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Patents, Innovation, and Access to Medicine

by: Kerrigan Unter

Patents, Innovation, and Access to Medicine PSC 2224

Marketplace > George Washington University > Political Science > PSC 2224 > Patents Innovation and Access to Medicine
Kerrigan Unter
GPA 3.0
Policy in the Cyber Age

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Policy in the Cyber Age
Class Notes
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This 2 page Class Notes was uploaded by Kerrigan Unter on Monday October 19, 2015. The Class Notes belongs to PSC 2224 at George Washington University taught by in Fall 2015. Since its upload, it has received 23 views. For similar materials see Policy in the Cyber Age in Political Science at George Washington University.

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Date Created: 10/19/15
PSC 2224 Patents Innovation and Access to Medicine What is the goal of the patent system The Congress shall have power to promote the progress of science and useful arts by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries Pharmaceuticals the branded pharmaceuticals industry is widely regarded to be the industry Branded vs Generic Branded means the originator pharmaceutical firm conducted research and development of a new drug and got a patent for it generic means any number of firms can produce the drug when generic drugs enter the market the price of drugs begins to decrease branded firms will often license an authorized generic to compete with other generic rms major pharmaceutical firms often own substantial stakes in generic firms generic drugs have to demonstrate bioequivalence bioavailability after administration in the same dose is so close that effects with respect to both ef cacy and safety now innovations are in biologics which are derived from living sources and are far more complex generic biologics have to demonstrate biosimilarity the threshold for biosimilarity is lower than bioequivalence branded doesn t necessarily mean patented company might have not filed it or the patent might have been rejected generic companies must wait a certain period of time to gain access to the original clinical trial data 5 years for regular drugs 12 years for biologics Drug Development costs lots of money 1 billion per drug includes the opportunity cost of capital companies spend a lot on marketing a lot of basic research that contributes towards drug development is publicly funded NIH does basic research that late is commercialized by private companies the government awards grants to scientists working at public and private universities who later license their discoveries to private companies private firms have incentives to develop drugs that serve wealthy markets Pharmaceutical Markets US market is unique other industrialized countries have either single payer or price controls people in the US pay very high prices for medicines income inequality affects the affordability and the access to the medicines even in poorer countries medicines can cost as much as they do in wealthy countries pharmaceutical firms was to maximize revenue even when the income inequality is not a problem companies fear the ow of cheap drugs back to more expensive markets Access to Medicines Antiretroviral treatments which are used US puts pressure on other countries to change patent laws activist campaign shamed the companies into dropping lawsuits against South Africa compulsory licenses governments can step in and allow generic companies to produce cheaper versions of stillpatented drugs improves access but it reduces the financial return to the patent holder intemational law requires countries to protect pharmaceutical inventions with patents countries have exibility to define what counts as an invention US shifted course dramatically post2000 Bush established PEPFAR committing 15 billion over the years 20032008 requires participating organizations to sign an antiprostitution pledge often requires purchases of more expensive branded drugs US no allocating amp65 billion per year The Global Fund Medicines Patent Pool formed in 2010 financed by UNITAID financing mechanism is a tax on airline tickets collected in 9 countries including France and Korea establishes licensing agreements with patent holders patent landscape has changed many more countries offer patents now than in 2000


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