March 2018 – UK Court of Appeal Judgment in Regeneron v Kymab
This is an important judgement on sufficiency. Regeneron’s patents relate to methods of producing human antibodies using transgenic mice. The mice are produced by “in situ replacement” of mouse variable regions with human variable regions whilst the mouse constant regions are retained (i.e. “reverse chimeric locus”). At first instance, Mr Justice Carr invalidated the patents for insufficiency because they did not enable the genetic modification across the breadth of the claims without undue burden and invention. He construed “in situ replacement” to cover the deletion of very large segments of mouse DNA and the insertion of the equivalent human regions (as per the method in Example 3 of the patent). On the basis of expert evidence, he found that the method in Example 3 was not achievable at the time of the invention.
The CoA reversed the decision on insufficiency. Regeneron did not challenge the finding that Example 3 could not be performed but instead they argued that the skilled person could have implemented the reverse chimeric locus without undue effort using technology described in the patent and by making simple and obvious adjustments which included making a “minigene”. The CoA held that minigenes were part of the CGK at the priority date and that it would have been obvious and technically feasible for the skilled team to create a transgenic mouse without undue burden using this construct. The technical contribution of the patents was the use of a “reverse chimeric locus” which was a principle of general application and was a feature of all claimed embodiments. Therefore, the claim was adequately enabled across its breadth and its scope was commensurate with its technical contribution. The patent was not insufficient simply because the specification promised too much.
September 2018 – UK High Court Judgment in Teva & others v Gilead
Mr Justice Arnold’s latest referral to the CJEU on supplementary protection certificates (SPCs) sought further guidance on the application of Article 3(a) of the SPC Regulation. Despite the CJEU’s July 2018 decision not being “pellucid” in places (to quote Arnold J), he extracted and applied a two-step test to revoke Gilead’s SPC for an HIV combination product (emtricitabine + tenofovir). First, the combination was not one that the skilled person would understand, on the basis of the description and drawings and their CGK, to embody the technical contribution made by the patent. Second, tenofovir was not specifically identifiable, in the light of all the information disclosed by the patent. He refused Gilead’s application, made after the CJEU decision was given, to adduce expert evidence on CGK. The CJEU’s key message, he said, is that “the purpose of the SPC Regulation is to enable the holder of the basic patent to obtain supplementary protection for what the patentee actually invented and not for what the patentee did not invent.”
Upcoming Judgments
Hot on the heels of 2017’s Lilly v Actavis, in February 2018 the UKSC grappled with another patent case – Warner Lambert v Actavis (pregabalin) – covering a range of issues including construction of second medical use patents, post-trial applications for amendment of invalid claims and the role of plausibility in the statutory test for sufficiency. A decision is expected imminently. The UKSC is due to hear another patent case in November about the correct approach to assessing inventiveness – Actavis v ICOS. A decision is anticipated in the first half of 2019. Another decision to watch out for in early 2019 is the CJEU’s postponed judgment in the Abraxis SPC case about what constitutes a first marketing authorisation where the product is a new formulation of an old active ingredient.
Emma Fulton is a life sciences IP senior associate at Hogan Lovells
