National Forensics Association
Lincoln-Douglas Debate Evidence Set
[Affirmative 2015-2016]
Page 1 of 13
Affirmative – Index
Affirmative – Index..................................................................... 1
Prior Informed Consent & Disclosure 1AC 1/.............................................. 2
Prior Informed Consent & Disclosure 1AC 1/.............................................. 3
Prior Informed Consent & Disclosure 1AC 1/.............................................. 4
Prior Informed Consent & Disclosure 1AC 1/.............................................. 5
Prior Informed Consent & Disclosure 1AC 1/.............................................. 6
Prior Informed Consent & Disclosure 1AC 1/.............................................. 7
Topicality Interpretations.............................................................. 8
AT International CP..................................................................... 9
AT Consult............................................................................. 10
Inherency Extension.................................................................... 11
Solvency Extension..................................................................... 12
Biodiversity Extensions................................................................ 13
National Forensics Association
Lincoln-Douglas Debate Evidence Set
[Affirmative 2015-2016]
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Prior Informed Consent & Disclosure 1AC 1/
Observation One is INHERENCY
A. The US has no provision requiring genetic or biological source disclosure and
prior informed consent (PIC) – this makes the US a contributor to biopiracy
Laura Grebe, Patent Attorney, Creighton Law Review, February 2011. [“Requiring genetic source disclosure in the
United States.” Lexis]
To combat biopiracy - the smuggling of genetic resources into the hands of corporations from developed nations who then claim ownership of
these resources - and regulate bioprospecting - the search for beneficial biological resources throughout the world by sampling - many
nations have implemented legislation requiring researchers to obtain prior informed consent ("PIC") from the
source nation and local authorities before commencing any research or sampling. n5 PIC agreements usually
include some provision regarding sharing profits or [*369] other benefits obtained from the research undertaken. n6
The Convention on Biological Diversity ("CBD") furthered the individual nations' efforts by requiring all parties to the
agreement obtain PIC. n7
The United States in not a member of the CBD and, therefore, is not required to obtain PIC before commencing
research on biological resources from another nation. n8 Further, the United States has no provision requiring
those applying for patents to disclose the source of any biological materials used in deriving the invention. n9 In
essence, companies in the United States can engage in biopiracy, patent any invention or discovery resulting
from the research on stolen biological resources and innovations, and prohibit other nations from utilizing their
own resources. n10
B. The US opposes disclosure obligations, instead opting for contractual
agreements with source nations
Arvid Lukauskas, et al. Professor at Columbia University, in his Handbook of Trade Policy and
Development, published in 2013. [Oxford University Press. Robert M. Stern, Gianni Zanini. page 756. Google Books]
developing countries (Brazil, Cuba, Ecuador, India, Pakistan,
argued for a requirement to disclose the source and origin of genetic
resources and traditional knowledge in patent applications. This group also calls for patent holders to submit
evidence that they have obtained “prior informed consent” for using genetic resources and traditional
knowledge and that benefits are shared in a fair and equitable manner. Where non-compliance with these requirements is
Since then, discussions at the WTO have gone into considerable detail. A group of
Peru, Thailand, Venezuela, and others) have
discovered after the grant of patents, those patents should be revoked.
the European Union has come
out to support an international disclosure requirement of the source and origin of genetic resources and
traditional knowledge, but opposes patent revocation in case of non-compliance. The United States, in turn, opposes a disclosure
obligation, claiming that such a move would introduce uncertainty into the patent system. It argues that there are other
Developed countries stress that they do not see a conflict between the TRIPS Agreement and the CBD. Still,
mechanisms to prevent the erroneous grant of patents, including the use of searchable databases of genetic resources and the examination of relevant
information already submitted by patent applicants. The United States also opposes the submission of evidence proving
“prior informed consent” in patent applications, favoring instead a contractual approach outside the patent
system to promote the fair and equitable sharing of benefits.
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PLAN – In order to substantially increase restrictions on bioprospecting, all
patent applications should be required to disclose prior informed consent and
genetic source information. Funding and enforcement will be through normal
means and the affirmative reserves the right to clarify the intent of plan in crossex and further speeches.
