Cannabis Embassy

Our own Position Paper was submitted to the US Federal Register.

Joshua Sarnoff, DePaul University College of Law

[His comments address in detail the following] “(1) premises in the definition of “country of origin” for the access and benefit sharing (“ABS”) regime that are perverse and inappropriate, but cannot readily be addressed without renegotiating the Convention on Biological Diversity (“CBD”) and revisiting the U.N. Permanent Declaration of National Sovereignty Over Genetic Resources (“Permanent Declaration”); (2) the need to adopt disclosures of origin to help assure that the intellectual property system is not misused in providing benefits from illegally obtained access to genetic resources or failures of benefit sharing obligations; (3) the need to include both genetic digital sequence information (“DSI”) and derivatives made from accessed genetic resources or DSI within any negotiated ABS treaty to assure that all forms of access are covered and that benefits from such access are shared equitably; (4) the need to mandate fully equitable, worldwide sharing of benefits resulting from access to genetic resources, particularly pathogenic genomes; and (5) to the extent that countries possess ownership over genetic resources, they should also have state liability when such resources result in harms under a strict liability, ferae naturae legal regime.” [He also submitted two other contribution (WIPO seminar + paper)]

Victoria Sutton (Law professor, Environmental Scientist, […] former Asst Director, White House Science Office, former Chief Counsel, US DOT/RITA, Lumbee [!!!???])

“Recent U.S. efforts to revamp federal consultation processes with Native Nations will go a long way to addressing most of these intellectual property law issues, but it is just as important that the private sector recognize that consultation and benefit sharing is essential. The White House joint letter to OSTP and CEQ to consult with Native Nations and to use indigenous traditional ecological knowledge (ITEK) is important but it also should include the protection of that ITEK, and it does not.

The WIPO is moving in the direction of making binding regulations for patent holders that seek registration in multiple countries through WIPO, and that is a good start.

I recommend a checklist that would include (as a quick start):

—dates of meaningful consultation with the tribes and who was present, including titles and authority to bind the Native Nation

—down payment to explore, sample and take specimens for further research

—royalty agreement, signed and ratified by the Native Nation legislative body

—plan for ongoing communication and return of benefits to the Native Nation in addition to royalties, i.e., access to free treatments.

Any patent applicant that cannot complete this checklist cannot patent their ITEK based invention. This requirement is already in international law through the CBD and its protocols, particularly the Bonn Guidelines and its progeny.” [Her complete submission: “TK & the patent dilemma: Our intellectual property laws do not serve all the people of the US, or the World”]

Veterans Action Council (VAC)

“Veterans Action Council supports and endorses the Position Paper of the Cannabis Embassy on the negotiations of the future Treaty on Genetic Resources and Associated Traditional Knowledge. Recognizing that Traditional knowledge (TK) is knowledge, know-how, skills and practices that are developed, sustained and passed on from generation to generation within a community, often forming part of its cultural or spiritual identity, our Veterans Action Council believes the rights expressed by those stakeholders to be basic human rights. […] Our Council appreciates measures to prevent unauthorized exploitation, ensure fair benefit-sharing, and establish intellectual property rights for traditional knowledge holders. We feel that such measures will help citizens ensure the long-term sustainability of medicinal plants and their associated knowledge. We hope by raising awareness, citizens can foster a greater appreciation for traditional knowledge and support its protection.”

Innovation Council

“To dedicate resources to medium- and long-term R&D and commercialization initiatives, innovators need certainty and stability. To this end, they rely on patents to move promising R&D outcomes to market. In certain sectors, such as biopharmaceuticals, R&D involving genetic resources and associated TK has been under pressure in recent years, due to factors including the inherent complexity of working with natural resources. Should it become even more burdensome, due to global implementation of the Instrument, to acquire and maintain patents for research outcomes from such R&D programs, this will undoubtedly influence R&D decision-making and, in turn, innovation.

Transparency is one stated goal of the IGC talks. If appropriately calibrated, a patent disclosure requirement aimed purely at transparency, free of undue burdens for patent applicants and IP offices, and treated as a purely administrative requirement in patent applications, could be hoped not to negatively affect R&D and commercialization. At this stage, it’s unclear whether this type of patent disclosure requirement can be agreed at the Dip Con.”

