Gilead Sciences Inc.

• Jurisdiction: Ireland
• Judge: Mr. Justice Denis McDonald
• Judgment Date: 11 October 2019
• Neutral Citation: [2019] IEHC 683
• Date: 11 October 2019
• Court: High Court
• Docket Number: [2017 No. 6494 P] [2017 No. 2984 P]

[2019] IEHC 683

THE HIGH COURT

COMMERCIAL

Denis McDonald

[2017 No. 6494 P]

[2017 No. 2984 P]

BETWEEN

GILEAD SCIENCES INC.

AND

GILEAD BIOPHARMACEUTICS IRELAND UC

PLAINTIFFS

AND

TEVA B.V. AND NORTON (WATERFORD) LIMITED TRADING AS TEVA PHARMACEUTICALS IRELAND

DEFENDANTS

AND

BETWEEN

GILEAD SCIENCES INC.

AND

GILEAD BIOPHARMACEUTICS IRELAND UC

PLAINTIFFS

AND

MYLAN S.A.S., GENERICS (UK) LIMITED TRADING AS MYLAN AND McDERMOTT LABORATORIES LIMITED TRADING AS GERARD LABORATORIES TRADING AS MYLAN DUBLIN

DEFENDANTS

Supplementary Protection Certificate – Validity – Patent – Plaintiffs claiming that it would be an infringement of a Supplementary Protection Certificate for the defendants to put any product on the Irish market containing a combination of tenofovir disoproxil and emtricitabine – Whether the Supplementary Protection Certificate was valid

Facts: By mid-1996, combination therapy had become the standard method of treatment for HIV infection. A number of different combination therapies were developed over the next number of years including a drug developed by the first plaintiff, Gilead Sciences inc., which was sold under the brand name Truvada which contained two anti-retroviral agents namely tenofovir disoproxil (TD) and emtricitabine (FTC). Truvada had the benefit of a Supplementary Protection Certificate (SPC) granted by the Controller of Patents Designs and Trade Marks under Co. Reg. EEC no. 1768/92 which had since been replaced by Co. Reg. (EC) No. 469/2009 (the SPC Regulation). The SPC was granted on 11th August, 2009 and was due to expire on 20th February, 2020. The SPC was, in turn, based on Irish Patent No. EP 0915894 (the 894 Patent) which expired on 25th July, 2017. The priority date of the 894 Patent was 26th July, 1996. The defendants, Teva B.V. and Norton (Waterford) Ltd trading as Teva Pharmaceuticals Ireland and Mylan S.A.S., Generics (UK) Ltd trading as Mylan and McDermott Laboratories Ltd, were involved in the manufacture and supply of generic pharmaceuticals. The plaintiffs, Gilead Sciences inc. and Gilead Biopharmaceutics Ireland UC, commenced proceedings against the defendants claiming that it would be an infringement of the SPC for the defendants to put any product on the Irish market containing a combination of TD and FTC. The defendants mounted a counterclaim in which they contended that the SPC was invalid. In broad terms, the grounds on which it was claimed that the SPC was invalid was that the combination of TD and FTC was not protected by the 894 Patent. In particular, it was contended that FTC was not identified or specified in the claims of the 894 Patent and, furthermore, that the combination was not part of the invention, the subject of the patent. As a consequence, the defendants both made the case that the combination of TD and FTC was not protected by the 894 Patent for the purposes of Article 3 (a) of the SPC Regulation. The proceedings were originally listed for hearing in 2018. However, they were subsequently adjourned pending the outcome of a reference made to the Court of Justice (CJEU) by the High Court of England & Wales. That reference was made in proceedings taken by (among others) Teva UK Ltd and Generics (UK) Ltd trading as Mylan against Gilead challenging the validity of the UK equivalent to the SPC. The CJEU gave judgment on foot of that reference in July 2018 and thereafter these proceedings were listed for hearing on 30th April, 2019. The hearing was confined to the question of the validity of the SPC. The hearing ultimately concluded on 23rd May, 2019.

Held by the High Court (McDonald J) that the defendants succeeded in relation to the first limb of the Teva v Gilead test. McDonald J held that they also succeeded in relation to the second limb. McDonald J concluded that the counterclaims of the defendants must be allowed in both cases and that the SPC should accordingly be revoked.

McDonald J held that the plaintiff’s case in both sets of proceedings should be dismissed and that he would hear counsel as to the precise form of the orders to be made.

Counterclaims allowed.

