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Patents are not new, their presence was noted long back during 16th Centaury. In U.S. at the Constitutional Convention of 1787, a federal patent power was proposed by James Madison and Charles Pinckney and was adopted without debate as Article 1, Sec. 8, clause 8. The history of Patent Law began all the way b

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

ack with the Constitution of the United States which was specific about providing protection for those who invent new and unique products. But after the TRIPS, intellectual property rights and patents gained importance to the business communities and industries. The retrieval of the patent information was mad

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

Examples of combination products may in

e easy by internet and access to different patent databases. Patent are the source of the technological innovation and detailed mining of patent literature is proven to be useful of the Completive Intelligence.

This article attempts to analyze importance and methods for the patent data mining and their futur

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

e use in the competitive intelligence. The key issues discussed in this article are:

a. Importance of the patent data mining;

b. Using patent data for competitive intelligence

Data Mining is a process of discovering meaningful new correlations, patterns and trends by sifting through large amounts of data s

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

ored in repositories, using statistical, data analysis and mathematical techniques. Patents are the most valuable and comprehensive source of the technological information and thus are very crucial for the industries. A very strong patent portfolio and IPR system is needed for a industry to compete the global

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

Combination pro

market. An organization’s patent portfolio forms a critical part of its IP holdings alongside its designs, trademarks, copyrights and trade secrets. Much of the value from a portfolio can only be realized through its effective management. In turn, that requires tools and techniques to help understand portfol

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

io content, how and where this fits in with the organization’s competencies and what the market opportunities are for exploiting the technology owned. There is also a need to identify gaps where complementary technology can be licensed in and identify non-core technology where know-how can be licensed out or

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

ivested for financial return. This is the province of patent mining. A clear and effective IP strategy critically incorporates a clear and effective strategy for managing an organization’s patent portfolio.

There are several free and paid patent databases consisting of billions of the patent documents. The d

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

atabases which are free to search the patents are as follows: USPTO, EPO, JPO, SurfIP, SIP, Freshpatents, Patentsonline, etc. Whereas different paid databases are, Delphion, Dialog, Micopat, etc. which also include inbuilt analysis tools.

The data obtained form these patent documents can be used for the comp

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

etitive Intelligence. It is defined as process of discovering "competitor's" strategic decisions, or of business area characteristics, using quantitative analysis techniques applied to data and information, obtained through legal process, regarding the chosen competitor or business area. Patent searching and

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

nalysis is done based on the objective. Patent data can be used for the completive intelligence in different ways as mentioned below:

• Theme Search: Theme searches provide the overview of patents related to your field of interest. These searches are helpful to detect the recent trend of your technology area

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

Following aspects would a

and to establish your R&D direction. As these searches are fully client-oriented, the point of our work and report format is supposed to be various according to your needs.

• Patentability Search (Novelty Search): Patentability search is the first step of patenting process. A patentability search surveys pa

dd to the challenges in developing combination products:

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

tents filed in each national intellectual property office to check whether there exist inventions similar to yours. If you have a plan to file your invention to other countries, this search is essential because the foreign application is quite costly.

• Search by keyword (Assignee, Inventor, etc): This searc

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

h provides the information of patents retrieved by specific keywords including assignee, inventors, or IPC, etc.

• Family patent / Legal status search.

• Current Awareness Search: This search is to report new development in particular technology or patenting activity of competitors regularly. You can keep i

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

touch with recent technology as well as detect your rival's R&D achievement and legal status of a particular patent with which you should consider continuously. This search is performed at interval specified by your requirement: weekly, monthly, or quarterly. Category.

• Legal Status report - Keep informed

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

the current legal status and expected legal action of a particular patent.

• New Patent report - Keep informed the newly published or granted patents categorized in specific technology area defined by your searching queries.

• Patenting Activity report - Keep informed patenting activity of a particular assi

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

Professional from academic institutions, pharmaceutical industries, health care indust

gnee or inventor who you are interested in.

• Infringement Search: Infringement search is to check whether patent which can be infringed by your product being supposed to launch newly in a certain country exist or not in that country.

• Invalidity Search: When you intend to make some claims of a particular

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

atent invalid, the invalid search can provide some prior art references that disclose claims that are infringed by the subject disclosure.

• Patent Map (Patent Analysis): Quantitative analysis based on statistical data of bibliographic information (country, assignee, IPC, etc). Qualitative analysis of core p

.

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

atents, Technological road map, multifarious analysis.

• Right-to-Use Searches: Right-to-Use searches are conducted, prior to marketing a new product, to confirm that the new product does not infringe on an existing patent or potentially infringe on a patent application.

Conclusion

These types of searches

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

Companies that provide selfless information through particip

are primarily done using the different patent database and are very useful for competitive intelligence in the todays global prospective. Patent analysis and mining in combination with market research and financial assessment can build up a strong competitive environment for the competitors for the industries

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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