Bayer Intellectual Property GmbH & Ors vs Aspire Pharma Limited & Ors

This case concerned Bayer's application for an interim injunction to prevent multiple pharmaceutical companies from selling a generic version of rivaroxaban, a drug used for once-daily administration.

TLDR:

• Bayer sought an interim injunction against several pharmaceutical companies.
• The dispute involved the sale of a generic version of rivaroxaban.
• The court granted the interim injunction to Bayer.

The applicants, Bayer Intellectual Property GmbH, Bayer AG, and Bayer PLC (collectively referred to as 'Bayer'), sought to restrain the respondents from selling a pharmaceutical product with the generic name rivaroxaban for once-daily administration. Bayer owns a patent protecting rivaroxaban, which was due to expire on 1 April 2024. However, Bayer also owns European Patent (UK) No. 1 845 961 ('EP 961'), which covers the use of rivaroxaban for once-daily oral administration and expires in January 2026.

The respondents, including Aspire Pharma Limited, Teva Pharmaceutical Industries Limited, and others, intended to start selling generic rivaroxaban after 1 April 2024. At the trial, six joined claims for revocation of EP 961 were heard, with Bayer counterclaiming for infringement. The trial focused on the validity of EP 961, particularly on inventive step and other grounds.

Judge Hacon, sitting as a Judge of the Patents Court, noted that judgment would be handed down in the first week of the next term, probably on 9 April 2024. The purpose of Bayer's application was to prevent the respondents from launching their generic products during the 9-10 days between the expiration of the compound patent and the potential issuance of a permanent injunction if EP 961 was held valid.

During the hearing, Aspire Pharma Limited consented to an interim injunction, while other respondents resisted. Bayer also sought permission to amend its Part 20 Counterclaim to include additional Bayer companies, which was granted. Additionally, Teva sought to rely on evidence from an economist, Dr. Avantika Chowdhury, which was allowed despite late submission.

The court considered the principles established in American Cyanamid Co v Ethicon Ltd [1975] AC 396, particularly whether there was a serious issue to be tried and the adequacy of damages as a remedy. The court also referenced Neurim Pharmaceuticals (1991) Limited v Generics (UK) Limited [2002] EWCA Civ 370, which highlighted the importance of maintaining the status quo and the potential for irreparable harm due to price wars in the generic market.

Judge Hacon concluded that the short 9-10 day period in question would not cause significant irreparable harm to either party. The status quo, where Bayer had a monopoly on the market, should be maintained. The court granted the interim injunction to Bayer, preventing the respondents from selling generic rivaroxaban until the order following the judgment was made.

Legal representatives: Thomas Hinchliffe KC and Miles Copeland (instructed by Allen & Overy LLP) for the Applicants, James Abrahams KC and Tom Alkin (instructed by Taylor Wessing LLP) for the First Respondent, Justin Turner KC and Jennifer Dixon (instructed by Bristows LLP) for the Second and Third Respondents, Guy Burkill KC and Tim Austen (instructed by Pinsent Masons LLP) for the Fourth to Sixth Respondents, Daniel Alexander KC and James Whyte (instructed by Pinsent Masons LLP) for the Seventh and Eighth Respondents, Henry Ward (instructed by Hgf Law LLP) for the Tenth and Eleventh Respondents.

Judicial Panel: His Honour Judge Hacon

Case Citation Reference: [2024] EWHC 711 (Pat)