Introduction
The concept of patentability and the requirement of an inventive step are central to intellectual property law, particularly in the protection of novel inventions. In the case of Biogen Inc. v. Medeva Plc [1997] RPC 1, Lord Hoffmann articulated a nuanced perspective on what constitutes an inventive step under patent law. His statement, as provided in the essay title, highlights the multifaceted nature of inventiveness: it may involve applying established techniques in an unprecedented manner, devising a novel method to achieve a desired goal, or overcoming a specific obstacle that hinders progress towards a known objective. This essay aims to critically discuss Lord Hoffmann’s observations on the inventive step within the context of patentability requirements under UK law, with reference to relevant decided cases. The discussion will explore the legal framework of patentability, analyse the significance of Lord Hoffmann’s interpretation in Biogen Inc. v. Medeva Plc, and evaluate how subsequent case law has shaped or challenged this understanding. Through this analysis, the essay seeks to demonstrate a sound understanding of the legal principles governing patent law while considering the practical implications of defining an inventive step.
The Legal Framework of Patentability and Inventive Step
Under UK law, the requirements for patentability are enshrined in the Patents Act 1977, which aligns with the European Patent Convention (EPC). Section 1(1) of the Act stipulates that a patent may be granted only if the invention is new, involves an inventive step, and is capable of industrial application. The inventive step, as defined under Section 3, requires that the invention is not obvious to a person skilled in the art, having regard to the state of the art at the time of the application. This principle ensures that patents are granted only for creations that represent a genuine advancement in the relevant field, rather than incremental or routine modifications (Kitchin et al., 2011).
The concept of an inventive step is inherently subjective and context-dependent, often requiring courts to balance technical innovation against common knowledge in the field. Lord Hoffmann’s statement in Biogen Inc. v. Medeva Plc reflects this complexity by suggesting that inventiveness can manifest in various forms: as a novel application of existing methods, as a solution to a long-standing problem, or as a specific mechanism to overcome a technical barrier. This perspective underscores the need for a flexible approach in assessing patentability, one that accounts for the diverse ways in which innovation can occur.
Analysis of Lord Hoffmann’s Statement in Biogen Inc. v. Medeva Plc
In Biogen Inc. v. Medeva Plc [1997] RPC 1, the House of Lords addressed the issue of patentability in the context of biotechnology, specifically regarding a patent for a method of producing hepatitis B virus antigens using recombinant DNA technology. Lord Hoffmann’s remarks, as quoted in the essay title, provide a conceptual framework for understanding the inventive step. He distinguishes between three scenarios: using known techniques in a novel way, devising a method to achieve a previously unattainable goal, and solving a specific problem that obstructs progress towards a known objective. In each case, the inventive step lies not necessarily in the end goal but in the specific innovation that enables progress.
Lord Hoffmann’s first point—that inventiveness can reside in applying established techniques to a previously unthought-of purpose—aligns with the notion that innovation need not always involve groundbreaking technology. For instance, in the case of Hickman v. Andrews [1983] RPC 147, the court upheld a patent for a workbench design (the ‘Workmate’) that combined existing mechanical principles in a novel manner to create a versatile tool. This decision illustrates how the inventive step can lie in the creative application of familiar ideas, resonating with Lord Hoffmann’s observation.
Secondly, Lord Hoffmann’s emphasis on devising a way to achieve a desired but unattainable goal highlights the problem-solving aspect of inventiveness. This is evident in Genentech Inc.’s Patent [1989] RPC 147, where the court considered a patent for the synthetic production of a human protein using genetic engineering. Although the goal (producing the protein) was known, the method to achieve it was deemed non-obvious and thus inventive. Such cases demonstrate that the inventive step can lie in the ‘how’ rather than the ‘what,’ a principle central to Lord Hoffmann’s reasoning in Biogen.
Finally, his third point—solving a specific problem obstructing a broader goal—focuses on incremental but critical advancements. In Biogen itself, the invention addressed a technical challenge in producing hepatitis B antigens, which, while not the ultimate goal of curing the disease, represented a significant step forward. This nuanced view challenges a simplistic interpretation of inventiveness, suggesting that even partial solutions can warrant patent protection if they involve non-obvious innovation.
