MDC Connects 2024: Webinar 4/5

Cost-effective IP strategies: spotting novelty in your inventions Dr Catrina Carroll

Why is Intellectual Property Important?

Protection

Business Growth

Brand Identity

Safeguards innovations from unauthorised exploitation and use

Can help create new revenue streams

Protection of distinctive logos, names & designs

Differentiation

Valuation

Sets products apart from competitive offerings

A critical component of your company's valuation

© 2024 Medicines Discovery Catapult. All rights reserved.

EXCELLENCE

INTEGRITY

COMMUNITY

INNOVATION

Different Types of IP Protection

PROTECTION

REGISTRATION

COSTS

PATENT

20 years from the filing date

yes

expensive

TRADEMARKS

Perpetual if reregistered

optional

inexpensive

DESIGN RIGHTS

At least 10 years (country-specific)

yes

inexpensive

COPYRIGHTS

Life of author +70 years

optional

inexpensive

TRADE SECRETS

Confidentiality

no

depends

DATA

Confidentiality

no

depends

© 2024 Medicines Discovery Catapult. All rights reserved.

EXCELLENCE

INTEGRITY

COMMUNITY

INNOVATION

Patentability: Conditions for Patent Eligibility

Novel

Invention has not been previously made public in any form, in any territory, before the patent application is filed.

Non-Obvious

The invention should not be obvious to someone with knowledge and expertise in the feild. (i.e., research assistant level)

Utility

The invention must have some industrial application and you need evidence to show that it could be used.

Other important considerations include inventorship, ownership, and freedom to operate. © 2024 Medicines Discovery Catapult. All rights reserved.

EXCELLENCE

INTEGRITY

COMMUNITY

INNOVATION

Cost-Effective Patenting: Mastering Patent Databases & Prior Art Searches

WIPO Patentscope

Access to international Patent Cooperation Treaty (PCT) applications in full text format on the day of publication, along with a powerful search engine to navigate patents from multiple jurisdictions. Can search chemical structures.

Global Dossier

Provided by the five major Intellectual Property Offices (IP5), facilitates the sharing and access to dossier information of patent families, streamlining the examination process and promoting transparency in the global patent system.

Google Patents

Google Patents includes over 120 million patent publications from 100+ patent offices around the world, as well as many more technical documents and books indexed in Google Scholar and Google Books, and documents from the Prior Art Archive

© 2024 Medicines Discovery Catapult. All rights reserved.

EXCELLENCE

INTEGRITY

COMMUNITY

INNOVATION

Steps to Refine your Patent Searches START

Keyword searches

AND/OR

Classification based searches

AND/OR

Patent assignee (owner), inventor, country, date search

Initial list of patents

Repeat search with additional and/or alternative search terms

Read patent abstracts Filter Read patent claims to understand scope of what is protected

Filter Final list of relevant patents

Reproduced from the WIPO publication Using Inventions in the Public Domain: A Guide for Inventors and Entrepreneurs (2020) © 2024 Medicines Discovery Catapult. All rights reserved.

EXCELLENCE

INTEGRITY

COMMUNITY

INNOVATION

Using AI to Help Build your Search Criteria

Be CAREFUL as what you put in the chat is a public disclosure!

© 2024 Medicines Discovery Catapult. All rights reserved.

EXCELLENCE

INTEGRITY

COMMUNITY

INNOVATION

Freedom-to-Operate

Determines if producing, marketing, or selling a product infringes on the IP rights of others.

Focus on active (pending & granted) patents and their claims to ensure commercial activities do not infringe on others' IP rights.

Conduct searches in relevant jurisdictions where you are commercially active.

Set up alerts to constantly monitor your FTO status & take proactive steps.

© 2024 Medicines Discovery Catapult. All rights reserved.

EXCELLENCE

INTEGRITY

COMMUNITY

INNOVATION

Using Global Dossier to Monitor Patent Examination Proceedings

Monitor pending patents for FTO risk Using global dossier you can view the examination proceedings, including the cited prior art, examiner's objections and amended claim sets, for patents that pose a potential Freedom to Operate (FTO) risk. This insight allows you to assess the strength and scope of the pending claims, understand the legal arguments made, and potentially identify vulnerabilities or limitations in the patent that could inform your FTO strategy.

© 2024 Medicines Discovery Catapult. All rights reserved.

