As one of many examples, millennial consumers have shown a greater preference than previous generations for using alternative medicine to prevent illness and maintain wellbeing. According to the American Psychological Association, millennial consumers are increasingly embracing herbal, nutritional, and plant-based supplements, as well as homeopathic remedies, in lieu of pharmaceuticals.¹ Indeed, they are the largest and fastest-growing subset to use such supplements. Approximately 70 percent of millennial consumers buy into the $30 billion supplement industry.²

Not only do many millennials embrace alternative medicine, they are also less likely than previous generations to opt for conventional medical treatment. Instead, millennials are more willing to try alternative treatments and seek consultation from alternative medical experts, such as medical intuitives, naturopaths, and mindfulness therapists. Even millennial physicians are more likely than older physicians to recommend alternative medicine. Despite little scientific evidence backing the efficacy of alternative medicine, many millennial consumers still view these natural remedies as safer, cleaner options that align better with their personal values.

In light of the different value system held by many millennials, some American companies have ramped up their marketing efforts targeting millennial consumers. One company that recognized this consumer-driven shift is biotech giant Monsanto Company, which went so far as to hire a director of millennial engagement to enhance its connection with this unique group of consumers and the ideas they represent. According to Monsanto’s new director of millennial engagement, “[m]illennials . . . have a new set of ideas that need to be incorporated into all aspects of global life.”³

As millennials are spending more on natural remedies, many companies will have increased incentive to commercialize and patent alternative medicines, many of which contain plants and herbs sourced from other countries. However, there are many potential legal and ethical concerns related to commercially accessing plants and herbs from developing countries, a practice encompassed in the terms “bioprospecting” and “biopiracy.”⁴ Bioprospecting can refer broadly to the search for biological resources (and sometimes the accompanying indigenous knowledge) for commercialization, while biopiracy refers more specifically to commercializing those resources and/or knowledge without identifying or compensating the source. An example of biopiracy occurs when foreign entities, such as pharmaceutical companies, seek patent coverage for products derived from medicinal plants and indigenous knowledge for using those plants without identifying or compensating their original sources. Officials in many resource-rich developing countries believe that these foreign entities commandeer this knowledge without permission from—and without rewarding or acknowledging—native cultivators. Many indigenous communities and developing countries consider biopiracy as improper commercial exploitation of the know-how they have developed and used for perhaps thousands of years. They note that the 1993 United Nations Convention on Biological Diversity “establishes sovereign national rights over biological resources and commits member countries to conserve them, develop them for sustainability, and share the benefits resulting from [their] use.”⁵

In contrast, many countries and entities support the use of medicinal plants (regardless of country of origin) and the accompanying indigenous knowledge as a proper and ethical practice, noting that the 1994 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) requires World Trade Organization (WTO) member states to provide intellectual property protection for plant varieties (though naturally occurring plants and animals can be excluded), and contains no requirement to identify or compensate the source of the plant or any related knowledge.⁶ They also maintain that affording citizens of developing countries what critics view as effectively exclusive rights to traditional knowledge of nature conflicts with universally held principles of patent law. For instance, according to critics of the biopiracy narrative, the practice of providing citizens of developing countries with exclusivity over knowledge of nature, some originating as far back as 3000 B.C., outwits this general intent behind the patent regime to encourage innovation.

Regardless of whether one subscribes to the biopiracy narrative, the negative repercussions for ignoring biopiracy concerns are very real. While there are many ways biopiracy issues can arise, this article focuses on potential biopiracy pitfalls for companies in the alternative medicine space using real-life examples involving turmeric (sourced from Pakistan and India), maca (sourced from Peru), rooibos (sourced from South Africa), and quinoa (sourced from Bolivia). In these cases, U.S. entities sought patent protection that incorporated an alternative medicine ingredient from a developing country (and sometimes related indigenous knowledge) without permission or attribution of the source, and suffered unexpected financial, legal, and public relations repercussions from the affected developing countries.

Turmeric Treasury

Turmeric is an herbaceous, perennial plant of the ginger root family with Pakistan and India being two of its largest producers. Traditionally, natives of these and nearby countries have used turmeric as a cooking spice and to heal wounds and abrasions of the skin.

