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SpringerBriefs in Biotech Patents

Series Editor
Ulrich Storz, Duesseldorf, Germany

For further volumes:


http://www.springer.com/series/10239

Ulrich Storz Wolfgang Flasche


Johanna Driehaus

Intellectual Property Issues


Therapeutics, Vaccines and Molecular
Diagnostics

123

Johanna Driehaus
Viering, Jentschura & Partner
Duesseldorf
Germany

Ulrich Storz
Patent Attorneys
Michalski Huettermann & Partner
Duesseldorf
Germany
Wolfgang Flasche
Immatics Biotechnologies GmbH
Martinsried
Germany

ISSN 2192-9904
ISBN 978-3-642-29525-6
DOI 10.1007/978-3-642-29526-3

ISSN 2192-9912 (electronic)


ISBN 978-3-642-29526-3 (eBook)

Springer Heidelberg New York Dordrecht London


Library of Congress Control Number: 2012937289
The Author(s) 2012
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Preface

This is the second volume of SpringerBriefs on Biotech Patents. Other than the
first volume, which addressed some fundamental issues of Biotech Patents, this
volume will deal with three commercially important technical disciplines within
the Biotech arena, namely therapeutic antibodies, molecular diagnostics and
peptide vaccines and peptide therapeutics.
Therapeutic antibodies are the fastest growing group of protein therapeutics.
Antibody patents are subject to similar principles as patents related to small molecular
drugs, although some differences apply, particularly with respect to inventive step. The
basics principles for protecting antibody compounds will be discussed. Further, additional ways to create follow-up protection for antibody therapeutics will be discussed.
Another important market relates to Molecular Diagnostics. According to the
latest figures the molecular diagnostic market in the US alone is worth about $2.9
billion, with a predicted annual growth of 15% until 2015, resulting in a volume of
$6.2 billion. This alone justifies a closer look at the relevant patent issues
accompanying these developments. An overview of the patent landscape in
molecular diagnostics is thus provided, and issues of patentability with respect to
the different technologies and compounds used therein are discussed.
Peptide Vaccines and Peptide Therapeutics are increasingly entering into the focus
of pharmaceutical companies. However, peptide patents pose particular problems
which are quite uncommon even for skilled biopatent experts. The peptide section is
intended to give a broad overview of areas of law that are particularly relevant to the
patenting of peptide vaccines and therapeutic peptides as products and in compositions. The scope of patentable subject matter will be discussed, as it has been the focus
of much wrangling and debate in the courts. Further, a comparative look is provided at
how American and Chinese authorities treat peptide-based inventions.
We hope that this volume will be helpful for patent practitioners to be able to anticipate,
or appropriately respond to, problems coming up in the patent prosecution process, and to
develop a suitable patent strategy with respect to these capital intensive technologies.
Duesseldorf

Ulrich Storz
Wolfgang Flasche
Johanna Driehaus
v

Contents

IP Issues of Therapeutic Antibodies . . . . . . . . . . .


Ulrich Storz
1
Introduction . . . . . . . . . . . . . . . . . . . . . . .
2
Compound Protection. . . . . . . . . . . . . . . . .
2.1
Specification by Target . . . . . . . . . .
2.2
Specification by Target-Independent
Functional Properties . . . . . . . . . . . .
2.3
Specification by Epitope . . . . . . . . .
2.4
Specification by Target-Dependent
Functional Properties . . . . . . . . . . . .
2.5
Specification by Sequence . . . . . . . .
2.6
Specification by Deposited Cell Line
or Product-by-Process . . . . . . . . . . .
3
Other Types of Follow-Up Protection . . . . .
3.1
Second Medical Use . . . . . . . . . . . .
3.2
Combination Therapy . . . . . . . . . . .
3.3
Dosage Regimen . . . . . . . . . . . . . . .
3.4
Formulation and Galenics . . . . . . . .
4
New Antibody Formats . . . . . . . . . . . . . . .
5
Antibody Mimetics . . . . . . . . . . . . . . . . . .
6
Conclusion . . . . . . . . . . . . . . . . . . . . . . . .
References . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Peptide Vaccines and Peptide Therapeutics
Wolfgang Flasche
1
Introduction . . . . . . . . . . . . . . . . .
2
Definition of Peptides . . . . . . . . . .
3
Market Overview. . . . . . . . . . . . . .
4
Therapeutic Peptides in Patents . . . .
5
Peptides in Vaccines . . . . . . . . . . .

