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It hurts when IP > Patents, in-depth > Flashcards

Patents, in-depth Flashcards

1
Q

What is the Pharma IP Paradox?

A
  • Drug development is an extremely expensive and lengthy process, usually 10 – 15 years
  • Drug candidates are kept secret for as long as possible
  • Every single day of patent protection is valuble
  • Patent term is limited, maximum 25 years (incl. extensions)
  • Patent term is counted from the day of filing
  • But patent applications are filed very early in the process!
  • Why do you file early in the process?
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2
Q

What’s the rough timeline for the development of a pharmaceutical product?

A

~ year 0-5 discovery
~ year 5-10 IND
~ year 10-12 NDA
~ year 12–> Marketing approval

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3
Q

What’s the absolute longest term one can have patent protection for?

A

25½ years

  • 20 years patent
  • 5 years SPC/PTE
  • ½ year for trials on children
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4
Q

What is a target and why is it called “target”?

A

A “target” is a native protein or similar in the body, which is related to one or more diseases or medical
conditions, a.k.a. “Indications”

Called “targets” because “shot” at with drug molecules, to modify their activity in order to obtain some desirable therapeutic effect

(the chili example)

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5
Q

What do you do during “hit identification” / “lead discovery”?

A

You find “keys” that fits to the “locks” (the targets).

You do this by High-Throughput Screening (HTS), where a large library of chemicals are tested for their ability to modify the target.

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6
Q

what is HTS?

A

High-Throughput Screening

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7
Q

What is the purpose of hit identification / lead discovery?

A

To find a Structure-Activity Relationship (SAR)

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8
Q

What is SAR?

A

Structure-Activity Relationship: the essential core of the drug molecule.

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9
Q

What is “lead optimisation”?

A

When you modify a promising lead compound to optimise efficacy and minimise side effects.

This often results in new compunds - “New Chemical Entities” (NCE)

This process results in a shortlist of possible candidate drugs.

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10
Q

What is NCE?

A

New Chemical Entities.

See lead optimisation.

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11
Q

What is Candidate Drug Nomination?

A

It’s the phase of identifying a candidate drug that meets most criteria and passes additional evalutions, such as sasfety assessments and process chemistry studies.

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12
Q

When does the transfer from the Discovery Team to the Development Team usually take place?

A

During the Candidate Drug Nomination.

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13
Q

What happens during Preclinical Development?

A

To obtain sufficient information to do a proper risk assessment for the product’s use in humans.

Also you develope formulations of the drug to optimise it as a pill (or for other means of administration).

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14
Q

What happens during Phase 1?

A

Phase I: In healthy volunteers to determine safety

and dosing

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15
Q

What happens during Phase 2?

A

Phase II: To get an initial reading of efficacy and further explore safety in small numbers of sick patients

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16
Q

What happens during Phase 3?

A

− Phase III: Large trials to determine safety and efficacy

in sufficiently large numbers of patients

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17
Q

How long is the average pharma process?

A

10-15 years.

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18
Q

Name some peculiarities in the pharma industry

A

It is highly regulated and controlled. You cannot market the product before you have finished development.

It is a lengthy process: some 10-15 years of development (which only gives you 5-10 years of patent protection)

There is “high attrition”, meaning that most compounds/projects fail and never becomes products. Successful compounds/products must finance the failed ones.

The development of compounds/products is extremely costly, therefore it is very profitable to produce copies in absence of IP protection - aka generics.

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19
Q

What is “generics”?

A

Copies of compounds/products that have lost their IP protection.

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20
Q

Who gives approval to pharmaceuticals, and with what limitation?

A

FDA (U.S. Food and Drug Administration) in the US,

EMA (European Medicines Agency) in Europe

You only get approval for specified indications.

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21
Q

What is “off-label” use?

A

When doctors (when they are allowed to) prescribe drugs for other indications than what they were approved for.

Pharma companies may not promote their drugs for non-approved indications.

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22
Q

What is “PTE”?

A

Patent Term Extension

US?

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23
Q

What is “SPC”?

A

Supplementary Protection Certificate.

Europe?

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24
Q

Roughly, what is the ratio of Attrition?

A

Out of 10 000 compounds, 5 make it to phase 1, and 1 becomes an approved drug.

