Theme 2: Science, technology and public health

Task 1: Knowing more about drug patenting

 

Study the following information about patenting and answer the questions:

 

 | A patent is… A patent is a property right granted by the sovereign state to the inventor of a novel, nonobvious and useful invention. Because the invention is novel (meaning that it has not been previously disclosed anywhere in the world) and because it cannot be obvious to one ordinarily skilled in the art, the granting of property right is used to protect public access to what already exists.  Rights of the patent owner The owner of a patent has the right to exclude others from making, using, offering for sale, or selling his or her invention for a period of 20 years from the filing of the patent application. An invention is any new or useful process, machine, article of manufacture, or composition of matter. An improvement on any of these items also can be an invention. Patent rights are territorial in nature and exist only in the national jurisdictions in which the patentee has applied for and received recognition of his property rights. Whether a claimed invention meets the tests of novelty and non-obviousness is determined by comparing it to the body of previously disclosed information in the same field.  Patent enforcement Patents are enforced by the National Patent Offices, World Trade Organization (WTO) and evaluated by the World Intellectual Property Organization (WIPO).  (Lehman, 2003) These organizations provide the patent protection to those seeking the protection by giving judicial enforcement of the intellectual property rights. (Lehman, 2003) This means that a company could sue a rival if it felt its patent was being violated and have official documents at the National Patent Offices to substantiate its claim to a product.  Importance of granting patent The benefit of granting an inventor the exclusive property right of a patent for the limited period of 20 years is that he or she is given a powerful incentive to create. The inventor is assured that investors will be given the incentive to commit the financial resources necessary to support the inventor’s research and to develop it to the point where it can be manufactured and made available to the market.  Whatever patent strategy is employed by the inventor, the aim is always the same – to maximize the profit accruing to the inventor and those who have supplied him or her with the capital necessary to develop and commercialize the invention. For a patent to have any commercial value there must be a market for the invention embodied in the patent, which will support the cost of development of the invention and return a profit. 

 

Put down your understanding in the box below.

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  | Knowing more: Is the pharmaceutical patent system corrupt? When considering the scrutiny that pharmaceutical companies go through to put a new prescription drug on the market, some say that the patent system is inadequate in issuing patents to companies. An example that displays the shortfall for the patent office to issue a patent to an undeserving company is Purdue Pharmaceutical’s patent on Oxycontin. Purdue made about a billion a year on the sales of its pain medicine Oxycontin and its patent was granted based on Purdue’s claim that it had a novel innovation in that Oxycontin could be administered in small doses and be effective. (Roth, 2005) In 2004, Endo Pharmaceuticals attempted to sell a lower cost version of Oxycontin and was sued by Purdue for patent infringement. It was then determined that Purdue had done no clinical studies or research experiments to validate the effectiveness and safety of Oxycontin when it sought the patent for Oxycontin. Endo Pharmaceutical was allowed to introduce its version of Oxycontin and Purdue’s patent was invalidated, but Purdue still got to keep its billions in profits that it earned under patent protection. (Roth, 2005)  How could this have happened? It seems that the patent office isn’t perfect. This example illustrates how difficult the patent application and approval process is, and should be. It goes without saying that if patents are valuable protection that allows pseudo-monopolistic markets to make profits from prescription drugs, then they should be granted only after an extremely scrutinizing patent review process in order to prevent instances like Purdue’s Oxycontin from happening again. Although this example displays the faults in patent enforcement, it still seems to be the best way to grant exclusive rights to a pharmaceutical company’s chemical formula.