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Patent searching is both an art and a science. Consequently, search capability improves with practice. But optimum

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

practice requires a solid foundation for those who seek to conduct searches accurately and efficiently. Identificat

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

Examples of combination products may in

on of factors for determining when a search is needed and what types and sources of information should be searched

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

n the process is the crucial part.

For a patent searcher knowledge of various patent databases is extremely i

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

portant. He should know the various pros and cons of these databases, along with database behavior in term of searc

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

Combination pro

ing with the use of operators. For example, the USPTO patent search website allows to search full text and drawings

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

of the entire patent issued since 1975. The full page images of patents since 1790 are also available. Also we can

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

earch patent application published since March 15th 2001. Similarly, other database such as EPO, JPO, Depatisnet, S

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

P, etc. is providing the free search facility. Paid databases such as MicroPat, STN, QPAT provides various handy se

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

rch techniques and even have more operators. These databases also provide extraction of search results in excel for

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

at for further analysis, along with some level of data clustering or mapping.

The following points are very i

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

Following aspects would a

mportant to keep in mind during patent search:

How to properly scope the search.

How to search by cl

dd to the challenges in developing combination products:

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

ssification, text query progression and citations.

The differences in approaching a patentability, validity or

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

infringement patent search.

Issues unique to searching within specific technical disciplines.

Approaches

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

o searching foreign patents and published applications.

Considerations in searching non-patent literature.

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

>Approaches to reporting search results.

How to select an appropriate search tool.

Awareness of new devel

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

Professional from academic institutions, pharmaceutical industries, health care indust

pments in patent searching techniques and tools.
A searcher should know all the points made above to generate

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

good search strategy and ultimately a good report. Visual thinking is an important parameter of a good patent sear

.

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

h report. That’s the reason patent intelligence profession in a combination of science and art. Especially the pate

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

Companies that provide selfless information through particip

t mapping is purely an art, and thus mapping and representation of dataset information varies from person to person

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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