International Obligations on Intellectual Property

R&D ON NEGLECTED DISEASESOF DEVELOPING WORLD, THREE LARGEST FUNDING SOURCES IN ORDER:

UNITED STATES (71% OF GOVERNMENT CONTRIBUTIONS) GATES FOUNDATION ( 78% OF PHILANTHROPIC) PHARMACEUTICAL INDUSTRY (68% OF PRIVATE SECTOR) ->LARGER THAN EC AND EU MEMBER STATE CONTRIBUTIONS (20%) ->CHEMICAL LIBRARY CONTRIBUTIONS VALUED AT 0

R&D ON NEGLECTED DISEASESOF DEVELOPING WORLD Three largest funding sources in order:

UNITED STATES (71% OF GOVERNMENT CONTRIBUTIONS) GATES FOUNDATION ( 78% OF PHILANTHROPIC) PHARMACEUTICAL INDUSTRY (68% OF PRIVATE SECTOR) LARGER THAN EC AND EU MEMBER STATE CONTRIBUTIONS (20%) CHEMICAL LIBRARY CONTRIBUTIONS VALUED AT 0

Trade Agreements - Enforcement

Dialogue - USTR reports global IP concerns to Congress annually ->Private Sector submits information to USTR - Special 301 process ->USTR meets with country officials and encourages implementation State to State Dispute Resolution Investor State Dispute Resolution

Ordre Public - Mice/EPO Decision

Harvard's Onco-mouse patent application in the EU claimed: "A transgenic non-human mammalian animal whose germ cells and somatic cells contain an activated oncogene sequence introduced into the said animal, or an ancestor of said animal, at a stage no later than the 8-cell stage." Patent was rejected as contrary to public morality Initially, the Examining Division refused to reject the claims on the basis of ordre public or morality. (V 0004/89; OJ 1989, 451, part 10) The Board, however, ordered the Examining Division to review claims with respect to the ordre public and morality using three balancing factors (T 0019/90; OJ 1990, 476, part 5). Conclusion of the Examining Division on Remand: The benefits outweighed the disadvantages. >cancer is a frequent cause of death >fewer animals needed for testing, reducing animal suffering >uncontrolled spread of the gene unlikely

Early Resolution of Pharmaceutical Patent Disputes in U.S.

History - Generic and innovators could not bring patent challenge until generic sales began. Congress passed law permitting generics to file and "abbreviated" application that relied on innovator data after RDP period. Generic required to certify: ->Wait till patent ends ->Patent invalid or not infringed

Hoodia Plant

Hoodia is a succulent plant long used to stave off hunger and thirst by the indigenous San peoples, one of the oldest communities of Africa. San peoples' knowledge of the plant was published by colonial botanists South African-based Council for Scientific and Industrial Research (CSIR) investigated the plant's potential as an appetite suppressant In 1997, after a lengthy period of development, the CSIR patented the use of the plant's active constituents responsible for suppressing appetite. Agreement entered in 1998 between the CSIR and the UK-based company Phytopharm, followed by a further license and royalty agreement between Phytopharm and Pfizer, the US-based pharmaceutical company. In 2001 the San were alerted to the use of their knowledge without consent. Until 2001, the San had no idea that their knowledge of Hoodia had commercial application, and that this knowledge had led to research, scientific validation, and the filing of international patents by the CSIR. Public outrage at "biopiracy" of Pfizer CSIR negotiate with the San a benefit-sharing agreement in 2003. San would receive 6 per cent of all royalties received by the CSIR from Phytopharm for products, and 8 per cent of milestone income when certain targets were reached. Criticized for not securing percentage of Pfizer sales

ICBG Goals

International Cooperative Biodiversity Groups >program aims to integrate improvement of human health through drug discovery, creation of incentives for conservation of biodiversity, and promotion of scientific research and sustainable economic activity that focuses on environment, health, equity and democracy. The ICBG program is based on the belief that discovery and development of pharmaceutical and other useful agents from natural products can promote scientific capacity development and economic incentives to conserve the biological resources from which these products are derived.

TPP - IP PERSPECTIVES

It is the opinion of ITAC-151 that to a reasonable extent and with consideration of the broader impact of this agreement, the TPP promotes the economic interests of the United States and advances the overall and principal negotiating objectives with respect to intellectual property set forth in section 102 of the Bipartisan Congressional Trade Priorities and Accountability Act of 2015.

