Sandoz AG & Ors v Bayer Intellectual Property GmbH
[2024] EWHC 796 (Pat)
Teva Pharmacuetical Industries Limited & Anor v Bayer Intellectual Property GmbH
8 December 2023
[2023] EWHC 3276 (Pat)
High Court
Several companies sued Bayer over a drug patent. They wanted to see Bayer's presentation slides from a 2004 conference, believing they showed the patent was obvious. Bayer refused, costing them a lot of money. The judge sided with the companies, saying Bayer should have just handed over the slides. Bayer's refusal to cooperate was deemed unreasonable and they had to pay all the legal costs.
Key Facts
- •Several generic drug manufacturers (claimants) challenged Bayer's patent EP UK 1845961B for rivaroxaban.
- •The claimants alleged obviousness based on prior art (Harder poster).
- •A Bayer scientist, Dr. Roehrig, presented at the ACS Conference (August 2004), identifying the chemical structure of BAY 59-7939 (rivaroxaban).
- •Claimants sought disclosure of presentation slides/handouts from the ACS Conference to demonstrate Bayer's approach to confidentiality.
- •Bayer resisted disclosure, incurring £39,000 in costs.
- •The court considered whether the document was 'mentioned' in a witness statement (PD 57 para 21) and whether disclosure was appropriate under extended disclosure principles (CPR PD 57 para 18).
Legal Principles
A document is 'mentioned' within CPR 31.14 (PD 57 para 21) if there is a direct allusion or specific mention; mere inference is insufficient.
CPR PD 57 para 21, FCA v Papadimitrakopoulos [2022] EWHC 2061 (CH) at [15], Expandable v Rubin [2008] EWCA Civ 59
The court may vary an order for extended disclosure if necessary for the just disposal of proceedings and reasonable and proportionate (PD 57 para 18.1, 6.4).
CPR PD 57 para 18.1, 6.4
The court has a residual power (CPR 3.1(1)(m)) to ensure the overriding objective is met.
CPR 3.1(1)(m)
Outcomes
The court ordered disclosure of the ACS Conference presentation documents.
The document was relevant to the issue of obviousness, its existence was highly likely, and production was easy. While the 'mentioned' test wasn't met, the court found the document disclosable under extended disclosure principles or de novo, considering the overall proportionality and overriding objective.
Indemnity costs were awarded against Bayer.
Bayer's resistance to disclosure was deemed unreasonable and disproportionate, given the ease of production and lack of valid objections.
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