The document discusses various aspects of drug patents including definitions, requirements, processes, strategies, impacts and issues. Some key points:
- A patent grants an inventor exclusive rights to an invention for a limited time (usually 20 years) in exchange for publicly disclosing the invention. It does not permit marketing the product which requires separate regulatory approval.
- To be patentable, an invention must be novel, involve an inventive step, and be industrially applicable. Strategies to extend patents include new formulations, uses and combinations.
- The TRIPS agreement harmonized intellectual property standards globally but some argue this restricts access to medicines in developing countries. The WTO recently approved a waiver allowing least developed countries
Intellectual Property Rights with Special Reference to HealthSHUBHAM SINGH
A presentation on "Intellectual Property Rights with Special Reference to Health" by Jasvir Kaur after having a research paper on 'Intellectual Property Rights with Special Reference to Health' from Sardar Patel University of Police, Security & Criminal Justice, Jodhpur.
The document discusses key aspects of the TRIPS (Trade Related Aspects of Intellectual Property Rights) agreement. It outlines how TRIPS harmonized global intellectual property rules and established minimum standards of protection for patents, copyrights, trademarks and other IP. The document also examines how TRIPS provisions relate to public health issues like access to medicines and the use of flexibilities like compulsory licensing by countries. It analyzes the impact of stronger IP rules on the price of drugs and the role of generic competition in increasing access.
Indian Patent Regime after 1995 amendments, NIB patent warsManasi Vakil
Post'1995 Indian patent regime, Loopholes, Advantages, disadvantages, Criticality of sec-3(d), NIB patent war and litigations of foreign nnovator companies, Imatinib, sorafenib, etc...
Trade Related Aspects Of Intellectual Property Rights (TRIPS)Anjita Khadka
TRIPS agreement covers the following areas:
Copyright and related rights (i.e. the rights of performers, producers of sound recordings and broadcasting organizations)
Trademarks including service marks
Geographical indications including appellations of origin
Industrial designs; patents including the protection of new varieties of plants
Layout-designs of integrated circuits and
Undisclosed information including trade secrets and test data
UNAIDS - The Potential Impact of Free Trade Agreements on Public HealthESTHHUB
The document discusses how free trade agreements can potentially impact public health policies regarding access to medicines. It notes that while free trade agreements aim to reduce trade barriers, some include "TRIPS-plus" provisions that exceed the World Trade Organization's intellectual property rules. Specifically, it outlines how provisions broadening patentability, restricting patent oppositions, and extending patent duration in certain free trade agreements can limit countries' flexibilities to facilitate more affordable access to medicines through generic competition.
Political Legal & Ethical Dilemmas in the Pharmaceutical.pptxAmrElBahnasawy1
The document discusses several political, legal, and ethical dilemmas faced by the global pharmaceutical industry. It addresses questions regarding country risks, the roles of governments, branded and generic drug companies, and steps the industry is taking to increase access to medicines in developing countries. The TRIPS agreement provides intellectual property protections for pharmaceutical patents but challenges remain in ensuring these protections are carried out, particularly in developing nations. Management strategies to mitigate political and legal risks include strengthening intellectual property protections, proactively scanning the operating environment in foreign markets, and developing a more compassionate corporate image.
This document discusses intellectual property rights in India, focusing on patents. It outlines the objectives of the patent system, which are to encourage indigenous industry and innovation. It describes the criteria for a patentable invention, including novelty, inventive step, and usefulness. It also discusses the patent application process, from filing a provisional or complete specification to opposition and granting of a patent. The document notes India's obligations under TRIPS to provide product patents and the implications for the pharmaceutical industry and access to medicines.
The document discusses several key issues related to the WTO and its impact on India and Indian farmers. It notes that TRIPS extended patent periods to 20 years, benefiting large pharmaceutical companies. However, this may not optimally balance innovation incentives with access to medicines. It also summarizes debates around the effects of regional trade agreements and the Doha Round negotiations, which have struggled to make progress on reducing agricultural subsidies and opening markets. The document raises concerns that WTO policies have contributed to the debt burden and suicides of some Indian farmers due to loss of livelihoods.
Intellectual Property Rights with Special Reference to HealthSHUBHAM SINGH
A presentation on "Intellectual Property Rights with Special Reference to Health" by Jasvir Kaur after having a research paper on 'Intellectual Property Rights with Special Reference to Health' from Sardar Patel University of Police, Security & Criminal Justice, Jodhpur.
