Model 2: Intellectual Property Processes and Problems

Obtaining a Patent – Detailed Notes

1. What is a Patent?

A patent is a legal right given to an inventor.

It allows the inventor to:

 Use the invention

 Sell the invention

 Stop others from copying it

A patent gives monopoly rights for a maximum of 20 years.

2. What Can Be Patented?

You can patent:

 Products (example: medical device)

 Processes (example: manufacturing method)

 Methods (example: certain technical methods)

You cannot patent:

 Ideas alone

 Scientific theories

 Laws of nature

 Plant or animal varieties

3. Requirements for a Patent

To get a patent, the invention must meet three main conditions:

1. Novelty (New)
The invention must not exist anywhere in the world before

2. Inventiveness (Non-obvious)
It should not be obvious to experts

3. Industrial Use
It must be useful and practical
4. Documents Required for Patent Application

You must provide:

 Complete description of the invention

 Technical details

 Claims (legal protection scope)

 Statement of inventorship (who invented it and why you have

rights)

5. Patent Process in the UK

Step 1: Patent Search

Before applying, check if a similar invention already exists.
You can search using:

 UK Intellectual Property Office

 Espacenet

Step 2: Hire a Patent Attorney

A patent attorney helps in legal drafting and increases success chances.

Step 3: File Patent Application

Submit your application with all documents.
After filing, you can use the term “Patent Pending”.

Step 4: Substantive Examination

The authority checks:

 Whether it is new

 Whether it is inventive

 Whether the claims are correct

Step 5: Patent Grant

If approved, you receive full legal protection.

Time required: Up to 5 years

Cost in the UK: Around £4,000 or more

6. International Patent Protection

Patents are territorial. This means protection is valid only in the country
where you apply.

Options for multiple countries:

1. Patent Cooperation Treaty (PCT)

One application for protection in more than 140 countries

2. European Patent Office

Protection across many European countries

3. Separate applications
Apply individually in each country

7. Problems and Challenges in Patenting

High cost
Patent filing and legal support are expensive

Time-consuming
Approval can take several years

Complex legal process

Requires technical and legal expertise

Risk of rejection
If the invention is not new or not inventive

Territorial limitation
You must apply in each country separately

Public disclosure
Your invention details become public after filing

8. Importance of Patent Information

A large amount of technical knowledge is available only in patents.

It is useful for:

 Research

 Innovation

 Understanding competitors

9. Other Types of Intellectual Property Protection

Design Rights
Protect the appearance of a product
Valid up to 25 years (renewed every 5 years)

Trademarks
Protect brand name and logo

Types:

 TM: Unregistered trademark

 R: Registered trademark with legal protection

10. Application in Healthcare Innovation

In healthcare, different aspects are protected in different ways:

 Technology or device → Patent

 Design or shape → Design rights

 Brand name → Trademark

Example:
A medical device company may patent the technology, protect the design,
and register the brand name separately.

11. Comparison: UK and India

UK system:

 More structured and faster

 Higher cost

 Strong enforcement

India system:

 Lower cost

 Slower processing time

 Managed by:

o Indian Patent Office

Main difference:
India is more affordable, while the UK system is more streamlined.
Expert View of Intellectual Property (IP)

1. Expert Background (Freddy Guemeni)

 Works as an IP manager and innovation consultant

 Experience in:

o Supporting students and researchers to protect inventions

o Licensing technology to industry

o Helping startups design business models

o Conducting due diligence (checking ownership of IP)

 Worked with institutions like

o Imperial College London

2. What is Intellectual Property?

Intellectual Property is:

 A legal field that deals with creations of the human mind

Important idea:

 Ideas alone cannot be owned

 To protect an idea, you must:

1. Convert it into a tangible form (write, design, build)

2. Legally protect it using IP

Key points:

 IP gives ownership rights over what you create

 IP is territorial (valid only in specific countries)

 IP gives monopoly rights (you can stop others from using it)

3. Key Characteristics of IP

1. Comes from Human Mind

 Innovation, creativity, knowledge

2. Must be Captured

 Example:

o Writing → copyright

o Invention → patent

3. Legal Ownership

 You can own, sell, or license it

4. Territorial

 Protection depends on country laws

5. Monopoly Rights

 You can:

o Stop others from copying

o Control usage

o Earn revenue

4. Why is IP Important?

Shift in Economy

 Earlier (1970s):

o 80% value = physical assets (machines, buildings)

