Exam 1 Flashcards
1
Q
Idea
A
Notebook-worthy description of a solution to the problem
2
Q
Innovation
A
Marketable solution, implemented in a product
3
Q
Invention
A
Patentable solution to the problem accompanied by enabling desciption
4
Q
Notebooks should not contain:
A
- Back-date entries when reporting prior observations
- White-off error
- Removing a page with error
5
Q
In the course of your work for a biomedical company you come up with an invention. Mark one most likely scenario:
A
You are the inventor, your company is the assignee
6
Q
In the market pull model of biomedical innovation, the innovation process starts by identifying:
A
Medical need
7
Q
Medical Need
A
Desired health outcome
8
Q
Solution
A
Technology that is applied
9
Q
Implementation
A
How solution is delivered
10
Q
Department of Health and Human Services (DHHS)
A
FDA is an agency within DHHS
a part of the executive branch of US government.
11
Q
First Stage of Drug Development Process
A
Drug Discovery
Concerned mostly with intellectual property
12
Q
Preclinical Studies
A
Animal testing on at least 2 different species (one rodent and one nonrodent)
13
Q
3rd State of Drug Development Process
A
Investigational New Drug (IND) Application
Required for all tests of new drugs except for off-label use
14
Q
Phase I Clinical Trials
A
Safety
15
Q
Phase II Clinical Trials
A
Efficacy
16
Q
Phase III Clinical Trials
A
Compare to the standard of care
17
Q
Gold standard of clinical trials
A
Randomized Control Trial (RCT)
18
Q
Methods of collecting clinical evidence from best to worst
A
Experimental studies, observational studies, case report
19
Q
5th stage in Drug Development Process
A
-New Drug Application (NDA)
- Marketing approval for a new drug issued by FDA
20
Q
NDA Review Process
A
- Received by FDA
- Technical Reviews
3.Day 60: Allow Review or Refuse to file - Medical and scientific reviewers, advisory committee, sponsor
- Decision by Division Director
- Approval, approvable or non-approval
21
Q
Phase IV
A
Post market surveillance, averse events reporting
22
Q
Orphan Drug Designation
A
- Diseases affecting less than 200,000 in US
- Same stages of approval, modified study design
- Special incentives: tax credits, marketing rights, intellectual property protection
23
Q
Abbreviated New Drug Application (ANDA)
A
- For approval of genetic drugs
- No animal of clinical data needed
- Required bioequivalency with the patented drug
24
Q
Over The Counter Drugs (OTC)
A
- For nonprescription medications
- No NDA process required
- Required conformity with OTC Monograph
25
Class I Medical Devices
- Not intended to support or sustain life
- Minimal risk of injury
- General controls
26
Class II Medical Devices
- May pose mild risk if used incorrectly
- Premarket notification 510(k)
- General and special controls
27
Class III Medical Devices
- Support or sustain life
- Present potential risk to patient
- Premarket Approval (PMA)
- General and special controls
28
510(k) Exempt Devices
- Low risk devices
29
General Controls
- Labeling
- Registered manufacturing distribution
- Good manufacturing practice
- Record keeping, adverse event reporting
30
510(k) Premarket Notifcation
- Low to no risk devices
- Based on concept of substantial equivalence to predicate device
31
Premarket Approval (PMA)
- Highest risk medical devices
- Similar to drug approval process
32
Investigation Device Exemption (IDE)
Request to allow clinical trials on unapproved device
Stages:
- Pilot
- Feasibility
- Pivotal
- Post market
33
Special cases of IDE
- IDE Treatment use
- Emergency/Compassionate use
34
Humanitarian Device Exemption (HDE)
- A device is not in clinical investigation under IDE.
- Population that may benefiting from the device < 8000
- HDE approves marketing of the Humanitarian Use Device (HUD)
35
Listed Medical Devices
- 510(k) exemption status
- Mostly classes I and II
36
Cleared Medical Devices
- 510(k) must be submitted
- Determined to be substantially equivalent to another legally marketed device
- Can be of any class
37
Approved Medical Devices
- FDA has accepted a PMA
- Class II & III
38
Animal Welfare Act of 1966
- Regulates use, research and exhibition of animals
- Administrated by the US Department of Agriculture (USDA)
39
Animals not protected by AWA
- Rats, mice and birds
- Farm animals
40
Public Health Service Policy
- Covers all vertebrates in research and education
- Requires institutions receiving PHS funds for research involving animals have a program for the care and use of animals, including mice, rats, and birds excluded under AWA
41
Public Health Services (PHS)
Includes FDA, NIH, CDC, etc
42
Direct oversight of the use of mice and rats in medical research is provided by:
Institutional Animal Care and Use Committee (IACUC)
43
Animal Welfare Assurance (AWA)
A document updated annually and resubmitted once every five years
44
Activities that do not require IACUC oversight
- Teaching or research involving invertebrate species (arachnids, crustaceans, insects, mollusks, nematodes, etc...)
