427.   The United States is pleased to co-sponsor this agenda item and contribute to the discussion of "Public-Private Collaborations in Innovation - IP Commercialization." 428.   I would like to thank Australia; Canada; Chile; Chinese Taipei; the European Union; Hong Kong, China; Japan; Republic of Korea; Singapore; and Switzerland for co-sponsoring this agenda item. 429.   I would also like to take the opportunity to invite Members and the Secretariat to the annual IP and Innovation side event sponsored by Japan, Switzerland and the United States. The 2019 side event focuses on the year-long theme discussed in TRIPS Council concerning Public-Private Collaborations in Innovation. We have a diverse panel for the side event that will discuss experiences concerning R&D partnerships, brand promotion, support for the creative industries and IP commercialization. For further reference, there are flyers with the schedule of the event in the back of the room. I hope to see you there at 1:00 pm in Room E and an "innovative" lunch will be provided. 430.   In general, the experience of the United States with public-private collaborations in innovation arises in the context of an economy in which private firms operate without substantial Government intervention. In the United States, innovation and development are the result of competition in the marketplace, without heavy state direction. One useful function of public-private collaborations is to help address the space that markets on their own cannot fill. 431.   For the next few minutes, I would like to talk briefly about the importance the United States places on research and development to solve today's challenges and improve lives, as well as the funding mechanisms and legal framework that facilitate innovation and technology commercialization for the benefit of the public. 432.   The United States Government spends about USD 150 billion annually for R&D activities. 433.   The federal R&D budget covers both research conducted by federal agencies or their contractors in government-owned facilities, and research conducted by universities and other contractors under funding agreements. 434.   The Government itself conducts over USD 50 billion of R&D. Eleven (11) federal agencies have substantial R&D facilities, or "federal laboratories". Each of the 310 or so federal laboratories has a specified mission, which addresses the needs of different users, and pursues the development of different technologies and products. 435.   About 50% of academic research in the United States is funded by the federal government. That corresponds to over USD 30 billion of federal research funding awarded to the higher education sector. 436.   The federal R&D investments are critical for US innovation, competitiveness and economic prosperity. 437.   The American innovation framework involves partnering with the private sector to further develop early stage inventions arising from federal investment in science and technology and bringing them to the marketplace. 438.   However, in the absence of strong intellectual property (IP) protection, investment in earlystage inventions would be too risky for businesses and most of these inventions would never see the light of day. 439.   Thus, patenting of inventions is critically important for licensing, securing investment and forming partnerships that lead to the commercialization of inventions. 440.   I would like to talk briefly about two very important pieces of legislation, both passed by Congress in 1980, that facilitated transfer and commercialization of technologies developed with federal funding. 441.   The first major US technology transfer law, the Stevenson-Wydler Act of 1980, established technology transfer as a federal policy. 442.   It required federal laboratories to set up formal technology transfer programmes and to actively seek opportunities to transfer technology to industry, universities, and state and local governments. 443.   The Federal Technology Transfer Act of 1986, which amended the Stevenson-Wydler Act, created a collaborative mechanism to encourage federal agencies and laboratories to work with nonfederal entities, such as universities, foundations and private companies, on joint research and development. 444.   Under a Cooperative Research and Development Agreement, or CRADA, a federal laboratory may provide personnel, services, facilities, intellectual property, equipment and other resources, but no funds, to the joint R&D effort. A non-federal party may provide funds, in addition to personnel, services, facilities, equipment, IP and other resources. 445.   A CRADA defines the tasks to be undertaken within an area of collaboration and the allocation of IP rights resulting from such cooperation. The laboratory may grant to a collaborating party patent licenses or assignments, or options thereto, in any invention made under the agreement. The federal government always retains a non-exclusive, royalty-free license to practice the invention or have the invention practiced throughout the world by or on behalf of the government (the so-called "government use" license). 446.   Let me give you a few examples (and there are many more!) of technologies developed in federal laboratories that found their way to the market because of public-private partnerships. 447.   