JUDGMENT of Mr. Justice Denis McDonald delivered on 11 October, 2019

Table of Contents

Introduction	3
The development of therapies for HIV infection	4
FTC	6
TD	11
The 542 Patent	12
The 894 Patent	12
The claims of the 894 patent	17
The contentions of the parties in relation to Claim 27	19
The Law	21
The extent of protection under national law and the EPC	22
The SPC Regulation	25
The case law of the CJEU prior to Teva v. Gilead	27
Teva v. Gilead	34
The first limb of the Teva v Gilead test	41
The second limb of the Teva v Gilead test	44
Other aspects of the CJEU judgment	49
The decision of Arnold J. in September 2018	50
Further issues raised by the plaintiff in relation to the Teva v Gilead test	50
The skilled person	53
Applying the First Limb of the Teva v. Gilead test	57
The application of the second limb of the test in Teva v. Gilead	66
The plaintiff's contention that HIV is the focus of Claim 27	66
The evidence does not support the plaintiff's contention	67
The terms of Claim 27 are also inconsistent with the standard of care for HIV treatment	72
FTC had not been established to be therapeutic as of the priority date	73
Common general knowledge	77
Conclusion	81

Introduction

1. In recent years, the full horrors of the AIDS crisis have faded from public consciousness. Yet, less than 30 years ago, AIDS was a major public health issue across the world provoking stark public health warnings and attracting widespread media coverage. Millions of people became infected with the HIV virus which causes AIDS. A HIV diagnosis was, in turn, perceived as an almost certain indication that the patient would, in time, succumb to AIDS and suffer an early death. Fatalities from the disease mounted across the world over the course of the 1980s and early 1990s.

2. The outlook for HIV positive patients remained very bleak until the mid-1990s when, thanks to intensive efforts by clinicians, pharmacologists and other experts, combination therapies (as described in more detail below) were developed which proved to be highly efficacious in stalling the progress of the HIV virus. By mid-1996, combination therapy had become the standard method of treatment for HIV infection. A number of different combination therapies were developed over the next number of years including a drug developed by the first named plaintiff in these proceedings which is sold under the brand name Truvada which contains two antiretroviral agents namely tenofovir disoproxil (“TD”) and emtricitabine (“FTC”). One significant practical advantage of Truvada is that the therapy can be administered to the patient in a single formulation taken orally. In that way, the number of individual medications to be taken by a patient can be minimised.

3. Truvada has the benefit of a Supplementary Protection Certificate (“SPC”) granted by the Controller of Patents Designs and Trade Marks (“the Controller”) under Co. Reg. EEC no. 1768/92 which has since been replaced by Co. Reg. (EC) No. 469/2009 (“the SPC Regulation”). The SPC was granted on 11^th August, 2009 and is due to expire on 20^th February, 2020. The SPC is, in turn, based on Irish Patent No. EP 0915894 (the 894 Patent”) which expired on 25^th July, 2017. The priority date of the 894 Patent is 26^th July, 1996.

4. The plaintiffs have commenced both of the above entitled proceedings against the Teva and Mylan defendants respectively claiming that it would be an infringement of the SPC for the defendants to put any product on the Irish market containing a combination of TD and FTC. In this context, it should be noted that the defendants are involved in the manufacture and supply of generic pharmaceuticals.

5. In both sets of proceedings, the defendants have mounted a counterclaim in which they contend that the SPC is invalid. In broad terms, the grounds on which it is claimed that the SPC is invalid is that the combination of TD and FTC is not protected by the 894 Patent. In particular, it is contended that FTC is not identified or specified in the claims of the 894 Patent and, furthermore, that the combination is not part of the invention, the subject of the patent. As a consequence, the defendants both make the case that the combination of TD and FTC is not protected by the 894 Patent for the purposes of Article 3 (a) of the SPC Regulation.

6. The proceedings were originally listed for hearing in 2018. However, they were subsequently adjourned pending the outcome of a reference made to the Court of Justice (“CJEU”) by the High Court of England & Wales. That reference was made in proceedings taken by (among others) Teva UK Ltd and Generics (UK) Ltd trading as Mylan against Gilead challenging the validity of the UK equivalent to the SPC. The CJEU gave judgment on foot of that reference in July 2018 and thereafter these proceedings were listed for hearing on 30^th April, 2019. The hearing was confined to the question of the validity of the SPC. It was agreed by all parties that the evidence in both sets of proceedings would be heard together and that the evidence in each set of proceedings would be admissible in both. The hearing ultimately concluded on 23^rd May, 2019.

The development of therapies for HIV infection

7. Before addressing the legal issues which arise, it may be helpful at this point, to summarise the evidence available to the court in relation to the development of therapies to deal with HIV. The first AIDS cases were described in the United States in 1981. The US Centre for Disease Control (“CDC”) identified a number of opportunistic infections and malignancies that arose when a patient's immune system was significantly impaired and this list was used to define a disease which became known as Acquired Immunity Deficiency...