Millennials are enthusiastically adding turmeric to their daily routines, as the root touts benefits as an energy supplement, skin brightener, and teeth whitener. Millennials also rely on turmeric for its antioxidant, antibacterial, anti-inflammatory, and even anticancer properties. Studies show that millennials sometimes even insist that natural products, like raw turmeric, be used to color pre-packaged foods instead of synthetic food coloring agents.

In the 1990s, turmeric was involved in the advent of India’s journey to protect Indian traditional knowledge and biodiversity. In 1995, scientists at the University of Mississippi Medical Center sought and were granted patent protection in the United States for medicinal use of turmeric powder as a wound healer.⁷ India’s Council of Scientific and Industrial Research (CSIR), an organization dedicated to building and preserving India’s intellectual property, requested reexamination of the patent by the United States Patent and Trademark Office (USPTO). The CSIR submitted evidence that the use of turmeric for wound healing was not novel, but rather a popular practice in India for thousands of years. The CSIR succeeded in getting the patent invalidated, adding turmeric to the biopiracy narrative in the United States and abroad.

To prevent similar occurrences in the future, India (via the CSIR and India’s Ministry of AYUSH) established the Traditional Knowledge Digital Library (TKDL)⁸ and enacted the Biological Diversity Act of 2002. The TKDL is a digital knowledge repository for traditional knowledge, such as medicinal plants, extracts, derivatives, and compositions, used in traditional Indian medicine. The repository was set up in 2001 with the objective of protecting the ancient and traditional medicinal knowledge of India from biopiracy or similar exploitation by ensuring that such knowledge was well documented electronically. The hope was to expand international awareness of India’s highly diverse native products, such as turmeric, and increase the body of prior art available to inform examination of future patent applications.

This massive repository, with 34 million pages of literature, caused a significant shift in the availability of previously unsearchable prior art during patent examination, and correspondingly shifted the nature of patents directed to herbal remedies. For instance, after introduction of the TKDL repository, increasing numbers of patent applications on herbal remedies were directed toward herbal/synthetic hybrid remedies.⁹ In fact, patent applications filed in 2006 in this area were 96 percent more likely to be directed toward a synthetic hybrid than in 2003.

Nonetheless, claims directed to synthetic hybrid formulations do not always prevail. In a recent case, the CSIR leveraged its TKDL to successfully challenge a patent application filed by Colgate-Palmolive with the European Patent Office (EPO).¹⁰ The claims at issue were directed to oral compositions comprising nutmeg, a synthetic carrier, and another “natural extract.” The application included an omnibus claim reciting that “natural extract” consists of a list of one or a mixture of over 40 known ingredients, including ginger, bakul tree, turmeric, oregano, and neem. The application then claimed use of the oral composition in a variety of applications, including toothpaste or products to treat oral cavity diseases. The CSIR challenged the novelty of Colgate-Palmolive’s supposed invention, citing Indian texts from the TKDL disclosing similar uses for turmeric, nutmeg, and the like to the EPO patent examiner. The CSIR’s challenges were successful, leading the EPO to ultimately reject the proposed claims.

In view of the overwhelming reliance on published material by patent offices throughout the world, the TKDL may provide an effective means of combating patenting of indigenous knowledge. In fact, the TKDL has grown in popularity in some patent offices as a resource for conducting patent searches, including the USPTO, the EPO, and the Japanese Patent Office.

Additionally, along with creating the TKDL, India enacted the Biological Diversity Act (BDA) in 2002, seeking to protect India’s biological diversity.¹¹ The BDA creates a scheme for equitable benefit sharing agreements as well as the creation of the National Biodiversity Authority to implement regulation of prohibited acts and opposing grant of intellectual property rights to foreign entities, among other advisory duties. In fact, the BDA prevents patent applications for any invention based on any research or information on biological resources obtained from India without prior approval. Additionally, the BDA provides for violation sanctions including imprisonment and fines.

In 2015, state biodiversity boards in India sent notices to several companies seeking a share of the profits for products using biological resources from their states, but data shows that only one levy has actually been collected. Though the BDA was passed 14 years ago, less than 3 percent of local bodies have completed the basic requirement of preparing a record of that region’s biological resources—but that requirement is mandatory for enforcement. In the case of plant species like the Indian Paphiopedilum species that face extinction from illegal overharvesting via undetected biopiracy, DNA barcoding has been developed to identify the presence of the species in a product, even if just a fragment is used.¹² India is taking a multifaceted approach to preventing biopiracy, weaving together legal and technical solutions to protect its resources.

