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A Crash Course in Intellectual Property Virginia Zaunbrecher Access to Essential Medicines De-Cal February 22nd 2007 Goal To understand the basics of intellectual property, especially patents, and set the stage for how it affects access to medicines Theme IP is an attempt to balance between providing financial incentive for innovation and allowing for access to technologies What is Intellectual Property? Intellectual Property (IP) is a person’s right to have control over the things s/he creates. Things people might receive IP protection for: Books Scientific innovations Paintings Logos How it is IP different from normal property? Intangible Not finite; an idea can be shared with many people without losing it’s value Must clear certain hurdles to receive protection Vs. Real Property Intellectual Property Why Have IP? To give people incentive to invent things (Economic Justifications) Sales Economic Justifications for IP Two years $100,000 Joe 6 Months $20,000 George Economic Justifications for IP WITHOUT INTELLECTUAL PROPERTY: Cost per piece for research and development Production costs for 10,000 $10.00/piece $100,000/10,000 = Total Production Price $20,000/10,000 = $10 $2 $20 $12 Economic Justifications for IP WITH INTELLECTUAL PROPERTY: Two years $100,000 The Balance of IP Law Patent law is a balance between two competing interests Public Domain •Allow the public to use and benefit from the invention •Create competition Property Rights •Promote research and protect investments Examples of Types of IP Patent Copyright Trademark The “quid pro quo” of Patent Law What you give A written description of your invention Enablement: disclose how to make and use your invention Best mode: disclose the best mode of patenting your invention What you get An exclusive right to exclude others from making, selling, or using your invention for a limited period of time The power to assign or license you rights to someone else Subject Matter You can only patent certain things; the Supreme Court said “Anything under the sun made by man.” What can’t you patent Laws of nature Physical phenomenon Biotechnology Patents Can patent DNA sequences even if the amino acid sequence of the protein is known Must meet the other requirements for patentability Must know the function of the DNA So is our DNA infringing? Requirements for Obtaining a Patent Novelty Usefulness Must not already be know to the public Must provide some identifiable benefit Can’t be primarily aesthetic or descriptive Non-obviousness Can’t patent something that would have been obvious to a person of ordinary skill in a particular field Product vs. Process Patents Process Product Overview of Patent Rights Time Rights last for 20 years from the date of filing, but are enforceable only after the patent is approved Right to exclude (not necessarily the right to practice the invention). Parameters of what is covered The rights are limited to what is claimed in the patent, so the language of the patent is very important Geography- patent rights only exist in the country or countries that the inventor files in. Infringement When someone uses an IP right without permission, it is called infringement Sue for damages or injunction Defenses: Invalidity Non-infringement Uses for Patents Assignment: give someone the entire patent Licensing: letting a third party use the patented technology under certain conditions Licensee Exclusive license Licensor Non-exclusive license Licensing Is a good way to “share” IP; allows more people to use the technology Different licensing schemes: Field of Use restrictions Royalty Payments Up-front licensing fees Free licensing Limits on Patent Rights Invalidating patents The government encourages third parties to challenge patents Exhaustion doctrine Exhaustion Doctrine Inventor Gets patent Mass manufacture Parallel Imports Y buys device in Country B and imports it into Country A, where it sells device for $75 Country A X holds patent for device and sells it for $100 Country B X holds patent for device and sells it for $50 The Reality of IP law The Patent and Trademark Office (PTO) is overworked and can’t always give the applications a through review Litigating patents costs a ton of money, and sometimes that controls whether bad patents are challenged The Bayh-Dohl Act (1980) Allows universities to patent inventions created with federal funding University must disclose invention to federal funding agency March-in provision