While many companies are working on new medicines and technologies to combat global health issues, the Patents for Humanity Program at the United States Patent and Trademark Office (“USPTO”), currently in its fifth year, aims to incentivize innovation and encourage even more companies to take on these challenges. Malaria is one example of the many current global humanitarian challenges. According to the World Health Organization, a child under the age of five dies every two minutes from malaria.1 One main barrier to eliminating malaria globally is the lack of efficient and wide-spread detection methods, as some of the current detection methods are costly and time-consuming, thus limiting their adoption.2 While the number of malaria cases have significantly decreased over recent years, elimination of malaria remains a costly goal (around US$ 2.9 billion).3 However, as declared by the World Intellectual Property Organization, innovation has the power to improve lives.4
The USPTO started the Patents for Humanity Program (“the Program”) as a pilot program in 2012. Since then, the Program has received hundreds of applications and awarded over twenty patent holders with a Patents for Humanity Award or an honorable mention.5 Award recipients include multinational companies, start-ups, and universities.6 Instituted by the USPTO, the Program is intended to “bring attention to humanitarian issues; provide success stories for others to emulate; and show how patents create solutions to global challenges.”7
As David Kappos and Edward Elliott8 explained, the Program helps provide “patent holders a return on their investment in humanitarian enterprises” by providing incentives.9 There are two main incentives that the Program provides. First, Program award recipients receive a certificate to accelerate one of their matters at the USPTO, such as a patent application or an ex parte proceeding. The certificate is valid for twelve months and can be applied to any matter that the award recipient owns.10 For example, an award recipient’s patent application could be granted special status and entitled to accelerated examination at the USPTO—giving the award recipient a final determination, excluding appeals, within twelve months or so.11 Similarly an award recipient’s ex parte reexamination proceeding or ex parte appeal could be fast-tracked. Second, the Program gives recipients public recognition at an awards ceremony and on the USPTO website. Some past award recipients have also been invited to the White House.
The innovation that the Patents for Humanity Program has recognized has significantly impacted the lives of many around the world. For example, past award recipients have included organizations that have developed a quick and simple diagnostic test for preeclampsia, provided rechargeable lanterns and portable energy stations as alternatives to kerosene lamps, and created a vitamin-A enriched rice to address blindness caused by vitamin-A deficiency.12 This past year, Case Western Reserve University (CWRU) received a Patents for Humanity award for inventing a low-cost and efficient malaria detection method, called the Magneto-Optical Detection (MOD) Device. The MOD is a battery-operated device which uses magnets and lasers to detect a byproduct of malaria parasites in the blood.13 According to CWRU’s Patents for Humanity application, “when malaria parasites eat red blood cells they release iron-containing crystals called hemozoin into the bloodstream.”14 The magnets in CWRU’s MOD cause the iron-containing hemozoin in a blood sample to align which prohibits a certain amount of light to be passed through the sample. The MOD detects the amount of light (or lack thereof) and determines in minutes whether, and to what extent, a person is infected with malaria.15
Compared to other methods of malaria detection, which do not use the magnetic characteristics of infected blood, the MOD provides a cost-effective and accurate detection method, according to CWRU. CWRU has applied for several patents on this technology and received a Patents for Humanity honorable mention in 2014, in addition to accepting an award this past year. CWRU’s technology and other technology recognized by the Program have already demonstrated an impact on the global world. As indicated in CWRU’s Program application, companies are interested in further developing its technology, and countries, such as Madagascar, have expressed an interest in using MOD as a method for detecting malaria.16
While addressing global challenges is a main concern, the Patents for Humanity Program also promotes that patent holders themselves can receive a benefit from participation. For example, past award recipients have noted that winning a Patents for Humanity award has improved brand awareness, fostered licensing opportunities, and increased inquiries from collaborative partners or clients.17 Further, the Program emphasizes that seeking patent protection in the United States, where the technology may not be used or needed as much, has benefits. The Program notes that “[a]mong other things, [U.S.] patents can help in securing funding, forming partnerships and attracting talent.”18 One example of an innovative partnership is a past award recipient licensing its technology to a lower-cost manufacturer for use in developing countries and selling another version of its technology in the United States.19
The USPTO’s Program is not the first or only time that patents have been discussed in the context of global health concerns. For example, certain developing countries have used compulsory patent licensing or the threat of compulsory licensing under Article 31 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to provide access to pharmaceutical drugs which help treat public health concerns, such as HIV/AIDs, cancer, and heart disease.20 In general, through TRIPS or other national laws, developing countries have licensed patented technologies, and in some cases these licenses are without the patent holder’s consent or at a discounted price in an effort to address public health issues or national emergencies.21
While these licenses can provide developing countries with pharmaceutical drugs that they would not otherwise have access to, these licenses are not without criticism. In particular, one concern is that patent licenses alone, particularly without the cooperation of the patentee, do not provide developing countries with the know-how to make the pharmaceutical drugs or the investment needed for the infrastructure to manufacture and distribute the technology.22 Another concern is that compulsory licenses can devalue a patentee’s intellectual property value by diminishing the patentee’s return on investment.
