The High Court's first patent decision of 2021, Illumina v MGI, has seen the first full consideration of the Supreme Court's judgment in Regeneron v Kymab. Mr Justice Birss, in what is thought to be his last trial before he is elevated to the Court of Appeal, has refined the insufficiency principles established by the Supreme Court in Regeneron, clarifying that the level of precision which businesses must provide when disclosing their inventions applies to patented processes as well as products.
This article considers Birss's refinement of Regeneron as an example of the English and Welsh justice system at its best: the Supreme Court addressed the policy issues relevant to the patent bargain and the first-instance court has applied the principles in a practical, workable manner, providing important clarification of some aspects of the Supreme Court decision.
Patent holder Illumina sued five companies in the Beijing Genomics Institute group (MGI), claiming that MGI's DNA sequencer systems infringed five of its patents. The patents in issue related to improved modified nucleotides for use in DNA sequencing. They derived from work undertaken by Solexa, a spin-out from Cambridge University which Illumina acquired in 2007.
MGI denied infringement and counterclaimed that the patents were invalid. The issues in this case were numerous, including arguments relating to infringement by the doctrine of equivalents, culminating in a decision of more than 500 paragraphs. However, the case is most notable for being the first to substantively apply and consider arguments in respect of Regeneron insufficiency.
The concept of sufficiency in UK patent law is derived from Section 72(1)(c) of the Patents Act 1977, which states that a patent is liable to be revoked if "the specification of the patent does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art". The relevant date for assessing a patent's sufficiency is that on which the patent application was filed.
It is established case law in England and Wales that the question of whether the requirements of sufficiency are met boils down to whether the skilled person can readily perform the invention over the whole area claimed without undue burden and without needing inventive skill.
In Summer 2020 the Supreme Court opined on the policy considerations underlying the principles of sufficiency in Regeneron. The Supreme Court held that Regeneron's patent claims concerning the production of human antibodies using transgenic mice were insufficient. The crux of the issue for the Supreme Court was whether a disclosure was sufficient if the teaching in the patent enabled only some, but not all, of the products within the claimed relevant range. The Supreme Court found the Regeneron patents to be insufficient because the patents in question enabled the skilled person to make products across only what was considered to be a small part of the deemed relevant range within the scope of the claims. The Supreme Court differed from the Court of Appeal by holding that if the disclosure was held to be sufficient in this case, it would defeat the patent bargain, even if the invention amounted to a principle of general application.
In giving the leading judgment for the Supreme Court in Regeneron, Lord Briggs put forward eight guiding principles following his review of the authorities on sufficiency. Birss revisited these principles when considering the dispute between Illumina and MGI. He said that although the principles were not limited to product claims, they were clearly focused on them. To resolve this issue, Birss 'recast' several of Briggs's principles in more general terms, reflecting the statutory language of Section 72(1)(c) of the Patents Act 1977. In doing so, the judge confirmed that the principles apply to patented processes in addition to products.
Insufficiency and Regeneron range
A key question in both Regeneron and Illumina was how the law of sufficiency applies to ranges and, specifically, the need to identify the relevant range and the type of range before determining the consequences where a patent does not enable the skilled person or team to work the claimed invention across its relevant range. Briggs's principle, as recast in Illumina, stated as follows:
The disclosure required of the patentee is such as will, coupled with the common general knowledge existing as at the priority date, be sufficient to enable the skilled person to perform substantially all the types or embodiments… within the scope of the claim. That is what…enablement means.
Briggs made it clear that the sufficiency test would not be defeated by an irrelevant factor, such as the length of a mouse's tail. The requirement to show enablement across the scope of a claim applies only to a relevant range. This begs the question of what 'a relevant range' means.
Birss discussed this concept in Illumina. For a 'relevant range in the Regeneron sense' to be sufficient there must be enablement across the whole scope of the claim within the relevant range without undue burden (subject to minor exceptions) at the relevant date. In such circumstances, the presence of an embodiment within the claimed range which could not be performed at the relevant date would be fatal.