Nagoya Protocol

It provides a legal framework [obligations] for the effective implementation of one of the three objectives of the CBD: the fair and equitable sharing of benefits arising out of the utilization of genetic resources. No reference to intellectual property in the Protocol - left to WIPO

Compulsory Licensing

Permitted by TRIPS with procedural safeguards Free to impose CLs for domestic needs Meant to be used in extraordinary circumstances Contention of some: Access to medicines is compromised by patents Granted by India (Cancer), Brazil (HIV), Thailand (Cancer, HIV, (Hepatitis)

Result in Hoodia incident

Pfizer closed its natural products research efforts Some interest in use as a dietary supplement but nothing stops others from cultivating Hoodia outside of Africa and extracting necessary substances - no benefits to the San Expectations of what bioprospecting can bring are both unrealistic and often, misleading. Bioprospecting is far more likely to help to build scientific and technological capacity than it is to alleviate poverty or improve biodiversity conservation. Companies - place burden of securing consent on licensor

No Discrimination -TRIPS Art. 27.1

"patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced." [No local "working" requirements]

Patentable Subject Matter-TRIPS

"patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are "new" [novelty in U.S.], involve an "inventive step" [non-obvious in U.S.] and are capable of "industrial application"" [utility in U.S.]

CBD three main goals

(1) the conservation of biodiversity; (2) sustainable use of the components of biodiversity; and (3) sharing the benefits arising from the commercial and other utilization of genetic resources in a fair and equitable way.

Trade Secrets and Undisclosed Test Data

(TRIPS Article 39) Clauses of TRIPS Provide Basis for: 1) Trade Secret Protection; and 2) Government Measures that prevent generic or biosimilar applicants from relying upon innovator's safety and efficacy data to support grant of marketing approval.

Many countries demanded a new disclosure in patents of:

-Source and origin of genetic resources -Prior informed consent -Mutually agreed terms of access and benefit sharing Invalidity could be consequence of non-compliance.

Balancing Factors:

1) the interest of mankind in providing remedies for dangerous diseases; 2) interest in protecting the environment from uncontrolled dissemination of unwanted genes; and 3) the interest in avoiding cruelty to animals.

Challenges Shaping ABS Evolution

1. Country ABS regimes - few in place or working reliably 2.Disclosure of PIC/Origin proposals: Limited coverage and legal complications 3. Certificate of Origin/Source/Legal Provenance proposals: Workable or will it collapse of own weight? Academics and small companies bear the burden. Most large pharmaceutical companies have closed their natural products research divisions.

ICBG Principles for the Treatment of Intellectual Property

1. Disclosure and consent of indigenous or other local stewards. 2. Clear designation of the rights and responsibilities of all partners at time of access. 3. Protection of inventions using patents or other legal mechanisms. 4. Sharing of benefits with the appropriate source country parties. 5. Information flow that balances proprietary, collaborative and public needs. 6. Respect for and compliance with relevant national and international laws, conventions and other standards.

TRIPS- Undisclosed Information

1. In the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention (1967), Members shall protect undisclosed information in accordance with paragraph 2 and data submitted to governments or governmental agencies in accordance with paragraph 3. 2. Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices [misappropriation] so long as such information: (a) is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question; (b) has commercial value because it is secret; and (c) has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret. 3. Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public . . . .

Case Study: Suriname

1. Sample Collection -Randome Collection (MGB) -Or Ethnobotanical collection (CI-suriname) 2. Extraction - samples prepped, encoded, and stripped of identifying information (CI-Suriname) -extraction and in-country screening (BGVS) 3. Testing -High-throughput screening (BMS) -->If BMS is not interested in a sample, Virginia Tech can make it available to third parties for additional testing 4. Drug Development -Fractionation and isolation of biologically active substances (BMS and Virginia Tech) -application for patent (BMS)

Conceptual Model - CBD/Nagoya

1. in-situ resource (expected value of GR) 2. Bioprospecting 3. Mutually agreed terms/PIC-- consultation with sovereign state and with indigenous/local communities 4. ex-situ R&D 5. development of commercial product 6. patenting of commercial product 7. sharing proceeds per MAT with the sovereign state and indigenous/local communities