With the many humanitarian challenges that exist today, are there incentives that can further inspire companies and organizations to get involved and address these global issues in developing countries? According to the Patents for Humanity Program the answer is yes. The Patents for Humanity Program offers another tool which provides companies and organizations an incentive to invest in drugs and other technologies which address public health concerns. According to the USPTO, five years into the Program, “hundreds of millions of lives” in over fifty countries have been improved from the patented technologies recognized by the Program.23
The next round of the award application process is underway, and applications are being accepted at the USPTO through early December 2017. The program accepts applications from all U.S. patent holders, including foreign entities. Patent holders and applicants can apply on the USPTO website by filling out an application and submitting information on how their patented technology addresses humanitarian challenges in one of five categories: Medicine, Nutrition, Sanitation, Household Energy, and Living Standards.24 Judges from outside the USPTO will evaluate applications based on the positive impact that the patented technology provides, including the extent to which others have built on or are using the patented technology.25 Awards will likely be granted sometime in the new year to the latest “game-changing technology to meet global humanitarian challenges.”26
1See 2016 World Malaria Report, WORLD HEALTH ORG. (2017) at xvi, 42, http://www.who.int/ malaria/publications/world-malaria-report-2016/report/en/.
2 Application of Case Western Reserve University, Magneto-Optical Detection of Malaria Device, Patents for Humanity, U.S. Pat. & Trademark Off. (2014) (on file with USPTO).
3 See 2016 World Malaria Report, supra note 1, at xii-xiii, xvii.
4 Edward Elliott, Patents For Humanity: Improving Lives Across the Globe, WIPO MAG. (April 2017), http://www.wipo.int/wipo_magazine/en/2017/02/article_0003.html.
5 See Elliot, supra note 4; see also Presentation on USPTO’s Patents for Humanity Program, U.S. Pat. & Trademark Off. at 4, https://www.uspto.gov/sites/default/files/documents/Patents%20for%20Humanity%20intro.pdf.
6 See Elliot, supra note 4.
7 See Presentation on USPTO’s Patents for Humanity Program, supra note 5, at 8.
8 Edward Elliot is the Patents for Humanity Program Manager at the USPTO. See Elliot, supra note 4.
9 Kappos and Elliot, Patents for Humanity, THE BLOG-HUFFPOST (Oct. 1, 2012, 12:14 PM, updated Dec. 1, 2012), https://www.huffingtonpost.com/entry/patents-for-humanity_b_1929395.html.
10 Patents for Humanity Award FAQ, U.S. PAT. & TRADEMARK OFF., https://www.uspto.gov/sites/default/files/ patents/init_events/patents_for_humanity/humanitarian_faq.pdf.
11 See id.
12 See Elliot, supra note 4; see also Patents for Humanity, U.S. PAT. & TRADEMARK OFF, https://www.uspto.gov/patent/initiatives/patents-humanity (last visited Nov. 11, 2017).
13 See Application, supra note 2.
15 See id.; Randy Rieland, This Device Could Revolutionize How Malaria Is Detected Around the World, SMITHSONIAN.COM (December 12, 2016), https://www.smithsonianmag.com/innovation/this-device-could-revolutionize-how-malaria-detected-around-world-180961385.
16 See Application, supra note 2.
17 Patents for Humanity, USPTOVIDEO (Oct. 27, 2017) (available on YOUTUBE), https://www. youtube.com/watch?v=2tZbiH9cOTo.
18 See Elliot, supra note 4.
19 See id.
20 See Dr. Paul A. Calvo, Compulsory Licensing of Biopharmaceutical Inventions, LEXOLOGY (Oct. 16, 2017), https://www.lexology.com/library/detail.aspx?g=a2141a69-7a65-464d-bd32-f428fcccf9a5; Unitalen, Public Health or Patent-The Role of Compulsory License Under Article 31 of Trips, LEXOLOGY (Sept. 16, 2015), https://www.lexology.com/library/detail.aspx?g=bb42fd79-3cbc-476c-adfd-f16b3e835b7c.
21 See id.
22 See Unitalen, supra note 20.
23 See Patents for Humanity, USPTOVIDEO, supra note 17.
24 See Learn More, Patents for Humanity, U.S. PAT. & TRADEMARK OFF., https://www. uspto.gov/patent/initiatives/patents-humanity/learn-more (last visited Nov. 11, 2017).
25 See id.
26 See id.
# # #About Baker Botts LLP
Baker Botts is an international law firm of approximately 725 lawyers practicing throughout a network of 14 offices around the globe. Based on our experience and knowledge of our clients’ industries, we are recognized as a leading firm in the energy and technology sectors. Throughout our 177-year history, we have provided creative and effective legal solutions for our clients while demonstrating an unrelenting commitment to excellence. For more information, please visit BakerBotts.com.