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25
Name some consequences of Attrition.
The one molecule that makes it to the end (becoming approved) must be very well protected. But you do not know which molecule that will be, when you start screening the 10 000 molecules. --> all molecules must be well protected! Also, the one that finally makes it will most likely be challenged in litigation. --> it must stand the test!
26
How much more costly is the R&D of pharma than other fields?
``` Roughly 2 or 2.5 times as costly as: computer stuff Aerospace Motor vehicles and parts telecom Machinery ```
27
What happens when the patent for a compound expires?
There is a very steep decline in price, as generics enter the market.
28
So why do you file your patents so early in the process? | The Pharma IP Paradox
Many competitors focuses on the same diseases: this means that they have the same Targets. Since they are shooting pretty much the same substances at the same target, they will most likely get the same hits. (You buy libraries of test molecules to shoot, and there aren't that many suppliers of that). --> you are most likely going to end up with the same SARs and optimise them to the same compounds. There is a high likelihood of arriving at the same result, and the First to File gets the patent!!!
29
When is it time to file for the first patent applications?
During the Lead Optimisation
30
What is the first patent applications composed of?
NCEs based on SARs
31
What do you do if the SAR is not patentable?
Patent the specific compound.
32
Give an example of a 1st Medical Indication
"Claim 30. The compound according to any one of claims 1 to 27, _for use in therapy_. "
33
Give an example of a 2nd Medical Indication
"Claim 33. The compound according to any one of claims 1 to 27, _for use in the treatment of acute and chronic nociceptive pain_. "
34
What do you do during the Candidate Drug Nomination?
You perform an FTO and a Patentability Status Check.
35
Patentability: purpose?
Can I patent my invention?
36
Patentability: search based on?
Invention
37
Patentability: documents searched?
All kinds.
38
Patentability: territory searched?
The world.
39
Patentability: primary screening criterion?
Does the document disclose my actually made invention?
40
FTO analysis: purpose?
Answering the question "Do I run the risk of infringing someone's patent?"
41
FTO analysis: search based on?
Product
42
FTO analysis: documents searched?
Granted patents and pending patent applications.
43
FTO analysis: territory searched?
Countries that you plan to produce and/or sell the product in.
44
FTO analysis: primary screening criterion?
Do the patent claims cover my product?
45
What do you do during Preclinical Development?
You try to find new formulations, salts, manufacturing processes, administration routes, dosage forms, et c. et c. (Optimising the product) No part of the drug development is yet public. Your own prior patent applications that are less than 18 months old are not public, and therefore not citable against Inventive Step.
46
What does Phase I, II, & III have in common?
1 They continue the process of the Preclinical Development: "You try to find new formulations, salts, manufacturing processes, administration routes, dosage forms, et c. et c. (Optimising the product)" 2 you do this in order to broaden the protection, so that you extend the effective patent term.
47
When you broaden the protection so that you extend the effective patent term, you do an activity that can be classified as what?
IP Life Cycle Management
48
IP Life Cycle Management
When you broaden the protection so that you extend the effective patent term, you do an activity that can be classified as what?
49
What is an absolute must of IP Life Cycle Management, and what are the disadvantages of being shoddy about this?
IP Life Cycle Management should relate to real life, i.e. real commercial advantages. If it doesn't relate to real commercial advantages, you are just 1 wasting resources, and 2 giving away information to competitors
50
What is important in addition to IP Life Cycle Management during/after Market Approval?
Pharma specific IP extensions Regulatory Exclusivity
51
What are Pharma Specific IP Extensions?
Patent Term Extension (PTE) in the US: − Up to maximum 5 years extension of the patent term to compensate for regulatory (FDA) delay ager patent grant − Extends the life of the patent Supplementary protection certificate (SPC) in the EU: − Up to maximum 5 years extension of protection − Extends the monopoly period for a "product" (active ingredient or a combination of active ingredients) that is protected by a patent (but not the patent itself!)
52
SPC?
Supplementary protection certificate (SPC) in the EU: − Up to maximum 5 years extension of protection − Extends the monopoly period for a "product" (active ingredient or a combination of active ingredients) that is protected by a patent (but not the patent itself!)
53
PTE?
− Patent Term Extension (PTE) in the US: − Up to maximum 5 years extension of the patent term to compensate for regulatory (FDA) delay ager patent grant − Extends the life of the patent
54
Regulatory Exclusivity is what?
Data Exclusivity: In the US and EU, generic drug manufacturers and drug regulatory authorities cannot rely upon the originator’s test data to approve generic applications during a pre-determined period of time − If generic entrant cannot get permission to use the test data from the company that first marketed the product (data exclusivity), they would have to re-conduct the tests, including the human use clinical trials, or wait until the data exclusivity period expires, in order to obtain marketing approval. Since producers of generics does not have the resources for making their own trials, they have to rely on the data from the big actors.
