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Current technological development necessitates conducting searches of patent information to avoid unnecessary investment

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

as well as gaining the seeds for technological development and the applicable fields contained in the patent information.

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

Examples of combination products may in

In order to accomplish this, visual representation of related patent information (hereinafter “Patent Map”) attracts the

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

attention of the persons concerned. A patent map is produced by gathering related patent information of a target technol

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

ogy field, processing, and analyzing it.

In simple terms, patent landscape mapping (PLM) is a tool to analyze existing I

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

Combination pro

P to determine the risks and opportunities of participating in a given technology and/or product space. It describes the

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

technologies and alternative solutions that have been applied to a particular product category. PLM identifies competit

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

rs based on their issued and filed IP, and outlines their strategies, strengths and problem-solving approaches. PLM enab

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

les a company’s scientific and commercial management teams to identify the best opportunities for investment in a selecte

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

d product area, to create a strategy to protect their IP, and to establish differentiation with respect to their competit

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

ors.

Also, in order to promote the use of patents, it is necessary for related institutions to deepen their understandin

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

Following aspects would a

g of patent information and strive to achieve efficient use of the information. The effectiveness of patent maps has also

dd to the challenges in developing combination products:

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

attracted attention with respect to this point as well. However, since experts are required for the gathering of patent

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

information etc. and analyzing, it is not always easy for the production of patent maps to be carried out by venture comp

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

nies, small and medium sized companies or universities and other research institutions on their own because they are unab

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

le to sufficiently invest human resources, economic resources and time.

The production of patent maps is conducted in th

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

Professional from academic institutions, pharmaceutical industries, health care indust

e form of a joint project by experts on patent information analysis and specialists on each technology field. Twenty to t

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

hirty thousand patents are extracted for each technology field then analyzed using various methods in order to perform th

.

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

is work.

The overall image of a title technology field, relevant technology classification (categories), structures for

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

Companies that provide selfless information through particip

related proliferating technology, comparisons between US and Japanese patents, structures of patent rights are introduced

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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