TAXOL-From Bench to Product

1960's National Cancer Institute (NCI) Collects plants 1960's Anti-tumor compound isolated from endangered Yew tree in N.W. USA. Known for medicinal properties by indigenous 1971 Taxol Structure published - in public domain 1977-83 Pre-Clinical Development & FDA process begun 1983-91 Research done in many Universities and Bristol labs (under a CRADA) to solve synthesis problem. 1991 Holton at Florida State Univ. solves synthesis problem and patents process 1993 Commercial sales of cancer therapeutic - 1.3 billion in worldwide sales by 1998 1997 Holton forms Taxolog, Inc. based on licenses from FSU on present and future patents not licensed to Bristol 2001 Announced license of new compound (TL-139) to Wyeth-Ayerst for pre-clinical trials as cancer therapeutic No Claims by Indigenous

Glivec Example

A breakthrough in treating two rare cancers: chronic myeloid leukemia and gastrointestinal stromal tumors. A patent was granted in 1993 for the molecule of imatinib; this molecule, however, could not be administered to patients and represented only the first step in development of Glivec. Novartis developed and patented the mesylate salt of imatinib and then the beta crystal form of imatinib mesylate to make it suitable for patients to take in pill form. It has been granted a patent in nearly 40 countries, including China, Russia and Taiwan. Launched in 2001. In 2009 India denied a Glevec patent application under 3d. Appeal - 2013 Supreme Court upheld rejection - additional patentability requirement.

Non-Patentable Subject Matter in India - SECTION 3 (h)

A method of agriculture and horticulture Any process for the medicinal, surgical, curative, prophylactic diagnostic therapeutic or other treatment of human being or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products. Plants and animals in whole or any part thereof other than microorganisms ***Recombinant or transgenic plants and animals are not patentable subject matter

Manipulation of Regulatory System (Abbott vs. Teva)

Abbott Laboratories marketed Tricor to reduce cholesterol. Teva prepared to introduce a generic of Tricor (fenofibrate) Just before patent expired changed formulation slightly (different dose) and introduced as new product Removed old product from market and changed national drug database listing to "obsolete" Teva could not rely on state laws that mandate generic substitution and had to start over with FDA to secure approval of generic with changed formulation

China - Data Protection

Agreed to give 6 years of Data Protection for pharmaceuticals - 10 years for ag- protection products in its WTO Accession Agreement Regulations attach DP for ag-protection products that are new to China even when first launch globally was elsewhere. Regulations attach DP for pharmaceuticals only to products that are first introduced globally in China - virtually never done by multinationals. Result: no DP in China for bio-pharmaceutical industry

India - Patent General Definition - SECTION 2 (1) (j)

An invention means a new product or process involving an inventive step and capable of industrial application

TRADE AGREEMENTS

Any contractual arrangement between states concerning their trade relations. They may be bilateral or multilateral. For most countries, international trade is regulated by unilateral barriers, including tariffs, nontariff barriers, and government prohibitions. Trade agreements aim to reduce such barriers and thus increased trade.

Inventions from Plants

Aventis Scientists isolated chemical substances from a Uvaria vine obtained from the Rabi/Gamba region of Gabon, Africa. Widespread in tropics. Active compounds not previously known. Prior medicinal uses of Uvaria plants disclosed. Prior related compounds disclosed, some with toxicity concerns, low efficacy, or side effects. Showed potential for slowing or stopping tumor growth. U.S. Patent 6,579,903 issued June 17, 2003. No Disclosure of Benefit Sharing.

Resistance to Intellectual Property

Belief that domestic industry can't win based on Innovation Belief that increasing IP protection will harm access for the poorest and weakening or eliminating IP protection will improve access for the poor.

"Evergreening"

CONTENTION: Patent protection on original product extended by grant of follow-on patents on new salts and formulations - prevents generics from commercializing the original product, even after expiration of the original product patent. REALITY: The secondary patent protects only the improved product, not the original product. Generic applicants are free to market the original product free of patent infringement allegations.

Early Patent Resolution-- U.S.

Certification of invalidity or non-infringement defined by federal law to be an act of infringement. ->Filing a paper defined gives courts jurisdiction to hear patent dispute while generic marketing approval application is pending. Innovator gets chance to stop infringing sales before generic is approved. Generic can challenge patent without damages risk.

