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The protection of ICH must take into account the inherently dynamic nature of the subject matter. Although different forms of protection for cultural expression and knowledge have been envisaged since the late 1800s, 65 the first international multilateral framework for this issue was not attained until October 2003, when the UNESCO General Conference adopted the International Convention on the Safeguarding of Intangible Cultural Heritage. 66 Until the end of the  [*141]  twentieth century, 67 the most important tools used to protect cultural heritage focused exclusively on its tangible expressions, the relevance of which was to be evaluated on the basis of an objective perception of their artistic, aesthetic, architectural, scientific, or economic value. 68 The lack of attention to intangible expressions of the cultural heritage was a direct consequence of the confidence that this heritage would continue to be developed at the local level and transmitted to new generations. Hence, there was an assumption that ICH would be protected as a fundamental part of the community's cultural and social life. This automatic and spontaneous process, however, was undermined by the advent of globalization, 69 which led to an intensification of intercultural relations, as well as cultural oppression and the imposition of certain cultural patterns over others. 70

Traditional knowledge is perhaps the most open-ended concept that one might choose in this field. Some knowledge, argues Polanyi, cannot be specified by means of rules and can be passed on only through relationships of close learning such as master and apprentice.50 This form of personal knowledge depends on tradition. All societies, including capitalist societies, have traditional knowledge. Not surprisingly, a range of definitions of traditional knowledge has emerged from the literature.51 Traditional knowledge is sometimes linked to environmental or ecological knowledge, or to local knowledge held by groups such as farmers and fishermen (who may or may not be indigenous). Other definitional strategies include contrasting traditional knowledge with scientific knowledge, or specifying key properties for it such as oral transmission and its embeddedness in a non-materialist cosmology. All definitional strategies run into problems of one kind or another. For example, the contrast with science can be overplayed, as both traditional knowledge systems and science depend on the making of observation statements and testing. Returning to our earlier examples of the Wagiman people’s knowledge of the calorific and storage properties of damper made from the bush palm, and of Māori knowledge of the properties of harakeke, it is clear that this kind of knowledge must have involved a process of observation and experimentation. Trying to confine traditional knowledge to a class of knowledge (for example, ecological knowledge) or a class of people is very difficult. The reason that legal definitions place an emphasis on a determinate class of people is not necessarily related to the role that knowledge plays in a society, or even what constitutes knowledge, but rather it is to attribute rights, or ownership, to that class of persons. However, the value of indigenous knowledge sometimes arises because of the fact that it is attributable to an open-ended class, as in the case of the inter-generational development of plant knowledge: it has a proven pedigree.

Two main points circumscribe our discussion. First, we take as central that a justification for TK rights should support rights of indefinite duration. We do so because TK advocates routinely stress indefinite duration and often point out that precisely in this way should normative TK differ from other IP rights. Indeed, it is implicit in the very concept of "traditional knowledge" that the knowledge in question is fairly old, and in many cases would, as a result, fall outside the bounds of ordinary IP rights.53 The practical terms of the current debate over TK thus lead us to view indefinite duration as central. Second, arguments based on distributive justice lie outside the scope of this Article, for two reasons.54 One is the impossibility of examining such arguments in depth within a single article even of substantial length. There are many such principles, even among those limited to distributive justice within a given society or nation-state. There are even more if one examines principles designed to work internationally, as the burgeoning literature on global justice makes plain. A different reason is that the practical impact of principles of distributive justice on IP rights in TK is doubtful. There may be many grounds for redistributing resources to indigenous peoples. Yet it is far from obvious that robust IP rights in TK would be an effective means for doing so, for the economic value of these rights is apt to be highly variable across indigenous peoples. Many such rights, even if vigorously enforced, would likely have little economic value.