Ginkgo Bioworks [A contribution insightful on DSI-related issues, with arguments against the inclusion of DSI, and alternative proposal of multilateral system…]

“Our biological foundry designs millions of genetic constructs in the course of our work performing biotechnology R&D on behalf of our partners. We work with large biopharma companies to enable the discovery and manufacturing of novel therapeutics and vaccines as well as with leading companies in the agriculture, food, flavor, fragrance, chemical, and other industries; i.e., we work with companies that are looking to commercialize products that include biological constructs or are made using biology. For each of these customers, Ginkgo designs an engineered biological product – such as a living microbial organism, a cell line, an enzyme, or a circular RNA or capsid to deliver a therapeutic or industrially relevant payload – or delivers data concerning biological questions […] Generally, Ginkgo does not make use of traditional knowledge, and so the comments below are confined to issues regarding the disclosure of GR”

“Ginkgo supports Decision 15/9 of the Convention on Biological Diversity to construct a scalable, practical, and fair multilateral approach to access and benefit sharing for DSI. As Ginkgo has described elsewhere, we believe that the most likely option to achieve this vision is a subscription-based model wherein commercial users pay flat rates to access entire databases, and benefit-sharing is divorced from commercialization of specific products. None of the discussion below should be understood as a criticism of access and benefit-sharing models that are based on subscription concepts. Ginkgo is concerned that the patent disclosure requirements under consideration in the Proposed Instrument are premised on an understanding of biological research that is not consistent with the actual methods of synthetic biology, and, as a result, would hinder access and benefit sharing and the productive utilization of biological data.”

“Genetic Resources are Most Useful as Digital Sequence Information and in the Aggregate Typically, in constructing a new biological product, Ginkgo begins with DSI, not natural product extracts. In an innovation cycle, we print synthetic DNA for thousands of candidate sequences without using any natural source material such as plant extracts or the like. […]

The Proposed Instrument Would Create Uncertainty for Synthetic Biology The Proposed Instrument is not explicit on the proposed treatment of DSI as a reflection of genetic resources, although we understand that some WIPO members take the position that “genetic information” should be within scope. Ginkgo’s comments relate principally to requirements for the disclosure of genetic resources embedded in DSI.”

05

Small Business & Entrepreneurship Council (SBE Council)

“if the USPTO fails to oppose the IGC’s newest PDR proposal, the longterm viability of America’s world-class IP system and IP leadership – along with the entrepreneurs who depend upon it – will no longer be guaranteed […] the IGC’s proposal would deprive people in every country of life-changing technologies.”

26

Biotechnology Innovation Organization (BIO). 

“Most of [our] members are small and medium sized enterprises (SMEs) that currently do not have products on the market. [and] rely heavily on the strength, scope, and reliable enforcement of their intellectual property (IP) to generate investments needed to develop and commercialize their technologies through collaborations. […] Patent Validity Should not be Affected by a New Disclosure Obligation”

36

United States Chamber of Commerce

“establishing new legal obligations […] would create a legal quagmire inhibiting both invention and expression. Enhanced uncertainty over such rights also may empower both state and non-state actors to unfairly exploit American innovation in critical economic sectors”

09

Japan Pharmaceutical Manufacturers Association

“From the viewpoint of the objectives of the patent system, the patent disclosure requirement should not be incorporated into the patent system in the context of genetic resources and associated traditional knowledge. The disclosure requirement on the country of origin or the source of GR & TK in the CBD and the Nagoya Protocol differs from the written description requirements in the patent system in its objectives. […] it would undermine the patent system in views of at least its stability, certainty and compliance. It is often challenging for patent applicants to obtain genetic resource information, making it difficult to comply with the patent disclosure requirement. Imposing unnecessary burdens which are irrelevant to the patent system on patent applicants through the patent disclosure requirement could hinder innovation and therefore potential benefits generated for society at large.”

27

PhRMA (Pharmaceutical Research and Manufacturers of America) [US Big Pharma]

“While PhRMA and its members support the general objectives of ensuring sustainable use of GRs and appropriate access to those resources based on prior informed consent (“PIC”), mutually agreed terms (“MAT”) and equitable benefitsharing, as established in the Convention on Biological Diversity (“CBD”) and its Nagoya Protocol, PDRs fail to advance these goals. Moreover, the United States is not even a party to the CBD or the Nagoya Protocol. For these reasons, we strongly urge USPTO to oppose the PDRs proposed in the IGC Chair’s text”

10

IFPMA (International Federation of Pharmaceutical Manufacturers & Associations) [Big Pharma Int’l] 

[Their contribution is titled as follows] “Opposition to adoption of a new International Instrument at WIPO related to Patent Disclosure Requirement.”