National Forensics Association
Lincoln-Douglas Debate Evidence Set
[Affirmative 2015-2016]
Page 4 of 13
Prior Informed Consent & Disclosure 1AC 1/
Observation Two is SOLVENCY
A. The United States should require all Bioprospectors to obtain prior informed
consent and the disclosure of genetic source material
Grebe, as previously cited. Laura Grebe, Patent Attorney, Creighton Law Review, February 2011. [“Requiring genetic source
disclosure in the United States.” Lexis]
Biopiracy and bioprospecting continue to put developing countries rich in biodiversity at a disadvantage.
Researchers essentially steal one of the only viable exports for these nations and proceed to patent the resource, effectively inhibiting the developing nations from utilizing
their own natural resources. The
Convention on Biological Diversity [*404] document ("CBD") works to rectify the inequities
caused by biopiracy and bioprospecting by requiring researchers to obtain prior informed consent from source
countries. Because the United States is not a party to the CBD, patent applicants and researchers have no
incentive to halt biopiracy and bioprospecting. The United States should therefore institute a source/PIC
disclosure requirement, requiring patent applicants to disclose the source country and PIC agreement (or evidence
of a good faith effort to obtain such an agreement) during the prosecution period. The applicant, however, should only be required to take reasonable steps to obtain reliable
source country and PIC information. If the disclosure is later found to be incorrect, a patent holder who, at all times during the prosecution, reasonably relied on the
information disclosed should be given a specified amount of time to reasonably obtain correct disclosure information, but the eventual lack of such information should not
invalidate the patent. However, if the incorrect information was due to inadequate investigation into the proper source/PIC information, or pure ignorance, the patent holder
should be given the same time in which to obtain correct information to maintain patent validity or incur a financial penalty if such information cannot be reasonably
ascertained. Finally, if the incorrect information was purposefully given, regardless of any intent to deceive, the patent should be invalidated. Requiring
this
genetic source and PIC information would bring the United States closer to compliance with the CBD, while still
performing in accordance with the United States' obligations as signatories to current international intellectual
property treaties.
B. Patent applications should be required to disclose prior informed consent and
genetic source information through the fraudulent procurement model
Grebe, as previously cited. Laura Grebe, Patent Attorney, Creighton Law Review, February 2011. [“Requiring genetic source
disclosure in the United States.” Lexis]
There has been little discussion to date regarding specifically how a genetic source disclosure can be worked
into existing United States patent law. The issue of requiring genetic source/prior informed consent ("PIC")
disclosure is usually considered from an international perspective. Leading proposals for change to international law include amending
Trade-Related Aspects of Intellectual Property Rights ("TRIPs") or the Patent Cooperation Treaty ("PCT"), or enacting the Mandatory Disclosure Proposal by the European
Union. n148 The TRIPs proposal would require the source of an invention, proof of attainment of PIC, and a fair benefits-sharing agreement before a patent is issued. n149
The PCT proposal would require disclosure of genetic sources on patent applications, but the patent would only be invalidated for non-compliance if it is shown the information
was withheld for fraudulent purposes. n150 The third, and last, main international proposal - the Mandatory Disclosure Proposal by the European Union - would also require
genetic source disclosure of those sources the inventor knew or should have had reason to know. n151 Patent proceedings will stop and no patent will issue if the applicant
refuses to disclose this information. n152 After the patent issues, however, any sanctions or punishments for non-compliance or supplying false information would lie outside
patent law. n153
As far as proposals for United States law specifically are concerned, such limited proposals are mostly based
on the doctrine of [*390] fraudulent procurement. n154 Patent applicants have a duty to provide full and complete
information on applications in order for examiners to best review the application. Failure to supply information
necessary to the final patentability determination (such as that information that would affect novelty, etc.) may
result in patent invalidity. When the failure to supply information relates to only non-essential matters, and the
patent issues, the fraudulent misinformation results in patent non-enforceability.
This same concept of fraudulent procurement has been suggested as a not-so-invasive way to implement a
genetic source disclosure requirement in the United States. n155 Genetic source information, such as the
country of origin, PIC and any benefit sharing agreements, would be suggested, though not required as an essential
element for patentability. n156 In other words, that information, when the patent applicant knows it, or should
reasonably know it, must be disclosed. Failure to do so would be considered fraudulent procurement of the
patent, and, if issued, the patent would not be enforced. n157
National Forensics Association
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C. Patent reform in the US, especially specific to IP law, will be modeled
internationally, as other nations look to us for guidance
Robert Stoll, former Commissioner of the US Patent and Trademark Office, the Hill, May 22nd, 2015. [“US
patent reform’s international impact,” http://thehill.com/blogs/pundits-blog/technology/242901-us-patent-reforms-international-impact]
In the past several years, the patent system has gone mainstream. There has been a steady stream of press stories — in The
New York Times but also local papers, on NPR and also on the local evening news at 11 p.m. — as Congress continues year three of legislative
It would be easy to see this as a domestic conversation about a
problem that exists only in the U.S. But that is incorrect — the rest of the world is watching.
discussions about the best way to reform the system.
