Actual - Legal

Legal Process Outsourcing (LPO), a forte sector within the Knowledge Process Outsourcing (KPO) space, is attracting international law firms who

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

are outsourcing legal work to India. Within the LPO industry, it is patent outsourcing, which is catching up faster than the rest of LPO jobs. W

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

Examples of combination products may in

ile major firms in the US quote up to $15,000 for preparing and filing a patent application, companies based in India deliver the same work for

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

2,500-3,500 in India. This allows companies to file additional patents within the same budgets.

India’s participation in the outsourcing

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

arket has been exceptional in the last decade. Both, overseas customers and Indian entrepreneurs constantly search for newer areas to render pro

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

Combination pro

essional and commercial support at reasonable costs with quick turnaround. The Indian involvement in the patent-related market is still in a nas

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

ent stage. In my view, it will soon take off – especially since India has many lawyers and even more people in science and engineering streams.

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

A marriage between them will surely support the patent-market.

Patent outsourcing includes literature searches, prior art searches, technol

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

gy and patentability assessment, patent proof reading, patent claim mapping, drafting response to objections by US examiners, preparing/filing/p

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

osecuting trademark applications, infringement studies, other IP litigation, IP asset management, Patent mining and administration.

During

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

he last few years dozens of Indian outsourcing services firms has emerged and most of them are making good business. These firms offer variety o

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

Following aspects would a

patent related research.

Technology changes rapidly and it is often difficult to keep track of all the trends swirling on the Internet,

dd to the challenges in developing combination products:

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

all the ideas bubbling in academia, and the range of innovations you and your competitors are working on. The outsourcing firms provide sophisti

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

ated service to track technology trends, juxtaposing academic research, market data and patent filings information worldwide. Dolcera, with an e

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

xception help you put together your technology roadmap and identify innovation partners around the world, along with other IP services. IP Land

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

cape Reports are detailed "as is" analysis of an existing technology. These reports cover broad landscape on areas of research and development -

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

Professional from academic institutions, pharmaceutical industries, health care indust

such as an entire product category - that are critical to the clients. These reports are based on analysis of several hundreds or even thousands

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

of patents and other unstructured information.

The Dolcera IP dashboard provides an integrated view of all the key performance indicators f

.

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

r your organization's intellectual property. The interactive executive IP dashboard allows users to perform their own what-if analysis. Behind t

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

Companies that provide selfless information through particip

e scenes, the Dolcera team performs extensive research and market + competitive analysis to drive the executive dashboard and keep it up-to-date

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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Is your ezine making the kinds of profits you would like it to? This article explores how you can make more money publishing each issue--in a way your readers will love.

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