- Purchase of commercially available antibodies
- Purchase of commercially available vertebrate products: animal blood, cells or tissue
45
Structure of Human Subject Protection
1. Ethical Principles
2. Law
3. Policy
4. Compliance
46
Protected groups in Human Research
- Pregnant women, neonates
- Prisoners
- Children
47
Federal-Wide Assurance (FWA)
- Institutional assurance accepted and approved by Office for Human Research Protections
- FWA holder must designate at least one Institutional Review Board (IRB)
48
Who regulates the tests for Significant Risk?
FDA
49
Who regulates the tests for Nonsignificant Risk?
IRB
50
Investigators keep records for at least __ years after completion of study.
3
51
Informed consent summary
- Description of study
- Risks and benefits
- Rights and remedies
52
Protections for Medical Records
- The Health Insurance Portability and Accountability Act (HIPAA)
- Americans with Disabilities Act (ADA)
- Family Educational Rights and Privacy Act (FERPA)
53
Title 45 CFR Flowchart
- Human Subject Research (Yes)
- Significant Risk (Y/N)
- Y: FDA/IRB Oversight
- Commercial (Y/N)
- N: IRB Oversight
54
Handles all patent appeals
United States Court of Appeals
55
Utility Patent
Concerned with unique function
56
Design Patent
Invention of a unique ornamental or esthetic (not functional) shape
57
Plant Patent
Asexually reproduced plants, by cuttings and grafts
58
4 Requirements for utility patent
1. Statutory Class
2. Utility
3. Novelty
4. Nonobviousness
59
Statutory Class Requirements
- Composition
- Method
- Machine
60
3-4-5
3 types of patents
4 requirements for utility
5 statutory classes for utility
61
What goes into a utility patent?
Title Page
Specifications
Claims
62
Broad/narrow claims:
Broad claims give greatest protection, harder to patent/prosecute narrow claims easier to prosecute, offer minimum protection
63
Independent/dependent claims:
Example of dependent claims structure:
1. A composition of matter made of trees.
2. The composition of claim 1 wherein said trees are pines.
64
Patent priority date
Original filing date
65
Direction if patent application pending but come up with new invention
File Continuation Patent Application
66
Direction if patent application pending but continue to research and add new knowledge
File Continuation In Part (CIP)
67
What to do if you claimed too much disjoined stuff in one patent application?
Divisional Application
68
What do you do if some of your claims in the issued patent are invalid?
Patent Reissue
69
Paris Convention for the Protection of
Industrial Property, 1883
Within countries participating in the Paris Convention, you have 12 months from the original filing date to file patents in any of the member country, and claim the priority date of the original filing
70
Patent Cooperation Treaty (PCT) of 1970
- Administered by World Intellectual Property Organization (WIPO), an agency of the United Nations
- Handles PCT patent application or international patent applications
- Note – there is no PCT patent
71
Trade Secrets
- Has actual or potential economic value derived from not being known by other persons
- Is subject of efforts to maintain its secrecy
- Do not require registration
72
Patent vs Trade Secret
- Patents last 20 years, trade secrets are forever
- Strick requirements for patents, few restrictions for trade secrets
- Patents are granted by governments, you guard trade secrets
- Trade secret can be reverse-engineered (legal discovery)
- Patents are published
- Patent laws are enforced in federal courts, trade secrets – well, it depends
73
Trademarks
- sign, design, phrase identifying the business
- It is a form of property
- Requires registration in USPTO
- Requires efforts to maintain
- If not maintained, it is subject to dilution or abandonment
74
Trademark registered with USPTO:
R with circle
75
Trademark intended for registration
TM
76
Copyright
- Exclusive rights to use and distribute the original work granted to its creator
- Copyrights do not have to be asserted, declared, registered
- Author is entitled to all copyrights
77
Fair use doctrine:
You can print copy of a copyrighted material for teaching, research, scholarship
78
First sale doctrine:
You can re-sell a legally acquired copyrighted work (e.g., textbooks)
79
Sonny Bono Copyright Term Extension Act
- Life of the author plus 70 years
- Corporate authorship: 120 years after creation or 95 years after publication, whichever is earlier
80
Copyleft License
- Share-alike/reciprocity requirement.
- Requires that all modifications to the product be freely available, any derivative work be released under the same license
81
Creative Commons
License allows to define which specific rights the author reserves
82
Types of Creative Common licenses
- Attribution (BY), requiring attribution to the original author
- Share Alike (SA), allowing derivative works under the same or a similar license (later or jurisdiction version)
- Non-Commercial (NC), requiring the work is not used for commercial purposes;
- No Derivative Works (ND), allowing only the original work, without derivatives
83
License
A promise by the licensor not to sue the licensee