The document discusses key aspects of the TRIPS (Trade Related Aspects of Intellectual Property Rights) agreement. It outlines how TRIPS harmonized global intellectual property rules and established minimum standards of protection for patents, copyrights, trademarks and other IP. The document also examines how TRIPS provisions relate to public health issues like access to medicines and the use of flexibilities like compulsory licensing by countries. It analyzes the impact of stronger IP rules on the price of drugs and the role of generic competition in increasing access.
Indian Patent Regime after 1995 amendments, NIB patent warsManasi Vakil
Post'1995 Indian patent regime, Loopholes, Advantages, disadvantages, Criticality of sec-3(d), NIB patent war and litigations of foreign nnovator companies, Imatinib, sorafenib, etc...
Trade Related Aspects Of Intellectual Property Rights (TRIPS)Anjita Khadka
TRIPS agreement covers the following areas:
Copyright and related rights (i.e. the rights of performers, producers of sound recordings and broadcasting organizations)
Trademarks including service marks
Geographical indications including appellations of origin
Industrial designs; patents including the protection of new varieties of plants
Layout-designs of integrated circuits and
Undisclosed information including trade secrets and test data
UNAIDS - The Potential Impact of Free Trade Agreements on Public HealthESTHHUB
The document discusses how free trade agreements can potentially impact public health policies regarding access to medicines. It notes that while free trade agreements aim to reduce trade barriers, some include "TRIPS-plus" provisions that exceed the World Trade Organization's intellectual property rules. Specifically, it outlines how provisions broadening patentability, restricting patent oppositions, and extending patent duration in certain free trade agreements can limit countries' flexibilities to facilitate more affordable access to medicines through generic competition.
Political Legal & Ethical Dilemmas in the Pharmaceutical.pptxAmrElBahnasawy1
The document discusses several political, legal, and ethical dilemmas faced by the global pharmaceutical industry. It addresses questions regarding country risks, the roles of governments, branded and generic drug companies, and steps the industry is taking to increase access to medicines in developing countries. The TRIPS agreement provides intellectual property protections for pharmaceutical patents but challenges remain in ensuring these protections are carried out, particularly in developing nations. Management strategies to mitigate political and legal risks include strengthening intellectual property protections, proactively scanning the operating environment in foreign markets, and developing a more compassionate corporate image.
This document discusses intellectual property rights in India, focusing on patents. It outlines the objectives of the patent system, which are to encourage indigenous industry and innovation. It describes the criteria for a patentable invention, including novelty, inventive step, and usefulness. It also discusses the patent application process, from filing a provisional or complete specification to opposition and granting of a patent. The document notes India's obligations under TRIPS to provide product patents and the implications for the pharmaceutical industry and access to medicines.
The document discusses several key issues related to the WTO and its impact on India and Indian farmers. It notes that TRIPS extended patent periods to 20 years, benefiting large pharmaceutical companies. However, this may not optimally balance innovation incentives with access to medicines. It also summarizes debates around the effects of regional trade agreements and the Doha Round negotiations, which have struggled to make progress on reducing agricultural subsidies and opening markets. The document raises concerns that WTO policies have contributed to the debt burden and suicides of some Indian farmers due to loss of livelihoods.
Patents: Indian and international patent laws, proposed
amendments as applicable to herbal/natural products and
process. Geographical indication, Copyright, Patentable subject
maters, novelty, non obviousness, utility, enablement and best
mode, procedure for Indian patent filing, patent processing, grant
of patents, rights of patents, cases of patents, opposition and
revocation of patents, patent search and literature, Controllers of
patents.
This document summarizes a presentation on Thailand's policy on compulsory licensing of patented medicines. It discusses how compulsory licensing works, the pharmaceutical business model and costs of drug development. It then analyzes Thailand's policy and whether it complies with international trade agreements. The presentation raises concerns that the policy was not implemented properly, questions the motive and legitimacy of the government's actions, and warns that such policies could discourage future pharmaceutical research and investment.
This document provides an introduction and overview of parallel imports in the pharmaceutical industry. It discusses the legal treatments of parallel imports according to international trade agreements and the impact of parallel imports on pricing and innovation. The document contains an acknowledgements section, table of contents, and bibliography. It examines the debate around parallel imports and international exhaustion of intellectual property rights as they relate to pharmaceutical patent and pricing policies in developing countries.
Surviving in an unhealthy world: TRIPS-Plus World.
Presented by Mohammad El Said, Professor of International Trade and Intellectual Property Law at the Lancashire Law School.
Dr. amit gangwal ka pharmaceutical patent presentation
highly exhaustive and updated ppt on pharmaceutical patents, a must watch by all those concerned with the same.
A project to increase access to HIV treatment in middle income countries. The project funded by UNITAID is led by International Treatment Preparedness Coaliton (ITPC). The presentation is prepared by Solange Baptiste from ITPC.
