Given the amount of time and resources that Life Sciences businesses invest into research and development, it is vital that they protect their investment, and one of the main ways this is done is by patenting the fruits of their R&D labours.
But one of the requirements that need to be met if an invention is to be patentable under the Patents Act 1977, is that it must involve an “inventive step”, which is defined as a step that is “not obvious to a person skilled in the art”. Therefore, questions over inventiveness and obviousness are often key battlegrounds in disputes over the validity of patents in the Life Sciences sector.
Pfizer and Moderna
The recent high profile case of ModernaTX Inc v Pfizer Ltd [2024] EWHC 1695 (Pat) is a good example of this in practice, as the Patents Court had to consider the validity and potential infringement of patents relating to the COVID-19 mRNA vaccine.
Moderna owned two European patents relating to the use of mRNA (messenger ribonucleic acid) in medicine. The first patent related to a particular type of mRNA, while the second related to a particular betacoronavirus mRNA vaccine. Moderna alleged that both of its patents had been infringed by the COVID-19 mRNA-based vaccine developed and produced by Pfizer and its partner BioNTech.
The Patents Court had to consider who constituted a “skilled person” for the purposes of assessing whether the patents had involved an inventive step that was “not obvious to a person skilled in the art”. While this question will always be very fact and context specific, the Patents Court confirmed that the correct approach was to define the “skilled person” as someone with a practical interest in the application of the invention, and not just a fundamental research interest.
Applying that reasoning to the facts of this case, the Patents Court decided that Moderna’s first patent was valid and had been infringed by Pfizer/BioNTech (because Moderna’s invention had satisfied the inventiveness requirement), but the Patents Court ruled that Moderna’ second patent was invalid (in part due to obviousness).
The disputes over mRNA-related patents did not end there, however, and in the later case of BioNTech SE & Pfizer Inc v CureVac SE [2024] EWHC 2538 (Pat), Pfizer and BioNTech challenged the validity of patents owned by CureVac in relation to mRNA structures, and the Patents Court agreed that CureVac’s patents were invalid for obviousness (as well as insufficiency).
Invalid patents for obviousness
The high-profile Moderna and Pfizer dispute is just one of a number of recent patent disputes in the pharmaceutical and biotechnology sectors that have involved arguments over inventiveness and obviousness:
- In Abbott Diabetes Care Inc v Dexcom Inc [2024] EWHC 1664 (Pat), the Patents Court decided that a patent for a glucose monitoring device was invalid for obviousness (and so had not been infringed), based on a careful analysis of the patent’s wording;
- The Patents Court also confirmed in Samsung Bioepis UK Ltd v Janssen Biotech Inc [2024] EWHC 1984 (Pat) that a patent for an antibody used in the treatment of ulcerative colitis was invalid for obviousness due to the very strong expectation of success in relation to prior art. However, the Court reinforced that obviousness was a multifactorial question, where a reasonable expectation of success from prior art should normally only be one of (and not the only) relevant factor to consider;
- The Court of Appeal also ruled in the case of Sandoz AG v Bayer Intellectual Property GmbH [2024] EWCA Civ 562 that a patent for a daily dose regimen of the anticoagulant drug rivaroxoban was invalid for obviousness (upholding an earlier decision of the Patents Court). In finding that there was a lack of an inventive step, the courts found that it would have been obvious to a “skilled person” to conduct a phase II clinical trial which included the relevant daily dose regimen;
- The Patents Court did, however, find in favour of the patent owner in Accord Healthcare Ltd v Regents of the University of California [2024] EWHC 2524 (Pat), when it rejected an attempt to revoke a patent for a medical product for the treatment of prostate cancer. In that case, the Patents Court rejected the arguments that the patent was invalid for obviousness (and insufficiency), after considering how the motivation of the “skilled person” may be relevant to the question of obviousness;
- Pfizer was recently back in the Patents Court in Pfizer Inc v UniQure Biopharma BV [2024] EWHC 2672 (Pat). This case involved a patent related to the treatment of haemophilia B using a naturally occurring mutant of an enzyme known as Factor IX (or FIX), which Pfizer alleged lacked the necessary inventive step. The key issue was whether there had been a reasonable expectation of success based on prior art, and the Patents Court found that there had not been. Pfizer’s allegations of obviousness failed therefore, meaning that the patent was valid and had been infringed.
‘Obviousness’ is not always obvious
The fact that questions of inventiveness and obviousness are so frequently considered by the Courts in patent disputes demonstrates how fact-specific these issues can be. The Courts will take into account various factors when determining if a patent meets the “inventive step” requirements, including considering issues such as the costs and resources needed for the relevant trials/experiments, what other avenues of research were available, and the expectations of success at the time.
For more information on this or any other issue relating to Life Sciences and intellectual property disputes, please contact Michael Axe by emailing Michael or by calling him on +44 (0)1628 502448.
This article is provided for information purposes only and does not constitute legal advice. Professional legal advice should be obtained before taking or refraining from taking any action as a result of the contents of this article.