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DDD > intellectual property pt.2 > Flashcards

intellectual property pt.2 Flashcards

1
Q

They safeguard the product name and formulation, ensuring exclusivity in the market.

A

Trademarks and Patents

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2
Q

It supports regulatory submissions and helps gain market access approvals.

A

IP Documentation

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3
Q

It allows companies to promote the product’s unique features and benefits to consumers.

A

Exclusive Rights

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4
Q

It extends product longevity and defends against generic competition.

A

Strategic IP Planning

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5
Q

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

A

Patent

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6
Q

Patents can protect a wide range of inventions, including new ___,___, and ___, as long as they meet certain criteria

A

Products
Processes
Compositions of Matter

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7
Q

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

A

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

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

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8
Q

Criteria for Patentability

A

• Subject Matter is Patentable
• New/Novel
• Useful
• Non-Obvious
• Enablement

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9
Q

To be patentable, an invention must be new and not anticipated by prior art. The patent office evaluates this by comparing the claimed invention to everything publicly known before the filing date.

A

Novelty

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10
Q

The invention must also be not obvious to a person having ordinary skill in the art. This ensures patents are not granted for trivial advances that would be naturally expected.

A

Non-Obviousness

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11
Q

Even if individual elements of an invention are known, the specific combination may be considered non-obvious if it produces an unexpected result or technical effect.

A
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12
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

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13
Q

The patent application must enable a person skilled in the art to make and use the invention without undue experimentation. The disclosure must provide enough detail for others to replicate the invention.

A

Enablement

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14
Q

Pharmaceutical Patent Application Process

A

• Invention Disclosure
• Prior Art Search
• Patent Filing

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15
Q

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

A

Invention Disclosure

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16
Q

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

A

Prior Art Search

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17
Q

Based on the patentability assessment, a patent application is drafted and filed with the relevant patent office.

A

Patent Filing

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18
Q

Patent Lifecycle Management Strategies

A

• Patent Term Extensions
• Line Extensions
• New Indication Patenting
• Lifecycle Planning

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19
Q

Leveraging regulatory processes to extend the effective patent term and market exclusivity for key drug products.

A

Patent Term Extensions

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20
Q

Securing additional patents by identifying and protecting new therapeutic uses for existing drug compounds.

A

New Indication Patenting

21
Q

Developing new formulations, dosages, or delivery mechanisms to maintain market share after initial patent expiry.

A

Line Extensions

22
Q

Strategically managing the patent por folio to maximize the commercial lifespan of pharmaceutical products.

A

Lifecycle Planning

23
Q

Regulatory Data Protection and Exclusivity

A

• Data Exclusivity
• Market Exclusivity
• Biologics and Biosimilars
• Orphan Drug Incentives

24
Q

It provides a period of exclusivity during which generic or biosimilar versions cannot rely on the originator’s clinical data.

A

Regulatory Data Protection (Data Exclusivity)

25
Q

Regulatory data protection is particularly important for ___, as biosimilars must demonstrate similarity to the reference product.

A

biologics

26
Q

This data exclusivity is distinct from patent-based market exclusivity, and can provide additional protection beyond patent terms.

A

Market Exclusivity

27
Q

Certain drugs for rare diseases may qualify for additional regulator data protection and market exclusivity incentives.

A

Orphan Drug Incentives

28
Q

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

A

Pediatric Exclusivity

6 months

29
Q

Drugs for rare diseases affecting fewer than 200,000 patients in the US

A

Orphan Drugs

30
Q

Encouraging the development of drugs for rare diseases affecting fewer than 200,000 patients in the US, providing:

A

tax credits and market exclusivity

31
Q

IP Considerations for Pharmaceutical Generic Drugs

A

• Patent Expiration
• Regulatory Approval
• Licensing Agreements

32
Q

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

T/F

A

True

33
Q

Generic drugs must undergo an approval process to demonstrate ___ to the original branded product, meeting stringent regulatory standards.

A

bioequivalence

34
Q

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

A

Generic manufacturers

35
Q

IP Considerations for Drug Repurposing

A

• Existing IP Protections
• Incremental Innovations
• Data Exclusivity
• Combination Therapies

36
Q

Assessing any existing patents, trademarks, or regulator y exclusivities on the repurposed drug is crucial to understand the IP landscape.

A

Existing IP Protections

37
Q

Leveraging regulator data
protection, such as ___, can provide an alternative form of IP exclusivity.

A

clinical trial data

38
Q

Identifying _____ can lead to incremental innovations and additional IP protection.

A

new formulations, dosages, or delivery methods

39
Q

It may create new IP oppor tinities through combination patents.

A

Combining a repurposed drug with other active ingredients

40
Q

It safeguards sensitive information not protected by patents, such as manufacturing processes, chemical formulas, and experimental data.

A

Trade secrets

41
Q

These are crucial for establishing a unique and recognizable brand identity for pharmaceutical products. They help consumers distinguish between different medications.

A

Trademarks

42
Q

Strict protocols control access to trade secret information, including non disclosure agreements, secure facilities, and limited personnel.

A

Confidentiality Measures

43
Q

Pharmaceutical companies must carefully select and register trademarks that are ___, ____, and ___ to existing marks.

A

distinctive
non-descriptive
not confusingly similar

44
Q

Undocumented know-how and expertise held by key scientists and researchers are also considered valuable trade secrets.

A
45
Q

It is essential to prevent counterfeit drugs and protect brand reputation. This includes monitoring the marketplace and taking legal action against infringers.

A

Active Enforcement of Trademarks

46
Q

They must comply with strict regulatory requirements, including guidelines on drug naming, packaging, and labeling to ensure patient safety.

A

Pharmaceutical Trademarks

47
Q

These are critical for providing essential information to patients and healthcare providers, including dosage, usage instructions, and safety warnings.

A

Pharmaceutical Product Labels

48
Q

It is protected by copyright law, ensuring the unique visual identity and branding of a product.

A

Pharmaceutical Packaging Design

49
Q

It covers the written content, images, and other creative elements used in pharmaceutical marketing and promotional materials.

A

Copyright

DDD (9 decks)

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