The point is that intangible property – information – is given certain degrees of protection depending on the nature of the information and overall social goals. The default position is that information is free for anyone to use as he or she will. With trade secret law, society seeks to improve economic efficiency with respect to information that, in any event, would not be made available to the public, by reducing the effort the possessor of the information must make to keep the information of value. With trademark law, society cabins off a tiny bit of information so that it can serve a signaling function for offerors of goods and services and their customers. With patent and copyright, society seeks to supply an incentive to create new and desirable works, with the details depending crucially on whether the information relates to technological function or to the nonfunctional world of art, literature, and music.19 Thus, any call to protect information that does not fall within traditional information-protection regimes needs to supply a reason both for protection at all and for the specific scope and duration of such protection. We do not believe that a single rationale exists for protection of a broad category of information under the rubric of “indigenous cultural heritage.” We do believe, however, that reasons can be given for a degree of protection of specific types of information that many would classify as “indigenous cultural heritage.” It is simply a matter of articulating the need for protection in terms beyond “I would like to have exclusive rights in X.” (We would each like to have exclusive rights to, say, the works of Shakespeare.) Once the necessity or desirability case has been made, we can set about limiting both the scope and duration of protection to meet the articulated need, subject to countervailing interests of the public for allowing the information to remain in the public domain. The basic problem for cultural heritage protection does not, therefore, lie in the absence of a known single author or group of authors. If a legitimate basis for protection can be articulated, it is relatively easy to write statutory language that accomplishes the task.20 Similarly, the problem does not inhere in the absence of a writing or other fixation of the work, such as stories handed down by means of oral tradition. While it is true that the United States does require fixation for the attachment of federal copyright protection, most countries do not have a fixation requirement, and even within the United States unfixed works may be protected, at least against unauthorized publication, by state law.21 The real problem for intangible cultural heritage protection, as a general matter, is that it requires us to go beyond patent and copyright, and beyond the default position that information is in the public domain, to protect information for an indefinite, potentially infinite, time. We know why nonprotection is the default position for information, and we know why (more or less) we make limited exceptions to that position for patent and copyright. If we are to go beyond the boundaries of these two paradigms, we must know why we are doing so.22

Each of the four major categories of intellectual property rights fails to protect Native American tribal names for a different reason, leaving them unprotected in the public domain for general use or misuse.  Trade secret law fails to protect tribal culture and names because tribes do not attempt to keep these things secret.  Sacred objects are widely known throughout the tribe and sometimes  as part of their ritual usage.  Patent similarly provides no obvious protection for tribal names and culture because they are not new scientific inventions or technological advancements.  Although some  with registering their names as a trademark, registration requires that a name or cultural object be used in commerce and that the word not be a generic term.  These requirements can quickly invalidate tribal names since many tribes do not commercialize their names or culture, nor do they want to do so, and tribal words have been appropriated by white companies for years which puts them in danger of being labeled generic.  Some tribal symbols have even been incorporated into  and are therefore specifically invalidated from being trademarked.  Copyright protections also frequently fail to protect tribal names and cultural symbols.  Copyright is generally reserved for expressive works, not individual works or short phrases, which prevents tribes from copyrighting their names.  Similarly, because copyright focuses on providing exclusivity to a creator, tribes are not able to identify a single person or small group of persons who whom they could attribute the name or cultural concept.  Finally, copyright is time restricted, usually applying only to the life of the author plus 70 years, which would leave tribal names and traditional symbols open to misappropriation again relatively quickly.  The  is also considered an intellectual property right which allows people to control their name and image, but this right is generally reserved only for individual identities and not for group identities, which generally fall under trademark law.

IV. CHALLENGES TO A LEGAL PROTECTION OF INTANGIBLE CULTURAL RIGHTS A. ENFORCEMENT Whether legislation protecting intangible indigenous cultural property rights is introduced at a tribal, state, or federal level, the enforcement of any resulting law would be one of the biggest challenges for proponents of such a system. A tribal law would likely prove the most problematic in this regard. A tribal ordinance would likely be enforceable against a member of the tribe or another Indian person on tribal land, 110 but at least as a criminal ordinance, it would be completely unenforceable against non-Indians. 111 Short of any interference by Congress, 112 civil enforcement would be difficult as well. Under Montana v. United States, 113 there is no tribal civil jurisdiction over non-Indians outside of Indian Country, i.e. almost anyone that tribes would truly want or need to regulate in situations of unauthorized cultural appropriation, except in two very specific cases: "activities of nonmembers who enter consensual relationships with the tribe or its members, through commercial dealing, contracts, leases, or other arrangements" 114 or "when those activities threaten to have a direct effect on the political integrity, the economic security, or the health or welfare of the tribe." 115 These exceptions would likely be difficult to apply to non-Indian parties such as musicians and sports teams, but perhaps not impossible with the right set of facts. Debra Harry & L'a Malia Kanehe argue in Asserting Tribal Sovereignty Over Cultural Property: Moving Towards Protection of Genetic Material and Indigenous Knowledge that the Montana proviso could possibly be successfully satisfied in an action against outside researchers if the right tribal law were on the books: 116

