A User’s Guide to Intellectual Property in Life Sciences

Description

DELETE Preface Table of Cases Table of Statutes Table of Statutory Instruments Introduction A decade of change Common intellectual property issues in life sciences Brexit Notes on the text Part I Patents in the Life Sciences: Validity and Enforcement Chapter 1 Requirements for a Valid Patent 1: Novelty Life sciences context General principles Disclosure and enablement Plausibility of the prior art Prior art: made available to the public Prior use KEY ISSUE: Confidentiality and clinical trials Prior art published on the internet Prior art: what has been made available? KEY ISSUE: Novelty and scope of claims Implicit disclosure, inevitability and inherency Selected compounds and parameters KEY ISSUE: Numerical ranges Increased purity and isolation Purpose limited claims Dosage regimes KEY ISSUE: Claims to treating a sub-population Priority Chapter 2 Requirements for a Valid Patent 2: Inventive Step Life sciences context General principles Factors when assessing inventive step Secondary indicia Bonus effects Collocations KEY CASE: 10 obviousness factors – Actavis v ICOS KEY ISSUE: Plausibility obviousness Selection inventions The plausibility threshold – dasatanib T 488/16 Chapter 3 Requirements for a Valid Patent 3: Patentable Subject Matter and Exclusions Life sciences context Industrial applicability KEY CASE: Sequence homology – Human Genome Sciences v Eli Lilly Exclusions KEY ISSUE: Computer programs and computer-implemented inventions Discoveries and scientific theories Mathematical methods and mental acts Business methods Presentations of information Non-patentable subject matter and the Biotechnology Directive Plant and animal varieties and essentially biological processes for their production Microbiological processes ‘Ordre public’ and morality Stem cell-based inventions KEY ISSUE: Methods of treatment and diagnostics Treatment by surgery and therapeutic methods Products used in therapy Chapter 4 Requirements for a Valid Patent 4: Sufficiency Life sciences context General principles KEY CASE: Classic insufficiency and principles of general application – Regeneron v Kymab ‘Hybrid’ claims to a recombinant DNA molecule – Biogen v Medeva A ‘pure’ product claim to escitalopram – Generics (UK) v Lundbeck Consistency with principles in Regeneron v Kymab Inventive improvements Depositing cell lines Reach-through claims Plausibility threshold KEY CASE: Pregabalin for treating pain – Warner-Lambert Plausibility under Articles 56 and 83 of the EPC compared Lack of clarity and uncertainty KEY CASE: Ceric oxide catalyst – Anan Kasei v Neo Chemicals Chapter 5 Patent Infringement 1: Scope of Protection of Claims Life sciences context General principles KEY ISSUE: Doctrine of equivalents KEY CASE: Dipotassium and disodium equivalent – Actavis v Eli Lilly Applying the doctrine of equivalents to a mechanical patent KEY ISSUE: Numerical ranges Taking account of novelty – a Formstein objection? Chapter 6 Patent Infringement 2: Acts of Infringement Life sciences context Direct infringement KEY ISSUE: Offers to supply made before patent expiry Process patents Products made by an infringing process KEY ISSUE: Second medical use claim infringement KEY CASE: Pregabalin – Warner-Lambert Infringement of DNA sequences Indirect infringement KEY CASE: Disposable canister for use in wound dressing treatment apparatus – KCI Licensing Inc v Smith & Nephew Double territoriality Second medical use claims and indirect infringement Common design Unjustified threats Chapter 7 Patent Infringement 3: Defences Life sciences context The Bolar and experimental use exemptions Original Experimental Use Exemption Bolar exemption KEY ISSUE: New Experimental Use Exemption Exhaustion The Gillette defence KEY ISSUE: ‘Arrow declarations’ Prior use Crown use defence De minimis defence Chapter 8 Patent Infringement 4: Remedies Life sciences context General provision of remedies KEY ISSUES: Preliminary injunctions Quia timet Preliminary injunction to appeal Final injunctions Damages, account of profits, or reasonable royalty? Other remedies Publication of judgment KEY ISSUES: Stays and tailored relief in life sciences cases Public interest defence Part II Patent Ownership, Dealings and Litigation Chapter 9 The European Patent System and Obtaining a Patent Introduction to the European Patent Organisation and European Patent Office Drafting strategies for European life sciences patents Prosecuting a patent application in the life sciences Priority at the EPO Chapter 10 Rights in a Patent Life sciences context Invention and ownership Effect on licensee of co-ownership and transfer Chapter 11 Patent Dealings Life sciences context Patent assignment Patent licence Registration Implied licence Competition rules Pay-for-delay Compulsory licences and licences of right Crown use Security over patents Insolvency Chapter 12 Patent Proceedings in the Courts of England and Wales Life sciences context Overview of procedure Timing Commencement and statements of case Case management, security and admissions Disclosure Confidentiality Privilege Evidence Post-trial issues Shortening proceedings Chapter 13 Amendment and Parallel Proceedings in the EPO and the English Courts Life sciences context Claim amendment Parallel EPO and English proceedings Post-trial amendment Chapter 14 Terminating Patent Agreements and Points of Dispute Life sciences context Terminating a licence agreement for breach The absence of termination provisions: common law rights Getting termination right KEY ISSUE: Royalty disputes PART III Other Rights Protecting Life Sciences Subject Matter Chapter 15 Supplementary Protection Certificates Life sciences context Qualifying for an SPC Fundamentals Marketing authorisations ‘Protected by a basic patent’ Resolving what ‘identified / specified’ means The meaning of product Paediatric extensions KEY ISSUE: The manufacturing waiver Chapter 16 Data and Market Exclusivity Rights Life sciences context The 8+2+1 regime New active substances and global marketing authorisations Orphan drugs Chapter 17 Trade Secrets Life sciences context What is a trade secret? The three elements of breach of confidence Remedies Chapter 18 Plants and Genetic Resources Life sciences context Plant breeders’ rights The Nagoya Protocol Chapter 19 Trade Marks, Passing Off, Designs and Copyright Overview Naming of medicinal products Trade marks Passing off Designs Copyright Chapter 20 Exhaustion of Rights, IP Offences and Customs Powers Application to life sciences Exhaustion of rights IP offences Customs powers and procedures Chapter 21 Personal Data – GDPR Rights and Obligations Life sciences context GDPR: General principles and features KEY ISSUE: Clinical trials and health research – selecting a lawful basis KEY ISSUE: Controller and processor roles in clinical research KEY ISSUE: Exemptions and derogations for scientific research Ongoing compliance Coda Brexit The impact of Brexit on EU-derived UK law Does a deal make a difference? Patents Participation in the UPC and Unitary Patent Supplementary protection certificates Data and market exclusivity rights The authority of CJEU case law Appendices Appendix A Patents Act 1977 Appendix B Trade Secrets (Enforcement, etc.) Regulations 2018 Appendix C Intellectual Property (Enforcement, etc.) Regulations 2006 Appendix D Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products Appendix E Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use Appendix F Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products Appendix G European Union (Withdrawal) Act 2018 Index