Introduction
This essay examines Lord Hoffman’s statement from the landmark case of Biogen Inc. v Medeva Plc [1997] RPC 1, which elucidates the concept of the inventive step in the context of patentability. Patent law, as enshrined in the Patents Act 1977 in the UK, establishes four core requirements for an invention to be patentable: novelty, inventive step, industrial applicability, and non-exclusion from patentability. While all requirements are critical, this discussion will focus predominantly on the inventive step, as highlighted by Lord Hoffman, using supporting case law to explore its nuances. The statement underscores the importance of distinguishing between the goal of an invention and the specific means of achieving it, a distinction pivotal to assessing inventiveness. By critically analysing relevant judicial decisions, this essay seeks to evaluate how Lord Hoffman’s interpretation shapes the understanding of patentability in UK intellectual property law.
Overview of Patentability Requirements
Under Section 1(1) of the Patents Act 1977, for an invention to be patentable, it must satisfy four conditions. First, it must be novel, meaning it does not form part of the state of the art (s.2). Second, it must involve an inventive step, requiring that it is not obvious to a person skilled in the art (s.3). Third, it must be capable of industrial application (s.4), and finally, it must not fall within excluded categories, such as discoveries or scientific theories (s.1(2)). While novelty ensures originality and industrial applicability confirms practical utility, the inventive step often proves the most contentious, as it demands a qualitative assessment of innovation. This criterion, central to Lord Hoffman’s statement, will form the core of this analysis.
The Inventive Step in Biogen Inc. v Medeva Plc
In Biogen Inc. v Medeva Plc [1997] RPC 1, Lord Hoffman articulated a nuanced perspective on the inventive step, emphasising that inventiveness may lie either in conceptualising a new application of known techniques or in devising a solution to a specific technical problem obstructing a desired goal. In this case, the dispute centred on a patent for a recombinant DNA method to produce antigens for hepatitis B. The House of Lords held that while the general goal of producing such antigens was known, Biogen’s specific method did not constitute an inventive step, as it was deemed obvious to a skilled person at the priority date. Lord Hoffman’s remarks suggest that the inventive step is not merely the overarching aim but the precise, non-obvious mechanism or insight that enables its achievement. This perspective prioritises technical contribution over mere aspiration.
Supporting Case Law on Inventive Step
The interpretation of inventive step has been further clarified in subsequent cases. For instance, in Pozzoli Spa v BDMO SA [2007] EWCA Civ 588, the Court of Appeal outlined a structured approach to assess inventiveness, which includes identifying the inventive concept and determining whether it would be obvious to a skilled person. This framework aligns with Lord Hoffman’s view by focusing on the specific contribution rather than the broader objective. Similarly, in Windsurfing International Inc. v Tabur Marine (Great Britain) Ltd [1985] RPC 59, the court established a structured test for obviousness, asking whether the step taken by the inventor was technically obvious. These cases reinforce the principle that inventiveness lies in overcoming specific barriers, not merely in envisioning an end result, echoing Lord Hoffman’s distinction between the goal and the means.
Critical Analysis of Lord Hoffman’s Statement
Lord Hoffman’s statement in Biogen offers a valuable lens for dissecting the inventive step, particularly in distinguishing between a general idea and a specific solution. However, its application can be complex. For instance, in fields like biotechnology, where incremental advancements are common, determining whether a solution is truly non-obvious remains challenging. Critics might argue that this focus on the specific step risks undervaluing the overall creative process, especially when the goal itself represents a significant conceptual leap. Nevertheless, cases like Actavis UK Ltd v Merck & Co Inc [2008] EWCA Civ 444 affirm that courts must prioritse the technical contribution over speculative intent, supporting Lord Hoffman’s position. Indeed, this approach ensures that patents reward genuine innovation rather than mere ambition, maintaining the integrity of the patent system.
Conclusion
In conclusion, Lord Hoffman’s statement in Biogen Inc. v Medeva Plc provides a critical framework for understanding the inventive step within the broader context of patentability. By distinguishing between the goal and the specific means of achieving it, his perspective ensures that patents are granted only for tangible, non-obvious contributions, as reinforced by cases such as Pozzoli and Windsurfing. While all four requirements of patentability—novelty, inventive step, industrial applicability, and non-exclusion—are essential, the inventive step remains a cornerstone of innovation assessment. The implications of this interpretation are significant, ensuring that the patent system incentivises genuine technical progress. However, its application must remain flexible to accommodate the complexities of modern innovation, particularly in rapidly evolving sectors. Ultimately, Lord Hoffman’s insights continue to guide courts in balancing the protection of ingenuity with the prevention of monopolistic overreach.
References
- Actavis UK Ltd v Merck & Co Inc [2008] EWCA Civ 444.
- Biogen Inc. v Medeva Plc [1997] RPC 1.
- Bently, L. and Sherman, B. (2014) Intellectual Property Law. 4th edn. Oxford University Press.
- Patents Act 1977. London: HMSO.
- Pozzoli Spa v BDMO SA [2007] EWCA Civ 588.
- Windsurfing International Inc. v Tabur Marine (Great Britain) Ltd [1985] RPC 59.
