Effect of secondary patents on drugs prices and generics competition““I am a

Effect of secondary patents on drugs prices and generics competition““I am a 75 year old retired nurse. I worked for over 50 years providing health care and health education. I have psoriatic arthritis. I was prescribed Enbrel injections for arthritis. This injection is very expensive and I am unable to afford them on a 6 fixed income. I was able to get a break on Enbrel from the company by special request for the time being, but it has been cost prohibitive for me – $600 for a month’s supply.” B.S {1}Objectives:- Define intellectual properties and patent terms- Define evergreening and secondary patent terms- Explain how secondary patents affect drugs prices and companies competition- Report a case to support the previous mentioned effects of secondary patentsIntroductionWhat is intellectual property?Social sciences have always considered property as a rock base component. It is somehow debatable if we can accommodate intellectual property within other accounts of property or whether it should belong to different ones. {2} Intellectual property (IP) is the preservation of the authors mind inventions by the federal and state laws through getting a grant of exclusive rights for benefiting and utilizing their inventions {2},{3}.Patents, copyrights, trademarks, and tradesecrets are all examples of the intangible intellectual properties that are issued by the federal level using the standards of the U.S. Patent and Trademark Office {4}. Patent is the power to prevent and exclude others from selling, utilizing and producing the invention in the United State of America for a limited twenty years duration {4}.Patents help the management of the investment in innovation, encourage the invention activities since drug development is a high cost business and need protection, help economic growth and national industry through companies which may trade internationally their patented products {5}.In order to earn patents approval inventions should have three main features which are novelty, nonobviousness and utility. Inventions that pass the requirements can get patents to guarantee exclusivity in the market for twenty years {6}. Pharmaceutical companies and manufacturers use patents to have a monopoly in the market and to increase their investments returns {6}. Companies use what is called secondary patents to extend the period of market monopoly and to prevent generics competition for more than twenty years {7}. This practice of filling “later issued“ patent usually called evergreening {7}. During the last 100 years, seventy-four percent of new patents were filed for previously existing drugs and eighty, eighty-five percent of top trading drugs prolong their patents once and twice respectively {7}. Secondary patents are patents that provide protection on other property than the origin component of the drug {8}. Examples are having patents on tablet coating of the drug or on drug administration methods; a company can get new patent on a formulation of temperature stable tablet instead of temperature sensitive soft gel {8}. Many people argue that those secondary patents are usually weak, unmerited, serve only business and just used for companies’ own interests and for delaying generics competition {7}.The process of new drug development and research costs companies a massive amount of money accompanied with many difficulties {7}. By applying for secondary patents, manufacturers and pharmaceutical companies may have the chance to dominate their existing products exclusively in the market for longer periods and to get huge profits and returns from the current products in the absence of competitors {8}. This enables them to charge very high prices of their brand drugs {7}. Secondary patents has also led to increase the number of conflicts and lawsuits among competitor companies since the longer patent period will prevent them from launching their generics to the market {6}. The next case will briefly summarize the effect of secondary patents on drugs prices, patient health and companies’ competitions {6].Case reportOne of the top selling drugs in US is Amgen’s drug Enbrel. Its active ingredient is entanercept, a fusion protein that inhibits tumor necrosis factor (TNF) which results in its anti-inflammatory effect for reducing rheumatoid arthritis symptoms. Amgen filed Enbrel’s first patent in 1990, giving twenty years ahead means that the expiration should be in 2010. However, Amgen has filed 57 patents for Enbrel including secondary ones for preventing generics competitors until 2029. Seventy two percent of all Enbrel applications were filed after Enbrel was on the market. Amgen did not file as many patents in US as in Europe; this reduced number of patents in Europe caused a drop in Enbrel price and led to increase market sharing with biosimilars which pushed Amgen to protect their market monopoly in US using overpatenting. The US market exclusivity causes overpricing of Enbrel with unaffordable prices that can seriously hurt patients’ health and well being and have bad effects on the health of Americans who are not able to purchase the drug , giving the previous quote from rheumatoid arithritis patient as an example. In 2015 Sandoz company triggered Amgen through filing license application with FDA on a drug that is considered a biosimilar to Enbrel to start a lawsuit against them so that Amgen can defend their monopoly rights until 2029. Amgen added five more patents to Enbrel application, three of them were for the indication of Enbrel on psoriasis which caused delay in Amgen’s market monopoly until 2019. The other more important two with regard to Amgen are the (182,522) patents that cover the entanercept fusion protein structure and the way to generate it. Sandoz attacked the authenticity of these additional two patents to prevent Amgen from compelling these patents and thereby disturb the goal of having 39 years market exclusivity since 1990. The claim was that the patents lack adequate description of the fusion protein entanercept structure and never mentioned the soluble TNF receptor region and the CH2-CH3 region of a human Immunoglobulin g that are essential for Enbrel binding to both receptors and thus exerts its activity. The issue is still under negotiating and the board stepped side it until the final decision {9}.ConclusionThe later issued patents may obligate other generics competitors to continuously track the patents landscape and spend many resources and time to try to overturn some patents in the court just like Sandoz in the previous case. This will make it harder for generics to enter the market and compete with the origin drug. Drugs patent monopolies raises prescription prices, especially in US where people always suffer from highest drug prices among the world. There is no limitation in the number of times a product can be modified in a distinctive patents way. Maybe it is the time to improve patents policy in a way that could decrease the unreasonable and the unlimited patent monopolies to help people in getting their medications and to improve competition between pharmaceutical companies. References:(1) IMAK.Overpatented, overpriced special edition Enbrel.I.MAK. https://www.i-mak.org/wp-content/uploads/2018/12/i-mak.enbrel.report-2018-11-30F.pdf.accessed at 01/29/2019.(2) eesa.intellectual propereties rights.eesa. https://m.esa.int/About_Us/Law_at_ESA/Intellectual_Property_Rights/What_is_intellectual_property.accessed at 01/25/2019.(3) Voss T, paranjpe AS, Cook TG, Garrison, Garrison NDW. A short introduction to intellectual properties rights.Tech Vasc Interv Radiol.2017 jun;20 (2):116-120. Doi:10.1053/j.tvir.2017.04.007.Epub 2017 Apr 18. Review. Pubmed pmid : 28673648.(4) Uslegal. intellectual property law and legal definition.uslegal. https://definitions.uslegal.com/i/intellectual-property/.access .last updated by Magee ECDI at 01/26/2019.(5) Torvall Martina.The use and abuse of patents-Evergreening in the pharmaceutical sector.Lund University.2013(6) Amin T.et al. Secondarypatenting of branded pharmaceuticals: a case study of how patents on two HIV drugs could be extended for decades.Health Aff (Millwood).2012 Oct;31.PMID:23048110(7) Radhakrishnan Priti. Pharma’a secret weapon to keep drug prices high.STAT.https:/www.statnews.com/2016/06/14/secondary patents.june 14.2016.accessed at 2/1/2019.(8) Kitch Edmund. The nature and function of the patent system. journal of law and economics.january 2019.(9) Silbersher.zacharyh.Did the federal circuit doom Amgen’s Enbrel monopoly?.ipwatch.ttp://www.ipwatchdog.com/2017/11/10/federal-circuits-doom-amgens-enbrel-monopoly/id=89929/.accessed at 01/29/2019.

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