1. You have three (3) hours to complete this exam.
2. This is an open book exam. You may use any written material.
3. This exam consists of one (1) essay question.
4. Please write your responses in the blue books provided. Please write clearly. Write on every other line and every other page to permit instructor comments.
5. Write your exam number on your exam envelope. Put your student exam # at the top of this page, each page of questions, and each blue book. Do not use your name, student ID number or Social Security Number on any exam materials.
6. At the conclusion of the exam, return all exam materials to the exam envelope and submit it to the proctor. Do not seal the envelope. Students who do not return all exam materials at the end of the exam may not be graded.
You are the intellectual property manager for Immuno, Inc., a pharmaceutical company that develops, markets, and licenses drugs. Immuno’s research scientists have developed a drug that appears to be effective in slowing the effects of the AIDS virus. The drug is based on a genetically engineered bacterium that was developed in part using simulation software capable of predicting the efficiency of the bacterium based on numerous design options. The software was written by one of Immuno’s in-house scientists. The bacterium itself was derived from a yeast culture that has been used by the Amazone Indians of Columbia, and that was first described in the Journal of Aboriginal Technology in 1853. The drug is marketed under the brand name Immuno for AIDS – the Silver Bullet.
The drug was first used in experimental trials on 1 January 2000 and was first sold commercially on 6 June 2000. The software was never marketed. Your research scientists published a research paper describing the drug in the Journal of Immunology on 31 December 2000. A patent application was filed for the software in the U.S. Patent Office on 7 June 2000, a Canadian counterpart being filed on 6 June 2001 and issuing on 7 June 2002 (after Immuno paid a $20k foreign applicant surcharge); a patent application was filed for the drug in the U.S. Patent Office on 10 January 2001.
Immuno’s primary competitor, Mechant, a French company, is marketing a similar drug throughout the world under the brand name AIDS Immune – the Gold Standard. Mechant’s drug was first produced on 5 June 2000 using a pirated copy of Immuno’s software, which was obtained by Mechant from a disgruntled former employee of Immuno. All of Mechant’s activities in connection with development of the their drug have taken place in France.
Mechant filed a patent application for their version of the drug in the French Patent Office on 1 January 2001. Mechant also filed a patent application for the software on 10 June 2000. Immuno filed its software patent application in France on 6 June 2001. The French Patent Office has rejected Immuno’s patent application stating that Mechant’s patent application had an earlier filing date. The French patent examiner also indicated that patent protection in France is not available because software has no technical effect. Mechant’s software patent issued in France on 6 June 2002.
Immuno has also been sued in Columbia by the Amazone Indians under the Columbian Native Knowledge Act. The Amazones are demanding a royalty from Immuno based on all sales, worldwide, of the Immuno drug.
To make matters worse, the government of Canada has declared Canada’s lack of a large software industry a national emergency and has started granted compulsory licenses to Immuno’s Canadian software patent to help address this emergency. As a result, Canadian drug companies are now exporting their versions of the Immuno drug to France. As a further result, Mechant has sued Immuno in France for contributory infringement of Mechant’s software patent, based upon Immuno’s compulsory license grant to the Canadian drug companies.
Your boss, Dr. Immuno, needs your advice. What should he do? What can he do?
END OF EXAM