Podcast
Questions and Answers
Intellectual property (IP) encompasses original creations of human ______: artistic, literary, technical, or scientific.
Intellectual property (IP) encompasses original creations of human ______: artistic, literary, technical, or scientific.
intellect
Intellectual property rights (IPR) are legal rights granted to ______ or creators to protect their inventions or creations.
Intellectual property rights (IPR) are legal rights granted to ______ or creators to protect their inventions or creations.
inventors
The cost of introducing new drugs is substantial ($300 million to $1000 million), prompting stringent ______ protection.
The cost of introducing new drugs is substantial ($300 million to $1000 million), prompting stringent ______ protection.
IP
[Blank] revolution underscores the need for prioritizing IP in decision-making processes.
[Blank] revolution underscores the need for prioritizing IP in decision-making processes.
Evolving strategies include outsourcing R&D, forming ______, and establishing alliances.
Evolving strategies include outsourcing R&D, forming ______, and establishing alliances.
Increased document submissions and longer approval times reduce ______ protection periods.
Increased document submissions and longer approval times reduce ______ protection periods.
Biotechnology drugs face more severe ______ challenges.
Biotechnology drugs face more severe ______ challenges.
The pharmaceutical sector, highly ______, necessitates robust IP systems.
The pharmaceutical sector, highly ______, necessitates robust IP systems.
The majority of patent applications in the pharmaceutical industry, including ______ drugs.
The majority of patent applications in the pharmaceutical industry, including ______ drugs.
The discovery of a new ______ in a known material is not patentable.
The discovery of a new ______ in a known material is not patentable.
Management of IP and IPR requires alignment with ______ laws and international treaties.
Management of IP and IPR requires alignment with ______ laws and international treaties.
The role of ______ law is to prevent the assertion of invalid rights and maintain fair competition.
The role of ______ law is to prevent the assertion of invalid rights and maintain fair competition.
Claims form the essence of the patent seeking ______ proprietary.
Claims form the essence of the patent seeking ______ proprietary.
Professional skill in patent requires ______, technological, and legal knowledge.
Professional skill in patent requires ______, technological, and legal knowledge.
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Study Notes
Intellectual Property in Drug Development
- Intellectual property (IP) encompasses original creations of human intellect, including artistic, literary, technical, or scientific works.
- IP plays a crucial role in the modern economy by protecting innovation and incentivizing investment in research and development (R&D).
Importance of IPR in Pharma Industry
- IPR safeguards investments, time, money, and effort invested by inventors/creators, fostering economic development.
- IPR fosters healthy competition, encourages industrial development, and stimulates economic growth.
Types of Intellectual Properties
- Patents, License, and Patent Cooperation Treaty (PCT) are essential in protecting pharma industry innovations.
Importance of IP Management in Pharma Industries
- Pharmaceutical sector, being highly globalized, necessitates robust IP systems.
- IP creation, acquisition, protection, and management should be integral to corporate activities, akin to resource raising.
- Knowledge revolution underscores the need for prioritizing IP in decision-making processes.
Impact of Regulatory Changes in Pharma Industries
- Increased document submissions and longer approval times reduce patent protection periods.
- Biotechnology drugs face more severe IP challenges.
- Calls for longer drug protection and increased price control likely.
- Drug industry faces conflicting requirements, requiring cost containment and trade advantage strategies.
Adaptation Strategies
- Evolving strategies include outsourcing R&D, forming partnerships, and establishing alliances.
Nature of Pharma Industry
- Some special aspects of drug patent specifications require professional skills in patent law.
Patent Specification Writing
- Patentability considerations: discovery of new property in known material not patentable.
- Invention possible if new property has practical use, leading to patentability.
- Combination of known substances patentable if exhibiting new results, even without chemical reaction.
- Methods of treatment for humans and animals generally not patentable, except in the USA.
Pharmaceutical Patent Applications
- Majority of patent applications in pharmaceutical industry, including herbal drugs.
- Importance of careful drafting of claims to avoid impression of treatment methods.
Management of IP and IPR
- Multifaceted task requiring alignment with national laws and international treaties.
- Influenced by market needs, response, and cost of translating IP into commercial ventures.
- Demands diverse domain knowledge such as science, engineering, law, finance, marketing, and economics.
- Each industry should develop its own IP policies and management strategies based on its specialization.
Role of Antitrust Law
- Necessary to prevent assertion of invalid rights and maintain fair competition.
- Important in resolving issues related to pharmaceutical industry monopolies and invalid IPR.
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