Medimmune Ltd v Novartis Pharmaceuticals UK Ltd & Ors

Factual and Procedural Background

These appeals arise from two related proceedings concerning patent infringement and validity disputes between Company A (formerly known as Company B) and Company C. Company A alleged that Company C infringed European Patents (UK) Nos. 0 774 511 and 2 055 777 (the "777 patent") by selling a product used to treat wet age-related macular degeneration. Company C denied infringement and counterclaimed for revocation of the patents.

The trial judge held both patents invalid on grounds of obviousness and lack of entitlement to priority from the relevant priority document, with the patents also found not to cover the process by which the product was made. Company A was granted permission to appeal but pursued the appeal only concerning the 777 patent. Company C filed a respondent's notice contending additional grounds for invalidity and non-infringement.

In a second action, Company C sought a declaration that a Supplementary Protection Certificate (SPC) granted in respect of the 777 patent was invalid. The judge held the SPC invalid based on the earlier findings and further on the basis that the product was not identified in the relevant claim as deriving from the claimed process. Company A appeals this further finding.

The appeals were heard with assistance from a scientific advisor, Professor Henderson of The University, who provided technical background and advice but did not express opinions on the matters in dispute. After hearing full argument on obviousness and priority, the court upheld the judge’s decision on obviousness and concluded that further argument on other issues was unnecessary.

Legal Issues Presented

1. Whether the 777 patent was invalid for obviousness in light of prior art, including a conference presentation by Professor Smith and the Parmley & Smith publication.
2. Whether the 777 patent was entitled to priority from the relevant priority document.
3. Whether the SPC granted in respect of the 777 patent was valid.

Arguments of the Parties

Appellant's Arguments (Company A)

• The judge erred in finding the patent invalid for obviousness, particularly in distinguishing the Banbury conference presentation from the Parmley & Smith publication.
• The patent was entitled to priority from the relevant priority document because the priority document disclosed the invention including post-phage display derivatisation.
• The judge mischaracterised the skilled team to whom the patent was addressed, contending that a less specialised team could implement the invention.

Respondent's Arguments (Company C)

• The patent was invalid for obviousness based on the Banbury conference presentation and Parmley & Smith.
• The patent was not entitled to priority as the claim extended beyond the disclosure of the priority document.
• The SPC was invalid as the product was not identified in the relevant claim as deriving from the claimed process.
• The skilled team was specialised, involving antibody engineering expertise.

Table of Precedents Cited

Court's Reasoning and Analysis

The court began by identifying the skilled team as a multidisciplinary group specialised in antibody engineering, consistent with real research teams in the field. The common general knowledge included key scientific papers on antibody engineering and phage display techniques.

Regarding obviousness, the court applied the Pozzoli structured test. It found that the Parmley & Smith publication disclosed antigen phage display but did not provide a reasonable expectation of success for antibody phage display, due to concerns about protein size, folding, and infectivity. The skilled team would have been discouraged by Parmley & Smith’s express warnings about insert size and protein breakdown.

By contrast, the Banbury conference presentation by Professor Smith explicitly proposed antibody phage display, addressed anticipated problems with potential solutions, and conveyed a positive, confident message about the experiment’s prospects. The court found that this presentation would have given the skilled team a reasonable expectation of success within a reasonable time, making the invention obvious.

The court carefully considered secondary evidence including Professor Smith’s grant application, his experimental results, and expert witness testimony. Although the project was described as speculative and long-term, the court accepted that the skilled team would have been encouraged to try the method based on Professor Smith’s optimism and scientific analysis.

On priority, the court examined the patent specification and priority document, focusing on whether the priority document disclosed the invention as claimed, particularly the post-phage display derivatisation step. The court concluded that the priority document did not clearly and unambiguously disclose the post-phage display derivatisation without further phage display selection, and thus the patent claim was not entitled to priority.

Overall, the court upheld the trial judge’s findings that the patent was invalid for obviousness and not entitled to priority. The SPC was invalid for corresponding reasons. The court emphasized adherence to the statutory framework and deference to the trial judge’s multifactorial evaluation of obviousness.

Holding and Implications

DISMISSED

The court dismissed the appeal, affirming that the 777 patent is invalid for obviousness and not entitled to priority from the relevant priority document. Consequently, the associated Supplementary Protection Certificate is also invalid. The decision directly affects the parties by upholding the invalidity of the patent and SPC, but does not establish new legal precedent beyond the application of established principles to the facts of this case.