Summary
A patent addressed to a skilled team is construed against the practical knowledge and experience of real research teams operating in the relevant field. Common general knowledge may include contradictory information, defined uncertainty and relevant negative knowledge, including awareness of failed approaches and the reasons for their failure.
For obviousness, the skilled team must read prior art fairly and with interest, taking account of its general teaching rather than confining it to an illustrated embodiment. An invention may be obvious where the skilled team would adapt a known combination of imaging, control and laser technology to a suggested ophthalmic application. A claim is also insufficient where the skilled team cannot put it into effect without undue burden.
Factual background
The claimants sought revocation of two patents owned by the defendant: EP(UK) 1 835 861 B2, concerning an OCT- or confocal-microscope-guided laser system for anterior capsulotomy, and EP(UK) 2 548 528 B1, concerning a similar system for lens fragmentation. The claimants accepted infringement if the patents were valid.
The principal issues were obviousness over Freedman and Mühlhoff, and insufficiency. The court considered the skilled team, its common general knowledge, the proper disclosure of the prior art, and whether the claimed systems involved an inventive step.
Held
- Skilled team and common general knowledge. The skilled team comprised a skilled ophthalmologist and skilled engineer who would collaborate in a real research and development environment. The relevant team was not confined to newcomers or persons merely implementing a specification. The court applied the principles in Garmin, Mayne, Illumina, Medimmune and Schlumberger.
- Common general knowledge may include intermediate knowledge, defined uncertainty and negative knowledge. The skilled team would know of earlier unsuccessful laser applications in cataract surgery, understand the collateral damage caused by longer pulses, and appreciate the potential of femtosecond lasers for precise intraocular incisions. The court applied and developed the approach discussed in KCI, General Tire, Merck v Ono and Dyson.
- Freedman. Although its specific embodiments concerned radial keratotomy using an ablating laser, its general teaching was of a laser surgery system controlled by interferometry, preferably OCT. The skilled team would read that teaching fairly, but the step from that disclosure to the claimed anterior capsulotomy and lens-fragmentation systems remained affected by hindsight. Claims 1 of both patents were therefore not obvious over Freedman.
- Mühlhoff. The document disclosed a precision-guided ultrashort-pulsed laser controlled by imaging. Its reference to other ophthalmological interventions and incisions in the lens was a serious and operative teaching, not hyperbole. The fifth embodiment was not confined to multiphoton fluorescence: the document expressly permitted use of the earlier OCT, confocal and slit-lamp measurement principles. The skilled team would use imaging in advance to establish the cutting pattern and then control the laser.
- Applying the structured approach in Pozzoli, as approved and summarised in Actavis, the differences between Mühlhoff and the claims were modest. The skilled team would adapt the disclosed system to anterior capsulotomy and lens fragmentation. Claims 1 of EP861 and EP528 were obvious over Mühlhoff. The bottom-up scanning features in claims 2 and 6 were common general knowledge or, alternatively, obvious from routine experimentation because gas bubbles shadowed later pulses.
- The patents were also insufficient if the claims were not obvious. Both patents were invalid, primarily for obviousness and, alternatively, for insufficiency. Further consideration of the form of order was adjourned.
The court’s approach to earlier authorities
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Key cases cited
19 authorities cited.
- Actavis Group PTC EHF and others v ICOS Corporation and another [2019] UKSC 15
- Koninklijke Philips N.V. v Asustek Computer Incorporation & Ors [2019] EWCA Civ 2230
- Medimmune Ltd v Novartis Pharmaceuticals UK Ltd & Ors [2012] EWCA Civ 1234
- Schlumberger Holdings Ltd v Electromagnetic Geoservices AS [2010] EWCA Civ 819
- Pozzoli Spa v BDMO SA & Anor [2007] EWCA Civ 588
- Dyson Appliances Limited v Hoover Limited [2001] EWCA Civ 1440
- Illumina Cambridge Ltd v Latvia MGI Tech SIA & Ors [2021] EWHC 57 (Pat)
- Merck, Sharp & Dohme v Wyeth [2020] EWHC 2636
- Garmin (Europe) Limited v Koninklijke Philips N.V. [2019] EWHC 107 (Pat)
- Merck Sharp & Dohme Ltd v Ono Pharmaceutical Co Ltd & Anor [2015] EWHC 2973 (Pat)
- Regeneron Pharmacueticals Inc v Genentech Inc [2012] EWHC 657 (Pat)
- KCI v Smith & Nephew [2010] EWHC 1487
- Generics (UK) Ltd & Ors v H Lundbeck A/S [2007] EWHC 1040 (Pat)
- Mayne Pharma Ltd & Anor v Debiopharm SA & Anor [2006] EWHC 1123 (Pat)
- Horne Engineering v Reliance Water Controls [2000] FSR 90
- Beloit Technologies Inc v Valmet Paper Machinery Inc [1997] RPC 489
- Richardson Vicks Inc’s Patent [1997] RPC 888
- General Tire v Firestone [1972] RPC 457
- Brugger v Medic-Aid
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Cases citing this case
5 later cases · 3 positive · 1 neutral · 1 caution
Most senior citing decisions:
- Pfizer Limited v GlaxoSmithKline Biological SA & Anor [2024] EWHC 2523 (Pat) followed
- Abbott Diabetes Care Inc & Ors v Dexcom Inc & Ors [2024] EWHC 1664 (Pat) considered
- Sandoz AG & Ors v Bayer Intellectual Property GmbH [2024] EWHC 796 (Pat) followed
- Astellas Pharma Industries Limited v Teva Pharmaceutical Industries Limited & Ors [2023] EWHC 2571 (Pat)
- Teva Pharmaceutical Industries Limited & Anor. v Novartis AG & Anor. [2022] EWHC 2847 (Pat)
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