Discussions about patent reform are no longer limited to the green eyeshade sect but are common topics in the boardrooms of national and international
companies. Governments around the world envy the success of our system as a stimulant for inventiveness and are watching to
see what next steps we take. They are also taking matters into their own hands: The EU is finalizing new rules of procedure for the Unified Patent Court;
the State Intellectual Property Office (SIPO) in China just published the latest updates to their patent laws; and Indian Prime Minister Narendra Modi has
called on India to update patent laws to boost international competitiveness.
The way we frame the problems in the U.S. patent system and the solutions we codify to address them matter
a great deal to the future success of the U.S. patent system and our country's economic competitiveness. The
vast majority of stakeholders are collectively motivated to craft solutions that deter abusive behavior by some who have used the threat of litigation to
extort payments for vague patents of questionable validity. The costs of the license are often below the likely litigation costs, making it difficult to justify
pursuing costly and uncertain litigation instead of just writing a check. There is no doubt that we can do more to curb this "trollish" behavior, no matter
who is engaging in it. In doing so, however, we need to be careful that we don't also deter legitimate plaintiffs from exercising their rights to benefit from
strong patents that resulted from their efforts and creativity. Small businesses especially need the ability to seek redress in court for infringement of their
patents. Otherwise, the large multinational corporations will be able to infringe without the threat of ever being held accountable and many small
businesses, the drivers of job creation, will perish.
The solutions we develop must also take into account the fact that our economy is global. Every country has its own
international treaties like
the Trade Related-Aspects of Intellectual Property (TRIPs), which sets minimum standards of intellectual property protection.
patent laws enacted to foster economic growth and job creation in their territories. Most countries are signatories to
Amongst other provisions, this treaty provides for national treatment, which levels the playing field for citizens of other member countries; most-favorednation status, which gives other nations those same enhanced benefits; and provisions that prevent discrimination based on patent subject matter.
are minimum standards,
leaving countries with significant flexibility and discretion in designing their domestic intellectual property
systems. Given the incentives government officials have to promote their domestic economy (and companies), there is an inherent risk that nations
While international treaties do limit the ability to enact laws that discriminate against outsiders, these provisions
will adopt policies that disadvantage foreign companies. This could include policies that limit the ability for foreign companies to enforce their patents,
with the goal of reducing licensing costs to local manufacturers and ensuring that their people get access to the latest gadgets at the lowest costs
whenever they can. It is the continuous task of our international servants to convince foreign officials that the domestic development of intellectual
property supports international trade and that economic growth in their countries is stimulated by strong patent protection for all. This message is diluted
when we in the United States harm the ability of the legitimate plaintiff to protect their rights or overly restrict the types of invention that can be protected
within our borders. Foreign governments may see the U.S. action as an opportunity to limit the ability of plaintiffs in their countries, many from outside
their territory, and thus advantage their domestic industries. Foreign governments already make it difficult for outside companies to prevail in patent
matters in their countries, with complicated procedures, aggressive application of competition laws to foreign patent holders, burdensome requirements
and delayed or even denied justice. Any limitations or exclusions to patentability or the enforcement of a patent in the
U.S. will be magnified in countries around the globe. Foreign governments will continue to seek ways to make the system better for
their own people at the cost of everyone else. We need to assure that the reforms we adopt are crafted in a surgical manner to avoid the unintended
consequences of preventing a legitimate patent holder from enforcing her rights or narrowing the technologies where we issue patents. This is very
important to patent holders in the U.S., but also critical to the thousands of innovative U.S. companies that rely on patent protection to sell their products
in foreign countries. We must always be cognizant that we are in a global economy and what we do here has
impacts on our patent holders in every country.
The world is watching.
