Regeneron Pharmaceuticals, Inc v Kymab Ltd & Anor [2018] EWCA Civ 671 (28 March 2018)

Regeneron Pharmaceuticals, Inc v Kymab Ltd & Anor [2018] EWCA Civ 671 (28 March 2018)

The Court held that 'in situ replacement' in the relevant patent claims means positional replacement—i.e., the insertion of human gene segments into the position previously occupied by mouse segments, regardless of whether the mouse segments are deleted, displaced, or inactivated. The claims do not require deletion or inactivation. On this construction, Kymab's mice infringe the claims. However, the Court did not disturb the High Court's finding of insufficiency, as the claims could not be performed across their breadth without undue burden at the priority date.

Citation
[2018] EWCA Civ 671
Parties
Appellant in Appeal No: A3/2016/1993; Respondent in Appeal No: A3/2016/1994: Regeneron Pharmaceuticals, Inc; Respondent in Appeal No: A3/2016/1993; Appellant in Appeal No: A3/2016/1994: Kymab Limited; Respondent in Appeal No: A3/2016/1993: Novo Nordisk A/S
Jurisdiction
England and Wales
Judgment Date
28 March 2018
Procedural Posture
Patent Appeal and Cross Appeal / Court of Appeal (civil Division) Judgment on Appeal From High Court (patents Court)
Outcome
Appeal allowed in part; cross-appeal dismissed; patents remain invalid for insufficiency.
Legal Topics
Patent Construction, Sufficiency of Disclosure, Infringement, Biotechnology Patents, Transgenic Animals
Intellectual Property Patent Law Biotechnology Patent Construction Sufficiency of Disclosure Infringement Biotechnology Patents Transgenic Animals

Case Brief

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Parties

Regeneron Pharmaceuticals, Inc

Appellant in Appeal No: A3/2016/1993; Respondent in Appeal No: A3/2016/1994

Kymab Limited

Respondent in Appeal No: A3/2016/1993; Appellant in Appeal No: A3/2016/1994

Novo Nordisk A/S

Respondent in Appeal No: A3/2016/1993

Procedural Posture

Patent Appeal and Cross Appeal / Court of Appeal (civil Division) Judgment on Appeal From High Court (patents Court)

Legal Issues

  1. 1 What is the correct construction of 'in situ replacement' in the relevant patent claims?
  2. 2 Do Kymab's mice infringe the claims as properly construed?
  3. 3 Are the claims invalid for insufficiency?

Ratio Decidendi

The Court held that 'in situ replacement' in the relevant patent claims means positional replacement—i.e., the insertion of human gene segments into the position previously occupied by mouse segments, regardless of whether the mouse segments are deleted, displaced, or inactivated. The claims do not require deletion or inactivation. On this construction, Kymab's mice infringe the claims. However, the Court did not disturb the High Court's finding of insufficiency, as the claims could not be performed across their breadth without undue burden at the priority date.

Court Disposition

Appeal allowed in part; cross-appeal dismissed; patents remain invalid for insufficiency.

Orders

  • The construction of 'in situ replacement' is as per Regeneron's argument (positional replacement).
  • Kymab's mice would infringe the claims as properly construed.