“In conclusion, not only is there any evidence that a PDR is needed, nor that a PDR would prevent the grant of any erroneously granted patents, nor could any PDR be set up in such a clear way that any intrinsic uncertainties created by the definition of key terms could be overcome. A PDR would have a significant negative impact on any R&D with genetic resources and TK associated with it. This would inevitably lead to much less innovation and therefore potential benefits generated for society at large.”

22

Market Access Solutions (Sandip Shah, founder and president)

“Adding such a mandate to patent application processes would inhibit life science firms’ ability to access and rely on genetic resources and, in turn, stifle innovation. Mandatory PDRs would shroud the patent system in uncertainty and add significant risk.”

30

Council for Innovation Promotion (C4IP)

“hopes that the USPTO will reject a dangerous proposal”

35

American Intellectual Property Law Association (AIPLA)

[They oppose the treaty, but add the following]

“Assuming, arguendo, the proposed patent disclosure requirement (PPDR) is adopted, which it should not be, the PPDR must be qualified (i.e., formal, appropriately limited in scope, not retroactive, not incurable, etc., as discussed in detail as follows). For example, the limits of such a PPDR must be explicitly delineated (e.g., the requirement is solely a formal one, patent validity is in no way affected, benefit sharing is not concerned, correction is available, etc.). The current disclosures of the USPTO and PCT (i.e., enablement, written description) are sufficient to ensure transparency and legal certainty.” (emphases are original)

16

Kristen Osenga (Associate Dean for Academic Affairs at the University of Richmond’s School of Law)

“Take pharmaceuticals. It takes an average of more than $2 billion, to discover, test, refine, and market a viable drug. And the failure rate is quite high, with only about 12% making it through clinical trials. Yet drug companies continue to invest in promising new medicines and treatments because they know that their patents give them a period of exclusivity to recoup their sizable investment. Mandatory PDRs would likely make this sort of process longer and more costly. Even assuming that a particular genetic resource can, in fact, be traced to its original source — which is by no means certain — it would obviously be no small feat to do so. This massive, additional outlay of time and funds will delay the introduction of new technologies and inevitably lead many promising discoveries to languish in obscurity. The potential chilling effect on innovation becomes even more apparent when one considers that mandatory PDRs would force companies to navigate unpredictable and contradictory compliance requirements from various countries and tribes. The growing desire to protect GRs has already led to an increased number of regulations around the globe, collectively referred to as AccessBenefit Sharing (ABS) systems. The experience of Brazil and India, two countries rich in GRs, shows that ABS systems significantly delay patent applications.”

08

Institute for Policy Innovation

“U.S. opposition to this WIPO proposal would help restore confidence in the commitment of the government to protect intellectual property at home and globally.”

29

Adam Mossoff (Antonin Scalia Law School) 

“the USPTO should oppose the IGC’s draft proposal of new patent disclosure requirements for genetic resources and traditional knowledge.”

18

Incubate Coalition 

“The ability to innovate, to take risks, is based on the certainty and predictability the global patent system provides. Mandating disclosure of GR and traditional knowledge would undermine this crucial foundation, depriving patients of much-needed future treatments and cures. The United States should keep with long-standing policy and resist efforts to burden inventors and examiners with needless red tape.”

20

Partnership to Fight Chronic Disease (PFCD)

“PFCD is an international organization of patients, providers, community organizations, business and labor groups, and health policy experts committed to raising awareness of chronic disease […] Measures that slows the pace of healthcare innovation, as the proposed PDRs would, poses a grave threat to people living with chronic diseases everywhere. By importing these failed policies to the United States, the IGC’s plan would also jeopardize America’s status as the world’s innovation leader in the life sciences and virtually every other technological sector –which is only made possible by robust IP protections. To ensure that groundbreaking innovations continue reaching those who need them most, we urge you to oppose the IGC’s proposal.”

03

Center for Medicine in the Public Interest (CMPI)

“CMPI […] is a nonprofit, nonpartisan research and educational organization seeking to support a patient-centered healthcare system. We are concerned that changes being considered […] relating to disclosure requirements for [GR & TK] could stifle life-saving biopharmaceutical innovation, leading to fewer new treatments and cures for patients. Instituting complex disclosure requirements for patent applicants would break with decades of precedent and ignore procedures already in place to promote fair and beneficial use of GR and TK. Since its establishment, the USPTO has protected America’s innovators domestically and abroad by promoting the enforcement of intellectual property rights.”

