Samsung Bioepis UK Ltd v Janssen Biotech, Inc.
[2024] EWHC 2442 (Pat)
Sandoz AG & Ors v Biogen MA Inc
11 October 2024
[2024] EWHC 2567 (Pat)
High Court
Biogen's patent for a blood test to predict a rare brain disease was too vague and didn't work for everyone, so the court threw it out. A similar test made by a different company wasn't found to break Biogen's rules because it's mainly done in a different country. The court also refused to preemptively say whether other, similar Biogen tests would be legal in the future.
Key Facts
- •Sandoz AG, Sandoz Limited, Sandoz GmbH, and Polpharma Biologics SA (Claimants) sought revocation of Biogen MA Inc.'s (Defendant) EP (UK) 3 575 792 patent ('EP792' or 'the Patent'), which concerns a method of assessing the risk of Progressive Multifocal Leukoencephalopathy (PML).
- •Biogen counterclaimed for infringement.
- •The Patent relates to a method of evaluating a patient's risk of developing PML based on anti-JC Virus (JCV) antibody titers determined by an ELISA assay and expressed as index values. A key element is an index value >1.5 indicating high risk.
- •Sandoz developed a biosimilar natalizumab product (Tyruko) and an associated assay (Sandoz Assay) for assessing PML risk.
- •The Sandoz Assay is performed outside the UK.
- •Sandoz argued invalidity based on insufficiency, uncertainty, lack of inventive step, added matter, and excluded subject matter.
- •Biogen asserted infringement, both literally and by equivalence.
Legal Principles
Patent claim construction involves purposive construction, considering the skilled person's understanding of the patentee's intent, but claims must not be construed in isolation from the description and drawings.
Saab Seaeye Ltd v Atlas Elektronik [2017] EWCA Civ 2175
Where a patentee uses general language, details of specific embodiments should not be read into the claim unless the patentee deliberately limited the claim.
Nokia v IPCom [2009] EWHC 3482 (Pat)
The specification must disclose the invention clearly and completely enough for a skilled person to perform it without undue burden, across the whole scope of the claim.
Eli Lilly v Human Genome Sciences [2008] R.P.C. 29
A claim is insufficient if it's impossible to ascertain the boundary of the invention due to unclear or meaningless terms, or if the patent doesn't explain how to decide where the boundary is.
Anan Kasei Co Ltd v Neo Chemicals & Oxides Ltd [2019] EWCA Civ 1646
Sufficiency requires enablement across the whole scope of the claim, considering relevant variables that affect the product or process's value or utility.
Regeneron v Kymab [2020] UKSC 27
For infringement under s.60(2) Patents Act 1977, the invention must be put into a state of effectiveness in the UK.
Menashe v William Hill [2002] EWCA Civ 1702
Inventive step requires a technical contribution to the art; doing what is suggested in prior art is not inventive unless there is a technical prejudice against that idea.
Various cases including Actavis v ICOS [2019] UKSC 15
For obviousness, consider if something was 'obvious to try', with a reasonable prospect of success. It doesn't need to be manifest that a test will work.
Actavis v ICOS [2019] UKSC 15
Arrow declarations may be granted in appropriate cases to provide commercial certainty where pending divisional applications create prolonged legal uncertainty, but the declaration must clearly define the product or process and not usurp the EPO's function.
Glaxo v Vectura [2019] RPC 2 and Fujifilm Kyowa Kirin Biologics Co., Ltd v AbbVie Biotechnology Limited [2017] EWCA Civ 1
If the description discloses multiple ways to achieve a technical effect, but only one is claimed, using other possibilities doesn't infringe by equivalence.
Akebia Therapeutics Inc v Fibrogen Inc [2020] EWHC 886
Outcomes
The Patent is invalid.
The patent was found invalid due to insufficiency (both classical and uncertainty), breadth of claim insufficiency, and added matter. The court determined that the patent did not provide sufficient detail for a skilled person to reproduce the assay reliably, particularly regarding the calibrator and HPVLPs. The claim scope was also deemed too broad, encompassing patient groups where the claimed method is not applicable. Finally, claim 8 was found to include added matter.
No infringement.
The Sandoz Assay, performed entirely outside the UK, did not infringe the patent. Even under a doctrine of equivalents analysis, the court found no infringement. The court determined that the core of the patented method resided outside the UK and only the interpretation of results occurred within the UK, which was deemed insufficient for infringement.
Declaratory relief denied.
The court declined to grant Sandoz's declaratory relief, deeming it would usurp the EPO's function in examining and deciding on pending divisional applications. The court held that it could not preemptively determine the validity of a patent application before grant.