This should be compared with 'ranges that are not relevant in the Regeneron sense'. For example, where descriptive features in a claim (functional or structural) cover a variety of things but the variety does not significantly affect the value or utility of the claimed process or product in achieving its purpose, the relevant purpose is judged in all circumstances including the essence of the invention. In these circumstances, the skilled person must still be able to make a suitable selection without undue burden within the range for the claim to be sufficient, but the claim will not be insufficient simply because its scope covers things that had not been invented at the relevant date.
The concept of the essence or core of an invention is an interesting one and Illumina is not the first case in which it has been considered by patent judges in England and Wales. There are interesting parallels with case law relating to the doctrine of equivalents and supplementary protection certificates (SPC). In respect of SPCs, the 'core inventive advance' concept was first proposed by Lord Justice Arnold as a key feature of his proposed test for determining whether a product is protected by a patent but was not adopted by the European Court of Justice in that context. In respect of the doctrine of equivalents, the English and Welsh courts have clearly identified the need to consider the inventive concept when considering whether a variant can be considered to infringe. This decision again brings the concept of the very essence of an invention to the fore.
When discussing relevant range, Birss highlighted the importance of knowing the essence of the invention and gave the very English example of a patent for a teapot that does not drip. The non-drip feature would be determined by spout length and shape, but the material from which the teapot is made would be irrelevant. The claim may therefore cover conventional materials, future types of material as yet unknown and even unsuitable materials such as chocolate. In short, the type of material of which the teapot is comprised would be important to enable the teapot to operate as intended but would not itself relate to the core inventive concept of the non-drip feature.
Therefore, following Regeneron, a non-drip teapot would not need to be enabled across the entire scope of all possible materials – the range of materials is not a relevant range in the Regeneron sense. However, the teapot must be enabled over all possible spout lengths and shapes that provide the non-drip feature, since these are the features which give value, utility and purpose to the invention.
Applying this to the facts in issue in Illumina, Birss held that the ranges put forward by Illumina were not Regeneron ranges. They did not amount to the essence of the invention. Beyond the fact of being suitable, the particular nucleotide, polymerase, linker and label in the first set of relevant claims do not significantly affect the value of the method to achieve the purpose for which it is being carried out. In another claim, as a matter of claim construction, the read length was also not considered a relevant range.
The judge went on to consider whether selecting suitable nucleotides, polymerases, linkers and labels would be an undue burden. In this case he held that that the skilled person would be able to perform DNA sequencing within the relevant range of Illumina's patent claims exercising "skill and some routine testing", which would not amount to an undue burden. Therefore the insufficiency arguments failed.
Implications for life sciences innovation and patent filing strategies
This decision provides clarity which will likely be welcomed by the life sciences sector. Birss's refinement of Regeneron applies the principles set out by a Supreme Court decision in a practical manner. There was some commentary post-Regeneron about whether the Supreme Court had got the balance right between rewarding invention through disclosure and allowing competition in the public interest. Biotech companies often grapple with when to file their patent applications: if they file too early, they may not be able to protect the full scope of their contribution, while filing too late can prevent them from securing investment.
However, as a result of Illumina, biotech companies should feel reassured that while Birss clarified that Regeneron applies to both product and process claims, he also said that Regeneron insufficiency will be limited in many respects:
Once the concept of a relevant range is properly understood, I think it will be an unusual case in which the kind of ordinary descriptive or functional language one sees in most patent claims will be regarded as a relevant range in the Regeneron sense.
Despite this, and while this decision provides guidance as to the application of the Regeneron decision, it is unlikely to be the end of the story. MGI has been granted permission to appeal the court's decision in Illumina. One of MGI's key grounds of appeal argues that the judge misapplied the test set out in Regeneron. More generally, the concept of a relevant range is fertile ground for future litigation and developments in this area are expected.