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vii

viii

Contents

6
7
8
9

Alignment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The Skilled Artisan . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fusion Proteins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Unity of the Invention . . . . . . . . . . . . . . . . . . . . . . . . . . .
9.1
Markush Claims . . . . . . . . . . . . . . . . . . . . . . . . . .
9.2
What About Peptides? . . . . . . . . . . . . . . . . . . . . . .
10 Definitions and Problems Related to Definitions . . . . . . . . .
10.1 Homology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.2 Variants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.3 Analogs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.4 Chemical Modifications . . . . . . . . . . . . . . . . . . . . .
10.5 Decisions of the Board of the Appeal of the
European Patent Office Concerning
Pharmaceutical Active Peptides . . . . . . . . . . . . . . .
10.6 Examples of Specific Problems Related
to Peptide-Related Inventions . . . . . . . . . . . . . . . . .
11 The Situation in the USA . . . . . . . . . . . . . . . . . . . . . . . . .
11.1 Patentable Subject Matter. . . . . . . . . . . . . . . . . . . .
11.2 35 U.S.C. 112, First Paragraph: Written Description
and Enablement . . . . . . . . . . . . . . . . . . . . . . . . . .
11.3 Restriction Practice and Improper Markush
Rejections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11.4 Obviousness . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12 Patenting Peptide-Related Inventions in China . . . . . . . . . .
12.1 Peptide-Related Inventions are Patentable Subject
Matter in China . . . . . . . . . . . . . . . . . . . . . . . . . .
12.2 Novelty and Inventiveness of Peptide-Related
Inventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12.3 Sufficiency of Disclosure Under Chinese Law . . . . .
12.4 Submission of Post-Filing Data. . . . . . . . . . . . . . . .
12.5 Unity of Invention. . . . . . . . . . . . . . . . . . . . . . . . .
12.6 Experimental Use Exemption to Patent Infringement.
13 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Patent Landscape in Molecular Diagnostics
Johanna Driehaus
1
Introduction . . . . . . . . . . . . . . . . .
2
Legal Background . . . . . . . . . . . . .
3
Key Technologies . . . . . . . . . . . . .
3.1
Polymerase Chain Reaction .
3.2
Reverse Transcriptase PCR .
3.3
Real-Time PCR . . . . . . . . .
3.4
Sequencing. . . . . . . . . . . . .

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Contents

3.5
Pyrosequencing. . . . . . . . . . . . . . . . . . . .
3.6
Nucleic Acid Extraction. . . . . . . . . . . . . .
3.7
Recombinant DNA and Molecular Cloning
3.8
DNA Methylation . . . . . . . . . . . . . . . . . .
4
Key Applications. . . . . . . . . . . . . . . . . . . . . . . .
4.1
Infectious Diseases . . . . . . . . . . . . . . . . .
4.2
Cancer-Related Applications. . . . . . . . . . .
4.3
Further Important Patents. . . . . . . . . . . . .
4.4
Laser Microdissection . . . . . . . . . . . . . . .
4.5
Forensics . . . . . . . . . . . . . . . . . . . . . . . .
5
Outlook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6
Considerations Concerning Patent Protection . . . .
6.1
Introduction . . . . . . . . . . . . . . . . . . . . . .
6.2
Biological Compounds. . . . . . . . . . . . . . .
7
Drafting Recommendations Concerning
Molecular Diagnostics . . . . . . . . . . . . . . . . . . . .
7.1
Nucleic Acid Patents . . . . . . . . . . . . . . . .
7.2
Depositing a Cell Line. . . . . . . . . . . . . . .
7.3
Claim Wording . . . . . . . . . . . . . . . . . . . .
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ix

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About the Authors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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