The presentation explains why the project focuses on middle-income countries, explains the intervention, describing objectives and outcomes.
Public health and intellectual propertyDawal Salve
This document provides an overview of public health and intellectual property. It discusses the role of innovation in health globally and the 3D cycle of innovation. It examines the TRIPS agreement and its impact on developing countries' access to medicines. Key points include that TRIPS extended patent protections but the Doha Declaration affirmed members' right to protect public health. India implemented TRIPS by restricting patentability scope and including compulsory licensing to facilitate access.
This document discusses different types of intellectual property rights, including patents, copyright, trademarks, and geographical indicators. It focuses on providing information about patents, including how they are granted, what can be patented, types of patents, benefits of patent protection, importance of patent information, and the steps involved in filing a patent application. Key points include that patents provide exclusive rights to inventors for a limited time, the requirements for something to be patented, and that patent protection encourages innovation.
This document discusses access to essential medicines and the influence of US statecraft. It analyzes the TRIPS waiver that allows compulsory licensing for exporting medicines to address urgent public health needs. Case studies of Brazil and Zimbabwe show how countries have used this flexibility despite pressure from the US. While the waiver aims to increase access, debates continue on whether it is too restrictive or liberal. The document recommends transparent legislation and information sharing to better facilitate public health goals within international intellectual property rules.
This document discusses intellectual property rights (IPR) and plant breeders' rights (PBR). It defines IPR as rights granted to inventors to economically benefit from their inventions. PBR specifically refers to rights granted to plant breeders for new plant varieties they develop. The document outlines the history and development of PBR laws internationally and in India. It describes key aspects of PBR such as scope of protection, time period of rights, exceptions for farmers, and compliance with international trade agreements. Patent rights for inventions are also discussed and compared with PBR.
This document discusses the importance of policy coherence among least developed countries (LDCs) in utilizing flexibilities under the TRIPS agreement to promote access to affordable medicines. It argues that while LDCs have certain flexibilities, many have not implemented these domestically or regionally. Strict standards for patentability, limitations on patent terms, exceptions, opposition procedures, compulsory licensing, and competition policies can be used coherently among LDC's to strengthen healthcare systems and reduce reliance on voluntary licenses alone. Coordinated action is needed to overcome pressure against adopting and using TRIPS flexibilities fully.
compulsory license for the patented inventionsPankaj Kumar
This document provides information about compulsory licensing of patented inventions under Indian patent law and the TRIPS agreement. It defines compulsory licensing and outlines the conditions for granting a compulsory license according to TRIPS Article 31 and the Indian Patents Act. These include attempting to obtain a voluntary license first, the scope being limited to the purpose authorized, the license being non-exclusive, and providing adequate remuneration to the patent holder. The document also discusses grounds for compulsory licensing in India such as circumstances of emergency or extreme urgency, and cases where compulsory licenses have been granted in India.
The document discusses various forms of intellectual property protection including patents, copyrights, trademarks, and trade secrets. Patents provide the strongest protection by giving owners the right to stop others from using their invention, but require public disclosure of how to practice the invention. Copyright and trademark protection have more limited scopes. Trade secrets do not require disclosure but can be lost if the secret becomes public. The document provides examples of intellectual property issues that commonly arise for biotech inventions and businesses.
The document discusses intellectual property rights (IPR) and the pharmaceutical industry. It notes that while IPR are meant to foster innovation, they can also limit access to medicines and raise prices. The document examines issues around IPR, pricing, access to medicines, and incentives for research and development. It provides background on epidemics like polio, malaria, and cholera. The document analyzes how IPR impact the pharmaceutical industry, including in India, and notes challenges in balancing IPR with public health concerns.
Patents provide exclusive rights to inventors for 20 years. For pharmaceuticals, patent protection is important due to high research and development costs and lengthy FDA approval process. Various tactics are used by pharmaceutical companies to extend patents, such as legislative lobbying. The Hatch-Waxman Act aims to balance brand and generic interests but is sometimes manipulated by brands. India's patent law changed in 2005 to allow pharmaceutical product patents to comply with TRIPS, which may impact the large generic industry.
The document discusses how intellectual property rights and trade policies can impact access to medicines in developing countries. It summarizes key issues including how patents extend drug company monopolies and raise drug prices, the flexibilities in international trade agreements like TRIPS that aim to promote access to generics, and ways powerful countries like the US have attempted to undermine these public health safeguards through additional trade agreements and political pressure on other nations.
This presentation was provided by Rebecca Benner, Ph.D., of the American Society of Anesthesiologists, for the second session of NISO's 2024 Training Series "DEIA in the Scholarly Landscape." Session Two: 'Expanding Pathways to Publishing Careers,' was held June 13, 2024.
