Factual and Procedural Background
The Appellant, Company A trading as Company A Pharmaceuticals Ireland Limited, initiated proceedings to challenge an Irish patent held by Company B for an asthma medicine commonly known as Seretide. The patent application was filed in Ireland on 7th September 1990 and granted on 12th October 1995, with a priority date of 8th September 1989. Company B also obtained a supplementary protection certificate extending the patent term to 6th September 2013.
Seretide is a combination pharmaceutical product administered via inhalers, containing two active compounds: salmeterol xinafoate, a long-acting 2-agonist bronchodilator, and fluticasone propionate, a steroid anti-inflammatory agent. The Appellant contended that the patent for the combination was invalid due to obviousness, arguing that combining two known drugs did not involve an inventive step. The procedural history includes reference to previous English litigation where the patent was revoked for obviousness, but the present case involved different facts and additional evidence requiring a full re-evaluation.
Legal Issues Presented
- Whether the combination of salmeterol xinafoate and fluticasone propionate in Seretide involves an inventive step or is obvious to a person skilled in the art as of the priority date.
- Whether the alleged prejudices in the common general knowledge at the priority date—specifically concerning chemical reactivity and medical practice regarding regular use of 2-agonists and combination therapy—affect the obviousness analysis.
- Whether the proposed amendment to the patent claims, removing the phrase "or sequential" administration to specify simultaneous administration only, extends the subject matter beyond the original disclosure and is allowable under the Patents Act.
Arguments of the Parties
Appellant's Arguments
- The patent for the combination of the two known drugs is invalid as it lacks an inventive step and is obvious.
- The combination of salmeterol and fluticasone propionate did not demonstrate a greater-than-additive effect as claimed and the evidence for such synergy was abandoned.
- The alleged prejudices regarding chemical reactivity and clinical practice against regular 2-agonist use and combination therapy did not exist or were not sufficient to render the invention non-obvious.
- The proposed amendment to the patent claims should be disallowed as it extends the subject matter and changes the scope of protection.
Respondent's Arguments
- There was a real prejudice in the state of the art regarding the chemical reactivity between the two compounds, making the combination non-obvious and inventive.
- The medical community had concerns about the regular use of 2-agonists and combination therapies, which were overcome by the invention.
- The combination produced a revolutionary and practice-changing therapy for asthma, meriting patent protection.
- The amendment to the patent claims clarifies the mode of administration and does not extend the subject matter beyond the original disclosure.
Table of Precedents Cited
| Precedent |
Rule or Principle Cited For |
Application by the Court |
| Cipla Limited v. Glaxo Group Limited [2004] RPC 43 |
Obviousness of the combination of drugs in Seretide. |
The Court considered but distinguished this prior decision due to substantially different facts and evidence in the present case. |
| Connor Medsystems v. Angiotech Pharmaceuticals [2008] R.P.C. 716 |
Requirement to construe patent claims precisely; analysis of "obvious to try" with reasonable expectation of success. |
The Court relied on this authority to emphasize the need for precise claim construction and to adopt updated analysis of obviousness, including the "obvious to try" concept with expectation of success. |
| Davey v. Magistrates of Edinburgh [1953] S.C. 34 |
Role and limits of expert evidence in patent cases. |
The Court used this precedent to guide its evaluation of expert testimony, emphasizing the judge’s role in forming independent judgment. |
| Generics (U.K.) Limited v. Lundbeckas [2007] RPC 32 |
Factors relevant to obviousness including motive, effort, and expectation of success. |
Guided the Court’s approach to assessing obviousness on the facts of the case. |
| Pozzoli S.P.A. v. B.D.M.O. S.A. [2007] FSR 37 |
Four-step test for obviousness. |
The Court adopted the four-step test to analyze the inventive concept and differences from prior art. |
| Johns-Manville Corporation's Patent [1967] RPC 479 |
Concept of "obvious to try" and its application. |
Used to explain the limitations of the "obvious to try" test and its relevance to pharmaceutical inventions. |
| Brugger v. Medic-Aid [1996] R.P.C. 635 |
Obviousness of multiple routes to an invention. |
Reinforced that the existence of multiple obvious routes does not negate obviousness. |
| Rambaxy Laboratories Limited v. Warner Lambert Company [2007] IEHC 256 |
Principles of patent claim construction and Article 69 EPC. |
Guided interpretation of the patent and proposed amendments. |
| Bonzel v. Intervention (No. 3) [1991] R.P.C. 553 |
Test for added matter in patent amendments. |
Applied to assess whether the proposed amendment extended the patent beyond the original disclosure. |
| Vector Corporation v. Glatta Air Techniques [2007] EWCA Civ 805 |
Approval of Bonzel test for added matter. |
Supported the Court’s approach to amendment validity. |
| European Central Bank v. Documents Security Systems [2007] EWHC 600 (Pat) |
Detailed principles for assessing patent amendments and added matter. |
Informed the Court’s strict comparison of original and amended disclosures. |
Court's Reasoning and Analysis
The Court began by outlining the statutory framework under the Patents Act 1992 as amended, aligned with the European Patent Convention, focusing primarily on the requirement of an inventive step and the test of obviousness as set out in Article 56 EPC. The Court recognized the burden on the Appellant to prove obviousness and carefully considered the prior art, including the existence of the earlier combination product Ventide, which combined a short-acting 2-agonist and a corticosteroid.
In assessing obviousness, the Court applied both the European problem-solution approach and the English four-step test, concluding that the invention was to be judged against the state of the art as of the priority date. The Court examined the scientific evidence and expert testimony on the chemical stability and potential reactivity of the two compounds, the nature of asthma treatment in the relevant period, and the medical community’s attitudes towards regular 2-agonist use and combination therapies.
The Court found that the alleged prejudices regarding chemical reactivity were not sufficiently supported by the evidence. It accepted that any theoretical chemical concerns would have been addressed by routine formulation tests, which would not have deterred a skilled team from attempting the combination. The Court preferred the evidence of formulation experts who indicated that stability testing was standard and manageable and that the solid-state nature of the compounds reduced reactivity risks.
Regarding the medical prejudice against regular 2-agonist therapy and combination treatment, the Court concluded that there was an ongoing debate at the priority date but no settled or overwhelming prejudice. It found evidence that some clinicians did prescribe regular 2-agonist therapy and used combination inhalers like Ventide, supporting the conclusion that the skilled team would have had motivation and no strong prejudice against developing the combination.
The Court also considered the proposed amendment to the patent claims, which sought to remove the option of sequential administration, specifying simultaneous administration only. Applying strict tests for added matter, the Court found the amendment did not add new subject matter beyond the original disclosure and was allowable.
In sum, the Court determined that the combination of salmeterol and fluticasone propionate was an obvious development to a skilled team given the prior art, common general knowledge, and the absence of any prohibitive prejudice or technical hurdle that would have deterred the combination.
Holding and Implications
The Court held that the patent should be revoked under section 58 of the Patents Act 1992, as amended by the 2006 Act, on the grounds that the subject matter of the patent did not involve an inventive step and was therefore not patentable.
The direct effect of this decision is that the patent for the combination pharmaceutical product is invalidated, removing its protection. The Court allowed the proposed amendment to the patent claims but noted that this did not affect the outcome. The decision does not establish new legal precedent but applies established principles of patent law concerning obviousness and added matter in the context of pharmaceutical inventions.