 Now:

o Around 90% value = intangible assets (ideas, innovation,

knowledge)

Importance for Innovators

1. Protects Value Proposition

 Your unique idea or product is your business value

2. Attracts Investment

 Investors prefer protected innovations

3. Secures Research Output

 Converts knowledge into valuable assets

 4. Enables Commercialization

 You can:

o Sell

o License

o Scale your innovation

5. Types of Intellectual Property

1. Patents

 Protect how things work

 Focus: function and technical features

Example:

 Medical device mechanism

2. Design Rights

 Protect how a product looks

 Focus: shape, appearance, design

Example:

 Shape of a medical device

3. Trademarks

 Protect brand identity

 Includes:

o Name

o Logo

Example:

 Healthcare brand name

4. Copyright

 Protect written and creative work

Example:

 Research papers

 Software code

5. Trade Secrets (Know-how)

 Protect confidential information

 Not registered

 Protected by secrecy

Example:

 Formula, process, internal method

6. Trade Secret vs Patent

Example:

 Coca-Cola recipe

Decision:

 Did not patent the formula

 Kept it as a trade secret

Comparison:

Patent:

 Protection up to 20 years

 Public disclosure required

Trade Secret:

 Protection unlimited (as long as secret is maintained)

 No registration needed

 Risk:

o If someone discovers it, protection is lost

7. Role of IP in Business Strategy

IP helps in:

 Building strong startups

 Creating competitive advantage

 Licensing technology to companies

 Increasing company valuation

8. IP and Knowledge Management

Problem:

 Knowledge stays in employees’ minds

Solution:

 IP helps to:

o Capture knowledge

o Store it

o Convert it into assets

9. Healthcare Innovation Context

In healthcare:

 Multiple IP types are used together

Example:

 Medical device:

o Patent → technology

o Design right → shape

o Trademark → brand

o Trade secret → internal process

10. Key Risks in IP

 Not protecting ideas early

 Losing ownership rights

 Employees leaving with knowledge

  Competitors copying innovation

 Poor documentation

11. Key Takeaways

 Ideas alone are not protected

 IP requires converting ideas into tangible form

 IP gives ownership, control, and commercial value

 Different IP types protect different aspects

 Trade secrets can be powerful but risky

 IP is essential for startups, especially in healthcare

Obtaining Intellectual Property

Interview Insights (Freddy Guemeni)

1. What is Frugal Innovation?

Frugal innovation means:

 Using existing technologies in a new way

 Solving problems at lower cost

 Maintaining high quality outcomes

Example:

 Adapting an existing tool for medical use instead of creating a new

one
2. Key Question in Frugal Innovation and IP

Common assumption:

 Frugal innovation cannot be protected by IP

Expert view:

 This is not true

 Frugal innovation can still be protected if it meets IP requirements

3. Applying IP in Pharma and Healthcare

In pharmaceutical and biotech innovation, different IP types are used:

Patents

 Protect new drugs

 Protect medical devices

 Protect technical innovations

Important point:

 Even if a drug already exists, you can still patent:

o New dosage method

o New way of administering the drug

Trademarks

 Protect brand name of the drug or product

Copyright

 Protect written materials such as:

o Instruction manuals

o Documentation

Clinical Data Protection

 Data from clinical trials is valuable

  It is confidential

 Used in regulatory submissions

 Considered an important IP asset

4. Frugal Innovation and Patent Protection

Even in frugal innovation, patent protection is possible.

Key questions to ask:

 Is it new?

 Is it inventive?

Example:

 A normal drill exists in the market

 You modify it for surgical use

 If the modification is innovative, it can be patented

Conclusion:

 Frugal innovation can qualify for patents if it adds something new

and non-obvious

5. Frugal Innovation and Other IP Rights

Trademark

 If you create a new brand name or logo

 You can register it

Design Rights

 If the product has a new appearance

 You can protect the design

Conclusion:

 Same IP rules apply to frugal innovation

 It is not “IP-free”
6. IP in Healthcare Services and Care Models

Examples:

 Care pathways

 Service delivery models

 Hospital processes

Can These Be Patented?

Generally, no.