In addition, throughout the history of the United States, there has been a long standing disconnect between the cultural values of Native American nations and the laws of the United States federal government. 132 For example, the Sioux Nation133 is the poorest Native American nation in the United States.134 Over the course of the last century, the Sioux Nation has asserted that the federal government breached the Fort Laramie Treaty of 1868135 by forcefully taking possession of land occupied by the tribe.136 The tribe brought a claim against the United States to regain what they consider to be sacred land.137 After a long fought court battle, the United States was eventually ordered to pay the Sioux Nation $122.5 million.138 Despite the Sioux Nation’s struggling financial standing, the tribe refused the money.139 The tribe, instead, argued that the compensation for the claim was incomparable to the cultural value of the land that the federal government expropriated.140 For these reasons, the WIPO should also consider the meaning of certain culturally significant designs when determining appropriate remedies and penalties for violating the proposed intellectual property provisions. As noted in the presented case law, in certain circumstances, monetary relief may not be sufficient to justify a sacred injury. In addition, it is also worth noting that there is no singular, “Native American perspective.” Therefore, what one Native group values, may be of no value to another group. Similarly, Native groups do not remain the same throughout time. Therefore, what may be of value to one Native group at one point in time, may be of no value in future years. For these reasons, it is also of great importance that the WIPO also take into consideration that indigenous groups are not monolithic or stagnant in their growth. Therefore, there is no set strategy that transcend the test of time and work favorably for all groups involved. For that reason, it is also worthwhile to consider using other legal theories in addition to intellectual property when protecting the cultural designs of indigenous people.

Proponents of a new legal regime for TK often invoke concepts of property in their defense. To denounce “biopiracy” and the plunder of TK assumes that what was pirated or plundered is property.2 A recent report by WIPO, for instance, states that "holders of TK should be entitled to fair and equitable sharing of benefits arising from the use of their knowledge."3 This statement likewise presupposes that the benefits of knowledge or the knowledge itself, or both, are property to be shared among TK holders. Proponents suggest that the legal protection of TK will serve several important goals. These include promoting respect for TK; deterring the misappropriation of TK; empowering TK holders, who are typically marginalized indigenous peoples; and protecting tradition-based innovation. The existing IP system is said to be unable to meet the needs of TK holders; as a result, extensive legal change is required.4 Some of the literature on TK takes as self-evident the proposition that TK ought to be protected, and focuses instead on how to do so: to revamp the patent system, to create sui generis rights via international treaties, to build global databases of TK that can be used to block patent applications, and so forth. Other analysts consider the more basic question of whether IP protection is in order. And still others contend that IP protection for at least some TK is contrary to how many indigenous communities conceive of their cultural heritage.

- even though this isnt the aff, its an important point that biases in the system could still exist because of constatnt racial biases against native Americans

Johnson 10 Johnson is a Third-year student, University of Oklahoma College of Law (Aaron Drue, “Just say no (to american capitalism): why american indians should reject the model tribal secured transactions act and other attempts to promote economic assimilation”, American Indian Law Review, 1-1-2010, , DOA: 6/29/24)//LFS – LMH

This past fall, the U.S. Patent and Trademark Office (USPTO) issued an uncommon request for public comment and notice of Tribal consultation regarding protections for Native American culture and traditional knowledge in the intellectual property system. This effort is a part of the USPTO’s work to develop U.S. positions on legal instruments being negotiated at the intellectual property arm of the United Nations (UN). Several legal instruments currently under negotiation could usher in an era of mutually beneficial collaboration and exciting innovations between Indigenous people and other parties, public and private. U.S. support for Indigenous rights in these international processes would offer hope to all Indigenous people for the future of these instruments. For Native Americans, there would be additional cause for optimism that urgently needed legal changes in the United States could be enacted to protect Native American cultures and related Indigenous human rights.

