Protecting and Enforcing Life Science Inventions in Europe under EPC and EU Law

Franz-Josef Zimmer, Steven M Zeman, Jens Hammer and Klara Goldbach are all Patentanwälte, European Patent Attorney, European Trade Mark Attorney in Munich. Bernd Allekotte is Rechtsanwalt, Attorney at Law in Munich.

Abbreviated Table of Contents:

A. Life Science Matter
A.I. Summary of historical development
A.II. Definition of life science matter
B. Legal Provisions
B.I. European Patent Convention (EPC)
B.II. EU Law (EU Biotech Directive and its Implementation into the EPC; EU Regulations Concerning the Creation of a Supplementary Protection Certificate [SPC] for Medicinal Products [MSPC], Pediatric Extension of Duration for Medicinal Products [PE] and Plant Protection Products [PSPC]; Council Regulation on Community Plant Variety Rights [CPVR]; EU Bolar Directive)
C. General Aspects on Protection
C.I. Protection under the EPC
C.II. Protection under the EU Regulations
D. Protectable Matter in the Life Sciences
D.I. Small Molecules and Polymers
D.II. Nucleic acids
D.III. Proteins
D.IV. Antibodies
D.V. Microorganisms
D.VI. Plants
D.VII. Animals
D.VIII. Human Body
E. Patent Infringement
E.I. Introduction (Pre-Suit Considerations; Cross-Border Issues; General Principles – limited territorial reach; Cross-Border Injunction; Torpedo Actions)
E.II. Scope of Protection (Claim Construction and Literal Infringement; Equivalent Infringement and Purposive Construction; Specific Claim Categories; Product Claims/Compound Claims; Composition claims; Product-by-Process Claims; Second Medical Use Claims/“Off label” Use; Companion Diagnostic Claims; Screening Processes and Reach Through Claims; SPCs; Plant Variety Rights; Effects of the Patent; Issues particular to life sciences; Bolar Provision; Experimental Use; Research Tools ; EU Biotech Directive; Limitations of patent protection available to gene sequences – the Monsanto-decision)
E.III. Enforcement options (Introduction; Cease and Desist Letter; Criminal Proceedings; Border Seizure; Decision on the merits; Bifurcation; Discovery; Preliminary Relief/Preliminary Injunctions)
E.IV. Antitrust Law (Introduction; Sector Inquiry [Pharmaceuticals]; “Pay-for-delay”/Lundbeck decision)
E.V. Unitary Patent and Unified Patent Court (Introduction; Language; Unified Patent Court ; Structure Jurisdiction Transitional Period and “opt out”; Panels ; Sources of Law; Provisional Measures; Parties and their Representation before the UPC; Procedural Issues)

ANNEX (EPC: Articles and Rules concerning Patentability, Biological sequences, Biological deposits, Form of claims; EU Directive 98/44/EC – Biotech Directive; EU Regulations on SPCs [Medicinal products/Plant protection products]; EU and international regulations relating to plant varieties; EU Directives 2001/82/EC [amended] and 2001/83/EC [amended]; Bolar Directives; Register of cited decisions)