The High Court has ruled that Teva did not need leave to amend its statement of opposition to proposed changes to a patent owned by Boehringer Ingelheim Pharma GmbH & Co KG. The court said the patent amendment application was a separate process from Teva’s earlier application to revoke the patent, and that pleadings did not govern the objections the court must consider in deciding whether amendments are proper.
Teva had sought leave as a precaution to add objections concerning proposed amended claim 6 and claims dependent on it. It said the claims lacked support in the patent application as filed and involved added matter. The proposed objections relied on evidence from Professor Buckton, including material concerning a UK Intellectual Property Office objection to a similar claim, and a report from Dr Kelly, a European patent attorney and registered Irish patent agent.
The judgment noted that the court had already refused Teva’s application to revoke the Irish designation of European Patent No. 1379220, entitled “Inhalation Capsules”. That earlier decision dealt with revocation; the patent amendment application remained to be heard. The court said its earlier findings in the revocation proceedings did not restrict its consideration of the separate amendment application.
Boehringer opposed Teva’s request, arguing that the new challenges went beyond the objections already pleaded. The court reviewed the parties’ correspondence and the handling of evidence at the earlier hearing. It concluded that the parties had understood that evidence and submissions on the amendment application would be dealt with separately, and rejected the contention that all evidence on that issue had already been given.
The court held that the rules do not require pleadings setting out objections to a patent amendment application. Under the Patents Act, the patent owner must satisfy the court that proposed amendments are appropriate and lawful. The court also said that, even if leave were required, the liberal approach to amendments of pleadings would support allowing Teva’s proposed changes, with no prejudice to Boehringer identified.
The court therefore ruled that leave was not required. It added that, without affecting that conclusion, leave could be granted if Teva still wanted it. The judgment did not decide whether Boehringer’s proposed patent amendments should be allowed; that application remained for determination.