As previously mentioned, the United States also codified NAGPRA at 25 U.S.C. § 3001, protecting Indigenous artifacts with particular cultural value.148 Not too long ago there was no recourse for misappropriation of Indigenous intellectual and cultural property, but now there are criminal penalties for violation of these protections.149 To date, Indigenous peoples have appealed to the courts, integrating Indigenous intellectual property with twenty-first century legal practices by filing lawsuits to protect their rights.150 For example, the Cow Creek Band of the Umpqua Tribe of Indians in Oregon joined the Indian trademark case involving the Indian Motorcycle Company consortium to "promote pride, dignity, and knowledge about Native American heritage."151 The federal suit was originally filed because Indian Motorcycles, a motorcycle manufacturing company, violated the Indian Arts and Crafts Act of 1990 by using "Indian" in its name.152 The Cow Creeks joined the suit with federal encouragement, and the case was one of the first to challenge the limited corporate responsibility when using Indigenous names and symbols. Recently, there has been collaboration between the USPTO and the Native American Intellectual Property Enterprise Council (NAIPEC). The groups joined together and signed the Memorandum of Understanding, which aims to increase Native American inventors' patent and trademark filing. The goals are to participate in "research and identify the IP education needs of specific Native American communities, and to provide that education in whatever way works best." A new office in the USPTO will facilitate their interactions and allow direct access for Native American intellectual property advocates. This new collaboration is a prime example of how nations can work in unison with their Indigenous communities to create systems that function in harmony to meet the needs of all.153

(Marcia Ellen DeGeer holds a Juris Doctorate from the New England School of Law, and is now a lawyer specializing in business. 2002, Biopiracy: The Appropriation of Indigenous Peoples’ Cultural Knowledge. New England Journal of International and Comparative Law, Vol. 9 no. 1, pages 179-208. CPSW - GHS-LHM//)

C. Enforce Public Policy and Morality Aspects of Patent Law. Under the test for patent applicability are the grounds to negate corporate patents of Indigenous Peoples’ plants. Under the usefulness prong of patent law, a patent will not be issued if it is illegal or immoral. The Patent Trade Office has recently used the Moral Utility doctrine to exclude inventions that combined human and animal cells. “The courts have interpreted the utility requirement to exclude inventions deemed to be ‘injurious to the well-being, good policy, or good morals of society.’” Placing pressure on our governments and the international community through public awareness could persuade the courts and the TRIPS agreement to consider the validity of the Indigenous Peoples’ claims to their plants and cultural knowledge. Public awareness could expose bioprospecting for what it is, illegal and immoral appropriation.

For decades, pharmaceutical companies have gamed the U.S. patent system and engaged in anticompetitive behaviors to drive up prices, making it increasingly difficult for American families to afford life-saving drugs.

Those findings, released Friday, were the culmination of three years of Congressional investigation into pharma’s price gouging and anticompetitive business practices.

Fraud, misconduct, and illegal activity are well-known aspects of pharmaceutical companies’ business practices. Unlike other large industries, while business practices may be potentially unethical, but not illegal, those in the pharmaceutical industry routinely and flagrantly engage in illegal activity without facing any deterrent consequences. The Food and Drug Administration (FDA) and the False Claims Act (FCA) deem pharmaceutical companies criminally and civilly liable for engaging in conduct including, but not limited to, misbranding and mislabeling products, promoting products for off-label or non-FDA approved uses, misrepresenting or adulterating data and clinical trial results, and failing to disclose or adequately warn consumers of potential risks and side effects. Violations of these laws and regulations are so widespread and regular, that it is difficult to argue that they are not purposeful. For example, a recent landmark bribery case, Insys Therapeutics executives were found guilty of bribing doctors to prescribe a fentanyl-based opioid pain medication without medical necessity. This case marks the first time pharmaceutical executives have been sentenced to jail time for their knowing participation in unethical and illegal conduct.

