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Top Articles - Patent - Marketing Strategy
In this article we're going to discuss the tricky aspect of marketing strategy when applying for a patent. Getting a patent is a tricky process under normal circumst 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 ances. Under laws of the United States a company or person is entitled to a patent unless the invention was on sale in the country for more than one year prior to th ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in application date of the patent. This applies to both sales and offers of sales. Therefore, companies conducting marketing campaigns must be careful not to destroy lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. heir patent rights. In a perfect world, application for a patent should be filed before any sales begin. But then that would hurt the company's bottom line because here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe hat ultimately puts profits on hold. In a competitive marketplace this could spell disaster for the company. Therefore, it is important for a company to understand d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro ust what it is that starts the one year clock ticking. In other words what can they do and what can't they do in order to avoid their product being put on the timer? 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 In order to answer that question we have to understand what exactly, according to law, starts the clock running. There are basically two conditions. The first one 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 is that the invention must be ready for patenting at the time of the sale. If it can be shown that the inventor had sufficient drawings that would enable another per nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically on to use the invention then this would satisfy the first criteria. The second criteria is that there has actually been an offer for sale. In other words, the inven 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 or or company that owns the invention approaches another company and offers to sell them the invention. This can either be in the form of a letter to the other compa ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi y or in an actual physical meeting between the two companies. Usually the meeting follows a letter. In the form of a letter the owner of the invention will usually ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a raw up a letter stating that they have such and such an invention and go on to say that they feel this is something that would enhance their business. In the letter dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod hey would describe what the invention does and how it would help them. They would then ask the other company to get back to them if interested. When it comes to the cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin meeting the inventor will bring drawings of his invention and present them to the company interested in acquiring the invention. Maybe the inventor even has a workin tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen g prototype he can show them. This is always a plus. Companies actually like to see that the invention they are interested in works. Where the law comes in, and th 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 s is where inventors can delay the clock, is that the following items do not fall within the two criteria. Solicitation of customer pricing information from distribu ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust ors and sales representatives; publication of preliminary data sheets and promotional information on invention features; communications to sales representatives; sale y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products representatives providing customers with preliminary data sheets; and sales representatives' requests for customer samples. Therefore, an inventor can engage in any . 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 of the above activities and NOT start the one year clock running. This allows the inventor to get as much preliminary leg work done for his patent without actually " elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip echnically" starting the process. This is important information for any inventor to have if he is trying to gain as much ground in his quest for a patent as possible 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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