The UK Supreme Court issued its decision today on the Warner Lambert vs Generics (UK) Ltd t/a Mylan. The decision concerns Swiss-form patent claims that relate to a specified medical use of a known pharmaceutical compound, in this case the use of pregabalin to treat pain. In particular, the Supreme Court considered how sufficient disclosure and infringement of these claims should be determined in the UK.
The Court decided that a Swiss claim is only sufficiently disclosed if the patent makes it plausible that the compound will be efficacious for all pathologies that fall within the scope of the claim. Plausibility can be in the form of experimental data or a sound scientific rationale, but must be more than a mere possibility and must be contained in the application as filed, so it cannot be remedied by additional post filing evidence.
The ruling increases the burden on rights holders and thus increases the cost and uncertainty of obtaining and enforcing patent rights. Specifically, the ruling emphasises the importance of experimental data or other evidence in substantiating patent claims successfully across their entire scope. To justify broad claims, patentees may need to increase the amount of experimental data in their patent filings or provide some underlying theory or mechanism that allows credible and plausible predictions to be made from the existing data. In particular, exemplification with multiple different compounds or model systems may be required to ensure that efficacy is made plausible across the scope of the claims and the sufficiency requirements are met.
Although the decision specifically relates to Swiss form claims, much of the Supreme Court’s reasoning would also appear apply to the medical use claims in the Art54(5) EPC2000 format. In apparently raising the bar for plausibility of Swiss form claims, the ruling will make medical use patents more vulnerable to invalidation and thus weaken patent holders’ rights and ability to innovate with confidence. Going forward, patentees must be aware that patent claims that cover anything that is not specifically exemplified in the patent is vulnerable to allegations of not being plausible from the disclosure of the patent. The risk may be reduced by increasing the amount of experimental data in patent filings and including narrow, focussed claims that are easier to defend from such allegations.
Further bad news for patentees was the Supreme Court’s ruling that infringement of a medical use claim requires the manufacturer to actively present a product as suitable for the intended use. Whilst this simplifies the test for infringement by removing consideration of “intention”, it also makes it much easier for third parties to avoid infringement of medical use claims. This reduces the value of the medical use claims on which many businesses in the biotechnology and pharmaceutical space rely.
Overall, the decision is potentially bad news for patentees in the biotechnology and pharmaceutical fields. The ruling will make medical use patents easier to avoid and more vulnerable to invalidation and thus weaken patent holders’ rights and ability to innovate with confidence.
Nick's comments on the case have been featured in the BMJ, Life Sciences Intellectual Property Review, IPPro Patents, Pharma Times and The Pharma Letter.