National Forensics Association
Lincoln-Douglas Debate Evidence Set
[Affirmative 2015-2016]
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Prior Informed Consent & Disclosure 1AC 1/
Observation Three is the ADVANTAGE
A. Biopiracy will continue in the status quo – despite the Nagoya Protocol,
inconsistent national legislation will allow biopiracy to continue
Janna Lawrence, staff writer for the Pharmaceutical Journal, February 12, 2015. [“Drug discovery returns to the
wild.” http://www.pharmaceutical-journal.com/news-and-analysis/features/drug-discovery-returns-to-the-wild/20067820.article]
The practice of bioprospecting has sometimes had murky associations with ‘biopiracy’ — the use of a country’s
biological resources without the proper consent or compensation of the host country. “You have to make sure
that the rights of less developed countries are taken into account and that these nations are not taken
advantage of by more industrialised countries,” says Esguerra.
In 1998, a research project called Maya ICBG set out to characterise compounds used by the Maya communities in Mexico. Various US government
departments provided funding, with collaboration from Mexican universities and the support of communities and the Mexican government[9]. But the
group was accused of unethical bioprospecting by non-governmental organisations. The criticism centred on the nature of prior informed consent.
Eventually the controversy led to the five-year project being terminated after only two years.
The issue of ethics in sourcing compounds is addressed in the Convention on Biological Diversity, which came into force in December 1993 and which
194 states are now party to. One of its main aims is the fair and equitable sharing of the benefits from the utilisation of genetic resources. This
goal
was formalised in the Nagoya Protocol, which came into force in October 2014.
“In theory, this protocol should promote the utilisation of natural resources by providing more legal certainty,”
says PharmaSea collaborator Thomas Vanagt, a marine ecologist who founded the eCOAST marine research centre in Belgium. He led PharmaSea’s
input into the Nagoya Protocol.
Vanagt warns that, in practice, the legal situation for researchers and ‘provider’ countries may still not be completely
clear. The protocol stipulates that any entity undertaking bioprospecting in a country must abide by that
country’s access legislation. “Making access legislation is a national prerogative,” he explains, but not every
country has this legislation in place. Costa Rica has had robust legislation for many years, for example, but
others still don’t have any.
B. Biopiracy appropriates biodiversity from indigenous cultivators using status
quo patent protections as a shield
Katherine Kelter, Litigation Associate, Conn Kavanaugh, Suffolk Law Review, 2014. [“Pirate Patents: Arguing
for Improved Biopiracy Prevention and Protection of Indigenous Rights Through a New Legislative Model.” Lexis]
Many common agricultural crops have developed through human tinkering; alteration
and experimentation have given rise to food
species whose existence depends entirely on humans. n2 The development of these crops has generated
specific, traditional knowledge associated with particular species, and this potent combination of genetic material and
phenotypic value creates a modern-day treasure trove of valuable commercial material. n3 Individual and corporate
parties have increasingly sought to collect such indigenous knowledge and capitalize on its value through
existing intellectual property patent protections. n4 This practice, known as "biopiracy," evades easy definition; by
common [*374] consensus, the practice may best be characterized as a form of biological theft, in which plants identified
and cultivated by indigenous communities are collected and patented by noncommunity members without
granting property protection to the original cultivators. n5 Biopiracy is also viewed as the appropriation of
biodiversity from its original owners and innovators through the creative definition of seeds, medicinal plants,
and associated medical knowledge as nature, thereby removing the plant materials from patent eligibility. n6 This
definition combines a variety of loosely associated but poorly defined notions of biopiracy, demonstrating the difficulty in identifying the practice. n7 The
derivation of genetic and biochemical materials is both scientifically and commercially valuable, and companies attempt to patent these materials to
"justify legal ownership through intellectual property law." n8 Additionally,
the lack of agreement over the actual subject matter
of the patent, namely the plant versus the traditional knowledge with which it is associated, further confuses
the issue. n9 "Biodiverse" developing countries have accused their developed Western counterparts of
removing genetic resources and the traditional knowledge with which they are associated and patenting these
resources in their original forms or in the form of derived inventions.