Supporting and Contrasting Case Law on Inventive Step
Subsequent and preceding case law provides further insight into the application of Lord Hoffmann’s principles. For example, in Pozzi v. Becton Dickinson [2005] EWCA Civ 594, the Court of Appeal considered whether a safety syringe mechanism constituted an inventive step. The court ruled that while the concept of a safety syringe was known, the specific mechanism to achieve retractability was non-obvious to a skilled person, thereby meeting the requirement for an inventive step. This decision mirrors Lord Hoffmann’s view that inventiveness can reside in solving a particular technical problem, even if the broader goal is not novel.
However, the interpretation of inventive step is not always straightforward, as demonstrated in Conor Medsystems Inc. v. Angiotech Pharmaceuticals Inc. [2008] UKHL 49. Here, the House of Lords, including Lord Hoffmann, grappled with the issue of obviousness in relation to a drug-eluting stent for treating vascular disease. The court held that the patent was valid, focusing on whether the invention as a whole was obvious, rather than dissecting individual components. This holistic approach somewhat contrasts with the granular focus on specific solutions in Biogen, suggesting that the context of the invention significantly influences the assessment of inventiveness.
Moreover, the European Patent Office’s (EPO) problem-solution approach, often adopted in UK courts, complements Lord Hoffmann’s observations. This method involves identifying the closest prior art, defining the technical problem solved by the invention, and determining whether the solution would have been obvious. Cases like T 939/92 AgrEvo illustrate how this framework prioritises the technical contribution of the invention, aligning with Lord Hoffmann’s emphasis on specific solutions over general goals.
Critical Reflections on the Inventive Step Requirement
While Lord Hoffmann’s statement provides a valuable framework for assessing inventiveness, it also raises questions about the subjectivity inherent in defining an inventive step. The determination of obviousness relies heavily on the hypothetical ‘skilled person,’ whose knowledge and creativity levels are often difficult to standardise. For instance, in fields like biotechnology, as seen in Biogen, rapid advancements can render yesterday’s innovation obvious today, complicating patent assessments (Sherman and Bently, 2008). Furthermore, the balance between rewarding genuine innovation and preventing monopolisation of trivial advancements remains a challenge, as overly broad patents can stifle further research.
Arguably, Lord Hoffmann’s nuanced perspective helps address these issues by focusing on the specific contribution of the invention, whether it be a novel application, a method, or a solution to a barrier. However, critics might contend that such flexibility risks inconsistency in judicial decisions, as courts may differ in prioritising one aspect of inventiveness over another. Indeed, the divergence in approaches between cases like Conor and Biogen highlights the need for clearer guidelines on assessing inventive step in complex technical fields.
Conclusion
In conclusion, Lord Hoffmann’s statement in Biogen Inc. v. Medeva Plc offers a comprehensive lens through which to view the inventive step requirement in UK patent law. By recognising that inventiveness can manifest in the novel use of known techniques, the creation of methods to achieve desired goals, or the resolution of specific technical problems, his analysis underscores the diverse nature of innovation. Supporting cases such as Hickman v. Andrews, Genentech Inc.’s Patent, and Pozzi v. Becton Dickinson illustrate the practical application of these principles, while contrasting decisions like Conor Medsystems Inc. v. Angiotech Pharmaceuticals Inc. highlight the contextual challenges in defining obviousness. Ultimately, while Lord Hoffmann’s framework provides a robust foundation for assessing patentability, the subjective nature of the inventive step and the rapid evolution of technology necessitate ongoing judicial and legislative refinement. The implications of this discussion extend beyond legal theory, influencing innovation policy and the balance between protection and competition in the intellectual property domain.
References
- Bently, L. and Sherman, B. (2008) Intellectual Property Law. 3rd edn. Oxford University Press.
- Kitchin, D., Llewelyn, D., Mellor, J., Meade, R., Moody-Stuart, T., Burkill, G. and Birss, C. (2011) Kerly’s Law of Trade Marks and Trade Names. 15th edn. Sweet & Maxwell.
- Biogen Inc. v. Medeva Plc [1997] RPC 1.
- Conor Medsystems Inc. v. Angiotech Pharmaceuticals Inc. [2008] UKHL 49.
- Genentech Inc.’s Patent [1989] RPC 147.
- Hickman v. Andrews [1983] RPC 147.
- Pozzi v. Becton Dickinson [2005] EWCA Civ 594.
- T 939/92 AgrEvo (European Patent Office Board of Appeal).
