Varian Medical Systems International AG v Elekta Ltd and Another
| Jurisdiction | England & Wales |
| Judge | Mr Justice Birss |
| Judgment Date | 06 April 2017 |
| Neutral Citation | [2017] EWHC 712 (Pat) |
| Docket Number | Case No: HP-2015-000046 |
| Court | Chancery Division (Patents Court) |
| Date | 06 April 2017 |
[2017] EWHC 712 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice
Rolls Building
Fetter Lane
London, EC4A 1NL
The Hon. Mr Justice Birss
Case No: HP-2015-000046
Mr Iain Purvis QC and Mr Brian Nicholson (instructed by Bristows LLP) for the Claimant
Mr James Abrahams QC and Mr James Whyte (instructed by Powell Gilbert LLP) for the Defendants
Hearing dates: 27, 28 February 2017, 1, 2, 7, 8 March 2017
Judgment Approved
| Topic | Paragraphs |
| Introduction | 1 – 6 |
| Procedural history | 7 – 9 |
| The issues | 10 |
| Technical background | 11 – 52 |
| The Elekta MR-Linac | 53 – 59 |
| The witnesses | 60 – 73 |
| The skilled team and the common general knowledge | 74 – 81 |
| The Green patent | 82 – 104 |
| Construction/infringement | 105 – 162 |
| Insufficiency | 163 – 278 |
| Obviousness | 279 – 287 |
| Van Vaals | 288 – 313 |
| Shepherd | 314 – 324 |
| Added matter | 325 – 349 |
| Conclusion | 350 – 351 |
| Postscript | 352 |
Introduction
This case concerns patent EP (UK) 0 963 218, entitled "Radiotherapy machine including magnetic resonance imaging system" granted on 8 th June 2005. The patent was filed on 21 st December 1998 claiming priority from a US filing on 19 th December 1997. The inventor is Michael Green and the patent is referred to as the Green patent. The Green patent relates to a combination of a magnetic resonance imaging (MRI) system with a radiotherapy system. The sort of radiotherapy system which is typically used consists of a linear accelerator (Linac) to generate the high energy X-rays used for treatment.
The Claimant, Varian Medical Systems International AG, is the patentee and is a developer of radiation oncology tools. The Defendants, Elekta Limited and Elekta Holdings Limited, provide radiation therapy and radiosurgery equipment. This action is now one of a total of 34 actions before various courts around the world including the United States, Germany and the UK.
Radiotherapy involves the application of a beam of radiation onto a cancerous tumour from various angles. The aim is for only cancerous tissue to suffer a high cumulative dose of radiation, while the surrounding healthy tissue receives as low a dose as possible.
Ideally, the beam must be precisely directed at the tumour for the entirety of the treatment period. In practice, however, this is not achievable. Although the direction of the beam can be fixed, the location of the tumour cannot be. Patients do not remain entirely motionless during treatment and tumours can move within a patient's body either gradually over time or regularly. For example, a lung cancer tumour may move as a patient breathes. It is not possible to see the beam interacting with the tumour and surrounding tissues. As a result, radiotherapy has to be delivered on the basis of earlier acquired anatomical images – such as those obtained with an MRI system — to locate the cancer. It also means that, to account for movement of the tumour, the targeted volume for the radiation has to be increased to ensure that the whole of the tumour is hit. The result is that a substantial amount of healthy tissue may also receive a high dose of radiation, which can have devastating consequences for the patient's quality of life.
In a consortium which includes the Dutch company Philips as Elekta's technical partner and the University of Utrecht, Elekta has been developing a clinical system comprising a Linac and an MRI machine that can operate simultaneously, called the MR-Linac. Currently the MR-Linac is not approved for clinical use, so references to tumours in the context of the MR-Linac's functionality in what follows are references to intended clinical functionality. Using the system, MRI images can be obtained while the patient is lying on the treatment couch and the Linac can be used to deliver the appropriate X-rays to treat the tumour. The MRI system can image the tumour in such a way that the movement of, for example, a lung cancer tumour due to breathing can be tracked. The system has an automatic function whereby the X-ray beam is turned off if the tumour moves more than a certain distance from the target zone of the beam. Turning the beam on and off is called gating. This automatic gating function allows the X-ray beam to be irradiating the patient only when the tumour is directly in the line of fire. This concentrates the beam energy on the tumour. Without this gating the beam would be on all the time with the result that more healthy tissue was irradiated.