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Prior Informed Consent & Disclosure 1AC 1/
C. Indigenous knowledge protection is key to biodiversity
Deepak Raj Parajuli and Tapash Das, graduate students at Kathmandu University, International Journal
of Scientific & Technology Research, August 2013 [“Indigenous Knowledge And Biodiversity: Interconnectedness For
Sustainable Development.” http://www.ijstr.org/final-print/aug2013/Indigenous-Knowledge-And-Biodiversity-Interconnectedness-ForSustainable-Development.pdf]
Indigenous knowledge is the local knowledge which is exclusive to a given culture or society. This indigenous
knowledge is really important in conserving the biological resources existing in different altitudinal and climatic variations.
Indigenous people are conserving the biodiversity in order to survive themselves, which eventually conserve
the whole environment. However due to globalization, environmental threats, no transfer of knowledge to younger generations, this unique cultures and
knowledge are gradually disappearing. Moreover, exclusionary practices, poverty as the capability deprivation and unequal policies are also responsible for making the
it is utmost important to
conserve indigenous knowledge their skills and technologies in order to conserve biodiversities, which can be
done by the effective implementation of the policies that are prepared for the conservation of indigenous
people their knowledge and biodiversity. Unless and until we do not conserve indigenous knowledge, we cannot achieve sustainable development as
indigenous knowledge more vulnerable, eventually affecting the diverse flora and fauna, causing them to extinction. Hence
indigenous and place-based knowledge always works to achieve sustainability.
D. Any mass extinction event will happen because of a lack of biodiversity –
every species lost drives us closer and closer to the end of humanity
Noah Greenwald, endangered species expert at the Center for Biological Diversity, February 2nd, 2014.
[“The Extinction Crisis” The Center for Biological diversity is a collective of hundreds of applicable professionals dedicated to securing a
future for all species, http://www.biologicaldiversity.org/about/index.html]
It’s frightening but true: Our planet is now in the midst of its sixth mass extinction of plants and animals — the sixth wave of extinctions in the past half-billion years. We’re
Although extinction is a natural
phenomenon, it occurs at a natural “background” rate of about one to five species per year. Scientists estimate
we’re now losing species at 1,000 to 10,000 times the background rate, with literally dozens going extinct every day [1]. It could be a
currently experiencing the worst spate of species die-offs since the loss of the dinosaurs 65 million years ago.
scary future indeed, with as many as 30 to 50 percent of all species possibly heading toward extinction by mid-century [2]. Unlike past mass extinctions, caused by events like
asteroid strikes, volcanic eruptions, and natural climate shifts, the current crisis is almost entirely caused by us — humans. In fact, 99 percent of currently threatened species
are at risk from human activities, primarily those driving habitat loss, introduction of exotic species, and global warming [3]. Because the rate of change in our biosphere is
increasing, and because every
species’ extinction potentially leads to the extinction of others bound to that species in a
complex ecological web, numbers of extinctions are likely to snowball in the coming decades as ecosystems unravel. Species diversity ensures
ecosystem resilience, giving ecological communities the scope they need to withstand stress. Thus while conservationists often justifiably focus their efforts on
species-rich ecosystems like rainforests and coral reefs — which have a lot to lose — a comprehensive strategy for saving biodiversity must also include habitat types with
fewer species, like grasslands, tundra, and polar seas — for which any loss could be irreversibly devastating. And while much concern over extinction focuses on globally lost
species, most of biodiversity’s benefits take place at a local level, and conserving local populations is
the only way to ensure genetic diversity
critical for a species’ long-term survival.
E. There is an ethical obligation to err on the side of preserving biodiversity and
the benefits of preservation outweigh the benefits of extraction
Andrea Aseff, attorney specializing in environmental and natural resource law, Colorado Journal of
International Environmental Law and Policy, Winter 2011. [“First Federal Prohibition on Bioprospecting within a Place
of Protection: Time to Spur the Legislative Dialogue. Accessed via LexisNexis.]
The acceleration of already high levels of biodiversity loss needs to be at the forefront of policy discussions.
Erring on the side of less environmental impact is the prudent approach, especially given the potentially severe
environmental impacts loss of biodiversity can have on local, national, and global levels. In fact, some conservation
biologists have argued that, in the face of uncertainty, scientists who base their work on public natural resources have
an ethical obligation to err on the side of preservation. n58 Inevitably, the Congressional discussion will include these debates and
others. But, preservation of biodiversity should ultimately guide the policy debate because the benefits of environmental sustainability
and preservation outweigh the benefits of extraction and genetic derivation, even if useful products can
sometimes be derived.