Maca Monitoring

Maca is a plant root cultivated in the Peruvian Andes and thought to first be cultivated by the Inca nearly 2,000 years ago. Peruvian civilization has since used maca as an energy supplement and aphrodisiac. Today, maca is wildly popular with many millennials for boosting energy, stamina, and fertility. Some report that it has almost instantaneous effects that can last for hours and without the crash often associated with caffeine. In addition, maca is rich in B vitamins, vitamin C, and zinc.

Like India, Peru also has organizations that seek to protect Peru’s indigenous knowledge and intellectual property. Peru’s National Institute for the Defense of Free Competition and the Protection of Intellectual Property (Indecopi) was founded in 1992 with the stated goal of promoting consumer protection and garnering fair competition in Peru. Indecopi takes the position that “the State exercises sovereign rights over its genetic resources, while indigenous peoples have rights over the collective knowledge they have created, developed[,] and preserved over the centuries.”¹³ Thus, to address biopiracy concerns, Peru has enacted extensive legislation for protection of its traditional knowledge.¹⁴ Four key components of the law stand out in protecting traditional knowledge of Peruvian indigenous tribes: (1) the law states that the rights of indigenous people in their traditional knowledge is “inalienable and indefeasible”; (2) the law appoints a tribal representative to communicate with outside parties; (3) the law establishes a negotiated percentage of gross sales from commercial use of traditional knowledge, payable to the indigenous tribe; and (4) the law criminalizes disobeying the law by exploiting traditional knowledge without consent.

While the Peruvian law protecting traditional knowledge is unique in that it specifically grants indigenous communities rights in their traditional knowledge, some of its enforcement measures face problems outside Peruvian borders. Effective enforcement, in many instances, would require robust treaties with foreign nations providing for recognition of Peru’s biodiversity law, which do not currently exist. Commentators suggest that such a change would require amendment to the TRIPS Agreement, protecting biodiversity at the expense of creating a narrow impedance to free trade.¹⁵

Additionally, Peru, like India, has a mechanism in place for combating patenting of its traditional knowledge and genetic resources. Peru maintains a National Commission against Biopiracy (Commission). The Commission actively monitors patent applications across the globe for biopiracy to initiate invalidity proceedings when necessary. So far, the Commission has invalidated six patent applications related to maca, most directed to nutritional supplements and alternative medicines.

The Commission also monitors patent applications relating to other Andean plants. According to the Commission, Peru has 4,400 species of native plants with various uses, including 1,200 with purported medicinal properties.¹⁶ The Commission monitors over 30 of those species for biopiracy. It has successfully invalidated U.S. patent application claims directed to two other herbs: yacón and sacha inchi.

Rooibos Rations

The rooibos plant, native to the Western Cape region of South Africa, is another favored herb among millennials. For example, millennials use rooibos to infuse teas and wines for an assortment of health benefits. Natives to the mountainous Western Cape region oxidize the leaves of the rooibos plant to produce both black and green teas, a practice dating back at least hundreds of years.

South Africa recently alleged improper exploitation of its rooibos plant by a foreign corporation. In 2010, Nestlé filed five international patent applications for using rooibos or its derivatives to treat acne, hair loss, and inflammation and designated many countries for prosecution, including South Africa. The applications caught the attention of two organizations, the African Centre for Biosafety (ACB) and the Berne Declaration (Public Eye). The ACB seeks to protect Africa’s biodiversity and traditional knowledge food-related systems, while Public Eye broadly seeks to protect human rights in developing countries. The ACB and Public Eye sought legal action against the patents, asserting that Nestlé’s claims were very broad, seeking protection of a wide product range that “stretches from cappuccino to salad dressing and from toothpaste to lipstick.”¹⁷

A key player in the rooibos dispute was the South African Biodiversity Act, which requires anyone engaged in bioprospecting to secure a permit from the government if they plan to engage in bioprospecting or export South African indigenous biological resources.¹⁸ The Biodiversity Act therefore requires a permit for commercial research or patent uses of the same. These permits can only be obtained if a benefit sharing agreement has been negotiated.¹⁹ According to the Department of Environmental Affairs of South Africa, Nestlé had neither requested nor received permits to research or patent rooibos.

