The Online IP Maps and I

.

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

P Dashboards are one of the achievement, and will change the reporting and representation format.

Thus there is

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

Companies that provide selfless information through particip

an increased need for more research to identify new improved tools and techniques to meet the high quality demand

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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