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Intellectual Property is gaining the attention of all industry sectors in recent few years. In today’s h 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 ypercompetitive environment, it is essential for organizations to gather competitive intelligence from d ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in fferent informational sources. Patents are one of the most organized and easily accessible competitive & lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. technological information sources. Patent intelligence is the transformation of content found in multipl here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe patent documents into technical, business and legal insight and is a key element to gain competitive ad d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro antage. Patent intelligence can provide so much more to a skilled business stakeholder, whether in 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 a legal, R&D, strategic or business development role. Patent information can be used to anticipate marke 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 entry, understand technical and business white spaces, identify licensing and sales targets, and assess nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically competitor strengths, weaknesses, opportunities and threats, among many other lucrative uses. It ha 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 been found that more than 80% of the information in patents cannot be found anywhere else. The importan ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi e of patent intelligence in technical and competitive monitoring of competitors activity can not be over ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a looked, since patents are a recurring output of the innovations in competitive environment. The informat dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod on available from looking across patent filings provides unique perspectives on: The information a cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin ailable from looking across patent filings provides unique perspectives on: tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen s between inventors, companies, attorneys, etc. 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 arch trends, etc. ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust ngths/weaknesses.
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products Motivations, applications, improvements, opportunities, investments, etc. Patent Intelligence . 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 rovides information about specific conditions in relation to technological or market-related development elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip which is very useful for the decision makers in tracking competitors activity and new innovation trends 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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