Varian alleges that the MR-Linac machine infringes the Green patent because it is able to carry out this gating function. Elekta denies any such infringement and counterclaims for invalidity.
Procedural history
During the course of proceedings, on 13 October 2016 an inspection of Elekta's MR-Linac machines in Crawley was ordered. The inspected machine is referred to as the Crawley MRL-Also in that period Elekta were ordered to provide further disclosure but on 1 December 2016, I found that Elekta were in breach of the disclosure order and an unless order followed.
At the pre-trial review on 13 January 2017, Arnold J held that Elekta had breached the unless order because they served a large quantity of electronic documents on Varian purportedly pursuant to the unless order without having reviewed them to remove irrelevant or privileged material. Arnold J granted Elekta relief from sanctions on the basis that the cases regarding the Green patent's validity and infringement relating to the Crawley MRL-1 proceed to trial, but that the infringement case relating to offers of MR-Linac machines with functionality beyond the Crawley MRL-1 be adjourned to be heard in May 2017.
This judgment concerns the first part of these now bifurcated proceedings — i.e. the questions of the validity of the Green patent and infringement regarding the Crawley MRL-1. The gating function described above is what the Crawley MRL-1 can do. In this judgment I am not concerned with what wider functions of their MR-Linac Elekta may (or may not) have been offering.
The issues
The issues before me in this trial are:
i) Construction. Varian's case is that claims 1, 4, 5, 7, 9 and 11 of the Green patent are independently valid and infringed. There are points on claim 1 and claim 4. No issues of construction arise on claims 5, 7, 9 or 11.
ii) Infringement. Varian assert that the Crawley MRL-1's automated gating function makes it a system as claimed in claim 1 and the coil spacing arrangement makes it a system within claim 4. Elekta deny infringement.
iii) Insufficiency. Elekta contend the patent is insufficient in that the invention cannot be made to work at all or without undue burden.
iv) Obviousness in light of:
a) United States patent US 5,537,452 (Shepherd); and
b) International application WO 9722015 A1 (Van Vaals).
v) Added matter. Elekta contend that claim 1 involves added matter relating to the inputs to the control of the radiation beam and the nature of the control.
Technical background
I am grateful to both parties for providing me with a detailed and helpful agreed Primer setting out the technical background to both MRI and radiotherapy. In order to provide some context to this judgment, I set out below a summary of the key background information.
Radiotherapy
Radiotherapy is the use of ionising radiation from X-rays, gamma rays, neutrons, protons and other sources to kill cancer cells, to shrink tumours, and for other medical uses. Ionising radiation is radiation that has a high enough level of energy to free electrons from atoms. The ionisation damages the DNA of cancerous cells, which in turn can prevent them from replicating and result in cell death. The effects are not specific to cancerous cells: ionising radiation damages DNA in healthy cells as well, although healthy cells are better able to repair DNA damage and so will be relatively less affected by – or at least better able to recover from – the radiation. The aim of radiotherapy is to target the cancerous cells and avoid damaging healthy cells as much as possible. It is this principle that underlies 'fractionation', a method of radiotherapy whereby the treatment is delivered through a number of discrete applications referred to as 'fractions', often given daily over several weeks.
There were various different types of radiotherapy in use at the priority date, which broadly fit into one of two groups: internal source or external source. Internal source radiotherapy can involve placing a small piece of radioactive material temporarily inside the body near the cancerous cells (brachytherapy). External source radiotherapy (which is the subject of this case) involves using radioactive radiation sources (such as Cobalt-60 which produces gamma rays) or electrically powered radiation sources (such as a Linac) outside the body to focus high-energy radiation beams onto the area requiring treatment.
Linacs use high-frequency electromagnetic fields to accelerate electrons to high energies through a linear tube. Most commonly, Linacs are used to deliver X-ray beam therapy. The agreed Primer contained a helpful schematic diagram at figure 6 showing the components of a Linac used to deliver X-ray beam therapy:
The electrons are produced in the first place by heating a metallic filament. They travel through a waveguide containing specially designed metallic chambers spaced at intervals along the waveguide in which the electrons are accelerated by being exposed to pulsing radiofrequency (RF) fields. The pulsed RF fields are produced using microwaves generated by a klystron or magnetron. The RF cavities in the accelerator are shaped...
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