Drafting Effective Pharmaceutical Patents Training Course

Course overview

The highly complex area of pharmaceutical patents is looked at in detail in this course. The expert faculty will take you through the key differences between the European and US systems and how these can impact your patents. They will explore the latest strategies and give you useful insights and practical solutions to your drafting issues. By understanding the importance of aligning your patent and regulatory strategies, you will improve your pharmaceutical claim drafting skills to the best advantage.

The practical claim drafting exercises included in the course will give you an opportunity to get to grips with the information in a safe environment and under the guidance of the trainers. They will help embed what you have learnt so that it can be taken back to the workplace and put into practice. As well as receiving inside knowledge and top tips and advice from the highly experienced professionals from industry and private practice, the course also provides a valuable opportunity to network with others in similar roles from different companies. By attending, you can discuss your challenges with colleagues and our expert faculty and find solutions to your questions.

Key topics covered in this intensive training programme include:

• Drafting primary patents and secondary patents
• Key differences between drafting for Europe versus the US
• Claim drafting strategies for antibodies and other biologics
• Drafting claims that ‘follow the label’
• Drafting patent applications with sufficient supporting data – how much is enough?
• Aligning your patent strategy with regulatory issues

Who should attend?

• Patent attorneys
• In-house lawyers
• Private practice lawyers
• Patent agents and consultants

Summary of the course

• Overview of the programme
• Patentability basics

Drafting primary patents – small molecules

• Protecting pharmaceutical compositions
• Protecting methods of treatment
• Protecting medical use claims (first, second and Swiss-type)

Drafting primary patents – biologics

• Drafting sequence disclosures
• Protecting antibodies, stem cells and microorganisms
• Drafting generic and species claims
• Drafting functional claim language
• Protecting gene therapy inventions

Primary patents workshop

• Selection inventions
• Drafting claims for infringement
  • Distilling down the invention disclosure
  • Patenting later developments
• Practical examples and drafting exercises

Drafting with a focus towards interplay with regulatory issues

• Patent term extension and SPCs
• Regulatory issues and data protection – drafting to ‘follow the label’
• The ANDA litigation process and enforcement of listed patents
• Overlay of patent protection with FDA exclusivity – the FDA Orange Book
• Strategies for protecting biologics

Data needed to support patent applications

• What data must be included?
• When must the data be included?
• Consideration of post-filing date data
• US written description
• The importance of correct data – avoiding inequitable conduct

Secondary patents

• Protecting dosage regimes, modes of administration, patient groups
• Protecting polymorphs (crystals, enantiomers, salts)
• Protecting metabolites
• Protecting new formulations
• Protecting process patents
• Protecting methods of diagnosis and surgery

Secondary patents workshop

• Establishing patentability: inventive step vs non-obviousness
• Strategies for using post-filing evidence
• Practical examples and drafting exercises