Reason:

 Patents protect technical inventions

 Not business methods or service models

According to European rules:

 Business models are not considered inventions

7. Alternative Protection for Service Innovations

Even if patents are not possible, other IP types can be used:

Copyright

 Protects:

o Written protocols

o Clinical guidelines

o Training materials

Trademark

 Protects:

o Brand name of service

o Program identity

Example:

 A healthcare service brand can be very valuable

8. Importance of Trademarks

Trademarks can have very high value.

Example:

 Apple

 Brand value estimated in billions

Insight:

 Trademark can sometimes be more valuable than patents

9. Trade Secrets in Healthcare

 Protect confidential knowledge

 Example:

o Internal processes

o Clinical methods

o Business strategies

Important:

 Value depends on secrecy

10. Key Challenges in Frugal Innovation IP

 Difficulty proving novelty

 Existing technologies already known

 Small improvements may not qualify

 Risk of copying

 Lack of awareness about IP protection

11. Strategic Approach to IP in Healthcare Innovation

Instead of focusing only on patents:

Use a combination:

 Patent for technical features

  Trademark for branding

 Copyright for documents

 Trade secrets for confidential processes

12. Key Takeaways

 Frugal innovation can be protected by IP

 Patents are possible if innovation is new and inventive

 Service models are usually not patentable

 Other IP types are very important

 Trademarks and trade secrets should not be ignored

 A strong IP strategy uses multiple protection methods

Intellectual Property Issues in Three

Contexts
1. Governing IP: Organizations and Policies

Global IP Governance

 Intellectual Property is regulated globally through:

o World Intellectual Property Organization

o World Trade Organization

 WTO ensures countries follow common IP rules (TRIPS Agreement)

Global Inequality in Patent Filing

Data:

 64.5% of patents → High-income countries

 2.9% → Lower-middle-income countries

 0.4% → Low-income countries

Reasons for This Disparity

1. High Cost

 Patent filing is expensive

 Legal fees are high

 Maintenance costs over time

2. Time-Consuming Process

 Takes years to get approval

 Delays innovation entry into market

3. Need for Legal Expertise

 Requires skilled IP lawyers

 Not easily available in low-income countries

4. Increased Product Cost

 IP costs increase final product price

 Not affordable in price-sensitive markets

5. Complex International Collaboration

 Different laws across countries

 Bureaucracy in technology transfer offices

 Delays in commercialization

Policy-Level Problem

 Same IP rules apply globally under WTO

 No flexibility for local needs

Example:

 Inventors in Uganda or Bangladesh follow same rules as UK or US

Impact on Low-Income Countries

Challenges:

 Limited access to IP protection

 Less innovation commercialization

  Weak legal enforcement

Reality in Low-Resource Settings

 High need for quick solutions

 Frugal innovation is common

 IP infringement often ignored to:

o Reduce cost

o Increase access

o Speed up availability

Ethical Debate

Two viewpoints:

1. Strict IP Protection

 Encourages innovation

 Protects investment

2. Open Innovation Approach

 Encourages sharing

 Faster global access

 Supports low-cost healthcare

Suggested Solutions

1. Financial Support

 Grants for patent filing

 Reduce economic burden

2. Legal Support

 Pro bono IP lawyers

 Simplified legal systems

3. Policy Reforms

 Flexible IP laws for different countries

 Context-specific regulations
4. Public-Private Partnerships

 Government + private collaboration

 Affordable healthcare innovation

5. Open-Source Innovation

 Sharing designs and knowledge

 Encouraging collaboration

 Reducing dependency on patents

Key Insight

 Innovation will continue even without strict IP systems

 Need better balance between:

o Protection

o Accessibility

2. Medical Innovations Register (Treatments of Last Resort)

What is the Medical Innovations Register?

 Part of the Medical Innovation Bill (UK)

 Open-access platform

 Records new or experimental treatments

Purpose

 Help patients with rare or untreatable conditions

 Provide alternative treatment options

 Build clinical evidence

How It Works (Step-by-Step)