Function of Inventorship Conception Decision

Conception is the work that society rewards with status of inventorship and patent. Line drawn between inventor and those who came before: -those who taught how to make similar compounds; -those who taught similar compounds slowed tumor growth; -those who taught plants had medicinal purposes; -traditional practices and medicines Patent system does not burden innovator with obligations to those who went before. Goal is to give inventor an asset that might enable him (investors) to secure a financial reward if commercialization is successful.

CBD

Convention on Biological Diversity (CBD) 1992 Prior to the CBD, international agreements contained the concept that genetic resources were the ''common heritage of mankind'' and subject to free exchange. -European grape fungus and -US root stock -Irish potato blight and Peruvian potato stocks Focus changed by the CBD's recognition of sovereign rights over genetic resources.

Statement of Understanding

Establishes a Forest People's Fund to compensate the local community for access to their forest resources. Fund oversees payments to indigenous groups. Payment formula varies according to whether the drug came of an ethnobotanical collection or a "random" collection

What is one of the most important multilateral trade agreements?

General Agreement on Tariffs and Trade (GATT) which reduced world trade barriers and expanded world trade. GATT was signed in 1947 and took effect in 1948. Additional agreements have modified GATT though "Rounds". Doha Round began in 2001 under the World Trade Organization (WTO). Called "development" round. Dormant.

WIPO Intergovernmental Committee (IGC)

Genetic Resources; Traditional Knowledge; and Traditional Cultural Expressions [patent disclosure requirement proposed]

State to State Dispute Resolution Mechanisms

Government v. Government (TRIPS and US Free Trade Agreements) Correct violation of trade agreement terms Remedy: Change Law & Economic Sanction

Research Agreement

Governs distribution of any royalty benefits from drug development, including to trust fund for indigenous communities. Stipulates duties of each participant. Outlines rules for inventorship and ownership in applying for patents. BMS has option for an exclusive, worldwide royalty-bearing license to any invention produced. Parties to Research Agreement include: BMS, Virginia Tech, Missouri Botanical Garden, Conservation International-Suriname, and BGVS.

Turmeric

In 1995, the USPTO granted a patent to ''Use of Turmeric in Healing Wounds'' that resulted in a flurry of criticism. The inventors were two Indian nationals working at the University of Mississippi Medical Center in Jackson, MS. After the patent was granted, a re-examination was filed in this case during which additional prior art that was not found by the patent examiner was cited. The prior art led to the subsequent cancellation of all the claims in the case. This case has been raised numerous times as evidence of ''bio-piracy'' Indian delegation to the WTO asserted that this patent could have been avoided if there had been a disclosure requirement for source and country of origin in effect Review of the "file wrapper" in the USPTO indicates that India was clearly disclosed as the country of origin and a specific source in Lincolnwood, Illinois, was identified as the place where the turmeric was obtained. As would typically be the case, that information was not relevant to patentability or to the grant of the patent. This examples seem to indicate that disclosure requirements regarding source and/or country of origin would not have prevented the granting of this patent and, more generally, that it will not prevent erroneous patenting, an objective raised frequently by proponents of such proposals.

WIPO

In 2000 WIPO set up the Intergovernmental Committee (IGC) on Intellectual Property and Genetic Resources, Traditional Knowledge and Traditional Cultural Expressions. Genetic resources, traditional knowledge and Traditional Cultural Expressions were combined because of importance of these issues to many developing countries and recognition that these issues were interrelated and could not, therefore, be considered separately from one another.

Biological Materials and IP Policy- Claims on IP rights and their benefits

In U.S. priority placed on rewarding inventors In some countries - priority placed on consent for access to biological materials and rewarding indigenous populations or governments through claims on innovators. -Timing of claims and valuation are key Some would invalidate patents if no disclosure of -Prior informed consent for access -Benefit sharing

Eliminating IP Does not Solve Access Problems for the Poor

India - Between 1970 and 2005 -no patents on medicines -large generic industry developed WHO - Between 2000 and 2007 in India Access to medicines among worst in world

India - Data Protection

India's Position: Protection against disclosure (i.e. trade secret protection) satisfies TRIPS - effectively erases the first sentence of section 3. [Brazil takes similar position] Reddy Report (2007) - proposed giving 5 years of data protection to traditional medicines - not yet implemented. Free Trade Negotiations with EU might result in data protection.

