Intellectual Property in Life Sciences

How to effectively patent your sequences

Description

The pace of technological advancements in biotechnology and the application of policy at a local level means that patent protection in this area is a constantly changing dynamic. In this course we join Juliana Melo, IP Lawyer and Craig McAuliffe, Life sciences Product Manager. The course investigates the interaction of science and law, exploring what it means for patenting sequences from a US, EU and global perspective. It includes information on eligibility and sequence listing, plus an assessment of recent case law. It is an advanced level course and takes about 30 minutes to complete.

Duration
This unit has 0 Minutes of videos.

Unit Progress

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Modules
  1. Introduction to sequences in the US and Europe
  2. Basic requirements for patenting sequences
  3. DNA eligibility and sequence listing
  4. Notable case examples
  5. Key learnings and further reading
  6. Quiz

Modules


Module 1

Introduction to sequences in the US and Europe

Duration: 0 Minutes

Completed

In this module, we take a brief look at the science behind sequences in patents and the differences between patentability in the United States and Europe. We investigate the reasons why patents might be granted or rejected. Finally, we will review the regulations that are mentioned in the CFR (Code of Federal Regulations) and the rules from the EPC and how it will affect a decision on where you want to file.

Additional Resources
European Commission 'Biotech Directive'
European Patent Convention - Filing and Requirements
Title 37 of the Code of Federal Regulations
Patentability and Scope of Protection for DNA Sequence-Related Inventions - An Essay by Radoslav M. Milkov
Module 2

Basic requirements for patenting sequences

Duration: 0 Minutes

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This module introduces us to some of the compulsory requirements set down by IP offices in order for an application to be successful. We investigate the SEQ-ID number and disclosure of the DNA sequence, as well as other information that is necessary here. We include an overview of the forms that you will need to complete.

Additional Resources
WIPO ST25 Nucleotide and Amino Acid Symbols and Feature Table
PCT 101 for PCT Applications
Form 1001 Request for grant of a European patent
Form 1200 Entry into the European phase
Module 3

DNA eligibility and sequence listing

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In this module, we dive deeper into what makes DNA eligible for acceptance by an IP examiner and we take another closer look at the SEQ-ID and the numeric identifier.

Additional Resources
WIPO ST25 Nucleotide and Amino Acid Symbols and Feature Table
Module 4

Notable case examples

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This module looks at the details of how these requirements and regulations have played out from a legal perspective, by considering two key cases in particular, namely D’Arcy versus Myriad Genetics and Oncomouse. The former was a milestone case when the Australian High Court ruled definitively that any naturally occurring substance, even if isolated, is not eligible for patenting. Meanwhile, the Oncomouse was a transgenic mouse, meaning it had been genetically modified to make it more susceptible to cancer but the question is, is this patentable?

Additional Resources
Grandmother Yvonne D'Arcy takes on global giant Myriad Genetics
Bioethics and Patent Law: The Case of the Oncomouse
Human Genome Sciences v Eli Lilly - A Little More on the SC judgment
Module 5

Key learnings and further reading

Duration: 0 Minutes

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The final module in this course summarises the key takeaways from this course, as well as providing other tips and tricks and sources of information.

Additional Resources
Genetech, Inc
Publication Site for Issued and Published Sequences (PSIPS)
Patentability and Scope of Protection for DNA Sequence-Related Inventions - An Essay by Radoslav M. Milkov
Webinar: How to Accelerate FTO Searches on Sequences
Test Your Knowledge

When you are ready to complete this unit, take the quiz to see what you remember.

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