Introduction

The case of Human Genome Sciences Inc v. Eli Lilly and Company ([2012] Bus LR D37) adjudicated by the United Kingdom Supreme Court centers on the validity of a patent claiming the nucleotide sequence of the gene encoding Neutrokine-α, a novel protein. The fundamental issue questioned the extent to which the requirement of industrial applicability under Articles 52 and 57 of the European Patent Convention (EPC) applies to patents for biological materials. The parties involved were Human Genome Sciences Ltd (HGS), the patent holder, and Eli Lilly and Company, which opposed the patent's validity.

Summary of the Judgment

HGS held a patent (European Patent (UK) 0,939,804) for Neutrokine-α, including its nucleotide sequence and associated claims. Eli Lilly challenged the patent's validity, leading to a series of legal proceedings. The European Patent Office's Opposition Division initially revoked the patent, a decision which the Board of Appeal later overturned, reinstating the patent based on the sufficiency of industrial applicability. However, in parallel proceedings in the English courts, Kitchin J and subsequently the Court of Appeal sided with Eli Lilly, revoking the patent on the grounds that it failed to meet the industrial applicability requirement. HGS appealed this decision to the Supreme Court.

The Supreme Court, led by Lord Neuberger and Lord Hope, overturned the Court of Appeal's decision, aligning UK jurisprudence more closely with that of the EPO. The Court concluded that the patent did satisfy the requirements of Article 57, emphasizing the plausible and credible basis for industrial application inherent in the patent's disclosure.

Analysis

Precedents Cited

The judgment extensively references previous EPO decisions to establish a consistent approach to assessing industrial applicability for biological materials:

• T 0870/04 BDP1 Phosphatase/Max-Planck: Emphasized the necessity of identifying a practical application beyond mere research tools.
• T 0898/05 Hematopoietic receptor/ZymoGenetics: Highlighted the importance of plausibility in the claimed use, even without experimental evidence.
• T 0604/04 PF4A receptors/Genentech: Differentiated between well-characterized functions and those requiring further elucidation.
• T 1329/04 Factor-9/John Hopkins: Discussed the plausibility of function based on structural features and family membership.
• T 1452/06 Serine protease/Bayer: Addressed the sufficiency of industrial applicability without direct evidence of activity.
• T 1165/06 IL-17 related polypeptide/Schering: Reinforced the need for plausible biological function based on family characteristics.

The judgment also references the Biotech Directive (99/44EC) and comparable US cases like Brenner v Manson and Fisher v Lalgudi to contextualize its reasoning within broader international patent law perspectives.

Legal Reasoning

The core of the Supreme Court's reasoning rests on aligning UK patent law with EPO jurisprudence. The Court outlined several key principles derived from the Board of Appeal's decisions:

• Practical Application: The patent must disclose a concrete and plausible industrial application, not merely a theoretical possibility.
• Plausibility and Credibility: Even in the absence of experimental evidence, if the disclosed invention is plausibly usable based on common general knowledge and family characteristics, it satisfies industrial applicability.
• Role of Bioinformatics: Modern techniques like bioinformatics can legitimately underpin claims of industrial applicability.
• Consistency with EPO Jurisprudence: UK courts are encouraged to follow EPO decisions to maintain uniformity across jurisdictions.

In this case, the Court found that the patent sufficiently disclosed Neutrokine-α's role based on its membership in the TNF ligand superfamily, supported by tissue distribution data and common general knowledge. The Supreme Court concluded that Kitchin J and the Court of Appeal had applied a more stringent standard than the EPO Board of Appeal, thereby incorrectly revoking the patent.

Impact

The judgment has significant implications for the biotech industry and patent law:

• Clarification of Industrial Applicability: Establishes that patents for biological materials need not always provide exhaustive experimental data if plausibility can be established through family characteristics and common knowledge.
• Alignment with EPO Jurisprudence: Enhances consistency between UK courts and the EPO, reducing uncertainty for patentees operating across jurisdictions.
• Encouragement for Early Patent Filings: Provides clarity for bioscience companies on patenting newly discovered genes and proteins, fostering innovation and investment by offering assurance of patent validity based on plausibility.
• Balancing Innovation and Public Interest: Ensures that patents are granted when there is a credible basis for industrial application, preventing the monopolization of undisclosed or speculative research areas.

Complex Concepts Simplified

Industrial Applicability

Under the EPC, an invention must be "susceptible of industrial application," meaning it can be made or used in any industry, including agriculture. For biological materials like genes or proteins, this doesn't necessarily require immediate commercial use but rather a plausible potential based on scientific understanding.

Plausibility and Credibility

A claim is plausible if, given the common general knowledge at the time, a skilled person would reasonably believe that the invention can be used as claimed without needing extensive further research. Credibility refers to the internal consistency and support from related scientific evidence.

Common General Knowledge

This refers to the collective understanding and information readily available to professionals in the field at the time of the patent application. It includes established scientific principles and recognized data about related technologies or biological families.

Bioinformatics

Bioinformatics involves the use of computational tools to analyze biological data, such as DNA or protein sequences. It allows scientists to identify relationships and functions of biological molecules based on sequence homology and structural features.

Conclusion

The Human Genome Sciences Inc v. Eli Lilly and Company judgment reinforces the necessity for patents on biological materials to demonstrate a credible potential for industrial application. By aligning UK law with EPO standards, the decision provides greater certainty for biotech innovators, ensuring that patents are granted based on plausible scientific foundations rather than exhaustive empirical validation at the application stage. This balance between fostering innovation and safeguarding public interest upholds the fundamental purpose of the patent system, promoting advancements in biotechnology while preventing the monopolization of nascent scientific discoveries.