National Forensics Association
Lincoln-Douglas Debate Evidence Set
[Affirmative 2015-2016]
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Topicality Interpretations
Restriction means a legal limiting condition
Google Definitions, last updated 2015 [“Restriction,” https://www.google.com/webhp?sourceid=chromeinstant&ion=1&espv=2&ie=UTF-8#q=restriction]
re·stric·tion rəˈstrikSH(ə)n/ noun a
limiting condition or measure, especially a legal one. "planning restrictions on
commercial development" synonyms: reduction, limitation, diminution, curtailment "the restriction of personal freedom" the limitation or
control of someone or something, or the state of being limited or restricted.
Genetic theft and biocolonialism is a form of bioprospecting
LorrieAnn Santos, Native Hawaiian Cancer Network, published in PMC with the US National Library of
Medicine, May 3rd, 2010 [“Genetic Research in Native Communities,” http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2862689/]
4. Who Profits from the Research? Indigenous
communities view commercially-driven genetic research that secures
ownership for profit or academic advancement as biocolonialism. Biocolonialism in the form of genetic
bioprospecting often arrives in Native communities without invitation. Such was the case of the Havasupai, who believed their
blood samples were to be used solely for their collective benefit and well-being, not the academic benefit of researchers, particularly unknown
researchers who did not have an established relationship with the tribe or its members. By early 2002, 23 academic papers, articles, and dissertations
had been published on research that examined Havasupai blood. Of these, 15 focused on schizophrenia, inbreeding, and migration….not diabetes. One
of the principal researchers on the study moved up the academic ladder to the highest level in the state’s university system -- and won acclaim as one of
the nation’s top scientists. One-fifth of human genes in the U.S. have been patented.
Bioprospecting is a term that encompasses and includes biopiracy
Jennifer Jolly, et al. Professor at the University of South Florida, World Journal of Social Sciences,
September 2012. [Stephen Baglione, Saint Leo University and Thomas Zimmerer, University of South Florida. “An empirical study
of bioprospecting: Ethical issues in conflict.” http://wbiaus.org/11.%20Stephen1.pdf]
Bioprospecting is a phrase that denotes commercial interest in the potential profitability of resources found in
biodiverse regions. The term, first coined by Walter V. Reid (Reid et al., 1993) “was created in response to the problematic
relationship between global commercial interests, the biological resources, and indigenous knowledge of local communities—and to the epidemic
of biopiracy, the patenting of indigenous knowledge related to biodiversity” (Shiva, 2007, p. 307).
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AT International CP
Global approaches to indigenous biopiracy protections fail
Tim Mackey and Bryan Liang, researchers at the Institute of Health Law Studies, American Journal of
Public Health, June 2012. [“Integrating biodiversity management and indigenous biopiracy protection to promote environmental
justice and global health.” http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3483946/]
Global governance, however, has been ineffective in protecting biodiversity from biopiracy. Global IPR rules comprise
domestic, multilateral, and supranational systems that establish minimum intellectual property standards. These global IPR
systems focus on patent systems and private economic development under the World Trade Organization (WTO) TRIPS regime (Agreement on
Trade-Related Aspects of Intellectual Property Rights) and on activities of the World Intellectual Property Organization. However, they have failed to
protect indigenous rights, promote access to life-saving drugs, prevent biopiracy, or provide for responsible
biodiversity development.5–9 Governance relies on market forces and state entities of independent governments within a defined territory,
which preclude the participation and protection of indigenous communities (both in developed and developing countries) that comprise groups of diverse
social self-identification. This traditional state-focused governance model has not created incentives for developing countries to invest in adequate
conservation, and thus, biodiversity resources in these countries are in danger of being depleted.4,6
In response, in October 2010, the UN Convention on Biodiversity adopted the Nagoya Protocol, which attempts to protect biodiversity and sets rules on
how nations access and share biodiversity benefits.10 It successfully introduces key components of resource sharing of biodiversity benefits by
the [Nagoya] protocol does
not adequately address several concerns, including the following: a forum for indigenous peoples to adjudicate
biopiracy claims, strong penalties to create disincentives for biopiracy, ensured indigenous access to
developed drugs, promotion of the planning and implementation of sustainable biodiversity conservation and
establishing a framework for norms and rules that may be implemented by member states in the future. However,
investment in public health infrastructures in developing countries, and adequate promotion of public–private partnerships (PPPs) that can leverage
resources from both public and private stakeholders. We therefore propose a policy employing a joint health–economics committee, a World Health
Organization (WHO)–WTO Joint Committee on Bioprospecting and Biopiracy, to address these equity issues and promote sustainable and responsible
global governance in biodiversity management.
