Illumina, Inc v Premaitha Health Plc

Illumina, Inc v Premaitha Health Plc

The patents in suit (Lo 1, Quake 1/2, Lo 2/3) are not obvious over the cited prior art (Kazakov, Shimkets) and are sufficiently enabled where they claim a principle of general application, except where claims are not entitled to priority due to non-enablement of certain clinical applications. The IONA and Harmony tests infringe the valid claims of the patents as construed, including by indirect detection. The claimants are not exclusive licensees under Lo 1 but are exclusive licensees for commercial purposes under Quake and Lo 2/3. Declarations of non-infringement are granted only in respect of the Additional Alternative Proposed Process for Lo 1.

Parties
Claimant: Illumina, Inc; Claimant: Verinata Health, Inc; Claimant: Sequenom, Inc; Claimant: The Trustees of the Leland Stanford Junior University; Claimant: The Chinese University of Hong Kong; Defendant: Premaitha Health Plc; Defendant: Premaitha Limited; Defendant: TDL Genetics Limited; Defendant: The Doctors Laboratory Limited; Defendant: Ariosa Diagnostics, Inc
Jurisdiction
England and Wales
Judgment Date
21 November 2017
Procedural Posture
Patent Infringement and Validity Proceedings / Judgment After Trial
Outcome
Partially allowed; some claims invalid, others valid and infringed; declarations of non-infringement granted in part.
Legal Topics
Patent Validity, Patent Infringement, Sufficiency, Obviousness, Entitlement to Priority, Added Matter, Exclusive Licence, Non Invasive Prenatal Diagnosis (nipd), Diagnostic Methods, Random Sequencing, Digital PCR
Intellectual Property Patent Law Biotechnology Law Patent Validity Patent Infringement Sufficiency Obviousness Entitlement to Priority +6 more

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Parties

Illumina, Inc

Claimant

Verinata Health, Inc

Claimant

Sequenom, Inc

Claimant

The Trustees of the Leland Stanford Junior University

Claimant

The Chinese University of Hong Kong

Claimant

Premaitha Health Plc

Defendant

Premaitha Limited

Defendant

TDL Genetics Limited

Defendant

The Doctors Laboratory Limited

Defendant

Ariosa Diagnostics, Inc

Defendant

Procedural Posture

Patent Infringement and Validity Proceedings / Judgment After Trial

Legal Issues

  1. 1 Whether the patents in suit are valid and/or infringed
  2. 2 Whether the patents are obvious over prior art (Kazakov, Shimkets)
  3. 3 Whether the patents are sufficiently enabled and entitled to priority

Ratio Decidendi

The patents in suit (Lo 1, Quake 1/2, Lo 2/3) are not obvious over the cited prior art (Kazakov, Shimkets) and are sufficiently enabled where they claim a principle of general application, except where claims are not entitled to priority due to non-enablement of certain clinical applications. The IONA and Harmony tests infringe the valid claims of the patents as construed, including by indirect detection. The claimants are not exclusive licensees under Lo 1 but are exclusive licensees for commercial purposes under Quake and Lo 2/3. Declarations of non-infringement are granted only in respect of the Additional Alternative Proposed Process for Lo 1.

Court Disposition

Partially allowed; some claims invalid, others valid and infringed; declarations of non-infringement granted in part.

Orders

  • Claims 1, 2, 5, 7 of Lo 1 invalid; claim 8 of Lo 1 valid and infringed by Harmony (non-polymorphic) and IONA (sex determination) tests.
  • Quake 1/2 and Lo 2/3 patents valid as amended and infringed by IONA test.