Generics (U.K.) Ltd trading as Mylan and Another v Yeda Research and Development Company Ltd Teva Pharmaceutical Industries Ltd (Third Party)
| Jurisdiction | England & Wales |
| Judge | Mr Justice Arnold |
| Judgment Date | 26 October 2017 |
| Neutral Citation | [2017] EWHC 2629 (Pat) |
| Court | Chancery Division (Patents Court) |
| Docket Number | Case No: HP-2017-000010 |
| Date | 26 October 2017 |
[2017] EWHC 2629 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Rolls Building
Fetter Lane, London, EC4A 1NL
Mr Justice Arnold
Case No: HP-2017-000010
and
Mark Vanhegan QC and Kathryn Pickard (instructed by Taylor Wessing LLP) for the Claimants
Andrew Waugh QC, Thomas HinchliffeQC and Katherine Moggridge (instructed by Bird & Bird LLP) for the Defendant and Third Party
Hearing dates: 10–12, 17 October 2017
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
| Contents | |
| Topic | Paragraphs |
| Introduction | 1–7 |
| Technical background | 8–53 |
| MS | 9–22 |
| MRI | 23–26 |
| Use of MRI in MS | 27–29 |
| Use of disability scores | 30 |
| Causes of MS | 31–34 |
| MS therapies | 35 |
| Disease-modifying therapies | 36–39 |
| Self-injection | 40 |
| Injection-related side effects | 41 |
| Clinical trials of GA | 44 |
| Bornstein 1987 | 45 |
| Johnson 1995 | 46 |
| Comi 2001 | 47 |
| Filippi 2006 (CORAL) | 49 |
| Cohen 2007 (FORTE Phase II) | 50 |
| COMI 2008 (FORTE Phase III) | 51 |
| Mode of action of GA | 52 |
| Pharmacokinetics of GA | 53 |
| The Patent | 54–71 |
| Background to the invention | 55–56 |
| Summary of the invention | 57–58 |
| Detailed description of the invention | 59 |
| Definitions | 60–61 |
| Experimental details | 62–65 |
| Results | 66–68 |
| Discussion | 69–71 |
| The claims | 72–74 |
| The skilled person | 75–78 |
| The expert witnesses | 79–93 |
| Common general knowledge | 94–133 |
| US versus UK Knowledge | 98–99 |
| Side effects of the DMTs | 100–101 |
| Adherence and convenience | 102–111 |
| The 20 mg QD regimen for GA administration | 112 |
| The FORTE trials | 113–127 |
| Work on lower frequency administration of GA | 128–132 |
| New treatments on the horizon | 133 |
| Claim interpretation | 134–144 |
| The law | 134–139 |
| Claim 1 | 140–143 |
| Claim 3 | 144 |
| The prior art | 145–156 |
| Pinchasi | 146–151 |
| Caon | 152–153 |
| Flechter | 154–156 |
| Novelty | 157–173 |
| The law | 157–167 |
| Novelty over Pinchasi | 168–173 |
| Claim 1 | 168–172 |
| Claim 3 | 173 |
| Obviousness over the prior art | 174–190 |
| The law | 174 |
| Obviousness over Pinchasi | 175 |
| Claim 1 | 175–184 |
| Claim 3 | 185 |
| Secondary evidence | 186–188 |
| Caon and Flechter | 190 |
| Lack of inventive step for want of technical contribution and insufficiency | 191–200 |
| Arrow declaration | 200–212 |
| The law | 201–203 |
| Assessment | 204–212 |
| Summary of conclusions | 213 |
Introduction
The Claimants ("Mylan" and "Synthon") seek revocation of European Patent (UK) No. 2 949 335 entitled "Low frequency glatiramer acetate therapy" ("the Patent") of which the Defendant ("Yeda") is the registered proprietor and the Third Party ("Teva") is the exclusive licensee. In addition, the Claimants seek an Arrow declaration. I will refer to the Defendant and the Third Party collectively as "the Defendants". The Defendants counterclaim for threatened infringement of the Patent.
This is the third round of proceedings in this Court between the parties, or some of them, concerning glatiramer acetate ("GA"). The first concerned European Patent (UK) No. 0 762 888 ("888"), the basic patent protecting low molecular weight GA. Mylan applied to revoke 888 and sought a declaration of non-infringement. I rejected the attack on the validity of 888 and refused a declaration of non-infringement ( [2012] EWHC 18438 (Pat)) and the Court of Appeal dismissed Mylan's appeal ( [2013] EWCA Civ 925, [2014] RPC 4). 888 expired on 23 May 2015.