Nestlé asserted that it did not source its rooibos from South Africa, but instead from South African suppliers in France and Switzerland, and that a biopiracy claim was unsubstantiated. Nestlé also argued that it did not file any patent applications directed to the plants or derivatives themselves, only to uses thereof. Nestlé further stated that it would fully comply with the Biodiversity Act’s benefit sharing provisions if the company ever commercialized inventions protected by its patents.

However, under the Biodiversity Act, commercial activity as it relates to biopiracy is measured from the time of patent application filing, not from actual commercialization. Further, the suppliers would have needed an export permit to supply the rooibos to Nestlé for research purposes. After two years, Nestlé abandoned the applications and entered into a benefit sharing agreement under the Biodiversity Act with rooibos farmers.

At the heart of this case was a fair amount of uncertainty regarding the Biodiversity Act’s terms. With clearer legislation, involved parties may have better understood how commercial activity is defined and whether its protection extends to derivatives of the plants, supplier permits, etc. Yet, the dispute over rooibos clarified at least that entities striving to receive patent protection on traditional South African knowledge must comply with the Biodiversity Act before filing a patent application.

In light of such disputes, South Africa and 69 other countries enacted the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity (Protocol).²⁰ The Protocol seeks to clarify existing legislation in this area. To complement the access and benefit sharing system, and to facilitate the handling of biopiracy allegations, governments and indigenous groups have called for patent laws to be amended to include a mandatory disclosure requirement. It would require inventors to explicitly reference the sources of the genetic resources or traditional knowledge related to the invention in the description of patent applications.

In fact, many countries have already imposed a mandatory disclosure requirement, including Belgium, Brazil, China, Costa Rica, Denmark, India, Norway, the Philippines, South Africa, Switzerland, Thailand, and Vietnam. On the other hand, some countries have strongly opposed it, including the United States, Japan, and Korea. For its part, the European Union has stayed neutral.

Quinoa Coercion

Some countries take less rigorous approaches to protecting their native resources from U.S. commercialization. Take for example the Bolivians’ fight to protect millennials’ beloved quinoa. This flowering plant has been domesticated for use in Bolivia and other South American nations for thousands of years. But in the 1990s, Colorado-based researchers sought and acquired patent protection on a quinoa seed of the Apelawa variety, which originated in Bolivia.²¹ But rather than setting up a database like India or seeking invalidation like Peru, Bolivia’s National Association of Quinoa Producers engaged in a public relations blitz. Ultimately, the Colorado researchers let the patent lapse, choosing not to pay the required maintenance fees. Bolivian activists, such as Jaime Bravo, embraced the result, announcing that quinoa is “the meat of the Andes and it was almost stolen from us.”²²

Conclusion

Alternative medicine is a rapidly growing industry with no sign of slowing in popularity among millennials. The influence of biopiracy and techniques developed to curb it may serve as cautionary tales for companies that continue to innovate in alternative medicine, providing awareness of how the traditional use of plants and herbs may ultimately affect the types of patent protection available, if any, as well as the commercialization process overall. Turmeric, maca, rooibos, and quinoa inform some ways in which biopiracy played a role in patentability and commercialization. In sum, there may be a wealth of prior art to overcome by way of the TKDL. There may be inevitable invalidity challenges to patents brought by organizations and government officials. There may be permitting requirements or negotiations required by law for research with traditional knowledge or mandatory disclosure requirements with source-citing requirements in international application filings. Furthermore, the ever-present influence of public relations may prove to be hurdles for companies allegedly committing biopiracy. Accordingly, knowing the bioprospecting landscape can be an invaluable tool for companies in the alternative medicine space.

Endnotes

1. Christine Carter, Millennials Are Using These Methods to Combat Their Stress (and You Can, Too), Forbes (Mar. 24, 2016), http://www.forbes.com/sites/under30network/2016/03/24/millennials-are-using-these-methods-to-combat-their-stress-and-you-can-too/#355b64ac2521.

2. David Koeppel, Millennials Embrace Alternative Medicine, a $32 Billion Business, Fiscal Times (July 14, 2014), http://www.thefiscaltimes.com/Articles/2014/07/14/Millennials-Embrace-Alternative-Medicine-32-Billion-Business.

