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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