A number of factors contribute to this pattern:

When a knowledge system importantly loses integrity, ceasing to provide the kinds of trusted knowledge expected of it, we can label this epistemic corruption. Epistemic corruption often occurs because the system has been co-opted for interests at odds with some of the central goals thought to lie behind it. There is now abundant evidence that the involvement of pharmaceutical companies corrupts medical science. Within the medical community, this is generally assumed to be the result of conflicts of interest. However, some important ways that the industry corrupts are not captured well by standard analyses in terms of conflicts of interest. It is not just that there is a body of medical science perverted by industry largesse. Instead, much of the corruption of medical science via the pharmaceutical industry happens through grafting activities: Pharmaceutical companies do their own research and smoothly integrate it with medical science, taking advantage of the legitimacy of the latter.

Introduction: Epistemic Corruption

The Congressional Budget Office estimated that reducing the pharmaceutical industry’s revenues would result in two fewer drugs in the next decade, 23 fewer in the following decade, and 34 fewer drugs in the third decade. Predictions 20 to 30 years out are necessarily imprecise, but in any case, many of those projected new therapies would likely be neither novel nor more valuable than existing drugs. That is, they wouldn’t be innovative.

Many would be modified versions of existing drugs, created merely to extend patent protections and thus monopolies over existing therapeutics. When Medicare Part D dramatically increased the pharmaceutical industry’s revenues 18 years ago, major drug companies directed their drug-development efforts primarily at drug classes where there were already five or more products on the market. Currently, the majority of new patents filed by large pharmaceutical companies are modifications of drugs already on the market.

Big Pharma has been spouting this argument for a long time. Does it hold any water? Two experts who closely study the pharmaceutical industry explain why it doesn’t. Fred Ledley and colleagues show how much taxpayers pony up through agencies like the National Institutes of Health (NIH), which fund research and provide resources for promising projects to the drug industry. William Lazonick exposes how the Wall Street-focused business models of contemporary pharmaceutical giants inhibit innovation and depend on exorbitant prices.

Bottom line: big drug companies rake in enormous profits without prioritizing investments in medication development or innovation. They simply snap up drug rights that the federal government paid for (us, in other words), focus on boosting their stock prices, and overcharge the public. Surely, Americans deserve better.

‌The biopharmaceutical industry has long argued that high prices are needed to sustain research and development (R&D) for new medicines. When asked to justify a price tag of $10 000 a month for a drug to treat prostate cancer, a senior executive at Johnson & Johnson responded: “The easy diseases have largely been solved. It gets harder and harder as we go after new treatments for ever more challenging diseases.”7 Drug companies often note how their shareholders and investors could easily shift their investments to other more profitable and less risky sectors. Indeed, there are large financial risks associated with bringing new medicines to market, as many candidate molecules will not make it because they are ineffective or harmful, or both. However, analysis of drug company spending and products raises questions about the claim that high drug prices are needed to sustain valuable innovation.

Accounting rules make comparisons of profits by the pharmaceutical and other industries complicated,8 but data suggest that drug companies are particularly profitable, even after adjusting for R&D spending as a share of revenues.910 There also seems to be a disconnect between product R&D costs and prices. One recent study found no association between how much drug companies spend on R&D and the prices they charge for new medicines.11

The rising cost of prescription drug prices is crushing small businesses. Nearly one in three small businesses currently providing health benefits to their workers have considered ending their sponsored coverage largely as a result of rising health care costs. 93 percent of small business owners believe the prescription drug market needs to undergo changes, with 66 percent calling for a major overhaul.

Small businesses are forced to pass along the increased costs of providing coverage to customers and workers. Many small businesses report wanting to “do the right thing” when it comes to providing health coverage for their workers. Tragically, that goal is being pushed increasingly out of reach, as many owners are being forced to raise prices on goods and services and/or increase deductibles and premiums in order to continue providing coverage.

In addition to using policy to manage inflation and keep drug prices low, a competitive marketplace that promotes innovation can also reduce drug spending.

“It is important to reward the continued investment in new drug development to treat conditions without adequate therapies. The challenge is that most diseases where innovation is critically needed are severe and frequently extremely specialized,” Lucio stated.