1. Standard treatments are exhausted

2. Doctor and patient search for new options

3. Doctor reviews available evidence

 4. Consultation with other doctors

5. Risks and benefits discussed with patient

6. Patient gives consent

7. Treatment is applied

8. Outcomes (positive and negative) recorded

Importance

1. Encourages Innovation in Practice

 Doctors can try new treatments

2. Evidence Generation

 Data collected for future research

3. Transparency

 Both success and failure recorded

IP Issues in This Context

1. Knowledge Sharing vs Protection

 Open sharing of treatment methods

 May reduce patent opportunities

2. Ethical Considerations

 Patient safety vs innovation

3. Data as an Asset

 Clinical data becomes valuable IP

4. Limited Patent Scope

 Many treatments may not qualify as inventions

Key Insight

 Focus is more on patient benefit than strict IP protection

  Promotes collaborative innovation

3. IP in Universities (Case: Imperial College London)

Importance of IP in Universities

 Universities generate:

o Research

o Inventions

o Technology

 Need clear ownership rules

IP Ownership Rules

1. Employees

 IP belongs to the university

 Based on:

o Patents Act 1977

o Copyright, Designs and Patents Act 1988

2. Students

 Students usually own their IP

Exceptions:

 External funding agreements

 Based on existing university IP

 Joint work with staff

 Student is also an employee

3. Associates

 Visiting researchers, collaborators

 May need to assign IP rights to university

Technology Transfer and Commercialization

 University uses specialized units for commercialization

Example:

 Imperial Innovations

Process

1. Innovation created

2. Ownership determined

3. Commercial potential evaluated

4. Patent filed if valuable

5. Licensing or startup creation

Revenue Sharing

 Inventors receive a share of profits

 Encourages innovation

Key Issues in University IP

1. Ownership Conflicts

 Between students, staff, and university

2. External Funding Conditions

 Sponsors may claim IP rights

3. Delay in Commercialization

 Due to legal processes

4. Bureaucracy

 Complex internal procedures

Importance of University IP Systems

 Protect research outputs

 Encourage innovation

 Enable industry collaboration

4. Cross-Context Comparison

Context Key Issue IP Challenge Approach

Low-income Access vs High cost, weak Open innovation,

countries protection systems support

Treatments of last Data sharing,

Patient need Limited patent scope
resort collaboration

Universities Ownership Complex rights Structured policies

5. Relevance to Healthcare Startups (Your Context)

For a healthcare company like Namma Health:

Key Learnings

 Do not rely only on patents

 Consider:

o Trademark for brand

o Copyright for systems

o Trade secrets for processes

Challenges You May Face

 High IP costs

 Partnership ownership issues

 Data protection concerns

 Regulatory barriers

Strategic Approach

 Use mixed IP strategy

 Focus on affordability

 Build partnerships

 Protect key innovations selectively

6. Final Key Takeaways

 IP systems are not equally effective globally

 Cost and complexity limit access in low-income countries

  Healthcare innovation often requires flexible IP approaches

 Universities have structured but complex IP ownership systems

 Open innovation and collaboration are becoming important

 Balance between protection and accessibility is critical

Intellectual Property – Loopholes and

Limitations
1. First Advice to Entrepreneurs

Before rushing into IP protection:

Step Back and Understand Your Innovation

 Clearly define:

o What exactly have you created?

o Is it a product, process, software, or design?

o Is it technical or non-technical?

 Identify:

o What is new?

o What is valuable?

Key insight:

 Not everything needs IP protection

 Only protect what has real business value

2. Focus on Value Proposition

 IP should protect something valuable

 Filing a patent without value is useless

Ask:

 Does this innovation solve a real problem?

  Will customers pay for it?

 Does it give competitive advantage?

3. Capture the Innovation Properly

 Write down your idea in detail

 Break it into:

o Features

o Functions

o Benefits

This helps:

 Understand protection opportunities

 Communicate with IP lawyers

4. Use Multiple Types of IP (Not Just Patents)

Do not depend only on patents. Use a combination:

Patents

 Protect technical features

 Example:

o Chemical composition

o Mechanism

Design Rights

 Protect appearance

 Example:

o Shape of product

Trademarks

 Protect brand name and logo

Copyright

 Protect written or creative content

 Example:
 o Instructions

o Software

5. One Product – Multiple IP Protections

Example:

 A spray product can have:

o Patent for chemical formula

o Patent for mechanism

o Design right for bottle

o Trademark for brand

o Copyright for content

Key idea:

 Strong protection comes from combining IP types

6. Common Pitfalls and How to Avoid Them

Pitfall 1: Lack of Confidentiality

Problem:

 Sharing idea publicly before filing

Impact:

 You lose novelty

 Cannot get patent

Solution:

 Keep idea confidential

 Use NDAs (Non-Disclosure Agreements)

