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DDD > INTELLECTUAL PROPERTY > Flashcards

INTELLECTUAL PROPERTY Flashcards

1
Q

Protecting valuable innovations and discoveries is crucial for the pharmaceutical industry.

A

INTELLECTUAL PROPERTY

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2
Q

Leveraging _____ rights can provide a competitive edge and ensure continued investment in research and development.

A

INTELLECTUAL PROPERTY

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3
Q

4 rights of intellectual property:

A

• PATENT
• TRADE SECRETS
• COPYRIGHT
• TRADEMARK

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4
Q

___ and ___ safeguard the product bame and formulation, ensuring exclusivity in the market.

A

TRADEMARKS AND PATENTS

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5
Q

Trademarks and Patents safeguard the product bame and formulation, ensuring exclusivity in the market.

A

BRAND PROTECTION

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6
Q

Trademark and Patents safeguard the product ___ and ____, ensuring exclusivity in the market.

A

NAME and FORMULATION

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7
Q

IP documentation support regulatory submissions and helps gain market access approvals.

A

REGULATORY APPROVALS

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8
Q

Exclusive rights allow companies to promote the product’s unique features and benefits to consumers.

A

MARKETING ADVANTAGES

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9
Q

Strategic IP planning extends product longevity and defends against generic competition.

A

LIFECYCLE MANAGEMENT

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10
Q

IPO

A

INTELLECTUAL PROPERTY OFFICE

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11
Q

It is a legal right granted by the government ti an inventor, providing them with exclusive rights to their innovation for a limited period of time.

A

PATENT

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12
Q

Patent is a legal right granted by the _____ ti an inventor, providing them with exclusive rights to their innovation for a limited period of time.

A

GOVERNMENT

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13
Q

It can provide wide range of inventions, including new products, processes, and compositions of matter, as long as they meet certain criteria.

A

PATENTS

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14
Q

To be patentable, an invention must be ___, ____ and have a _____.

A

NOVEL
NON-OBVIOUS
PRACTICAL APPLICATION or UTILITY

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15
Q

New drug molecules and compounds that demonstrate therapeutic utility and eligible for patent protection, provided they meet the requirements of novelty and non-obviousness.

A

PHARMACEUTICAL COMPOUNDS

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16
Q

Specialized medical devices and delivery systems developed for administering drugs and medications can also be patented as part of the pharmaceutical innovation.

A

PHARMACEUTICAL DEVICES

17
Q

Innovative manufacturing processes and methods used to produce pharmaceutical products may be eligible for patent protection, especially if they enhance efficiency product quality.

A

PHARMACEUTICAL PROCESSES

18
Q

Patentability:

A

• SUBJECT MATTER IS PATENTABLE
• USEFUL
• NEW/NOVEL
• NON-OBVIOUS
• ENABLEMENT

19
Q

To be patentable, an invention must be new and not anticipated by prior art. The patents of evaluates novelty by comparing the claimed invention to everything publicly known before the filing.

A

NOVELTY

20
Q

The invention must also be ____ to a person having ordinary skill in the art.

A

NON-OBVIOUSNESS

21
Q

This ensures patents are not granted for trivial advances that would be naturally expected.

A

NON-OBVIOUSNESS

22
Q

Inventions must have a specific substantial, and credible use to be eligible for patent protection. The disclosed invention must provide some identifiable and tangible benefit to society.

A

UTILITY

23
Q

The patent application must be enable a person skilled in the art to make and use the invention with undue experimentation: the disclosure must provide enough detail for others to replicate the invention.

A

ENABLEMENT

24
Q

Steps in Patent Application:

A

• INVENTION DISCLOSURE
• PRIOR ART SEARCH
• PATENT FILING

25
Q

The first step is to document the novel invention and submit an invention disclosure to the company’s patent team.

A

INVENTION DISCLOSURE

26
Q

A comprehensive search is conducted to ensure the invention is novel and non-obvious compared to existing patents and publications.

A

PRIOR ART SEARCH

27
Q

Based on the patentability assessment, a patent application is drafted and filed with the relevant patent of…

A

PATENT FILING

28
Q

Incentive for pharmaceutical companies to conduct pediatric clinical trials, extending market exclusivity by an additional 6 months.

A

PEDIATRIC EXCLUSIVITY

29
Q

Encouraging the development of drugs for rare diseases affecting fewer than 200,000 patients in the US, providing tax credits and market exclusivity.

A

ORPHAN DRUG DESIGNATIONS

30
Q

These programs aims to address critical gaps in treatment options for children and patients with rare, debilitating conditions.

A

UNMET MEDICAL NEEDS

31
Q

Such as therapeutic proteins and monoclonal antibodies, are complex molecules derived from living cells.

A

BIOLOGICAL PRODUCTS

32
Q

Are highly similar versions of these biologics, developed after the original patent expires

A

BIOSIMILARS

33
Q

BIOSIMILAR ARE ALSO KNOWN AS GENERIC DRUGS

A
34
Q

They must wait until key patents on a branded drug have expired before they can produce and market a generic version.

A

GENERIC DRUG

35
Q

Generic drug manufacturer must wait until key patents on a branded drug have expired before they can produce and market a generic version.

A

PATENT EXPIRATION

36
Q

Generic drug must undergo an approval process to demonstrate bio equivalence to the original brand product, meeting stringent regulatory standards.

A

REGULATORY APPROVAL

37
Q

Have the same bioavailability.

A

BIOEQUIVALENCE

38
Q

Generic manufacturers may license the right to produce a branded drug from the originator company, often under specific terms and conditions.

A

LICENSING AGREEMENTS

39
Q

IP Considerations for Pharmaceutical Generic Drugs:

A

• PATENT EXPIRATION
• REGULATORY APPROVAL
• LICENSING AGREEMENTS

DDD (11 decks)

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