Neurim v. Mylan-- the Illiad was shorter

The Neurim v. Mylan saga, which started two years ago, is still going strong. The latest was a ruling by the High Court on 24 January 2022 (2022) EWHC 109 (Pat) (read here).

The ups and downs, and the turns this dispute have taken, remind one of a rollercoaster. A year ago, Neurim was successful in the UK trial ([2020] EWHC 3270 (Pat)) when its claims of infringement were accepted by the court and counterclaims on the invalidation of its patent were rejected, only to shortly thereafter see its patent invalidated in the EPO (patent EP 1 441 702). For the sake of precision, the invalidity of the patent was the result of Neurim withdrawing its appeal to the Technical Board of Appeal (TBA), this in order to avoid an unfavorable decision.

Some months ago, the court gave Neurim a new chance at obtaining injunctive relief against Mylan by agreeing that Neurim could have a expediated preliminary issue trial ([2021] EWHC 2198 (Pat)). On 24 January 2022, the court then ruled on preliminary issues of the case ((2022) EWHC 109 Pat).

The patent in question

Neurim was granted a Divisional patent (EP 3 103 443) on 30 June 2021 to expire on 12 August 2022. Neurim then moved to change the claims of the Divisional patent to align them with ”parent” patent (EP 1 441 702), which had invalidated the year before by the EPO.

The invention in question

The invention at the center of this litigation saga is related to Neurim’s medical product, Circadin. The claims of the patent are second medical use claims, namely on the use of melatonin for the tratment of insomnia characterised by non-restorative sleep for patients over 55. Non-restorative sleep refers to a condition where a patient spends time asleep but does not feel refreshed.

The procedure

The parent patent was attacked on various grounds in the 2020 action, principally obviousness, anticipation over Haimov and various insufficiencies, including uncertainty, insufficiency and lack of plausibility insufficiencies. Mylan pursued the attacks based on insuffiency in the action against the Divisional patent as well, and it is also related to the ”lay-patient” argument. The patent in question is a second medical indication, the clinical result of which must be made plausible by the specification. Taking into consideration that the claims specifically adress restorative sleep, general improvements in sleep quality are not enough.

Finally, there is a lack of objective measurement to determine sleep quality, subjective experiences of patients being the only measurement available . Even here, the documentation provided in the patent lacks specificity regarding the questions posed to patients or to the patients' answers.

Mylan tried to convince the Patents Court to stay UK proceedings pending final determination of the EPO opposition proceedings concerning the Divisional. The judgement, though brief was clear and Mylan’s application was refused [2021] EWHC 2897 (Pat).By applying the IPCom v HTC ([2013] EWCA Civ 1496) and taking into consideration the limited period for relief for Neurim within the patent term, set to expire in August 2022, the court ruled in favor of Neurim.

A decisive factor was Neurim’s offer of an undertaking to repay any damages or profits awarded should the patent be finally revoked either in the EPO or on an application by Teva in the UK courts (Teva has recently launched another generic product, against which proceedings are likely to be taken by Neurim). The judge commented that Neurim’s proposal was offered late in the day but took it into account as shifting the “” seventh IPCom factor (achieve a commercial certainty at a considerably earlier date in the UK than in the EPO).

                                        

The ruling on the preliminary issues of the High Court of the 24th of January 2022

The preliminary issues considered by the Court can be summed up in the following points:

- Whether Mylan is issue-estopped from challenging the validity of the Divisional patent in the light of the 2020 action, in which the parent patent was declared valid. Neurim claimed that taking into consideration the 2021 ruling on the validity and infringement of the parent patent EP702, and since the Divisional patent was changed to so its claims would be identical to the claims of the parent patent, the validity and infringement of the patent could not be contested anew by Mylan.

- Whether Neurim’s conduct in amending the Divisional patent is abuse of patent. The fact that Neurim changed the claims of the Divisional patent to turn them into identical claims to the parent patent that the TBA had invalidated just a year ago, this in order to support a claim of issue-estoppel and to prevent Mylan from attacking its validity, constituted patent abuse. In other words, Mylan claimed that although Neurim accepted the invalidity of the parent patent, by withdrawing the appeal, it now asserts the same right again.

- Whether Neurim’s conduct amounts to an abuse of a dominant position (on the assumption of dominance and market definition). Mylan's competition-law related claims were used as a safety net, should the court rule in favor of issue-estoppel. Such claims would potentially also give Mylan a right to damages.

The court answered in the negative on all three points, ruling that Mylan is not issue-estopped from challenging the validity of the Divisional patent, and that Neurim’s conduct should be considered patent abuse. The court did not grant issue-estoppel on the ground that the reasoning and findings in the main judgement were not fundamental to the overall result in this litigation.

As well, the court noted that Neurim’s actions regarding its Divisional patent do not constitute a patent abuse, both because Divisional patents are frequently used as back-ups, and this per se is not considered an abuse. Furthermore, since the court has not allowed issue-estoppel, there cannot be an issue of patent abuse. For the same reason, the court decided that the alleged competition law-related abuses need not be considered.

Some comments

There are several issues that are of interest. First is the question of Divisional patents and how in paricular they are used when the parent patent has been invalidated. Another is that of sufficiency of disclosure in cases of second medical indications.When the invention is such that both the description and the results of the invention are dependent on the experiences of the ’lay patient’, how are these experiences to be documented in the patent specification.

In the proceedings in the High Court, Neurim makes detailed claims as to the lack of a fair trial offered in the TBA procedures. This seems peculiar, and while the court tries not make too much of it, it does adresses the question.

Such a claim in a national proceeding, however peculiar, is a side-effect of the European Patent system. Procedures in the EPO will undoubtedly influence national enforcement procedures. However whether claims of a fair trial in the EPO can potentially be taken into consideration by national courts seems not so straightforward.

Finally, this Kat personally welcomes more interplay between the patent system and competition law rules. Although a detailed ruling on the competition law claims was not deemed necessary, it seems obvious to this Kat that these two areas of law will only get closer. If so, this may be what it takes to achieve greater balance in the exercise of patent rights.