Patents: Indian and international patent laws, proposed
amendments as applicable to herbal/natural products and
process. Geographical indication, Copyright, Patentable subject
maters, novelty, non obviousness, utility, enablement and best
mode, procedure for Indian patent filing, patent processing, grant
of patents, rights of patents, cases of patents, opposition and
revocation of patents, patent search and literature, Controllers of
patents.
This document summarizes a presentation on Thailand's policy on compulsory licensing of patented medicines. It discusses how compulsory licensing works, the pharmaceutical business model and costs of drug development. It then analyzes Thailand's policy and whether it complies with international trade agreements. The presentation raises concerns that the policy was not implemented properly, questions the motive and legitimacy of the government's actions, and warns that such policies could discourage future pharmaceutical research and investment.
This document provides an introduction and overview of parallel imports in the pharmaceutical industry. It discusses the legal treatments of parallel imports according to international trade agreements and the impact of parallel imports on pricing and innovation. The document contains an acknowledgements section, table of contents, and bibliography. It examines the debate around parallel imports and international exhaustion of intellectual property rights as they relate to pharmaceutical patent and pricing policies in developing countries.
Surviving in an unhealthy world: TRIPS-Plus World.
Presented by Mohammad El Said, Professor of International Trade and Intellectual Property Law at the Lancashire Law School.
Dr. amit gangwal ka pharmaceutical patent presentation
highly exhaustive and updated ppt on pharmaceutical patents, a must watch by all those concerned with the same.
A project to increase access to HIV treatment in middle income countries. The project funded by UNITAID is led by International Treatment Preparedness Coaliton (ITPC). The presentation is prepared by Solange Baptiste from ITPC.
The presentation explains why the project focuses on middle-income countries, explains the intervention, describing objectives and outcomes.
Public health and intellectual propertyDawal Salve
This document provides an overview of public health and intellectual property. It discusses the role of innovation in health globally and the 3D cycle of innovation. It examines the TRIPS agreement and its impact on developing countries' access to medicines. Key points include that TRIPS extended patent protections but the Doha Declaration affirmed members' right to protect public health. India implemented TRIPS by restricting patentability scope and including compulsory licensing to facilitate access.
This document discusses different types of intellectual property rights, including patents, copyright, trademarks, and geographical indicators. It focuses on providing information about patents, including how they are granted, what can be patented, types of patents, benefits of patent protection, importance of patent information, and the steps involved in filing a patent application. Key points include that patents provide exclusive rights to inventors for a limited time, the requirements for something to be patented, and that patent protection encourages innovation.
This document discusses access to essential medicines and the influence of US statecraft. It analyzes the TRIPS waiver that allows compulsory licensing for exporting medicines to address urgent public health needs. Case studies of Brazil and Zimbabwe show how countries have used this flexibility despite pressure from the US. While the waiver aims to increase access, debates continue on whether it is too restrictive or liberal. The document recommends transparent legislation and information sharing to better facilitate public health goals within international intellectual property rules.
This document discusses intellectual property rights (IPR) and plant breeders' rights (PBR). It defines IPR as rights granted to inventors to economically benefit from their inventions. PBR specifically refers to rights granted to plant breeders for new plant varieties they develop. The document outlines the history and development of PBR laws internationally and in India. It describes key aspects of PBR such as scope of protection, time period of rights, exceptions for farmers, and compliance with international trade agreements. Patent rights for inventions are also discussed and compared with PBR.
This document discusses the importance of policy coherence among least developed countries (LDCs) in utilizing flexibilities under the TRIPS agreement to promote access to affordable medicines. It argues that while LDCs have certain flexibilities, many have not implemented these domestically or regionally. Strict standards for patentability, limitations on patent terms, exceptions, opposition procedures, compulsory licensing, and competition policies can be used coherently among LDC's to strengthen healthcare systems and reduce reliance on voluntary licenses alone. Coordinated action is needed to overcome pressure against adopting and using TRIPS flexibilities fully.
compulsory license for the patented inventionsPankaj Kumar
This document provides information about compulsory licensing of patented inventions under Indian patent law and the TRIPS agreement. It defines compulsory licensing and outlines the conditions for granting a compulsory license according to TRIPS Article 31 and the Indian Patents Act. These include attempting to obtain a voluntary license first, the scope being limited to the purpose authorized, the license being non-exclusive, and providing adequate remuneration to the patent holder. The document also discusses grounds for compulsory licensing in India such as circumstances of emergency or extreme urgency, and cases where compulsory licenses have been granted in India.