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AT Consult
Indigenous people have already demanded prior informed consent, they see it as
a right – consent gives indigenous groups the power to negotiate agreements on
their own terms
Agnes Portalewska, communications manager and contributor at Cultural Survival Quarterly,
December 2012. [“Free, Prior and Informed Consent: Protecting Indigenous Peoples’ rights to self-determination, participation, and
decision-making.” http://www.culturalsurvival.org/publications/cultural-survival-quarterly/free-prior-and-informed-consent-protectingindigenous]
Nmehielle, who is an Indigenous rights lawyer and international law professor, elaborates. “F PIC
is a concept based on autonomy of the
individual. Indigenous Peoples’ rights have been so violated in the past by those who felt they knew what’s
best for Indigenous Peoples, it becomes a concept to allow them to make the decision on their own as to
whether a project or action is beneficial to them. It’s like taking a referendum: do we really want this or not? We want to make sure
Indigenous Peoples are not taken for granted, are consulted regularly, and make decisions based on what they know to be true—the positives and
negatives about the particular initiative that affects them. That is the bottom line.”
Friederichs, a law school clinician, adds, “When you are talking about FPIC, you are talking about the broader duty to consult and then the overarching
principle of participation. The way I read the Declaration is that states have a duty to consult with Indigenous Peoples and the goal of consultations
should be to obtain their FPIC. Participation
is about remedying centuries of denying Indigenous Peoples access to
decision-making that was happening without their voice at all. This is a way to make sure that the states recognize they have an obligation to actually
bring Indigenous people to the table and listen to them.”
A Process Right vs. Substantive Right
As Grand Chief John sees it, “FPIC is a right. It’s not simply a concept; it is a right to [a] process. In many cases the
natural relation is to lands, territories, and resources. If somebody’s coming in to your territory to put a pipeline or a mine, then they should talk to you
and determine what it is that they’re planning. [There are] those who just go to the state government or national government and then come and say, ‘we
got a permit from the government to put a pipeline in here.’ What they need is permits from the Indigenous people themselves.”
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Inherency Extension
The academy is focused on all or nothing approaches to US patent changes –
like ratification of the CBD – little attention is given to small changes to bring the
US in line with international law without upsetting the apple cart
Grebe, as previously cited. Laura Grebe, Patent Attorney, Creighton Law Review, February 2011. [“Requiring genetic source
disclosure in the United States.” Lexis]
To date, many
scholars have analyzed the provisions of the CBD, and even reconciled the seeming
inconsistencies between the CBD, to which the United States is not a party, and the Agreement on Trade-Related Aspects of Intellectual
Property Rights ("TRIPs"), to which the United States is a party. n11 There has also been much discussion on whether or not
the United States can or should ratify the CBD. On the one side, some argue that the United States, as a powerful leader nation,
should ratify the CBD because it has an obligation to act in a responsible and respectful manner toward other nations and set an example for other
countries to do the same. On the other side, others argue that complying with the CBD would not only require significant changes to the patent system,
but also disregard the competitive market advantages the current regime bestows upon the inventors who put time and money into research and
development. There
is little discussion, however, of the possibility of bringing United States policy more in line with
the spirit of the CBD without overhauling the entire patent system. This Article will fill the gap by proposing a genetic
source/PIC disclosure requirement that is easily workable into the United States' current patent regime.
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Solvency Extension
The plan will have many positive effects – clarifying the novelty requirement,
reducing economic harm to developing nations, encourage conservation, and
lead to more defensible patents
Grebe, as previously cited. Laura Grebe, Patent Attorney, Creighton Law Review, February 2011. [“Requiring genetic source
disclosure in the United States.” Lexis] JB
First, disclosures
will help to enforce the novelty requirement. The United States patent regime places high value
on the novelty requirement. n161 Oftentimes when biopirates and bioprospectors hunt the jungles and ecosystems for useful biological
specimens, their hunts are aided by indigenous peoples' use of various local resources in natural treatments. n162 Use of a biological source among
indigenous [*394] peoples should qualify as prior art when prosecuting patents, and at the very least block the patent from issuing on novelty grounds
under 35 U.S.C. § 112. Allowing companies to patent resulting drugs derived from those specimens, therefore, makes a mockery of the novelty
requirement. n163
Second, patenting
biological resources causes definite economic harm to the source countries. United States
patents confer on the patent holder the right to block import of infringing articles. n164 The developing source
nations, therefore, are effectively stopped from utilizing their own resources for economic advancement. The
developing nation, even if it had the means to commercially develop a resulting product from its biological resources, could not export that product, nor
Requiring genetic source/prior informed consent ("PIC")
disclosure would alert patent examiners to prior uses and raise societal awareness that native cultures are
utilizing resources that could, potentially, be beneficial to the world. Source nations, therefore, would be able to
use and market their resources appropriately.
