Regeneron and Illumina: a case for (and against) ranges

Insufficiency in patents, especially in emerging and complex technologies, can be a real problem for patent applicants. They are keen to progress to filing for obvious reasons and yet are expected to disclose how the invention works to its fullest extent. Problems arise in cases where a patent claim seeks to reserve a range of some sort. Recent judgments of the English Patents Court and the UK Supreme Court have suggested that this is not a trivial problem in most cases of analysis. The upshot appears to be that a range patent is not to be struck down as insufficient simply because a range exists. Much depends upon the importance of the range to the claim or, in the Illumina case, whether mention or the existence of a range is in any way relevant. An analysis of two recent judgments in the UK concerning sufficiency of disclosure sheds considerable light on the current ambit of legal thinking in this area of patent law.

Pharmaceutical Law and Patent Law

The patent law and pharma laws and regulations need to be coordinated. The interpretative proposal of the author is that a patent claim aiming at protecting the invention as a medicinal product must necessarily be expressed using the appropriate terms provided for by the laws and regulations concerning the industrial medicinal product, such as “medicinal product” and “active substance”; otherwise the patent may not be considered as covering a “medicinal product” or an “active substance”. Moreover, as a consequence, the presentation of a product in a patent claim as a medicinal product or an active substance implies that the enforceability of such claim is conditioned upon the demonstration of the efficacy and safety of the product through the preparation and approval by the competent authorities of a dossier of pharmacological and clinical trials. The legal system taken into consideration by the author is the European one, but the interpretative proposal is, mutatis mutandis, applicable to other systems of law.

Congenericity of Claimed Compounds in Patent Applications

A method is presented to analyze quantitatively the degree of congenericity of claimed compounds in patent applications. The approach successfully differentiates patents exemplified with highly congeneric compounds of a structurally compact and well defined chemical series from patents containing a more diverse set of compounds around a more vaguely described patent claim. An application to 750 common patents available in SureChEMBL, SureChEMBLccs and ChEMBL is presented and the congenericity of patent compounds in those different sources discussed.

Vagueness of Patent Claim Language, Claim Construction and Patent Infringement – What a Mess!

The claim drafting process, which is inherently related to inventions, is not exempt from difficulties. Prominent among these is vagueness, which can often be the chief characteristic of patent claims. This paper argues that such ambiguities may hamper the development and teaching functions of patent documents and can also distort infringement systems. It addresses legal issues related to patent claim construction, including the use of intrinsic or extrinsic evidence to clarify an ambiguous or vague claim. Confusion surrounding the use of expert testimony for determining the meaning of a claim is also highlighted. Largely based on the US law, the paper suggests ways to reduce claim ambiguity, such as the use of claim charts. Emphasis is placed on the clarity of the claims’ wording, because this acts as a safeguard against any infringement risk. In brief, constructing patent claims remains largely an unsettled and uncertain area of patent law. What really matters is the clarity of the claim language because definiteness, preciseness, conciseness and exactness are major guarantees of a patent’s validity.