The document discusses various forms of intellectual property protection including patents, copyrights, trademarks, and trade secrets. Patents provide the strongest protection by giving owners the right to stop others from using their invention, but require public disclosure of how to practice the invention. Copyright and trademark protection have more limited scopes. Trade secrets do not require disclosure but can be lost if the secret becomes public. The document provides examples of intellectual property issues that commonly arise for biotech inventions and businesses.
The document discusses intellectual property rights (IPR) and the pharmaceutical industry. It notes that while IPR are meant to foster innovation, they can also limit access to medicines and raise prices. The document examines issues around IPR, pricing, access to medicines, and incentives for research and development. It provides background on epidemics like polio, malaria, and cholera. The document analyzes how IPR impact the pharmaceutical industry, including in India, and notes challenges in balancing IPR with public health concerns.
Patents provide exclusive rights to inventors for 20 years. For pharmaceuticals, patent protection is important due to high research and development costs and lengthy FDA approval process. Various tactics are used by pharmaceutical companies to extend patents, such as legislative lobbying. The Hatch-Waxman Act aims to balance brand and generic interests but is sometimes manipulated by brands. India's patent law changed in 2005 to allow pharmaceutical product patents to comply with TRIPS, which may impact the large generic industry.
The document discusses how intellectual property rights and trade policies can impact access to medicines in developing countries. It summarizes key issues including how patents extend drug company monopolies and raise drug prices, the flexibilities in international trade agreements like TRIPS that aim to promote access to generics, and ways powerful countries like the US have attempted to undermine these public health safeguards through additional trade agreements and political pressure on other nations.
This presentation was provided by Rebecca Benner, Ph.D., of the American Society of Anesthesiologists, for the second session of NISO's 2024 Training Series "DEIA in the Scholarly Landscape." Session Two: 'Expanding Pathways to Publishing Careers,' was held June 13, 2024.
How to Setup Warehouse & Location in Odoo 17 InventoryCeline George
In this slide, we'll explore how to set up warehouses and locations in Odoo 17 Inventory. This will help us manage our stock effectively, track inventory levels, and streamline warehouse operations.
Beyond Degrees - Empowering the Workforce in the Context of Skills-First.pptxEduSkills OECD
Iván Bornacelly, Policy Analyst at the OECD Centre for Skills, OECD, presents at the webinar 'Tackling job market gaps with a skills-first approach' on 12 June 2024
How to Make a Field Mandatory in Odoo 17Celine George
In Odoo, making a field required can be done through both Python code and XML views. When you set the required attribute to True in Python code, it makes the field required across all views where it's used. Conversely, when you set the required attribute in XML views, it makes the field required only in the context of that particular view.
LAND USE LAND COVER AND NDVI OF MIRZAPUR DISTRICT, UPRAHUL
This Dissertation explores the particular circumstances of Mirzapur, a region located in the
core of India. Mirzapur, with its varied terrains and abundant biodiversity, offers an optimal
environment for investigating the changes in vegetation cover dynamics. Our study utilizes
advanced technologies such as GIS (Geographic Information Systems) and Remote sensing to
analyze the transformations that have taken place over the course of a decade.
The complex relationship between human activities and the environment has been the focus
of extensive research and worry. As the global community grapples with swift urbanization,
population expansion, and economic progress, the effects on natural ecosystems are becoming
more evident. A crucial element of this impact is the alteration of vegetation cover, which plays a
significant role in maintaining the ecological equilibrium of our planet.Land serves as the foundation for all human activities and provides the necessary materials for
these activities. As the most crucial natural resource, its utilization by humans results in different
'Land uses,' which are determined by both human activities and the physical characteristics of the
land.
The utilization of land is impacted by human needs and environmental factors. In countries
like India, rapid population growth and the emphasis on extensive resource exploitation can lead
to significant land degradation, adversely affecting the region's land cover.
Therefore, human intervention has significantly influenced land use patterns over many
centuries, evolving its structure over time and space. In the present era, these changes have
accelerated due to factors such as agriculture and urbanization. Information regarding land use and
cover is essential for various planning and management tasks related to the Earth's surface,
providing crucial environmental data for scientific, resource management, policy purposes, and
diverse human activities.
Accurate understanding of land use and cover is imperative for the development planning
of any area. Consequently, a wide range of professionals, including earth system scientists, land
and water managers, and urban planners, are interested in obtaining data on land use and cover
changes, conversion trends, and other related patterns. The spatial dimensions of land use and
cover support policymakers and scientists in making well-informed decisions, as alterations in
these patterns indicate shifts in economic and social conditions. Monitoring such changes with the
help of Advanced technologies like Remote Sensing and Geographic Information Systems is
crucial for coordinated efforts across different administrative levels. Advanced technologies like
Remote Sensing and Geographic Information Systems
9
Changes in vegetation cover refer to variations in the distribution, composition, and overall
structure of plant communities across different temporal and spatial scales. These changes can
occur natural.