Third, as a form of information regulation, a source and PIC disclosure requirement will encourage conservation
and ethical treatment of developing nations. Information regulation is a means to alter certain behaviors by requiring disclosure of
could it export the bare source for economic gain when a patent is obtained.
certain information related to the activity, as opposed to regulating the activity itself. n165 One example of a law acting via information regulation is the
Emergency Planning and Community Right to Know Act. n166 In the current case, a
disclosure requirement will oblige researchers
seeking patents to be more aware of where resources come from; research, biopiracy, and bioprospecting are
not directly prohibited.
The disclosure requirement may also influence researchers to obtain their resources from reliable and
reputable handlers to avoid potential downstream difficulties when prosecuting a patent. Bad publicity ruins reputations
among consumers. Requiring researchers to disclose PIC will also encourage conservation by putting local
communities, [*395] the people who know the natural resources the best, in charge of their use. If a resource is
running low, or further removal of a resource will endanger the local ecosystem or biological balance, local
communities can withhold their consent and preserve the resource.
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Biodiversity Extensions
Indigenous knowledge protection is key to biodiversity
Mervyn Claxton, Distinguished Lecturer at St. Augustine University, Trinidad and Tobago, The Cropper
Foundation Lecture Series, September 1st 2010 “[Indigenous Knowledge and Sustainable Development”
https://sta.uwi.edu/resources/speeches/2010/September1_Indigenous%20Culture%20and%20sustainable%20Development.pdf]
Biodiversity, indigenous knowledge, and sustainable development are very closely linked. The indigenous
knowledge systems of the peoples of the South constitute the world largest reservoir of knowledege of the
diverse species of plant and animal life on earth. For many centuries, their indigenous agricultural systems
have utilized practices and techniques which embody, what one scientist has called «Principles of
Permanence»- principles that permit continuous cropping all year around without the use of chemicals which
degrade the environment. Furthermore, not only do they not deplete the earth’s natural resources but they
often replenish them.
We are at a cross roads – Either we chose the path of increasing biodiversity, or
the path of extinction.
Jeffrey V. Yule, et al., PhD, the School of Biological Sciences, Humanities Journal 2013. [“Biodiversity,
Extinction, and Humanity’s Future: The Ecological and Evolutionary Consequences of Human Population and Resource Use” PDF]
As a species, Homo sapiens has either already arrived or will shortly arrive at a fork in the road, and the route
we choose will determine what sort of world our species will occupy. One road leads to a relatively biodiverse
future in which a significant majority of today’s non-domestic species persist. The other leads to a future in
which the majority of today’s non-domestic species are extinct. Along both courses, we suspect that global human population will
likely stabilize below the current OPEN ACCESS Humanities 2013, 2 148 estimated total of slightly above seven billion. Our species has
already experienced and, to a considerable extent, contributed to a significant extinction event, so both
prehistoric and historic human actions have already shaped global biology. At issue now is the extent and
direction of ongoing human effects on global ecology and evolution, including the probability that our species
will be a long-term or short-term component of global biological communities. In speculating about humanity’s biological
future, it is important to recognize that the details depend on how far into the future we opt to look. Ours is not an especially old species. Depending on
the criteria used to differentiate modern humans from our ancestors, we are either at least a 200,000 year-old species (based on anatomy) or a 50,000
year-old species (based on behavioral criteria) [1]. Assuming a future of roughly the same duration as our past, we will generally look less than 100,000–
200,000 years into the future. While that amount of time is vast from a human cultural perspective— and, indeed, from the ecological and evolutionary
perspectives of microorganisms—from other perspectives, it is comparatively brief