Barriers to Access

Insufficient infrastructure - lack of: -trained health care workers; -health care systems; -transportation Inadequate Government investment Significant mark ups in distribution chain High government taxes and tariffs

Trans Pacific Partnership Agreement

Key Free Trade Agreement Countries: Australia; New Zealand; U.S.; Peru; Chile; Malaysia; Vietnam; Singapore; Brunei, Japan, Canada, Mexico Negotiations began with the U.S. in 2010 Biopharmaceutical text - U.S. reported to demand 12 years RDP for biologics Regulatory Data Protection (RDP) Biologics: 12 years demanded/ 8 or 5 + 3 Small molecules: at least 5 years demanded/yes Effective Patent Enforcement (Linkage)/yes Patent Term Extensions: Patent Office Delays - all industries/yes Regulatory Delays - Pharmaceutical/yes

Preventing "Unfair Commercial Use" - TRIPS Concept

Regulatory Data Protection - United States & EU prevent "reliance" on innovator's data - this prevents "unfair commercial use" of that data. Post Marketing Exclusivity - Japan and Korea prevent any generic entry for specified period of years.

Exclusions from Patentability-TRIPS

Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is: necessary to protect order public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law. Diagnostic, therapeutic and surgical methods for the treatment of humans or animals; Plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof.

Prevent Unfair Commercial Use of Regulatory Test Data - TRIPS

Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public . . . .

Consequences of Moore Case

Moore's tissues used to develop cell line and products Researchers usually inform or secure permission from people whose tissues are sought for research and possible innovation purposes with commercial potential. Provider of biological material (tissue) has no legal claim to inventor's patent or financial rewards. Provider of biological material (tissue) does not have a claim for conversion Limits on liability and claims combined with consent obligation protects patients' rights of privacy and autonomy without unnecessarily hindering research.

Elements of Early Patent Resolution FTA GOALS

Notice of the filing of a generic or bio-similar application Identifying relevant patents Effective resolution of patent issues before generic marketing

FOGARTY INTERNATIONAL CENTER - NIH

One function is to form International Cooperative Biodiversity Groups (ICBG)

Implementation of Early Patent Resolution

Only through free-trade agreements with U.S. to date. Korea - implementing now Australia - litigation system is effective surrogate Chile - obligated but no implementation Mexico - effective system - regulatory None in China, India, Brazil, EU - No Free Trade Agreements with U.S.

Patents covering follow-on innovations (prozac example)

PROZAC®, a first-in-class therapy for major depressive disorder, launched in 1987 >Daily dosage regimen, generally 20mg/day >Patent protection expired August 2001 PROZAC® WeeklyTM approved February 2001 >Separate patent protection for weekly dosing regimen >Launched only months before expiration of PROZAC compound patent Generic applicants were free to launch Prozac for daily use after expiration of the compound patent Patients & Doctors decide whether the secondary patent has value

Working Requirements

Patent "working requirements" are national laws that require owners of a patent to practice his or her patented invention (make the product) within the country that granted the patent. Penalty includes loss of patent rights through compulsory license. Requiring patent rights be enjoyable "without discrimination as to ... whether products are imported or locally produced" means working provisions must be written or applied so that importation of products is "working" an invention.

Typical Composition of an ICBG Consortium

Principal Investigator based at a US university One or more Associate Programs >Can be at US or foreign universities or non-governmental organizations >At least one Associate Program should be based in a developing country institution >Associate programs will focus on specific areas such as ecology, microbiology, cell biology, ethnobiology, sociology, anthropology, botany, zoology, entomology, pharmacology or chemistry U.S. Government Project Coordinator Private Sector partner not required but strongly recommended

Investor State Dispute Resolution Mechanisms:

Private Company v. Government (US and EU Free Trade Agreements) Prevent expropriation of property through unfair treatment and/or discrimination Remedy: Damages only IP specific - Lilly v. Canada Main issue was whether Patent Utility Standard expropriated IP rights by discriminating against pharmaceutical companies

Different perspectives of value in CBD

Public: Reference case for many is "blockbuster" drug discovery from natural GR ->Assumes Dependence of pharma on natural GR Companies: Increased reliance upon new technologies for "drug design", CRISPR etc. ->Less dependence upon natural GRs ->Many major pharma firms reducing or eliminating natural product research Remaining industries less likely to have "blockbuster" yields ->Plant breeding, agrochemicals, flavors & fragrances, industrial enzymes, herbals, etc.

