Ruling sheds further light on patent disclosure requirements

Mr Justice Birss confirmed the point in a ruling that explored the validity of patents for sequencing DNA, and whether those patents had been infringed.

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 derive from work by Solexa, a spin out company from Cambridge University which Illumina acquired in 2007.

However, MGI argued it had not infringed Illumina's patents and counterclaimed that the patents were in fact invalid. One of the arguments they raised in this regard was that the patents were 'insufficient'.

The concept of sufficiency 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 the time 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.

Last summer the UK Supreme Court opined on the policy considerations around sufficiency in a case between biotech rivals Regeneron and Kymab, and set out eight principles to guide assessments of sufficiency by businesses, patent granting authorities and the courts. That case centred on two patents Regeneron owned concerning the production of human antibodies using transgenic mice. The patents described a technique for making such antibodies for treating human disease.

The Supreme Court held that Regeneron's patent claims "failed for insufficiency". This was because Regeneron had not specified precisely enough how a skilled person might insert the full range of human variable genes into mice even though its patents claimed rights over that full range.

Mr Justice Birss revisited the principles set out in the Regeneron decision when considering the dispute between Illumina and MGI. He said that while the principles from the Regeneron case were "not limited to product claims" they were "clearly focussed on product claims", and so he put forward amended wording to "recast" some of the principles in "general terms". In doing so, the judge confirmed that the principles apply to patented processes as well as to products.

"This decision provides clarity which will likely be welcomed by the life sciences sector," said Nicole Jadeja of Pinsent Masons, the law firm behind Out-Law.  "The judge's refinement of the principles established in the Regeneron case is a good example of the English justice system at its best: the Supreme Court has addressed the policy issues and the first instance court has applied the principles in a practical, workable manner, clarifying some aspects at least which would likely have given rise to further litigation." 

Mr Justice Birss' findings meant Illumina's patents had to be scrutinised in reference to the recast principles and in so doing he ruled that none of Illumina's patents failed for insufficiency.

There was some commentary in the aftermath of the ruling in the Regeneron case about whether the UK Supreme Court had got the balance right between rewarding invention through disclosure and allowing competition in the public interest.  Jadeja said: "Interestingly, Mr Justice Birss has  now clarified that the Regeneron case law applies to both product and process claims, but he has also said that so-called Regeneron insufficiency will be limited in many respects."

In reaching his decision, Mr Justice Birss considered the wording of Illumina's patents, which provided for a variety of possibilities. However, for the purposes of assessing sufficiency, the judge said that there is a need to determine the "relevant range" of those variables by reference to what is being claimed with the invention.  Anna Harley of Pinsent Masons said: "The court looked at what a relevant range might be, and said it depends on an examination of all the circumstances and the essence or core of the invention in the relevant context. Characterisation of the core invention of the patent is therefore crucial."

It must be possible for the skilled person to perform the invention across the whole scope of the claim within that relevant range, the judge confirmed, to meet the requirements of sufficiency.

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 despite accepting that "there would be tests to perform and a lot of work" involved. He determined, however, that this work would not amount to an undue burden on the skilled person.

Sarah Taylor of Pinsent Masons said: "Of interest is the fact that UK judges are engaging with precisely what constitutes the core invention of a patent, which is positive for innovation and industry. There are interesting parallels with supplementary protection certificate case law here, where the ‘core inventive advance’ concept was proposed by Mr Justice Arnold in the High Court in London but rejected by the Court of Justice of the EU in that context. However, this decision demonstrates that this idea is still clearly in the minds of the UK judiciary, highlighting the importance of clear patent drafting."

While this decision provides guidance as to the application of the Regeneron decision, it is unlikely to be the end of the story. Harley said: "The concept of what is a relevant range is fertile ground for future litigation, and we expect to see developments in this area over the months and years to come."

Co-written by Anna Harley of Pinsent Masons.