Chapter wise All Notes of First year Basic Civil Engineering.pptxDenish Jangid
Chapter wise All Notes of First year Basic Civil Engineering
Syllabus
Chapter-1
Introduction to objective, scope and outcome the subject
Chapter 2
Introduction: Scope and Specialization of Civil Engineering, Role of civil Engineer in Society, Impact of infrastructural development on economy of country.
Chapter 3
Surveying: Object Principles & Types of Surveying; Site Plans, Plans & Maps; Scales & Unit of different Measurements.
Linear Measurements: Instruments used. Linear Measurement by Tape, Ranging out Survey Lines and overcoming Obstructions; Measurements on sloping ground; Tape corrections, conventional symbols. Angular Measurements: Instruments used; Introduction to Compass Surveying, Bearings and Longitude & Latitude of a Line, Introduction to total station.
Levelling: Instrument used Object of levelling, Methods of levelling in brief, and Contour maps.
Chapter 4
Buildings: Selection of site for Buildings, Layout of Building Plan, Types of buildings, Plinth area, carpet area, floor space index, Introduction to building byelaws, concept of sun light & ventilation. Components of Buildings & their functions, Basic concept of R.C.C., Introduction to types of foundation
Chapter 5
Transportation: Introduction to Transportation Engineering; Traffic and Road Safety: Types and Characteristics of Various Modes of Transportation; Various Road Traffic Signs, Causes of Accidents and Road Safety Measures.
Chapter 6
Environmental Engineering: Environmental Pollution, Environmental Acts and Regulations, Functional Concepts of Ecology, Basics of Species, Biodiversity, Ecosystem, Hydrological Cycle; Chemical Cycles: Carbon, Nitrogen & Phosphorus; Energy Flow in Ecosystems.
Water Pollution: Water Quality standards, Introduction to Treatment & Disposal of Waste Water. Reuse and Saving of Water, Rain Water Harvesting. Solid Waste Management: Classification of Solid Waste, Collection, Transportation and Disposal of Solid. Recycling of Solid Waste: Energy Recovery, Sanitary Landfill, On-Site Sanitation. Air & Noise Pollution: Primary and Secondary air pollutants, Harmful effects of Air Pollution, Control of Air Pollution. . Noise Pollution Harmful Effects of noise pollution, control of noise pollution, Global warming & Climate Change, Ozone depletion, Greenhouse effect
Text Books:
1. Palancharmy, Basic Civil Engineering, McGraw Hill publishers.
2. Satheesh Gopi, Basic Civil Engineering, Pearson Publishers.
3. Ketki Rangwala Dalal, Essentials of Civil Engineering, Charotar Publishing House.
4. BCP, Surveying volume 1
Temple of Asclepius in Thrace. Excavation resultsKrassimira Luka
The temple and the sanctuary around were dedicated to Asklepios Zmidrenus. This name has been known since 1875 when an inscription dedicated to him was discovered in Rome. The inscription is dated in 227 AD and was left by soldiers originating from the city of Philippopolis (modern Plovdiv).
Level 3 NCEA - NZ: A Nation In the Making 1872 - 1900 SML.pptHenry Hollis
The History of NZ 1870-1900.
Making of a Nation.
From the NZ Wars to Liberals,
Richard Seddon, George Grey,
Social Laboratory, New Zealand,
Confiscations, Kotahitanga, Kingitanga, Parliament, Suffrage, Repudiation, Economic Change, Agriculture, Gold Mining, Timber, Flax, Sheep, Dairying,
Leveraging Generative AI to Drive Nonprofit InnovationTechSoup
In this webinar, participants learned how to utilize Generative AI to streamline operations and elevate member engagement. Amazon Web Service experts provided a customer specific use cases and dived into low/no-code tools that are quick and easy to deploy through Amazon Web Service (AWS.)
2. Did you know that “Patent” and
“Exclusivity” are two of the most
commonly searched terms on the
FDA website?
2
3. Patent Definition
• Patent: is a property right issued to an
inventor “to exclude others from making,
using, offering for sale, selling or importing
the invention for a limited time, in exchange
for public disclosure of the invention when
the patent is granted.
• Generally, the term of a new patent is 20
years from the date on which the
application for the patent was filed.
3
4. The Contract of Patency
Reveal invention Get exclusivity
So that others can learn from it
and improve upon it! 4
5. Key facts about Patents
Isn't a permit to put a
product on the market
Says nothing about
whether the product is
safe
still have to go through
rigorous testing and
approval
5
6. Territoriality of Patency
The exclusive rights are only applicable in the
country or region in which a patent has been
filed and granted, in accordance with the law
of that country or region.
