Novartis AG v Generics (UK) Ltd (t/a Mylan)

Factual and Procedural Background

This is an appeal against the judgment of Judge Floyd dated 30 September 2011 and his subsequent order of 20 October 2011 revoking Supplementary Protection Certificate SPC/GB98/038 ("the SPC") and its basic patent, UK Patent No. 2,203,040, on the basis that claims 1 to 9 of the patent were invalid. The SPC and patent are owned by the Appellant, Company A, protecting a drug used for the treatment of Alzheimer's disease. The Appellee, Company B, sought revocation of the SPC and claims in order to market a generic version of the drug, accepting that it falls within the product and process claims of the patent. The trial focused solely on the validity of the patent claims.

The disputed drug is the (-)-enantiomer of a racemic compound disclosed in two prior publications by a research team led by a scientist at The University. The prior publications disclosed the racemic compound as RA7 but did not suggest resolving it into individual enantiomers. The key issue was whether, in light of these prior publications, it would have been obvious to a skilled pharmaceutical team to select RA7, resolve it into its enantiomers, and use the (-) enantiomer as a medicinal product for Alzheimer's disease.

The trial judge concluded that deciding to resolve and test RA7 for advantages or disadvantages of its enantiomers was not inventive, and that a pharmaceutical composition comprising rivastigmine was conceptually obvious. Consequently, the narrowest patent claim was invalid for lack of inventive step. The Appellant contended the judge erred in law and fact, while the Appellee maintained the appeal invited an impermissible re-evaluation of facts.

Legal Issues Presented

1. Whether claims 1 to 9 of the basic patent, relating to the (-) enantiomer of RA7 (rivastigmine), are invalid for lack of inventive step.
2. Whether, in light of the prior art disclosures, it was obvious to a skilled team to select RA7, resolve it into enantiomers, and formulate the (-) enantiomer as a treatment for Alzheimer's disease.
3. Whether the judge correctly applied the legal test for obviousness, including the "obvious to try" standard and the assessment of a fair expectation of success.
4. Whether the judge erred in his factual findings concerning the drug development process and the skilled team's approach to resolution of racemic compounds.

Arguments of the Parties

Appellant's Arguments

• The judge erred by failing to distinguish between drug research and drug development stages, particularly that resolution of candidate compounds would only occur at the development phase.
• The prior art disclosed RA7 as a candidate compound requiring extensive further testing before selection for development, making any decision to resolve RA7 speculative and not obvious.
• The judge failed to properly consider whether the skilled team had a fair expectation of success that rivastigmine would treat Alzheimer's disease, misapplying the "obvious to try" test.
• The judge wrongly accepted a generalized rationale that resolution was obvious due to risk reduction, which would invalidate most single enantiomer claims absent inventive resolution chemistry.
• Reliance on FDA guidelines was misplaced, as evidence showed that routine resolution was not obligatory at the priority date.
• The judge mischaracterized the objective technical effect of the invention, which should be the use of rivastigmine to treat Alzheimer's disease, not the mere resolution of a chiral compound.

Appellee's Arguments

• The prior art publications disclosed RA7 with promising properties, encouraging further investigation and development.
• The skilled team would have found it obvious to select RA7 for development, given its promising profile relative to known compounds.
• The skilled team would routinely consider resolving racemic compounds, including RA7, to identify practical benefits such as metabolic differences, blood-brain barrier penetration, and avoidance of stereo-specific side effects.
• The judge correctly applied the law on obviousness, including the "obvious to try" test, and appropriately assessed the evidence without impermissible hindsight.
• The judge's preference for the practical evidence of the Appellee's expert over the theoretical reasoning of the Appellant's expert was justified.
• FDA guidelines did not establish that resolution was obligatory, but there was ample evidence that resolution was standard practice in the industry.
• The judge correctly characterized the objective technical effect as expected from resolving the racemate, consistent with the prior art.

Table of Precedents Cited

Court's Reasoning and Analysis

The court began by affirming the trial judge’s correct application of the legal framework for assessing obviousness, particularly the guidance of Lord Hoffmann in Conor and the holistic approach emphasizing the "obvious to try" test as requiring a fair expectation of success. The court rejected the Appellant’s attempt to dissect the question of obviousness into isolated sub-questions, emphasizing that the statutory test must be applied to the invention as a whole.

The court accepted that the prior publications disclosed RA7 as a promising compound with improved properties over known cholinesterase inhibitors, thus encouraging skilled teams to pursue its development. It found no error in the judge's conclusion that selecting RA7 for development was an obvious step given the prior art, rejecting the Appellant’s argument that further testing was required before such selection could be obvious.

Regarding resolution of RA7 into its enantiomers, the court accepted the judge’s preference for the practical evidence of the Appellee’s expert, who explained that resolution was a routine and rational step in pharmaceutical development to explore potential differences in metabolism, blood-brain barrier penetration, and side effects. The court found no error in the judge’s rejection of the Appellant’s theoretical objections to the obviousness of resolution.

The court also dismissed the Appellant’s submission that the judge failed to properly assess the expectation of success, holding that the judge applied the correct legal principles and considered the evidence appropriately. The court noted that the expectation of success is one factor among many in the obviousness inquiry and that the statutory question is whether the invention was obvious to the skilled but unimaginative person at the priority date.

Finally, the court rejected the Appellant’s contention that the judge mischaracterized the objective technical effect of the invention, affirming that the effect was the expected result of resolving the racemate and formulating the (-) enantiomer, consistent with the prior art teachings.

Holding and Implications

The court DISMISSED THE APPEAL, affirming the trial judge’s revocation of the SPC and the basic patent claims 1 to 9 on grounds of invalidity for lack of inventive step.

The direct effect of this decision is that the patent and associated SPC protecting the drug rivastigmine are revoked, allowing the Appellee to market a generic version. The court’s reasoning reinforces established principles on the assessment of obviousness in pharmaceutical patent cases, particularly the application of the "obvious to try" test requiring a fair expectation of success and the importance of considering the invention as a whole without undue dissection into isolated issues. No new precedent was set beyond the reaffirmation and application of existing legal principles.