Commitments for RDP

Russia - 6 years - Condition of WTO Entry China - 6 years - Condition of WTO Entry

NEW ISSUE IN CBD/NAGOYA

Should use of published, public domain genetic sequence information (GSI) create financial obligation to country where genetic information was derived. Sequence data today in gene banks is open to all. Is lab use of published GSI the same accessing the physical resource? What is the value of GSI and when is that determined.

Interpretation of "Chemical Entity"

Some countries contend that biologics are not "chemical entities" and are therefor not entitled to protections against unfair commercial use of data. Result: No regulatory data protection for biologics in: Mexico; Peru; Chile and other countries. TPP would have changed this.

Committed to Sustainable Access Solutions

Support over 340 initiatives with more than 600 partners to improve health Second [sometimes third] largest funder of R&D for Neglected Diseases - behind only the U.S. [sometimes Gates Foundation] $94.8 billion contributed since 2000 towards achieving UN Millennium Development Goals on Health Product donations and wide array of capacity building interventions to strengthen local health care institutions and improve access

ICBG Results

Tens of thousands of species of plants, animals and micro-organisms collected and screened for pharmaceutical activity since 1993. No pharmaceutical products approved by regulators No new chemical entities ("lead compounds") have been evaluated in clinical trials.

HeLa Cell Line

The HeLa cell line, the first "immortal" cell line, is the solution to overcoming many impediments in biomedical research, and a key tool in developing certain cures and drugs that have the potential to improve the lives of millions of people. Derived in 1950's from the now-deceased Henrietta Lacks, an African-American mother from Baltimore, Maryland. Without Lacks' knowledge or consent, her doctor shared a sample of her tumors with a researcher, Dr. George Gey With Lacks' tumor cells, the researcher succeeded in making the line that led to medical advancements and profits.

Options for protecting traditional knowledge

The application of existing intellectual property rights The possible creation of new rights--Issues and difficulties to be resolved before introducing new rights

India - New Patentability Criteria - Section 3 (d)

The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Footnote Explanation to Section 3 (d): "Salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations, and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy."

TRIPS

Trade Related Aspects of Intellectual Property Rights Agreement Intellectual Property Rules became part of enforceable international trading system Negotiated at the World Trade Organization (WTO) 1986 - 1993 (149 countries are members) Creates minimum obligations on countries to protect and enforce intellectual property rights (20 year patent term from filing) 2005 - Deadline for compliance by most countries 2033 Least Developed Countries - pharmaceutical product waiver (49 countries - 34 Africa; 10 Asia; 4 Pacific; 1 Caribbean)

Terms of RDP or Market Exclusivity

United States (RDP): At least 5 years for small molecules At least 12 years for biologics EU: 10 years Japan: 8 years Canada: 8 years Korea: 6 years

Market Share IP Protected Products

WHO Essential Medicines List: 90 - 95 % are off patent India: Less than 1% of medicines sold are subject to patents today United States - 80 - 85% of prescriptions filled by generics

"Captain Hook Awards"

given by the Coalition Against Biopiracy to "the world's foremost practitioners of the art of appropriating knowledge and biological resources from indigenous peoples and traditional communities." (Pfizer enjoys a place of honor, together with the NIH, NYU, University of Colorado, University of Wisconsin, Shaman Pharmaceuticals, et al.) (see: http://twm.co.nz/CptHook.htm)

WTO

in 1999, four years after the adoption of the TRIPs Agreement - began study of relationship between TRIPS and CBD - request by India included proposals to study relationship was demand to require disclosure of biological source, the country of origin and prior informed consent. Since this time, discussion on these matters has been carried out in the TRIPs Council. While no specific work plan has been agreed, it seems that work should continue on the ''fact-based'' discussion to try to work through concerns raised in a pragmatic, case-by-case manner to resolve differences among members.

Public Domain Concept

knowledge and things that are publicly known or available can be freely accessed by all Inventorship requirements and patentability criteria protect the public domain in the U.S. Patents can not/should not impinge on anything in the public domain. Inventor must participate in the conception of the claimed invention. ->This requires formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is to be applied in practice