Country A
Country B
6
7. Why do we need a
Patent Law?
Rewards time, money & effort
associated with research
Stimulates further research as
competitors invent alternatives
Encourages innovation and
research by permitting
companies to recover R&D
costs during period of exclusive
rights
Limited term encourages quick
commercialization.
Patents allow exchange of
information between research
groups:
Avoiding duplicate efforts
Increasing general pool of
public information
7
8. Patentability Requirements
Novelty
• The invention
does not form
part of the
prior art.
• Prior art = any
knowledge
made
available to
the public
before the
filing date of
the relevant
patent
application
Inventive
step
• The invention
could not
“easily have
been made”
by “a person
with ordinary
skill in the
art” on the
basis of the
prior art.
Industrial
Applicability
• The invention
could be
manufactured
or utilized in
any type of
industry.
Sufficiency
of
disclosure
• An applicant
must disclose
the invention
in a
sufficiently
clear and
complete
manner for
the invention
to be carried
out by a
person skilled
in the art
8
9. Manufacturing a Generic Drug
This encourages competition and results in a
significant drop in drug costs, which ensures that life-
saving and important drugs reach the general
population at comparative prices.
Its patent has
expired.
Patents held on
the drug are
either
unenforceable,
are invalid or
would not be
infringed upon.
There has never
been any
patents on the
drug before.
In countries
where the drug
has no patent
protection.
9
11. Disadvantages of patents (Innovator)
Technical information about
invention publicly available
High Cost (application,
searches for existing patents,
patent attorney's fees, annual
fee)
Application time-consuming
and lengthy process
(typically 3 to 4 years)
You'll need to be prepared to
defend your patent. Taking
action against an infringer can
be very expensive
11
12. Patents Bad Impact (on the market)
Products patents restricts the ability of local firms to manufacture
copies of new drugs leading in developing countries to:
Less Competition
12
Higher Drug Prices Lower Welfare
13. • Ever Greening: When brand-name companies patent “new
inventions” that are really just slight modifications of old
drugs.
• No significant therapeutic advantage, but for company’s
economic advantage.
The Ever Greening problem
13
14. Patent Protection Strategies
Pharmaceutical companies can employ
a number of strategies to maximize
patent protection on important
compounds, thereby maximizing the
commercial lifecycle.
STRATEGIES
• New Formulations
• New route of administration
• Stereoselectivity/Chiral Switches
• New Uses
• Combinations
• polymorphism
14
15. Patent Law Can Block Lifesaving Drugs
Pharmaceutical
companies
systematically screen
their drug candidates
to exclude the ones
lacking strong patent
protection.
Patents can be denied for
great drugs that might not
come to market because
they are:
• Disclosed in the past
(not novel)
• Naturally extended
existing knowledge
(obvious)
15
16. We don’t want to provide patent protection
for profit-increasing activities that do not benefit
patients, like “me too” drugs.
But some things that are obvious might be beneficial,
and for those we want to encourage development. 16
17. Patent Process Overview:
In order to protect your drug in multiple countries:
Direct or Paris route:
• File separate patent applications at the
same time in all countries in national or
regional offices.
• File in a Paris Convention country
within 12 months from the filing date
giving you benefit of claiming this date.
PCT route:
• File an application under the PCT
directly or within 12 months period
provided by Paris Convention from
the filing date which is valid in all
Contracting States of PCT.
17
18. WTO AND THE TRIPS AGREEMENT
Of these agreements, TRIPS
have the greatest impact on
the pharmaceutical sector and
access to medicines and
members adapt their laws to
the minimum standards of IPR
protection.
The World Trade Organization (WTO):
international organization dealing with the
rules of trade between nations.
In becoming Members of the WTO,
countries undertake to adhere to the 18
specific agreements.
18
19. WTO AND THE TRIPS AGREEMENT
Laws in all countries that belong to WTO require
permission from a current patent-holder, not only to
use the patented technology, but also to import
products embodying or produced by this technology.
The definition of novelty,
non‐obviousness, and
usefulness of inventions may
vary from country to country.
The TRIPS Agreement is flexible
in national patent‐protection
system design.
19
20. WTO Waiver
20
The countries that will benefit from the
waiver are the 49 poorest nations, classified
by the United Nations as “Least Developed
Countries” or LDCs.
All other countries, including developing
countries such as India and China, are still
bound by the WTO’s agreement on TRIPS with
respect to drug patents.
