Michela Errico analyses Patentability Requirements on Biomarkers and Diagnostic Methods

1. Patentability Requirements on
Biomarkers and Diagnostic
Methods
Michela Errico, Ph.D
BioCog 7-9-2016 Siena

2. Where We Are
12 Italian Offices
Bologna , Florence, Milan, Modena Parma,
Reggio Emilia, Reggio Calabria, Rimini,
Rome, Udine, Varese, Verona
4 Additional Offices
Munich (Germany)
Alicante (Spain) – OHIM
Republic Of San Marino
Los Angeles (U.S.A.) - European Work
BioCog 7-9-2016 Siena

3. Biomarker - Definition
“a characteristic that is objectively measured and evaluated as an
indicator of normal biological processes, pathogenic processes, or
pharmacologic responses to a therapeutic intervention.”
National Institutes of Health Biomarkers Definitions Working Group
“any substance, structure, or process that can be measured in the
body or its products and influence or predict the incidence of
outcome or disease”
World Health Organization (WHO) and United Nations and the International Labor Organization
BioCog 7-9-2016 Siena
Examples: Metabolites, Gene Mutations; Nucleic Acid
Sequences, Antigens; Proteins.
Biomarkers are - naturally occurring - biological materials!

4. BioCog 7-9-2016 Siena
Biomarker Patentability - US
35 U.S. Code § 101 - Inventions patentable
“Whoever invents or discovers any new and useful
process, machine, manufacture, or composition of
matter, or any new and useful improvement thereof,
may obtain a patent therefore, subject to the conditions
and requirements of this title.”
However, excluded from patentability are inventions
deemed to be “laws of nature” and “natural
phenomena”.
US Supreme Court interpretation on:
•Metabolite Level - Mayo Collaborative Services v. Prometheus
Laboratories, Inc. (2012)
•DNA and cDNA - AMP v. Myriad Genetics (2013)

5. La presentazione integrale è disponibile
a richiesta sul sito Bugnion
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