Course overview

In the highly competitive pharmaceutical industry, patent strategies for generic medicines are crucial for success. To successfully bring a generic medicine to market, it is necessary to navigate a complex patent landscape in order to avoid infringing existing patents.

Attending this course will give you a thorough understanding of IP strategies specifically tailored for generic medicines, equipping you with the tools to navigate the complex landscape of pharmaceutical patents and SPCs.

The course will cover how to conduct a robust Freedom to Operate (FTO) analysis to identify and analyse potential patent infringement issues. Drawing on the shared experience of the expert trainers, you will learn to navigate the patent landscape and identify the risks for generic products entering the market.

Acquiring insights into identifying and managing blocking patents, with a focus on when and where to take action, you will understand whether to pursue oppositions or litigation.

It’s crucial to stay updated with the most recent EPO case law, particularly on inventive step as this is the area that has proven to be most successful when challenging patent validity. This will enable you to craft strong arguments for challenging a patent and improve your patent strategy.

Understanding the legal framework surrounding Supplementary Protection Certificates (SPCs) in the EU and UK, will ensure you are fully aware of the specific requirements for these separate IP rights when compared to the patents they are based on. Options for challenging the validity of SPCs based on most recent case law will be explored.

The expert trainers for this course will use case studies and real-world examples to help embed the learning and enhance your practical knowledge. You will leave the course with the understanding and skills to be able to apply these strategies effectively within your own context.

Key topics covered in this course include:

Comprehensive IP knowledge for generic medicines
Freedom to operate (FTO)
Strategic management of blocking patents
Latest legal insights
SPC legal landscape
Practical applications

This course is part of our collection of IP & Patents Training Courses.

Benefits of attending

By attending this course you will:

Get to grips with the process of Freedom to Operate (FTO) analysis, including assessing potential patent infringement risks and understanding issues around data exclusivity
Develop the ability to identify and manage blocking patents
Evaluate whether to pursue oppositions at the EPO or seek revocation of a patent at the new Unified Patent Court (UPC)
Gain up-to-date knowledge on EPO case law concerning inventive step, and on emerging UPC case law, and how such arguments can be used to challenge the validity of patents
Understand the legal intricacies and case law of Supplementary Protection Certificates (SPCs), including strategies to challenge their validity
Learn how to implement these IP strategies in the context of generic medicines, ensuring such products can effectively compete in the pharmaceutical market

Who should attend?

This course has been specially designed for professionals in generic medicines, including:

In-house IP and patent lawyers and legal advisers
Private practice patent lawyers
IP managers/professionals
Senior patent administrators and paralegals
Other professionals responsible for managing a patent portfolio

Enrol/reserve

This course will cover:

Freedom to operate

What is ‘Freedom to operate’ analysis?
Data exclusivity
Assessing patent infringement
Watch out for potential specific patent issues around the following:
- Stereochemistry
- Polymorphs
- New formulations
- Process patents
- Methods of use patents

Problem patents – assessing and managing blocking patents

Oppositions at the European Patent office (EPO)
Litigation at the Unified Patent Court (UPC)
Oppositions versus litigation – factors in deciding on strategy
Where to take action? When to take action?
Successful strategies from case law

The latest updates from EPO case law: Inventive step

EPO problem-solution approach to assessing inventive step
Developing arguments for lack of inventive step
Impact of emerging UPC case law

Supplementary Protection Certificates (SPCs)

The EU legal framework
The UK legal framework

Exploring the validity of SPCs - lessons from the case law

Questions that arise under Article 3?
Same or different - EU and UK?

Other aspects arising from SPCs

Paediatric extensions
Manufacturing waiver
Regulatory exclusivities

Enrol/reserve

Marie Walsh
HGF

Marie Walsh is a European Patent Attorney and Chartered (UK) Patent Attorney with over 25 years of experience in advising clients including start-ups and SME’s to large corporations. She has worked across a number of technology areas and specialises in industrial chemistry, materials science, polymer chemistry, and pharmaceutical chemistry. Marie also has in-depth experience in obtaining Supplementary Protection Certificates (SPCs).

Marie has a strong focus on providing commercially relevant, pragmatic advice based on individual clients’ goals. She has an MBA from the Open University which supports her commercially focused approach to advising on IP strategy.

Marie is based in Dublin, Ireland and has worked with clients across the globe, including firms in Ireland and the UK, as well as US and Chinese clients and her objective is on clear communication with the clients’ commercial aims as the central focus. Marie has previously worked with another leading firm of patent attorneys in Ireland where she had the role of Director of Operations for China and Chief Representative of the local China office.

She also has extensive experience of providing opinions and advising in relation to freedom to operate (FTO). In addition, she has represented clients at Oppositions and Appeals at the EPO and achieved successful outcomes for clients.

More details

Lawrence Cullen

After a long career at the UK Intellectual Property Office (IPO), Dr Lawrence Cullen recently established his own consultancy to provide advice and develop his interests in IP, especially in the role and relevance of SPCs.

From 2007 to 2024, Dr Cullen was the Deputy Director at the Intellectual Property Office (IPO) in the UK responsible for the patent examination teams in the fields of pharmaceuticals, organic chemistry and biotechnology. He also led the team responsible for the examination and grant, or refusal, of supplementary protection certificates (SPCs) at the IPO. This included the development of UK practice in relation to SPCs and keeping the IPO Manual of Patent Practice chapter on SPCs up to date.

Dr Cullen has a wide experience dealing with questions of validity in the patent and SPC fields. As a hearing officer at the IPO, he was directly involved in over 50 patent cases across all areas of technology including computer implemented inventions as well as biotechnology and pharmaceuticals. In addition, he decided over 25 SPC cases before the IPO gaining a wide experience of UK and EU law in this area. He also has extensive experience of dealing with appeals before the UK courts and, prior to 31 December 2021, referrals to the Court of Justice of the European Union (CJEU).

Dr Cullen gained his BSc in Industrial Chemistry in Ireland and his PhD in organic chemistry in UK. He worked as a research scientist at various universities in Europe, USA and UK before joining the UK-IPO to embark on his career in IP.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

27 February 2025

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 15485

GBP 599 699
EUR 839 979
USD 963 1,119

Until 23 Jan

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

10 June 2025

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 15486

GBP 599 699
EUR 839 979
USD 963 1,119

Until 06 May

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

21 October 2025

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 15487

GBP 599 699
EUR 839 979
USD 963 1,119

Until 16 Sep

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.