BioNTech SE & Anor v CureVac SE & Anor
[2024] EWHC 2538 (Pat)
Gilead Sciences Inc & Anor v Nucana Plc
21 March 2023
[2023] EWHC 611 (Pat)
High Court
Imagine you have a recipe for a special cake, but it's so vague that it's unclear if it'll actually work, and even if it does, many versions will be inedible. That's what the judge said about these patents. They claimed too many things (added matter) that were not clearly defined in the original documents and it's not likely they would all work (lack of plausibility). Even if they did work, it would be too difficult to make some versions (undue burden). So, the judge said the patents are no good.
Key Facts
- •Gilead sought revocation of NuCana's EP190 and EP365 patents.
- •The patents concerned nucleoside analogues for cancer treatment.
- •Gilead counterclaimed for infringement by its sofosbuvir drug.
- •NuCana proposed amendments to EP190.
- •Gilead challenged the patents for added matter, lack of plausibility, lack of industrial applicability, lack of technical effect, undue burden insufficiency, and unallowable amendments.
- •The case involved extensive expert evidence on medicinal chemistry, oncology, and synthetic chemistry.
- •EPO opposition proceedings were ongoing concurrently.
Legal Principles
Added matter test: A skilled person should not learn anything new about the invention from the amended specification compared to the original application.
Nokia v IPCom [2012] EWCA Civ 567
Added matter – deletions from multiple lists: Deleting elements from lists is permissible if it doesn't single out a previously undisclosed combination or generate another invention.
EPO Case Law, 10th Edition, 2022
Industrial applicability requires a plausible practical application and commercial benefit, not merely speculative use.
HGS v Lilly [2011] UKSC 51
Plausibility requires a reasonable prospect that the assertion of the invention's utility will prove true.
Warner-Lambert, relevant sections not specified in the document
Undue burden insufficiency: The skilled person must be able to make the claimed compounds without undue burden, considering ordinary trial and error but requiring adequate instructions for success.
Mentor v Hollister [1991] FSR 557, T226/85 Unilever/stable bleaches
Outcomes
EP190 and EP365 patents are invalid.
The patents suffered from added matter, lack of plausibility (both ab initio plausibility and implausibility tests), and undue burden insufficiency.
Proposed amendments to EP190 are unallowable.
The amendments introduced added matter by narrowing the claims to a significantly different class of compounds not clearly disclosed in the original application.
Obviousness over Shepard prior art fails.
Gilead's case lacked sufficient evidence and failed to demonstrate a conventional obviousness case.
Infringement would have occurred had the patents been valid.
Sofosbuvir fell within the scope of the claims.