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Abbott Laboratories Ltd v Evysio Medical Devices ULC
Factual and Procedural Background
These three related patent actions concern coronary stents, medical devices used to expand blocked coronary arteries. The claimant, Plaintiff, seeks declarations that certain coronary stents do not infringe three patents held by Defendant and seeks revocation of those patents. Defendant counterclaims for infringement. Plaintiff is a UK subsidiary of a multinational healthcare company and acquired the vascular device business of Company A, which produced the Multi-Link stent, a predecessor to the alleged infringing products. Defendant is a Canadian company with an exclusive licensee healthcare company.
The three patents in suit are European Patents ("093", "094", and "804"), sharing priority from four applications filed in 1996 and two PCT applications filed in 1997. The patents contain numerous claims, but the court limited consideration to specific claims of each patent. The products alleged to infringe include the Multi-Link Vision stent (small and medium sizes), the Multi-Link Xience stent (a coated variant), and modified versions with deeper dimples on certain ring curves. The parties agreed to focus on the Vision stent and its modified versions.
Plaintiff challenges the patents on grounds of lack of novelty and inventive step, added matter, insufficiency, and entitlement to priority. Defendant maintains validity and infringement. The court heard evidence from experts in interventional cardiology and bioengineering for both parties.
Legal Issues Presented
- Whether the original and modified Vision stents infringe any of the asserted claims.
- Whether the claims entitled to priority are anticipated or obvious over prior art, specifically the Medinol disclosure and the Multi-Link stent, considering common general knowledge.
- Whether claims are entitled to priority from earlier applications, particularly in light of public disclosure at a cardiology meeting in Rotterdam in 1996.
- Whether patents 093 and 804 are invalid for added matter due to amendments made during prosecution.
- Whether the patents are insufficient due to unclear claim terms, notably the requirement of "flat" apices.
Arguments of the Parties
The opinion does not contain a detailed account of the parties' legal arguments.
Table of Precedents Cited
| Precedent | Rule or Principle Cited For | Application by the Court |
|---|---|---|
| General Tire & Rubber Co v Firestone Tyre & Rubber Ltd [1972] RPC 457 | Definition and identification of common general knowledge in patent law. | Used to establish the nature of common general knowledge relevant to the skilled addressee in the patent field. |
| Beloit Technologies Inc v Valmet Paper Machinery Inc [1997] RPC 489 | Differentiation between common general knowledge and knowledge by some individuals. | Applied to reject the claim that all conference disclosures and patents automatically form part of common general knowledge. |
| Angiotech Pharmaceuticals Inc v Connor Medsystems Inc [2007] RPC 20 | Common general knowledge includes what the skilled person would know and take for granted, even if unproven. | Supported the court's approach to the skilled addressee’s understanding of emerging technologies. |
| Kirin-Amgen v Hoechst Marion Roussel [2004] UKHL 46; [2005] RPC 9 | Principles of purposive construction of patent claims. | Guided the court’s interpretation of claim language in the patents. |
| Pozzoli v BDMO [2007] EWCA Civ 588; [2007] FSR 38 | Framework for assessing inventive step (obviousness). | Applied to evaluate whether the patent claims involved an inventive step over prior art and common general knowledge. |
| Haberman v Jackel [1999] FSR 683 | Warnings against hindsight in assessing obviousness. | Used to caution the court against hindsight bias in evaluating inventive step. |
| Coflexip v Stolt Connex Seaway [2000] IP&T 1332 | Risk of hindsight in combining prior art for obviousness attacks. | Emphasized the need to assess obviousness from the perspective of the skilled but uninventive person. |
| Sabaf v MFI Furniture [2004] UKHL 45; [2005] RPC 10 | Distinction between single invention and collocation of known elements. | Considered to determine whether the patent claimed a single inventive concept or mere aggregation of known features. |
| Unilin Beheer v Berry Floor [2004] EWCA (Civ) 1021; [2005] FSR 6 | Requirements for entitlement to priority including direct and unambiguous disclosure. | Applied to assess whether the patents’ claims were supported by earlier priority documents. |
| Bonzel v Intervention Ltd [1991] RPC 553 | Test for added matter and extension beyond original disclosure. | Applied to evaluate whether amendments introduced new matter beyond the original application. |
| European Central Bank v Document Security Systems [2008] EWCA Civ 192 | Clarifications on assessment of added matter and strict comparison of disclosures. | Guided the court’s strict approach to added matter objections. |
| LG Philips v Tatung [2006] EWCA Civ 1774; [2007] RPC 21 | Intermediate generalisation and added matter in patent amendments. | Used to assess whether claim amendments improperly isolated features from their original context. |
| PPG Industries Disclaimer (G1/03) [2004] EPOR 33 | Permissibility of disclaimers to exclude accidental anticipations. | Considered in relation to claim amendments to avoid prior art disclosures. |
Court's Reasoning and Analysis
The court conducted a detailed technical and legal analysis of the patents, the accused products, and the prior art. It carefully construed key claim terms, notably "arcuate flexure means," "substantially complementary extension and compression," "diametrically opposed struts," and "substantially flat apices," applying purposive construction principles.
The skilled addressee was identified as a team comprising an interventional cardiologist and a design engineer, with the cardiologist primarily responsible for identifying problems and the engineer for technical design.
On infringement, the court found that the original medium Vision products infringe patents 093 and 804, but the modified products do not infringe due to the absence of substantially flat apices. The small Vision products do not infringe 093 or 804 because the flexure means are not disposed between two straight sections as required. None of the products infringe 094 since the claimed pattern of polygons with distinct concave and convex walls is not present.
Regarding validity, the court found claims 093 and 804 invalid for obviousness over the Medinol disclosure and common general knowledge, accepting that rounding flexure means to be arcuate was an obvious design choice. The attack on claim 094 failed due to differences in phase relationship and polygonal wall configuration.
On priority, the court rejected several objections, finding that the priority documents sufficiently disclosed the claimed invention except for claims involving the generalized feature of curved flexure means disposed between two straight sections, which lacked direct and unambiguous support and thus were not entitled to priority. Similarly, claim 804's broadening to polygons without distinct concave and convex walls was not supported by the priority documents.
On added matter, the court found that amendments introducing the feature of arcuate flexure means between two straight sections added matter not disclosed in the priority documents. Other added matter objections were aligned with priority issues and upheld accordingly.
The sufficiency challenge failed as the skilled person could understand and implement the "substantially flat" apex limitation.
Holding and Implications
Holding: Patents 093 and 804 are held invalid for lack of inventive step and priority entitlement issues but would have been infringed by the original medium Vision and Xience stents. Patent 094 is held valid but not infringed by any of the products.
Implications: The direct effect is that Plaintiff’s modified stents do not infringe any patent, and the original medium stents infringe only invalid patents. No new precedent is established beyond the application of settled principles of patent law to the facts of this case.
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