The camera in every cell phone runs on a sensor originally developed at the National Aeronautics and Space Administration (NASA) Jet Propulsion Laboratory in the 1990s. These digital image sensors were significantly smaller and more efficient than the technology of the day and eventually enabled tiny, battery-friendly cell phone cameras, high-definition video cameras-such as GoPro-and social media as we know it today. It took nearly two decades for the technology to achieve its dominance in the field of digital imaging. By 2015, the market for these sensors reached nearly USD 10 billion. 448.   Another example is an earpiece system (ACCES) developed by the Air Force Research Laboratory and Westone, a hearing protection technology company, through a CRADA. ACCES includes a silicone custom-moulded earpiece that joins with a speaker cable to deliver audio to the user at very high altitudes and detaches easily if the pilot needs to eject. It reduces risk of hearing loss due to extreme noise, increases pilots' ability to communicate with others during flight, and reduces risk of injury if they eject from the aircraft while wearing this earpiece. Although the Air Force remains the dominant purchaser of ACCES, Westone also markets the product to other branches of the military, law enforcement, and the commercial space industry. 449.   Of course, there are many success stories of technologies invented in federal laboratories and commercialized by private industry partners. But let's turn now to federally-funded research performed at universities. As I mentioned earlier, universities perform over USD 30 billion of publicly-funded research annually. 450.   In the United States, technology transfer from universities to the private sector is made possible in large part by legislation commonly known as the Bayh-Dole Act. 451.   In fact, at the time the Bayh-Dole Act was enacted in 1980, the federal government held title to approximately 28,000 patents, fewer than 5% of which were licensed to industry for development of commercial products. 452.   Companies were reluctant to invest in developing new products and markets, since competitors could later acquire the same licenses from the Government and then manufacture and sell the same products. This meant that American taxpayers were not getting the full benefit from the billions of dollars invested in cutting-edge research. 453.   The Bayh-Dole Act created for the first time a uniform patent policy for government-funded research. It allowed universities and other recipients of federal funding to retain title to their government-funded inventions and grant exclusive licenses. 454.   As a result of this policy, universities are encouraged to collaborate with industry to translate research results into products that benefit the public. 455.   Robust university research, coupled with the enabling legal environment created by the BayhDole Act, spawned entire new industries in the United States, such as biotechnology, where the United States continues to have a leadership role. 456.   Since the enactment of the Bayh-Dole Act in 1980, over 200 drugs and vaccines have been developed through public-private partnerships, more than 11,000 start-ups have formed based on the results of university research, millions of jobs have been supported and hundreds of billions of dollars have been contributed to US gross domestic product. 457.   Let me give you an example of successful collaborations between federal agencies, universities and private industry. 458.   Melanoma, the most dangerous form of skin cancer, is caused by uncontrolled growth in pigment-producing skin cells. Highly curable in the early stages, it often spreads to other parts of the body, making treatment more difficult. In the late stages of metastatic melanoma, the average survival rate is just six months. In 1995, James Allison, a professor at the University of California, Berkeley, discovered ways to activate the immune system to unleash a robust antitumor response. Dr. Allison transformed the field of immunology and achieved clinical success by performing basic research on T-cells. This basic research was funded, at least partially, by federal dollars, through National Institutes of Health (NIH), and later, by private funding. It took many years and a number of private industry partners to translate Dr Allison's discovery into a life-saving medicine. In March 2011, the immunotherapy treatment for melanoma was approved by the U.S. Food and Drug Administration, and it is now being tested for the treatment of other cancers. Dr Allison shared a Nobel Prize in Medicine in 2018 for his discovery on how to fight cancer using the body's immune system. 459.   Federally funded university research also ignited the innovative engines of Qualcomm, Symantec and Netscape, among many other companies. 460.   The United States' experience with public-private collaborations in innovation has been a positive one. 461.   Important legislation such as the Bayh-Dole Act, the Stevenson-Wydler Act and the Federal Technology Transfer Act, created a policy and legal framework that encourages, facilitates and promotes public-private partnerships and the transfer of technology developed with public funding or in federal research institutions to private industry for further development and commercialization. 462.   It is important to keep in mind the main objective of this framework - public benefit in the form of new products and technologies, jobs and local economic development. We are proud of our achievements and happy to share our experience with others. 463.   We look forward to hearing from other Members on this topic.