Patents & Health Care Industry

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    Most importantly, unlike industries which produce products requiring expensive and complexmanufacturing infrastructures, the patented products of pharmaceutical companies can beeasily and cheaply replicated by copiers with little capital investment . Since capitalinvestment in the pharmaceutical industry disproportionately is directed to laboratory researchand clinical trials rather than the manufacture of the final product, patent exclusivity is the only

    effective way to protect and receive a return on that investment.

    The pharmaceutical industry has an important characteristic that sets it apart from other industries that rely on patent protection. In many technology-based industries it is possible tokeep inventions a secret until the moment they are marketed. This enables inventors to delay

    patent filings until the last possible moment and, therefore, to maximize the effect of the 20 year patent term which runs from filing of the patent application. The culture of medical research,however, emphasizes very early disclosure of inventions, usually long before a resulting productcan be placed on the market. This is because scientists working in the field of human pathologyhave an obligation to share their findings as soon as possible with their peers so that those peerswill be able to benefit from the new knowledge in their own research. And, unlike industries

    such as computers and software, the pharmaceutical industry is heavily regulated by governmentagencies to assure the safety and efficacy of products which will be sold to consumers. In theUnited States the Food and Drug Administration performs this function. Much of the investmentin new drugs is in the clinical trials which are necessary to satisfy safety and efficacy regulators.The tolerance for a buyer beware philosophy in the pharmaceutical industry is extremely lowcompared to other industries.

    The lengthy time period between patent filing and placing a product on the market means that pharmaceutical manufacturers receive far shorter periods of patent exclusivity than is the case for other patent dependent industries. This problem has been addressed in legislation in the UnitedStates and elsewhere which permits a patent applicant to apply for extensions of patent termto compensate for the inability to market inventions due to safety and efficacy regulation. However, the time periods permitted for such extensions do not equal the time lost in ability tomarket. In the United States patents can be extended only for half the time period consumed bythe regulatory approval process, and for a maximum effective patent term of fourteen years.

    Further, the legislation restricts the exclusive right of use which normally accompanies the patentgrant by permitting generic competitors to use the product for testing and developing the genericalternative while the patent is still in effect. This permits a generic product to be marketedvirtually the moment the patent expires.

    Drug companies usually apply for patent protection before they actually begin producing thedrug, opting instead to secure their rights to a particular compound at the beginning of the testing process. By the time a drug comes to market, there may only be 8-10 years of patent protectionremaining, which is significantly less than the 20 offered by the patent. Companies oftenattempt to extend these patents by making slight reformulations of the original compoundor proving its effectiveness at treating a condition other than the one for which it wasoriginally granted a patent. This is referred to as "evergreening", a practice which manycriticize.

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    Is there a world-wide patent?

    N o. Patents are exclusively national affairs. A US patent does not help you at all againstsomeone who makes your invention in Canada, and a German patent cannot provide protectionagainst French pirates. Some countries have concluded treaties under which patents can be

    granted that are valid automatically in all the parties to the treaty. The most famous one is probably the European Patent Convention.

    Since 1973 there is the European Patent Convention (EPC), a treaty between Austria, Belgium,Switzerland, Cyprus, Germany, Denmark, Spain, Finland, France, Greece, Ireland, Italy,Liechtenstein, Luxembourg, Monaco, the N etherlands, Portugal, Sweden, Turkey and the UnitedKingdom. Patents under the EPC are granted by the European Patent Office (EPO) in Munich.An inventor now only has to follow one procedure at the EPO and to indicate the EPC countriesin which he wants to have a patent.

    Health care providers

    y Facilitiesy Medical products, research and development

    Health care payment

    Doctors and hospitals are generally funded by payments from patients and insurance plans inreturn for services rendered.

    Major Segments of US Healthcare Industry

    Healthcare industry in US is one of the major providers of job and wages. Although this industryis very vast but it can be divided into following major segments:

    y Medical Equipment and Suppliesy Pharmaceutical Industryy Healthcare Services Industryy Biotechnology Industryy Alternative Medication Industryy D ietary Supplements Industryy Hospital Furniture Industryy Medical Instruments Industryy Medicated Personal Care Product Industryy Cleanrooms Industryy W aste Management Plants and Equipment Industryy Medical Clothing Industry

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    y Pharmaceutical Raw Materials Industry

    G overnment Role in US Healthcare Industry

    Government plays an important role in US healthcare industry by providing help to the elderly

    people, military service families, veterans and disabled. Federal laws in US ensure that every person has an access to the public emergency services whether they can pay or not.