3. Eliza Barclay, Monsanto Hired This Guy to Help It Win over Millennials, NPR (Oct. 29, 2014), http://www.npr.org/sections/thesalt/2014/10/29/359836350/monsanto-hired-this-guy-to-help-it-win-over-millennials.

4. An additional legal barrier inventors may face in the alternative medicine space is subject matter eligibility for claims to naturally occurring materials. Recent Supreme Court decisions confirm that naturally occurring materials may be ineligible for patent protection. See Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014); Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013); Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012). In the wake of this, inventors can expect pushback from the USPTO on claims drawn to plants and herbs sourced from developing countries, even in modified form.

5. Michael A. Gollin, Biopiracy: The Legal Perspective, ActionBioscience (Feb. 2001), Article no longer available.

6. TRIPS Agreement art. 27(3)(b), Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 29. Article 27(3)(b) is controversial and criticized as potentially conflicting with the U.N. Convention on Biological Diversity. See Developing Countries and TRIPs: A Case for a Full-Fledged Review of Article 27.3(b), 4 Bridges (Int’l Ctr. for Trade & Sustainable Dev.), no. 2, Mar. 1, 2000,  Background and the Current Situation, WTO (Nov. 2008), https://www.wto.org/english/tratop_e/trips_e/art27_3b_background_e.htm.

7. U.S. Patent No. 5,401,504 (filed Dec. 28, 1993) (issued Mar. 28, 1995).

8. Traditional Knowledge Digital Libr., http://www.tkdl.res.in/tkdl/langdefault/common/Home.asp?GL=Eng (last visited Jan. 17, 2017).

9. Carmen Nobel, Bio-Piracy: When Western Firms Usurp Eastern Medicine, Forbes (Apr. 21, 2014), http://www.forbes.com/sites/hbsworkingknowledge/2014/04/21/bio-piracy-when-western-firms-usurp-eastern-medicine/#.

10. European Patent Application No. 2,689,806 A1 (filed Dec. 1, 2010).

11. The Biological Diversity Act, No. 18 of 2003, India Code (2002), available at http://www.wipo.int/wipolex/en/text.jsp?file_id=185798.

12. Iffat Parveen et al., DNA Barcoding of Endangered Indian Paphiopedilum Species, 12 Molecular Ecology Resources 82 (2011).

13. Simon Wilson Cortijo, The Successes and Drawbacks of Peru’s Fight against Biopiracy, Latin Correspondent (Mar. 7, 2016), Article no longer available.

14. Law No. 27,811, Aug. 10, 2002, El Peruano (Peru), available at http://www.wipo.int/edocs/lexdocs/laws/en/pe/pe011en.pdf.

15. Ameera Haider, Reconciling Patent Law and Traditional Knowledge: Strategies for Countries with Traditional Knowledge to Successfully Protect Their Knowledge from Abuse, 48 Case W. Res. J. Int’l L. 347 (2016).

16. Rael Mora, Corporate “Biopiracy” in Peru Threatens Indigenous Knowledge, teleSUR (Oct. 7, 2016), http://www.telesurtv.net/english/news/Corporate-Biopiracy-in-Peru-Threatens-Indigenous-Knowledge-20161005-0020.html.

17. Nestlé Slammed for Bio-Pirating, News24 (May 27, 2010), http://www.news24.com/SciTech/News/Nestle-slammed-for-bio-pirating-20100527.

18. National Environmental Management: Biodiversity Act 10 of 2004 (S. Afr.).

19. Bilateral benefit sharing agreements of the type suggested by the South African Biodiversity Act have occurred in South America as well, such as the bilateral agreement between major drug company Merck and Costa Rica’s National Biodiversity Institute (INBio) in the early 1990s. See Richard Conniff, A Bitter Pill, Conservation (Mar. 9, 2012), available at http://conservationmagazine.org/2012/03/a-bitter-pill/.

20. The Nagoya Protocol on Access and Benefit-Sharing, Convention on Biological Diversity, https://www.cbd.int/abs/ (last visited Jan. 17, 2017). The United States is not among the signatories of the Nagoya Protocol.

21. U.S. Patent No. 5,304,718 (filed Feb. 3, 1992) (issued Apr. 19, 1994).

22. Press Release, Rural Advancement Found. Int’l, Quinoa Patent Dropped (May 26, 1998), http://www.goodfoodworld.com/wp-content/uploads/2013/08/quinoa-patent-dropped.pdf.