Intellectual Property in Drug Development

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.