EXCELLENCE

INTEGRITY

COMMUNITY

INNOVATION

Final Tips

• Stay Informed: Regularly monitor patent landscapes in your field to stay updated on new filings and granted patents that could impact your FTO and patentability assessments.

• Engage Early: Conduct preliminary FTO and patentability searches as early as possible in the product development process to identify potential IP barriers and opportunities.

• Utilise Professional Services: Consider consulting with IP professionals for complex analysis and legal opinions on FTO to ensure informed decisions and risk mitigation.

• Document Your Process: Keep detailed records of your FTO and patentability search processes, findings, and decision-making rationale to support future legal and strategic decisions.

• Plan Strategically: Use insights from your FTO and patentability analyses to inform strategic business decisions, including product design, market entry strategies, and IP filing priorities.

© 2024 Medicines Discovery Catapult. All rights reserved.

EXCELLENCE

INTEGRITY

COMMUNITY

INNOVATION

Q&A Speak to us or follow up with a question on email to info@md.catapult.org.uk

© 2020 Medicines Discovery Catapult. All rights reserved.

IP for Investment Readiness

Medicines Discovery Catapult Connects 5th March 2024 Anis Naidu (Senior Associate - European & UK Patent Attorney)

Summary Preparing for IP due diligence is critical when trying to secure inward investment. The following will be checked: • Ownership • Coverage • IP territories versus key markets • Freedom to Operate (FTO)

© 2024 Marks & Clerk LLP | Marks & Clerk is a registered trade mark.

IP Due Diligence • Typically involves institutional investors / corporate investment teams (e.g. Big Pharma) as well as grant funding bodies.

• Level of scrutiny applied is normally commensurate with the size of the investment.

• Looking for an IP strategy that speaks to the value proposition - checking whether the crown jewels are protected.

• Carefully control your confidential information during the due diligence process.

© 2024 Marks & Clerk LLP | Marks & Clerk is a registered trade mark.

© 2024 Marks & Clerk LLP | Marks & Clerk is a registered trade mark.

Ownership & Collaborations • Who is an inventor and who owns the IP? • Record details of meetings, experiments and discussions to help determine inventors.

• Ownership usually passes from the inventors to the employer (University) automatically.

• Employment contracts and assignments will be reviewed.

• Ensure collaboration agreements are executed when working with external parties (e.g. joint ventures).

• Careful using contractors and consultants (e.g. CROs and product design agencies).

Coverage - do you know which IP rights to use?

IP by virtue of the law Patents Trade marks Registered design rights

Registration required

Copyright Design rights

Automatically exist

Knowledge-based IP Know how Trade secrets

© 2024 Marks & Clerk LLP | Marks & Clerk is a registered trade mark.

Others

Patent Coverage • Patent claims cover the product / candidate?

Candidate covered

• How broad are the patent claims?

• Are there any problematic prior art disclosures?

Prior art Patent scope

• Strength / defensibility of patent claims?

• Is the pipeline covered by patent portfolio?

© 2024 Marks & Clerk LLP | Marks & Clerk is a registered trade mark.

Product / candidate

R

Technical field

Patent Coverage • Patent claims cover the product / candidate?

Candidate covered

• How broad are the patent claims?

• Are there any problematic prior art disclosures?

Prior art Patent scope

• Strength / defensibility of patent claims?

• Is the pipeline covered by patent portfolio?

© 2024 Marks & Clerk LLP | Marks & Clerk is a registered trade mark.

Product / candidate

R

Technical field

Patent Coverage • Patent claims cover the product / candidate?

Claims too broad

• How broad are the patent claims?

• Are there any problematic prior art disclosures?

Prior art Patent scope

• Strength / defensibility of patent claims?

• Is the pipeline covered by patent portfolio?

© 2024 Marks & Clerk LLP | Marks & Clerk is a registered trade mark.

Product / candidate

S

Technical field

Patent Coverage • Patent claims cover the product / candidate?

Narrow claims

• How broad are the patent claims?

• Are there any problematic prior art disclosures?

Prior art Patent scope

• Strength / defensibility of patent claims?

• Is the pipeline covered by patent portfolio?

© 2024 Marks & Clerk LLP | Marks & Clerk is a registered trade mark.

Product / candidate

R

Technical field

Patent Coverage • Patent claims cover the product / candidate?

