Accord Healthcare Limited v Medac Medac Gesellschaft für Klinische Spezialpräparate Mbh

For obviousness, the skilled person may be a team comprising people from different disciplines where such a team existed in reality and was relevant to the problem addressed by the invention. The court must assess the invention against the single statutory test, having regard to all relevant circumstances and avoiding hindsight. A published study reporting pain from parenteral methotrexate may provide sufficient impetus to optimise injection volume. Where a patent relies on safety as part of the inventive concept, plausibility must be supported by the patent’s technical disclosure. The identity or reputation of the patentee cannot establish plausibility.

Accord sought to clear the way to market a concentrated methotrexate product. Medac’s patent concerned subcutaneous administration of methotrexate at about 50 mg/ml for inflammatory autoimmune diseases, including rheumatoid arthritis. Accord challenged claims 1, 13, 15 and 27 for obviousness over common general knowledge, Jansen, and Russo, and raised insufficiency based on lack of plausibility concerning safety.

The central questions were the identity of the skilled person, whether the claimed formulation was obvious over the cited prior art, whether the claims encompassed embodiments lacking technical benefit, and whether the patent made safety plausible.

1. Skilled team. The patent was addressed to a team comprising a clinician and a formulator. Such a team existed in reality independently of the patent. It was therefore legitimate to assess obviousness from that perspective. The conclusion did not involve hindsight.
2. Obviousness over Russo. Russo disclosed higher-dose parenteral methotrexate for juvenile chronic arthritis and reported pain at the injection site. A skilled team would regard parenteral administration as including subcutaneous administration and would be prompted to develop a subcutaneous formulation for inflammatory autoimmune diseases. It would be obvious to optimise injection volume to reduce pain and to target a small volume such as 0.5 ml.
3. The skilled formulator could readily produce a formulation at about 50 mg/ml to deliver a typical 25 mg dose in approximately 0.5 ml. Concern about local toxicity would lead to verification by testing, but would not deter the team. The team would have a high expectation of success.
4. The secondary evidence, including the absence of an earlier product and the commercial success of Medac’s product, did not overcome the powerful case of obviousness over Russo. The claims therefore lacked inventive step under Patents Act 1977, section 3.
5. The common-general-knowledge-only attack failed because UK clinicians lacked an impetus to address the problem without a concrete starting point. The no-technical-benefit argument also failed on the evidence.
6. The insufficiency issue did not arise for the result. However, had safety concerns materially supported inventive step, the claims would have been insufficient because the patent contained no data, reasoning or information making safety plausible. The patent was invalid and was ordered to be revoked.