11

Licensing Executives Society, USA & Canada, Inc.

“The problem is not the IGC’s objective, but its means. LES is committed to supporting the work of those discovering, developing, and commercializing genetic resources and traditional knowledge in a fair, equitable, and sustainable manner. It supports ethical best practices such as informed consent, consistent with accepted international norms and local laws. LES submits, however, that international agreements governing patent protection is not an appropriate, or effective, mechanism for instituting such safeguards. […] LES strongly urges the USPTO to oppose the Intergovernmental Council’s initiative to impose unworkable and counterproductive new requirements on patent applicants.”

17

James Pooley (former WIPO Vice-Director General)

[Strongly opposed]

07

Wolfgang Klietmann (Harvard Medical School)

[Opposed]

25

Global Colon Cancer Association

[Opposed]

15

Walter Copan (vice president for research and technology transfer at Colorado School of Mines. I am also the co-founder of the Renewing American Innovation Project at the Center for Strategic and International Studies)

[Opposed]

13

Hon. Paul R. Michel (Ret.) United States Court of Appeals for the Federal Circuit (CAFC)

[Opposed]

23

Jon Soderstrom (IP Lawyer)

[Opposed]

06

Nicholas Matich

[Opposed]

37

Intellectual Property Owners Association (IPOA)

04

Comment by Conservatives for Property Rights

32

33

The Songwriters Guild of America Foundation, Inc., The Society of Composers & Lyricists, The U.S. Members of Music Creators North America, Inc., & The Songwriters Guild of America, Inc.

“The Independent Music Creators are acutely aware of the critical contributions that indigenous music and other art forms have made (and continue to make) toward the progress of global and national culture, creativity and commerce. We strongly believe that supporting the preservation and celebration of such indigenous works need to be a high priority for governments and societies throughout the world, an obligation made even more poignant by the long history of the ill-treatment of indigenous peoples and the frequent, willful obliteration and uncredited appropriation of their traditional arts and culture in pursuit of political and economic subjugation, or worse.

[Yet they oppose the GRATK because] Intellectual Property Law Exceptions and Exemptions Are Not the Answer […]

There are better ways to accomplish the goals of preserving and perpetuating indigenous culture and art while at the same time benefitting indigenous peoples and entire societies. Those solutions start with serious economic investment by governments in indigenous cultural and arts education programs and indigenous creator and artist development projects, in full partnership and consultation with indigenous communities themselves”

38

Independent Film and Television Alliance (ITFA)

“Headquartered in Los Angeles, IFTA is the only organization that represents the

independent film and television industry globally […] IFTA would respectfully urge WIPO and its Member States to instead focus on the ratification and full implementation of the existing international Copyright Treaties, including the WCT, WPPT and BTPA, to protect the interests of the owners/custodians of TCEs in independent production. […] we respectfully assert that the IGC’s objective of protecting TCEs is unlikely to be achieved under the current proposed approach. We support the engagement of the [USPTO]”

14

CreativeFuture

“CreativeFuture is a nonprofit coalition of over 500 companies and organizations and over 300,000 individuals devoted to promoting the value of creativity in the digital age. Our members come from across the industry, from coast to coast and around the world. Many of us are Academy Award®, Emmy®, and Golden Globe® nominees and winners.” 

“Instead of creating an entirely new system of rights, WIPO should enhance its assistance efforts for implementation of existing WIPO treaties around the world […] We look forward to continuing to engage with the USPTO to collaboratively resolve this critical issue in a way that benefits freedom of expression while protecting the creativity of valuable indigenous cultures from around the world.”

12

International Intellectual Property Alliance (IIPA)

“A Sui Generis System is Unnecessary Because the Existing International Copyright Framework Provides Adequate Protection. […] A Sui Generis System Would Subvert the Principles of the Existing International Copyright System. […] A Sui Generis System Would Be Unworkable and Create Legal Uncertainty”

21

Recording Industry Association of America (RIAAAAAAAAH)

[Their submission is similar to IIPA’s, but shorter] “Our members, […] include several hundred companies ranging from small […] to global businesses”

28

Motion Picture Association

31

The National Music Council of the United States (NMC)