Pitfall 2: Lack of Data

Problem:

 Not enough proof or evidence

Requirement:

 Patent must be reproducible

Concept:

 Sufficiency requirement
Solution:

 Collect strong data

 Ensure others can understand and replicate

Pitfall 3: Filing Too Early

Problem:

 Incomplete data

 Weak patent

Pitfall 4: Filing Too Late

Problem:

 Competitors may file first

 Lose priority

Key Challenge:

 Finding the right timing

Pitfall 5: Focusing Only on Cost

Problem:

 Avoiding IP due to expense

Insight:

 If innovation is valuable, IP is worth investment

Pitfall 6: No Long-Term Strategy

Problem:

 One-time patent thinking

Reality:

 Innovation evolves over time

Risk:

 Patent may not cover final product

7. Importance of IP Strategy
IP is not a one-time activity.

It requires:

 Continuous planning

 Regular updates

8. Dynamic Nature of Innovation

 Products change during development

 Research evolves

 Market needs change

Risk:

 Patent filed today may not match product later

9. Long-Term Planning

Entrepreneurs must:

 Review IP regularly

 Update protection

 Align IP with product development

10. Assign Responsibility

 IP management should be handled by a specific person

 Even if not full-time

Responsibilities include:

 Monitoring innovation

 Managing filings

 Ensuring protection

11. Key Limitations of IP

 Expensive

 Time-consuming

 Requires expertise

 Not all innovations qualify

 Protection is country-specific
  Can become outdated

12. Strategic Approach for Entrepreneurs

Best practice:

1. Identify valuable innovation

2. Keep it confidential

3. Choose right IP types

4. File at the right time

5. Build long-term IP strategy

6. Continuously update protection

13. Key Takeaways

 Do not rush into patenting

 Understand what you are protecting

 Combine multiple IP types

 Maintain confidentiality

 Timing is critical

 Data is essential

 IP requires long-term strategy

 Assign responsibility for IP management

Intellectual Property Case Study

Avastin vs Lucentis

1. Background of the Case

Two drugs:

 Avastin

 Lucentis

Used for:

 Wet Age-related Macular Degeneration (AMD), an eye disease

2. Scientific Similarity

 Both drugs are derived from the same monoclonal antibody

 Both work by:

o Blocking vascular endothelial growth factor (VEGF)

 This helps prevent abnormal blood vessel growth in the eye

3. Key Difference

Lucenti
Factor Avastin
s

Wet
Approved use Cancer
AMD

License for
No Yes
AMD

£50–
Cost per dose £890
£100

4. Why Did the Problem Arise?

 Only Lucentis was officially tested and licensed for AMD

  Avastin was not tested for AMD (only cancer)

However:

 Clinical evidence showed Avastin works equally well

5. What Did Doctors Do?

 Doctors started using Avastin for AMD

 This is called:

o Off-label use (using a drug for a non-approved condition)

Reason:

 Huge cost savings for NHS

 Similar effectiveness

6. Drug Approval Process in the UK

To understand the issue, we must know the process:

Step 1: Clinical Trials

 Test safety and effectiveness

Step 2: Approval by

 Medicines and Healthcare products Regulatory Agency

Checks:

 Safety

 Quality

 Effectiveness

Step 3: Cost Evaluation by

 National Institute for Health and Care Excellence

Checks:

 Cost-effectiveness

 Value for NHS

Step 4: Guidelines by

 General Medical Council

Controls:

 Doctor prescribing practices

7. Where Avastin Failed in Process

 Avastin did not go through:

o MHRA approval for AMD

o NICE cost evaluation for AMD

Reason:

 Manufacturer did not apply for license

8. Main Conflict

Doctors’ Argument

 Avastin is:

o Equally effective

o Much cheaper

 Benefits:

o Saves millions for NHS

o More patients can be treated

 Ethical duty:

o Provide best care within limited resources

Pharmaceutical Industry Argument

Companies involved:

 Roche

 Novartis

Their concerns:

1. Safety

 Repackaging Avastin increases infection risk

2. Regulation

 Avastin not approved for AMD

3. Ethical argument

 Patient safety should not depend on cost

9. Regulatory Confusion

Off-label vs Unlicensed

Off-label:

 Approved drug used for different condition

 Legal with patient consent

Unlicensed:

 Drug not approved at all

 Illegal to use

Problem

 Avastin required repackaging

 Regulators classified it as:

o Unlicensed (not just off-label)

This restricted its use

10. Role of Lobbying

Organizations involved:

 Association of the British Pharmaceutical Industry

Actions:

 Pressured regulators

 Raised safety concerns

 Influenced guidelines

11. Government Intervention

 Government funded clinical trials

 Results showed:

o No difference in effectiveness

o No difference in safety

12. Legal Decision (2018)

 NHS groups won legal case

  Allowed use of Avastin for AMD

Court statement:

 Pharma companies should not control treatment availability

 Public health interest is more important

13. Previous Legal Issue

 Roche and Novartis fined £150 million

 Reason:

o Allegedly restricting Avastin use

14. Key Intellectual Property Issues

1. Strategic Licensing

 Company chooses which indication to license

2. Market Control

 Licensing creates monopoly

 High pricing possible

3. Repurposing Drugs

 New use of existing drug may not be protected

 Creates legal and ethical issues

4. Data Control

 Clinical trial data is controlled by companies

5. IP vs Public Health

 Conflict between:

o Profit

o Accessibility

15. Ethical Issues

 Should cost influence treatment decisions?

  Should cheaper alternatives be ignored?

 Who decides:

o Doctors

o Regulators

o Companies

16. Key Lessons

1. Evidence Alone is Not Enough

 Even strong data may not change practice

2. Power of Pharmaceutical Companies

 Influence pricing and access

3. Importance of Regulation

 Multiple bodies create complexity

4. Need for Policy Coordination

 Government and regulators must align

5. Public Interest vs Private Profit

 Constant conflict in healthcare

17. Relevance to Your Context (India / Healthcare Startup)

 Similar issues may arise:

o High drug costs

o Off-label use

o Regulatory delays

For a startup like Namma Health

Key insights:

 Cost-effective solutions are critical

 Evidence-based decisions are important

  Regulatory navigation is complex

 Partnerships and compliance matter

18. Final Takeaways

 IP can control access to healthcare

 Repurposing innovations creates legal challenges

 Regulatory systems can delay affordable solutions

 Courts may intervene in public interest

 Balance needed between innovation, profit, and access

Frugal Innovation and Intellectual Property

1. What is Frugal Innovation?

Frugal innovation means:

 Using existing technologies in a new way

 Solving problems at low cost

 Maintaining high-quality outcomes

Key idea:

 Not creating from scratch

 Adapting what already exists

2. Common Misunderstanding

Many people think:

  Frugal innovation cannot be protected by IP

Reality:

 This is incorrect

 Frugal innovation can be protected if it meets IP criteria

3. IP Protection in Pharma and Biotech

In healthcare innovation, multiple IP types are used:

3.1 Patents

Used to protect:

 New drugs

 Medical devices

 Technical features

Important insight:

 You can also patent:

o New dosage methods

o New ways of administering existing drugs

This is very important in frugal innovation

3.2 Trademarks

 Protect brand name and logo

 Useful even if product is adapted

3.3 Copyright

 Protect written materials

 Examples:

o Instructions

o Manuals

o Documentation

3.4 Clinical Data as IP

 Clinical trial data is:

 o Confidential

o Valuable

 Used for regulatory approval

 Considered an important asset in pharma

4. Frugal Innovation and Patent Eligibility

Key question:

 Does the adapted product qualify for a patent?

Criteria:

1. Is it new?

2. Is it inventive?

Example

 A normal drill exists

 You modify it for surgical use

If modification includes:

 New feature

 Improved function

Then:

 It may qualify for patent protection

5. Key Principle

Frugal innovation is not equal to “no innovation”

Even small improvements can be protected if:

 They are non-obvious

 They add technical value

6. IP Protection in Frugal Innovation

Same rules apply as regular innovation:

Patent

 For technical improvements

Trademark

 For new brand identity

Design Rights

 For new appearance or structure

Conclusion:

 Frugal innovation can use full IP system

7. Design Protection in Frugal Innovation

If the product:

 Looks different

 Has unique appearance

Then:

 Design rights can be applied

8. Trademark Importance

If you create:

 New name

 New logo

Then:

 Trademark protection is possible

Example:

 Apple

Insight:

 Brand value alone can be extremely high

9. IP in Healthcare Service Innovation

Examples:

 Care pathways

 Service delivery models

  Hospital systems

10. Can These Be Patented?

Generally:

 No

Reason:

 Patents protect technical inventions

 Not business methods or service models

11. Legal Limitation

Under European rules:

 Business models are not considered inventions

So:

 Care pathways are usually not patentable

12. Alternative Protection for Service Innovation

Even if patents are not possible, other IP applies:

Copyright

 Protects:

o Clinical protocols

o Training materials

o Documentation

Trademark

 Protects:

o Brand name of service

o Program identity

13. Strategic Insight

Do not depend only on patents

Use a mix of:

  Patent

 Trademark

 Copyright

 Trade secrets

14. Key Challenges in Frugal Innovation IP

 Hard to prove novelty

 Existing products already available

 Small improvements may be questioned

 Regulatory barriers

 Risk of copying

15. Key Takeaways

 Frugal innovation can be protected

 Patent depends on novelty and inventiveness

 New use of existing product can be patented

 Service innovations are usually not patentable

 Other IP types are equally important

 Trademark and branding are very valuable

 A combination of IP strategies is essential

16. Practical Insight for Healthcare Startups

For a company like Namma Health:

 Focus on:

o Service innovation

o Cost-effective solutions

 Use:

o Trademark for brand

o Copyright for systems

o Trade secrets for processes

 Do not rely only on patents

Compulsory Licensing and Exceptions
1. What is Compulsory Licensing?

Compulsory licensing means:

 A government allows someone else to produce a patented product

 Permission is given without consent of the patent owner

Usually:

 Used to produce generic versions of medicines

2. Legal Framework

Compulsory licensing is governed globally under:

 World Trade Organization

 Agreement:

o TRIPS Agreement

3. Types of Compulsory Licensing

1. Domestic Use

 A country produces a generic drug for its own population

2. Export to Other Countries

 A country produces medicine for another country

 Used when:

o The receiving country lacks manufacturing capacity

4. Key Conditions for Compulsory Licensing

Normally, the following must be met:

1. Attempt Voluntary License

 Government must first try to get permission from patent holder

2. Payment Required

 Patent owner must be paid compensation

3. Limited Use

 Only for specific purpose (e.g., public health)

5. Exception: National Emergency

In emergency situations:

 No need to negotiate with patent holder

 But payment is still required

6. Major Limitations and Loopholes

1. No Clear Definition of “National Emergency”

 Countries decide what qualifies

Examples (possible):

 Pandemic

 Epidemic

 Severe drug shortage

2. No Fixed Rule for Compensation

 “Adequate payment” is not clearly defined

 Leads to disputes

3. Political and Economic Pressure

 Strong countries or companies may oppose it

 Can influence decision-making

4. Legal Complexity

 Process can still be slow

 Requires administrative capacity

7. When Should Compulsory Licensing Be Used?

Compulsory licensing should be considered when:

1. Public Health Crisis

  Life-saving drugs are not accessible

2. High Drug Prices

 Medicines are unaffordable

3. Lack of Availability

 Patent holder not supplying enough

4. Monopoly Abuse

 Patent owner is restricting access

8. What Counts as a National Emergency?

Possible situations:

 Pandemic (example: COVID-19)

 Rapid spread of infectious disease

 Critical shortage of essential medicines

 High mortality conditions needing urgent treatment

9. What is Adequate Payment?

There is no fixed rule, but it should:

 Be fair to patent holder

 Reflect:

o Production cost

o Economic condition of country

o Public health need

Practical View:

 Lower-income countries may pay less

 High-income countries may pay more

10. Does Context Matter?

Yes, context is very important.

In Low-Income Countries:

 Limited healthcare budget

 High need for affordable medicines

 Compulsory licensing is more justified

In High-Income Countries:

 Strong IP enforcement

 More negotiation power

 Less frequent use

In Emergencies:

 Faster decisions

 Public health priority over profit

11. Advantages of Compulsory Licensing

 Improves access to medicines

 Reduces drug prices

 Saves lives

 Supports public health systems

12. Disadvantages

 May discourage innovation

 Reduces incentives for pharmaceutical companies

 Can lead to legal disputes

 Political tensions between countries

13. Balance Between Two Goals

Compulsory licensing tries to balance:

1. Protecting innovation (patents)

2. Ensuring public access to medicines

14. Real-World Relevance (India Context)

 India has used compulsory licensing in some cases

 Focus on:

o Affordable healthcare

o Generic drug production

15. Key Takeaways

 Compulsory licensing allows use of patents without permission

 Used mainly for public health needs

 Governed by TRIPS agreement

 National emergency allows faster action

 No clear rules on emergency or payment

 Context plays a major role

 Balance needed between innovation and access

 Intellectual Property Around the World
– Part I
1. Starting Example: Thomas Edison

 Invented carbon filament for light bulb

 Immediately filed for a patent in the United States

Key idea:

 In high-income countries, innovation is closely linked to patents and

commercialization

2. Changing Nature of Innovation

Historical trend:

 1963: 25% patents by individual inventors

 2003: Around 12%

Reason:

 Growth of corporate research and development (R&D)

3. What is Intellectual Property (IP)?

Defined by:

 World Intellectual Property Organization

Definition:

 Legal rights given for creations of the mind

 Includes:

o Industrial

o Scientific

o Literary

o Artistic work

4. Purpose of Intellectual Property Rights (IPR)

Main Goals:

 Encourage innovation

 Provide financial return

 Protect inventors
How IPR Works:

 Gives temporary monopoly

 Allows recovery of R&D costs

 Encourages investment in innovation

5. Impact of Strong IP Systems

Positive Effects:

 Growth in:

o Biotechnology

o Pharmaceuticals

o Chemical industries

Negative Effects:

 Shift toward corporate dominance

 Small inventors pushed out or absorbed

6. Grassroots Innovation in Low-Income Countries

Characteristics:

 Developed by individuals or small communities

 Based on local needs

 Uses available resources

 Often informal

Motivation:

In high-income countries:

 Profit

 Commercialization

In low-income countries:

 Solve community problems

 Help others

 Improve daily life

7. Differences in Innovation Models

High-Income
Aspect Low-Income Countries
Countries

Motivation Profit-driven Community-driven

Expensive and
R&D Low-cost, improvised
long

Innovation Adaptation of existing

New inventions
type tools

IP
High Low
awareness

8. Challenges Faced by Grassroots Innovators

1. Lack of Awareness

 Many do not know about patents or IP

2. Lack of Access

 Legal and financial barriers

3. Informal Development

 No regulatory framework

4. Risk of Exploitation

 Large companies may copy ideas

9. Role of National Innovation Foundation India

 Supports grassroots innovators

 Helps in:

o Patent filing

o Protection

10. Findings from Study (20 Innovators)

Awareness:
  Only 2 out of 20 knew about IP

Motivation:

 Only 7 motivated by IP protection

Cost Awareness:

 Most unaware of patent costs

Commercialization Impact:

 All 20 said patents did NOT help commercialization

Cost Impact:

 18 out of 20 innovations became more expensive after patenting

11. Why Did Costs Increase?

 Need to modify products for large markets

 Compliance with regulations

 Standardization requirements

12. Major Problem Identified

Patenting led to:

 Higher costs

 Reduced affordability

Result:

 Innovation no longer accessible to target users

13. Key Insight

IPR may:

 Help large-scale innovation

 But harm grassroots innovation

14. Core Limitation of Current IP System

  Designed for:

o Corporate innovation

o Profit-based models

 Not suitable for:

o Community-based innovation

o Low-resource settings

15. Diffusion vs Protection Conflict

Goal of IP:

 Spread innovation

Reality:

 May restrict access

 Slows down dissemination

16. Need for New IP Models

Suggested solution:

 Develop alternative protection systems

These should:

 Fit local needs

 Be affordable

 Encourage sharing

 Protect without increasing cost

17. Key Takeaways

 IP systems favor high-income countries

 Grassroots innovators focus on solving problems, not profit

 Patents can increase costs and reduce access

 Awareness and accessibility are major issues

 Current IP frameworks are not suitable for all contexts

 New, flexible systems are needed

18. Relevance to Your Context (India / Healthcare Startup)

For a company like Namma Health:

 Many solutions may be:

o Frugal

o Community-focused

Strategy Insight:

 Do not blindly patent everything

 Focus on:

o Accessibility

o Affordability

 Use:

o Selective IP protection

o Open innovation where needed

19. Final Thought

 Innovation is not only about profit

 It is also about impact

 IP systems must balance:

o Protection

o Accessibility

o Social benefit