The second round concerned European Patents (UK) Nos. 2 177 528 and 2 361 924 ("924"), which concerned improved processes for the preparation of GA. Synthon applied to revoke both patents. Birss J rejected the attacks on the validity of both patents with the exception of claims 20, 27 and 28 of 924. The Court of Appeal dismissed both Synthon's and Teva's appeals with respect to 924 ( [2017] EWCA Civ 148) and the Supreme Court refused Synthon permission to appeal. On 12 September 2017, however, a Technical Board of Appeal of the European Patent Office revoked 924 in its entirety.
The Patent is directed to a dosage regimen for the administration of GA for the treatment of relapsing forms of multiple sclerosis ("MS") consisting of three subcutaneous injections of 40 mg GA every seven days with at least one day between each injection ("40 mg TIW"). Previously, GA was approved for administration in a regimen consisting of a daily subcutaneous injection of 20 mg ("20 mg QD"). The Claimants contend that the Patent is invalid on the grounds of lack of novelty, lack of inventive step and insufficiency. There is no challenge to the earliest claimed priority date of 20 August 2009.
A fourth round of proceedings is scheduled for trial in April 2018. That concerns European Patent (UK) No. 3,050,556, which is another patent for an improved process for the preparation of GA.
The reason for the current litigation is not hard to find. Teva markets GA under the trade mark Copaxone. Worldwide sales of Copaxone in the year ending 31 December 2016 were about $4.2 billion, representing nearly a fifth of Teva's worldwide sales and a significantly higher percentage of its profits. Since GA has been authorised for administration in accordance with the 40 mg TIW regimen, a large proportion of prescriptions of GA has been written for that regimen. The Claimants have previously introduced a 20 mg GA generic product. Now they wish to clear the way for the launch of a 40 mg GA generic product for which they obtained a marketing authorisation on 5 October 2017 ("the Claimants' Product"). There is no dispute that, if the Patent is valid, the Claimants' intended acts in relation to the Claimants' Product would infringe it.
One measure of the importance of the case to the parties is provided by the fact that the Claimants' closing written submissions extend to 191 paragraphs (plus three annexes) while the Defendants' closing written submissions extend to 306 paragraphs (plus one annexe) even though the issues are, with one exception, fairly straightforward. I have taken all these submissions into account, but it is not necessary or appropriate for me to address every single one in this judgment.
Technical background
Most of the following account of the technical background is based on the primer which was sensibly agreed between the parties. Like the primer, it is expressed in the present tense for convenience, but records the position as at August 2009. I have added sections on clinical trials, injection-related side effects and the pharmacokinetics of GA based on the expert evidence which could usefully have been included in the primer.
MS
MS is a chronic, disabling, neurodegenerative autoimmune disease of the central nervous system ("CNS"). Because diagnosis often coincides with individuals beginning or building a family, as well as with the time of life that may include critical career decisions, education or training, MS can be particularly devastating to family, social and professional relationships as well as adversely affecting a patient's ability to work.
MS is an autoimmune inflammatory condition in which the body's immune system attacks elements of the CNS, namely the insulating myelin sheath in the brain, optic nerve and spinal cord. Immune cells from the periphery enter the CNS and those cells (including lymphocytes) of the immune system mount an immune response against elements of myelin. Myelin is an insulating substance constituted by the cell membrane of a specialised cell known as the oligodendrocyte that surrounds nerve fibres. The myelin sheath is essential for the efficient conduction of nerve signals and provides trophic support to maintain the survival of nerve fibres. In patients affected by MS, the immune-mediated breakdown of myelin ("demyelination") interferes with the conduction of nerve signals and leads to abnormalities including, but not limited to, motor, sensory, cognitive, visual and sphincter-based neurological dysfunction.
Although full details of the cause or causes of MS remain unknown, a tremendous amount about the disease and how the immune system behaves in the CNS has been learned and is now known. There is a significant genetic contribution, and environmental factors also appear to play a role (people living in cold temperate climates are at increased risk which may be due to low vitamin D levels). The timing of certain viral infections may play a role in triggering the onset of MS in susceptible individuals.
Demyelination may occur at various sites within the CNS, affecting movement and sensory functions, as well as in the optic nerves, affecting vision. The symptoms experienced by a patient depend upon the site or sites within the CNS that are affected by demyelination and by the size of the lesions.
Characteristic clinical manifestations of MS include: motor weakness; partial paralysis of the limbs; prickling or tingling sensations on the skin; loss of awareness of the body's position in space; blurred vision or loss of sight; loss of muscle coordination; walking difficulties; cognitive problems and bladder dysfunction.
MS is a chronic condition of varying severity. Some MS patients are minimally affected by the disease, while other affected patients progress relatively swiftly to significant levels of disability. Although every individual will experience a different combination of MS symptoms, a number of distinct patterns relating to...
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