ON APPEAL FROM THE HIGH COURT OF JUSTICE
CHANCERY DIVISION, PATENTS COURT
MR JUSTICE HENRY CARR
Strand, London, WC2A 2LL
B e f o r e :
LORD JUSTICE KITCHIN
LORD JUSTICE FLOYD
| REGENERON PHARMACEUTICALS, INC
||Appellant in Appeal No: A3/2016/1993
Respondent in Appeal No: A3/2016/1994
|- and –
|(1) KYMAB LIMITED
(2) NOVO NORDISK A/S
|Respondent in Appeal No: A3/2016/1993
Appellant in Appeal No: A3/2016/1994
Respondent in Appeal No: A3/2016/1993
Michael Tappin QC and James Whyte (instructed by Powell Gilbert LLP) for Kymab Limited
Hearing dates of the substantive appeal: 17- 20 October 2017
Crown Copyright ©
Lord Justice Kitchin:
Permission to appeal
"any mouse being kept for the purpose of making a mouse which does not infringe European Patent (UK) No. EP 1,360, 287 and/or European Patent (UK) No. EP 2,264,163, provided that any infringing mice used or generated in such programme are not used save for such a purpose and at the end of such programme are destroyed or delivered up in accordance with paragraph [ ]."
Delivery up or destruction
"2. A method of making a human antibody comprising:
(a) exposing a mouse of claim 1 to an antigenic stimulation, such that the mouse produces an antibody against the antigen;
(b) isolating the DNA encoding the variable regions of the heavy and light chains of the antibody;
(c) operably linking the DNA sequence encoding the variable regions of (b) to DNA encoding the human heavy and light chain constant regions in a cell capable of expressing active antibodies;
(d) growing the cell under such conditions as to express the human antibody; and
(e) recovering the antibody."
"any cell engineered to produce antibodies or antibody being kept for the purpose of a medicinal product assessment within the meaning of s.60(6D)-(6E) Patents Act 1977".
i) Products that were made or kept by Kymab in infringement of the 287 patent or the 163 patent, or the progeny of such Products, being in either case products or progeny which are not in the UK but are still in Kymab's possession or control.
ii) Antibodies or cells engineered to produce Antibodies which are (a) derived from Products in the UK, or (b) derived from the Products or progeny referred to in (i) above and which are not in the UK but are within Kymab's possession or control, and in either case the making or keeping of which in the UK would infringe the 163 patent.
iii) (a) Products that were made or kept by Kymab in infringement of the 287 patent or the 163 patent but which are no longer in its possession or control, and (b) the progeny of such Products.
iv) Antibodies or cells engineered to produce Antibodies that are either (a) derived from products in the UK, or (b) derived from the Products (or their progeny) referred to in (iii) above, and in either case the making or keeping of which in the UK would infringe the 163 patent.
Scope of any enquiry as to damages
i) there be an enquiry as to the damages suffered, or at Regeneron's option, an account of the profits made, by reason of Kymab's acts of infringement of European Patent (UK) No. EP 1,360,287 and European Patent (UK) No. EP 2,264,163; and
ii) Regeneron and Kymab be at liberty to apply to the Patents Court for directions in respect of the account or enquiry.
i) Costs of the appeal.
ii) Costs at first instance.
iii) The amount of any interim payment or payments.
Costs of the appeal
Costs at first instance
i) How the costs of the issue of sufficiency should be dealt with.
ii) Novo's position in relation to costs at first instance.
iii) Whether Novo should repay the previous interim award.
Cost below: sufficiency
Costs below: Novo
"[Regeneron] shall pay [Novo]:
(a) its costs of [Regeneron's] discontinued claim for infringement of the Patents, and
(b) 90% of its costs of its counterclaim for revocation."
Return of interim payments
The amount of any interim payment or payments
|Regeneron's costs of the appeal (split 65/35 Kymab/Novo)||1,080,000||702,000||378,000|
|Deduct Kymab's costs in relation to replacement skeleton (for reasons given by Dr Gilbert in her ninth witness statement at paragraph )||(107,574)|
|62% of Regeneron's validity costs below||2,672,200||1,336,100||1,336,100|
|Adjust for infringement costs below payable by Kymab or to Novo, respectively||117,000||(100,000)|
|Interim payment at 50%||1,023,763||807,050|
Stay pending any further appeal, and the terms of any stay
"A. dispose of or remove from the jurisdiction any mice or cells made in infringement of European Patent (UK) No. 1,360, 287 or European Patent (UK) No. 2,264,163 or any antibodies made in accordance with claim 2 of European Patent (UK) No. 2,264,163 or any cells which produce antibodies made in accordance with claim 2 of European Patent (UK) No. 2,264,163.
Save that nothing in this undertaking shall prevent Kymab from disposing of or exporting:
(i) antibodies or mouse serum for the purposes of:
(a) Kymab's collaborations funded by the Bill & Melinda Gates Foundation; or
(b) Kymab's collaborations with the International AIDS Vaccine Initiative and Heptares Therapeutics Limited; or
(ii) antibodies or mouse serum for the purposes of preparing for and conducting pre-clinical or clinical trials; or
(iii) antibody producing CHO cells which may be sent to Kymab's manufacturing CRO Lonza (and which will remain under Kymab's control) solely for the purposes of manufacturing antibodies under GMP conditions for use in pre-clinical or clinical trials;
B. enter into any collaboration or partnership (other than a collaboration funded by the Bill & Melinda Gates Foundation) that would involve the immunisation of mice in the UK made in infringement of European Patent (UK) No. 1,360,287 or European Patent (UK) No. 2,264,163."
Ability to pay
Stay of the order for disclosure