Candidate not covered

• How broad are the patent claims?

• Are there any problematic prior art disclosures?

S

Technical field Patent scope

• Strength / defensibility of patent claims?

• Is the pipeline covered by patent portfolio?

© 2024 Marks & Clerk LLP | Marks & Clerk is a registered trade mark.

Product / candidate Prior art

IP Territories versus Key Markets • Patents are territorial rights – are patent rights filed in the key markets?

• Where are the patient populations, generic manufacturers, distribution hubs, clinical trials?

• Are your patent rights easily enforced?

• What are the patent filing, examination and maintenance costs?

© 2024 Marks & Clerk LLP | Marks & Clerk is a registered trade mark.

Freedom To Operate Analysis • Surveying the patent landscape to avoid being sued for infringement of patent rights owned by third parties.

• Multiple steps to the analysis: • Search for the relevant patent rights (granted + pending in your markets).

• Review the claims of the relevant patent rights – not the abstract!

• Traffic light analysis to establish risk level for each patent.

• Do you have a plan to clear potential obstacles: • Negotiate a licence.

• Challenge the validity of the third party patent.

• Design around.

• Monitor your competitors’ patent rights and top-up your analysis frequently – proactive approach!

© 2024 Marks & Clerk LLP | Marks & Clerk is a registered trade mark.

© 2024 Marks & Clerk LLP | Marks & Clerk is a registered trade mark.

Questions?

• Click to edit Master text styles ○ Second level § Third level • Fourth level ○ Fifth level

Anis Naidu

IP Protection Strategy: University Technology Transfer Office Perspective Geraint Lewis, Head of Enterprise Services geraint.lewis@newcastle.ac.uk From Newcastle. For the world.

What drives us to seek IP protection?

Pathway to “Impact”

From Newcastle. For the world.

26

Developing an IP strategy that provides support for the business model In the “Assessment” Phase of the Invention Disclosure: 1. Identify the business model and business objectives.

- This will help to determine the IP & technology strategy to help achieve those goals.

2. Understand the industry sector(s) and competitors.

- Important to understand how our invention compares and what is the value proposition - Identify the IP strategies (what are companies filing and where?).

3. Assess the intellectual assets in the invention.

- We are trying to identify IP assets to determine which ones may be most valuable to the business.

- Can we patent the valuable IP assets (novel, inventive, freedom to operate).

4. Make the decision about which key assets to seek IP protection.

- This includes considering the potential revenue that these assets could generate through licencing, or provides a competitive advantage to a university spin-out.

- Carefully consider the timing of seeking IP protection considering the likelihood of needing to undertake further technical development and how that can be resourced.

From Newcastle. For the world.

27

What Happens When the University Files a Patent

•

Extra time is given (18 months, compared with not using the PCT) to investigate the commercial possibilities of the invention and further technical de-risking of the invention.

•

University TTOs utilise schemes such as ICURe, Impact Acceleration Accounts, Confidence in Concept, DPFS, Follow on Funding etc to de-risk the IP.

•

At National Phase (30/31 month) we are very selective in which territories because of costs.

From Newcastle. For the world.

28

Our Approach to IP Strategy

Summary • Closely align IP creation, portfolio maintenance and exploitation with relevant business objectives.

• Maximises value creation and capture by ensuring the ‘right’ and “necessary” IP is protected.

• Some of university patenting is reactive rather than strategic, in that patent filing tends to be considered only when a public disclosure is near and universities are often forced to file before optimal experimental support or market pull is understood.

From Newcastle. For the world.

29

Technology Transfer of IPRs from the University to Industry FINDING AND ACCESSING UNIVERSITY TECHNOLOGY

• Personal contacts between university inventors and industry as the most important source of successful university tech transfer, usually between an industry’s R&D staff and university personnel • Patent searches, publications and online marketing resources - Universities advertise their IPR e.g. University website, IN-Part, Konfer, Edge Only

Leading

• Direct contact from or to the Technology Transfer Office (e.g. https://www.ncl.ac.uk/businessand-partnerships/contact-us/) • Prepare your business plan/commercialisation plan of the technology.

From Newcastle. For the world.

30

Finish

From Newcastle. For the world.

Thank you Speak to us or follow up with a question on email to info@md.catapult.org.uk

© 2020 Medicines Discovery Catapult. All rights reserved.