Patent strategy in the life sciences Flashcards

1
Q

patents are limited in what they offer

A

– The ability to (threaten to) sue
– The ability to promise not to sue
– The ability to sell the right to sue

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2
Q

true or false: a patent does not allow you to do anything with your invention

A

true

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3
Q

why is the right to sue uncertain with a patent

A

– A patent may be successfully attacked if you try to use it
– In US, between 43% and 46% of contested patents (those that make it to court) were held
invalid for the last few decades

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4
Q

your ability to sue depends on what when you have a patent

A

-how much activity your patent covers
-if narrow, you may not succeed in preventing others from using slighlty different technology
-resources

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5
Q

why is your ability to sue also constrained by resources

A

patent litigation costs 3.5 million$ per side

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6
Q

Patents work by helping organizations bridge gap between….

A

invention and innovation

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7
Q

what is invention

A

the process of coming up with a concrete new idea

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8
Q

what is innovation

A

an actual change in the products/services available to end-users

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9
Q

While patents provide rights over inventions their purpose is to keep ….

A

others away so that the organization can invest in
the process leading to innovation

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10
Q

why is innovation difficult and complex

A
  • it usually fails for reasons other than the value/usefulness of the idea
    -Poor business strategy
  • Unreasonable expectations re value
  • Failure to partner
  • Failure to address risk (time, liability, etc.)
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11
Q

what is most likely to make a patent sucessful

A

A so-so idea with good management, marketing and reasonable expectations likely to have more success than a great idea with one of these missing

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12
Q

Public Research and Patents:
Ebola vaccine

A

Researchers at Canada’s National Microbiology Laboratory a recombinant
virus to prevent Ebola
* NML patented vaccine and licensed it to
small US corporation
* US firm did nothing to advance vaccine
development

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13
Q

Ebola vaccine: patent

A
  • NML was going to cut funding to the vaccine except one lone researcher, Judie Alimonti, on a
    short-term contract kept working to ensure production of clinical grade vaccines
  • When 2014 Ebola outbreak erupted in West Africa, Canada was able to contribute the vials
    that Alimonti had produced
  • These had close to 100% efficacy and saved lives
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14
Q

ebola vaccine part 2 patents

A
  • Meanwhile, small US firm sold to larger firm that gave rights to Merck
  • None of these did anything up to 2014 except reap financial rewards that followed
  • Merck was 2 years late on
    getting FDA approval
  • If not for Alimonti, there would not have been clinical trials and lives would have been lost
  • Patents were distraction, almost dangerously so
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15
Q

Universities and Patents

A

They do poorly on the former – 52% of universities lose money on just running a tech transfer office

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16
Q

which are the unis that make most money from patents

A

-northwestern
-nyu
-princeton
-columbia

17
Q

pharma industry faces a decline in its level of productivity, what is the result?

A

industry has moved to collaborations with public and private sector partners

18
Q

what are the 3 main collaboration driverss

A

-people
-data and materials
-tools

18
Q

collaboration drivers: people

A
  • Takes longer to graduate
  • Increased specialization
  • Cultural change toward sharing
19
Q

collaboration drivers: data and materials

A
  • Lots and lots of data & materials
  • Yet, standardization and interoperability not common
  • Quality of data & materials/reproducibility of results
  • Cost of uploading/curating data and materials
  • Cost of integrating data
  • Managing data and
    material resources
20
Q

collaboration drivers: tools

A

-New tools (e.g. CRISPR)
- Artificial intelligence
- Cloud/diffuse storage
- Databanks and biobanks

21
Q

Forms of Regulatory Exclusivity

A

Regulatory exclusivity refers to the protection granted to pharmaceutical products by regulatory agencies, such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe. This protection prevents generic manufacturers from obtaining marketing approval for a certain period, allowing the original developer to recoup their investment in research and development. Here are some common forms of regulatory exclusivity:

22
Q

new chemical entity

A

-5 years in US (practically 6)
* Prevents competitors
from using original data to
seek approval

23
Q

orphan drug

A
  • 7 years protection
  • Protects against any approval of same drug for same
    indication
24
Q

pediatric

A

Extends other exclusivity by 6
months if conduct pediatric
studies

25
Q

new uses

A

3 years protection for new indication, dosage, or to switch to over-thecounter

26
Q

antimicrobial

A

Extends exclusivity by 5 years for drugs “intended to treat a serious or lifethreatening
infection”

27
Q

new biologics

A

12 years of exclusivity (4 before an application can be submitted & 8 more before approval)

28
Q

Patents and Trade Secrets: negotiating partnership

A
  • Existing patents and secrets
  • Future inventions and derivative research
  • Long delays in negotiating with universities
  • Value sharing
29
Q

patents and trade secrets: governing partnership

A
  • Identifying/applying for patents and secrets
  • Monitoring infringement and litigation
  • Assigning rights/value
30
Q

Regulatory Exclusivities: negotiating partnership

A
  • Value sharing
  • Assignment of data
  • Standard agreements possible
31
Q

Regulatory Exclusivities: Governing partnership

A
  • No patent management or trade secrecy monitoring
  • No litigation
32
Q

leukemia: which countries worked on the probe

A

australia, us and austria

33
Q

Signed agreement with Cellgene for….

A

US$40 million upfront, up to US $1 billion if successful

34
Q

what is Medicines 4 Kids

A

is a spinout from the SGC dedicated to developing drugs without patents

35
Q

what does m4k do

A

-developing a drug to treat diffuse intrinsic pontine glioma (DIPG), an extremely rare brain
cancer
-Developed thesis that inhibition of ALK2 kinase would kill tumour cells

36
Q
A