Sandoz AG & Ors v Bayer Intellectual Property GmbH
[2024] EWHC 796 (Pat)
Pfizer Inc v Uniqure Biopharma BV
25 October 2024
[2024] EWHC 2672 (Pat)
High Court
A company's patent for a better treatment for haemophilia was challenged. The judge decided the patent was valid because, even though the idea was in an earlier document, no one had tried it before. Experts agreed that while it was easy to try, there wasn't a good reason to think it would work, so it was an invention.
Key Facts
- •Pfizer Inc. challenged the validity of European Patent (UK) 3 581 650 ('the Patent') owned by Uniqure BioPharma B.V. for lack of inventive step and insufficiency.
- •The Patent concerns a Factor IX polypeptide mutant with increased clotting activity for use in haemophilia B gene therapy.
- •Uniqure BioPharma and its licensee alleged infringement by Pfizer.
- •The prior art cited was PCT Application WO 99/0496 ('Stafford'), disclosing Factor IX mutants with amino acid substitutions at position 338, including leucine.
- •The key dispute centered on whether the selection of the Padua variant (R338L-FIX) from the possibilities disclosed in Stafford was obvious.
Legal Principles
Obviousness is a multifactorial assessment considering factors like motive, possible avenues of research, effort involved, and expectation of success.
Generics (UK) Ltd v H. Lundbeck A/S [2007] EWHC 1040 (Pat); Conor Medsystems Inc v Angiotech Pharmaceuticals Inc [2008] UKHL 49
The statutory question is whether the invention was obvious at the priority date, not simply whether it was obvious to try. Expectation of success is an aspect of this question, not an independent hurdle.
Medimmune Ltd v Novartis Pharmaceuticals UK Ltd [2012] EWCA Civ 1234
The patentee's monopoly should be commensurate with their technical contribution. There is no invention in simply following directions from prior art unless there's an established prejudice against that idea.
Hoechst Celanese Corp v BP Chemicals Ltd [1997] FSR 547; Pozzoli SPA v BDMO SA [2007] EWCA Civ 588; Modernatx Inc v Pfizer Ltd [2024] EWHC 1695 (Pat)
Motive is important; it is necessary to demonstrate some reason for taking a step, even if small.
Hoechst Celanese Corp v BP Chemicals Ltd [1997] FSR 547
Secondary evidence (e.g., industry practice) can be important in assessing inventive step, particularly when the problem was long-standing and the seemingly obvious solution was not previously adopted.
Schlumberger Holdings Ltd v Electromagnetic Geoservices AS [2010] EWCA Civ 819
The skilled person is deemed to read a patent specification with some knowledge of patent law.
Virgin Airways Ltd v Premium Aircraft Interiors UK Ltd [2009] EWCA Civ 1062
Outcomes
The Patent is valid.
There was no reasonable expectation of success in using R338L-FIX for gene therapy at the priority date. The secondary evidence (lack of attempts to use R338L-FIX despite its obviousness in Stafford and ease of testing) and the primary evidence (expert testimony on the lack of scientific reason to try R338L given its hydrophobicity and the conserved nature of the region) strongly support this conclusion. The reference to leucine in Stafford was deemed to be a meaningless patent drafting strategy, not a meaningful scientific suggestion.
The Patent is infringed.
Since the Patent is valid and Pfizer admitted to infringing acts if the Patent were valid, infringement is established.
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