The Nonobvious Invention:
Recognizing the Hallmarks of Patentable
Bio/Pharma Inventions
November 17, 2014
Presented by
Mark J. Feldstein, Ph.D. and Mary R. Henninger, Ph.D.
Entrepreneurship Essentials Seminar Series
Nonobvious Bio/Pharma Inventions
• Chemical species
– New chemical entity
– Salts and purified materials
– Solid forms
– Synthesis
– Intermediates
– Metabolite
• Drug product
– Formulation
components
– Release profile
• Method of treatment
– Dosing
– Special populations
– Regimens
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Nonobvious Bio/Pharma Inventions
• Biologics**
– CDR sequences
– Variable region sequences
– Full length heavy and light chain sequences
• Diagnostics**
– Identifying biomarker
– cDNA
** Claim must be directed to patentable subject matter
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Building Evidence of Nonobviousness
•
Problems with prior art
•
Prior art teaches solutions in a different
direction
•
Long-felt, unmet need
•
Too many possibilities in the art
•
Invention is a success
•
Skepticism
•
Results are unpredictable
•
Invention has unexpected properties
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Hallmarks of Nonobvious Inventions:
• Identifying the problem
– Discovery of unknown issue may frame invention story
• Solving problem was not routine
– Empirical research
– Many failures on the path to unpredictable success
• Improvement in unpredictable properties
– Better properties compared with similar materials or methods
– Interactions between and among components
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Hallmarks of Nonobvious Inventions:
• Overcoming conflicting goals, beyond “optimization”
– e.g., stability vs. dissolution rate
• Unexpected improvements in
– Stability
– Dissolution
– Bioavailability
– Efficacy
• What problem did the invention solve?
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Please contact Mark Feldstein or Mary Henninger for
a complete copy of the presentation
Mark J. Feldstein, Ph.D.
Finnegan, Henderson,
Farabow, Garrett & Dunner, LLP
901 New York Avenue, NW
Washington, DC 20001-4413
Tel +1 202 408 4092
Fax +1 202 408 4400
[email protected]
Mary R. Henninger, Ph.D.
Finnegan, Henderson,
Farabow, Garrett & Dunner, LLP
3500 SunTrust Plaza
303 Peachtree Street, NE
Atlanta, GA 30308-3263
Tel +1 404 653 6558
Fax +1 404 653 6444
[email protected]
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Speaker Information
Mark Feldstein focuses on U.S. district court litigation,
primarily concerning the enforcement of U.S. patent rights
and trade secret issues. He also maintains an active
patent prosecution practice, preparing and prosecuting
U.S. patent applications on behalf of domestic and
international clients.
Mary Henninger practices litigation, patent prosecution,
and strategic counseling relating to biotechnology,
pharmaceuticals, chemicals, and medical and mechanical
devices.
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Disclaimer
These materials have been prepared solely for educational and
entertainment purposes to contribute to the understanding of U.S. and
European intellectual property law. These materials reflect only the
personal views of the authors and are not individualized legal advice. It is
understood that each case is fact specific, and that the appropriate solution
in any case will vary. Therefore, these materials may or may not be relevant
to any particular situation. Thus, the authors, Finnegan, Henderson,
Farabow, Garrett & Dunner, LLP (including Finnegan Europe LLP, and Fei
Han Foreign Legal Affairs Law Firm) cannot be bound either philosophically
or as representatives of their various present and future clients to the
comments expressed in these materials. The presentation of these
materials does not establish any form of attorney-client relationship with
these authors. While every attempt was made to ensure that these
materials are accurate, errors or omissions may be contained therein, for
which any liability is disclaimed.
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