55
Data Exclusivity in the US?
5 year data exclusivity from FDA approval to new drug products containing the NCE.
56
Data Exclusivity in the EU?
8 year data exclusivity, with additional 2 year market exclusivity provision, and a possible 1 yaer addition if the originator obtains an authorisation for other new indications with a significant clinical benefit.
57
What is the difference between Data and Market Exclusivity?
The Generic Competitor cannot circumvent Market Exclusivity by generating its own data and submitting a new application for market approval - it is an absolute bar to market approval of the same drug for the same indication.
58
Name something special with Pharma IP protection:
It makes use of all the tools in the IP toolbox AND a few additional ones, AS WELL AS regulatory tools.
59
What does Pharma IP protection require?
Careful coordination and thorough strategy work.
60
Name a basic prerequisite for having a patent
``` It must be an invention NOT - a discovery - a theory - rules for a game ```
61
What types of patents are there?
- Product patents - Application/Use patents - Method/Process patents
62
What are criterias for having a patent?
1 - Novelty 2 - Non-obviousness/inventive step 3 - Industrial application
63
What are the criterias for Novelty?
Absolute: it has to be new everywhere Objective: it has to be new for everyone (Remember that there is public access to official documents in Sweden)
64
What are criterias for non-obviousness/inventive step?
- There must be a leap of knowledge - The leap depends on the technology area - There are more or less revolutionary patents A person skilled in the art (depends, but usually a civil engineer) with access to everything in the state of the art, but with no curiosity or creativity, should not have been able to come up with the invention.
65
What are criterias for Industrial Application?
- Technical Character - Technical Effect - Reproducible Broad scope: there is no requisite for commercial value.
66
What is the scope of a patent?
The scope of a patent is defined by its Claims (PA art. 8 p. 2 and art. 39) The Doctrine of equivalence gives that technically similar substitutes can be within the scope. With a less obvious invention, the room for equivalence is bigger, in other words: the scope is wider for a less obvious invention.
67
What are the limitations to the scope of a patent?
- Prior user's rights - Non-commercial use - Compulsory licenses - Exhaustion of rights - Experimental use (does not cover experiments with the help of the invention) - The time and space aspect: only 20 years and inside the national jurisdiction.
68
What is the exception to the exception in terms of a patent's scope?
The SPC (supplementary patent certificate) which may extend the patent's term for a maximum of 5 additional years.
69
Super trivia in terms of patent scope:
If you do trials on children for pharmaceutical patents you can be rewarded with an extra 6 months of patent protection.
70
What are the subjects that can hold the rights to a patent?
The inventor The inventor's successor in title - the assignee Those that the assignee gives dispositives rights - the licensee
71
What is very important to know in regards of the patent application?
That there is a first-to-file principle in case of contesting applications concerning the same invention.
72
What is the interrelation between a national and a regional or international patent application?
There is a 12-month grace period for making EPO and PCT applications, after having made a national application.
73
EPO application?
One application can result in a bundle of European patents: if the one patent application is approved you automatically get national patents in the designated EPO jurisdictions. If the application is denied you cannot get a patent in any of the countries which have ratified the convention.
74
PCT application?
A central examination and a global priority date. After the PCT you have to make national applications, but can draw benefit from having made the central examination before (PCT Highway). You get 18 months of secrecy. You can postpone payments for the applications 18 months.
75
How do you uphold a patent?
You pay its annual fees, You perform surveillance of infringement. You negotiate with/litigate against infringers.
76
What are the sanctions for patent infringement?
Damages Punishment Prohibition through penalty payment.
77
What can you be sure of if you sue someone for patent infringement?
That they will claim that your patent is invalid.
78
What is the timeline for the patent journey from idea to market?
``` 1 PRIOR ART SEARCH 2 Patent mapping 3 Monitoring services 4 Technical surveys 5 NOVELTY SEARCH 6 Preliminary patentability report 7 FTO SEARCH 8 Now you can submit your application 9 Citation search 10 Validity search 11 IP due diligence ```
79
Questions answered by patent information:
General - _Is my invention patentable?_ Technical: - _What solutions exists to a technical problem?_ Legal: - _am I infringing on someone's patent or am I free to use it?_ Business: - _what technologies are my competitors developing?_ - _who's strong in a (new) technology field?_
80
How can you use patent information to seee what your competitors are developing?
Check distribution of patent applications by technical field.
81
How can you use patent information to see who's strong in a technology field?
Check patent applications per company in every technical field, each year.
82
What use can patent information be of in terms of business information?
- Technological trends - M&A (DD) - Headhunting of prolific inventors - Investment decisions.

It hurts when IP (4 decks)

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