Waiver
2033
22. WTO Waiver Necessity
Critical due to higher
disease burden, especially
infectious diseases such
as HIV and malaria which
drugs are still under
patent
Developing and
strengthening the
manufacturing capacities
of developing countries as
these countries are often
unable to import cheap
copies of patent
protected drugs from
countries like India
Patents not effective
incentive in countries
which haven’t reached an
adequate level of
economic development
because they have no IP
to protect
22
23. Patent Laws in the Developing Countries
Why developing countries are
concerned about embracing the
patent protection?
Without implementing legal,
economic, and political structures
associated with free‐trade systems,
developing countries may not reap
the economic benefits of patent
protection.
Economic
23
24. Patent Laws in the Developing Countries
Stronger patent protection system will allow developing
countries to:
Attract foreign direct
investment (FDI)
Increase investments
in research and
development (R&D)
Encourage national
scientists to invent
new drugs and invest
in their national
economies
Improve the overall
quality of health
Enhance
competitiveness in
the world market
Accelerate economic
development for
developing countries
24
25. Patent Laws in the Developing Countries
1988 1995
425 billion
25
Economic Growth
Developing countries that have
embraced the TRIPS Agreement:
26. Japan Experience
After it strengthened pharmaceutical patent
protection in 1978, Japan experienced a
substantial increase in U.S. pharmaceutical
R&D investment: $135.8
million
$505.5
million
26
27. Lebanon's accession to the World Trade
Organization
Until today,
Lebanon didn’t get
the approval to
become a member,
noting that, the
period of
negotiations usually
varies between 2 to
5 years.
Preparation of the
basic documents
needed began in
late 2000, and
Lebanon proceeded
to submit the
documents and
negotiate their
content.
The first efforts for
Lebanon’s accession
to the WTO began
in 1998 with the
aim to
“Put Lebanon on
the world trade
map“.
27
28. TRIPS compatible Patent Law
was enacted on August 7,
2000, and entered into force
on August 14, 2000
Paris Convention membership
accession on June 18, 1924,
and entered into force on
September 1, 1924 28
29. Conclusion
• Patents and other forms of intellectual
property protection play essential roles
in encouraging innovation.
• However, countries should always have
certain amount of freedom in modifying
their regulations and various options in
formulating their national legislation.
29
Goal of providing
incentives for
future inventions
of new drugs
Goal of
affordable access
to existing
medicines
30. References:
National Center for Biotechnology Information (2013.). Drug patents: the evergreening problem. Retrieved Jan 22, 2018, from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3680578/
AIPLA QUARTERLY JOURNAL (2005.). HOW PATENT PROTECTION HELPS DEVELOPING COUNTRIES. Retrieved Jan 22, 2018, from
http://developmentstudio.bskb.com/news/articles/documents/Ali_Imam_s_AIPLA_Quarterly_journal1.pdf
World intellectual property organization. Legal Requirements for Patentability. Retrieved Jan 23, 2018, from
http://www.wipo.int/edocs/mdocs/africa/en/wipo_pat_hre_15/wipo_pat_hre_15_t_3.pdf
The Conversation (2015.). World’s poorest countries allowed to keep copying patent-protected drugs. Retrieved Jan 22, 2018, from
https://theconversation.com/worlds-poorest-countries-allowed-to-keep-copying-patent-protected-drugs-50799
The new health care ( 2015.). How Patent Law Can Block Even Lifesaving Drugs.Retrieved Jan 23, 2018, from https://www.nytimes.com/2015/09/29/upshot/how-
patent-law-can-block-even-lifesaving-drugs.html
New Medical Life Sciences (2014.). Drug Patents and Generic Pharmaceutical Drugs. Retrieved Jan 18, 2018, from https://www.news-medical.net/health/Drug-Patents-
and-Generics.aspx
National Center for Biotechnology Information (2010.). Patent protection strategies. Retrieved Jan 23, 2018, from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3146086/
NIBUSINESS INFO .CO.UK. Get patent protection for your business. Retrieved Jan 18, 2018 , from https://www.nibusinessinfo.co.uk/content/get-patent-protection-your-
business 30
31. References:
31
• FDA/CDER SBIA CHRONICLES(2015.). Patents and exclusivity. Retrieved Jan 19, 2018,
fromhttps://www.fda.gov/downloads/drugs/developmentapprovalprocess/smallbusinessassistance/ucm447307.pdf
• Ministry of Economy & Trade (2000.). Patents law of Lebanon. Retrieved Jan 23,2018, from
http://www.economy.gov.lb/public/uploads/files/6061_8660_6573.pdf
• United Nations. LDC list. Retrieved Jan 23, 2018, from https://www.un.org/development/desa/dpad/least-developed-country-category/ldcs-at-a-glance.html