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Conor Medsystems Inc v Angiotech Pharmaceuticals Inc & Ors
Factual and Procedural Background
Company A, a Canadian corporation, and The University jointly own European Patent No. 0 706 376, which claims (inter alia) a stent coated with taxol for the purpose of treating or preventing recurrent stenosis. Company B, a United States competitor, sought revocation of the patent for obviousness in both the United Kingdom and the Netherlands. In first-instance proceedings before Judge [Pumfrey] and, on appeal, before Judges [Mummery], [Tuckey] and [Jacob] in the Court of Appeal, Company B succeeded. The District Court of The City in the Netherlands reached the opposite conclusion and upheld the patent.
After the litigation began, Company A and Company B settled. Because patent validity is a question in rem, the House of Lords invited Official A (the Comptroller-General of Patents) to present the case for invalidity. The appeal before the House therefore proceeded with Company A as Appellant and Official A opposing in place of Company B.
Legal Issues Presented
- Whether Claim 12 of European Patent No. 0 706 376—“a stent coated with taxol for treating or preventing recurrent stenosis”—involves an inventive step or is obvious under Article 56 EPC and section 1(1)(b) of the Patents Act 1977.
- Whether the lower courts erred by conflating the statutory requirements of inventive step with those of sufficiency and support when assessing obviousness.
- How the “obvious to try” test should be applied where the patent discloses that the claimed product possesses a therapeutic property but supplies limited experimental data.
Arguments of the Parties
Appellant’s Arguments (Company A)
- The claimed invention is the taxol-coated stent itself; obviousness must be assessed against that concrete product, not against a “mere idea” to test taxol.
- The specification makes a plausible disclosure that taxol-coated stents prevent or treat restenosis, supported by CAM assay data; further experimental proof is unnecessary for inventive-step analysis.
- The prior art (Wolff, Kopia, Katsuda and the “Holy Grail” review) did not make it obvious to select taxol from the many anti-proliferative candidates or to expect it to succeed in vivo.
- The lower courts wrongly mixed sufficiency requirements (Articles 83/84 EPC) into the obviousness enquiry, thereby applying an “obvious to try without expectation of success” test unknown to patent law.
Opponent’s Arguments (Official A, adopting Company B’s earlier position)
- The patent offers no in vivo data or dosing guidance; it therefore discloses only that taxol is “worth trying,” which adds nothing inventive to the common general knowledge.
- At the priority date taxol was highly publicised as an anti-proliferative cancer drug; any skilled cardiovascular specialist, consulting an oncologist, would have considered it an obvious candidate for testing on a drug-eluting stent.
- Because the specification fails to demonstrate that taxol-coated stents actually work, the contribution to the art is merely speculative; such speculation does not satisfy the requirement for an inventive step.
Table of Precedents Cited
| Precedent | Rule or Principle Cited For | Application by the Court |
|---|---|---|
| Halliburton v Smith International [2006] EWCA Civ 1715 | Permitting the Comptroller to appear where parties settle but validity remains in issue. | House of Lords followed this procedure in inviting Official A to oppose the appeal. |
| Pharmacia v Merck [2002] RPC 41 | Inventiveness may reside in the discovery that a known product possesses a new property. | Cited to support viewing the taxol-coated stent’s therapeutic effect as the potential inventive step. |
| Re Prendergast’s Applications [2000] RPC 446 | Claims unsupported by the description (Article 84 EPC) are invalid. | Distinguished; unlike Prendergast, the present patent contained a plausible disclosure. |
| AGREVO (T 0939/92, EPO) | Broad chemical claims fail for lack of inventive step if common technical effect across the class is unsubstantiated. | House held AGREVO inapposite; the single compound (taxol) was plausibly linked to the claimed effect. |
| Johns Hopkins (T 1329/04, EPO) | Speculation without evidence cannot establish inventive step; post-filed data cannot rescue. | Distinguished on grounds that the present patent’s disclosure was already plausible at filing. |
| Johns-Manville Corp’s Patent [1967] RPC 479 | “Obvious to try” is relevant only where there is a reasonable expectation of success. | Used to reaffirm that expectation of success is essential; lower courts misapplied this principle. |
| Generics (UK) Ltd v Lundbeck A/S [2007] RPC 32 | Factors relevant to obviousness include motive, alternatives, effort and expectation of success. | Cited approvingly; House applied these factors to conclude obviousness was not established. |
| Brugger v Medic-Aid (citation in judgment) | Illustrative discussion of commercial incentives in “obvious to try” contexts. | Mentioned in policy discussion; not determinative of the result. |
Court’s Reasoning and Analysis
The House identified the central error below as conflating inventive-step analysis with sufficiency/support requirements. Claim 12 defined a specific product—a taxol-coated stent—for a specific therapeutic purpose. Because the product was new, the only inventive-step question was whether, at the priority date, it was obvious to a skilled cardiovascular team to use that product to prevent or treat restenosis.
Reviewing the evidence, the House concluded:
- The patent made a plausible disclosure that taxol-coated stents would combat restenosis, supported by favourable CAM assay results identifying taxol as the best anti-angiogenic tested.
- No item of prior art (Wolff, Kopia, or Katsuda) singled out taxol or provided a fair expectation that it would succeed in vivo; the field contained numerous candidate drugs, and taxol’s toxicity would have discouraged selection.
- An “obvious to try” standard without an accompanying expectation of success is insufficient at law; such an “oxymoronic concept” would reduce inventive-step analysis to mere speculation.
- Article 84 EPC concerns had already been addressed in EPO opposition proceedings; they could not be repackaged as an obviousness attack.
- Uniform interpretation of the EPC favoured alignment with the Netherlands judgment and EPO practice rather than the divergent approach of the English courts below.
Holding and Implications
APPEAL ALLOWED; the challenge based on obviousness fails and Claim 12 of European Patent No. 0 706 376 remains valid in the United Kingdom.
Implications: The decision clarifies UK law on inventive step by confirming that:
- Obviousness must be assessed against the claimed invention itself, not against a paraphrased “idea” extracted from alleged deficiencies in the specification.
- The “obvious to try” doctrine applies only where there is a reasonable expectation of success; mere worthiness of experimentation is insufficient.
- Sufficiency and support requirements under Articles 83/84 EPC are conceptually and analytically distinct from the inventive-step enquiry under Article 56.
- The judgment promotes consistency with EPO jurisprudence, thereby fostering greater uniformity across EPC contracting states.
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