Irides: Weekly patent litigation update

The Irides Weekly Update is our round-up of patent litigation news highlights from around the world. Taking its name from the plural of “iris” - a nod to the ability of Irides to see what’s happening around the world.

Our latest edition - 17 May 2024 - is below:

UK - STOP PRESS

Court of Appeal dismisses appeal in Rivaroxaban litigation.

On 16 May 2024, following an expedited appeal hearing, the Court of Appeal gave a short oral judgment dismissing Bayer's Grounds of Appeal and upheld the decision of His Honour Judge Hacon in which he held the patent to be invalid for obviousness (as reported in Irides Weekly Update 16/2024). The Court of Appeal also lifted the injunction that had been in place pending the appeal hearing.  The Court's full reasoning will be handed down in due course.

AU

Australian Federal Court hands down decision in Neurim, providing further guidance on infringement of second medical use claims.

In a decision of 12 April 2024, the Federal Court of Australia handed down its judgment in Neurim Pharmaceutics (1991) v Generic Partners Pty Ltd (No 5), finding Neurim’s patent valid and infringed by the respondents. The applicant, Neurim, brought proceedings against the first and second respondents (Generic Partners and Apotex, respectively) for infringement of claims 1-7 of Australian Patent 2002326114 (the Patent). The Patent’s second medical use claims relate to the prolonged release of melatonin to treat primary insomnia characterised by non-restorative sleep. Such second medical use claims included both Swiss-style claims and method of treatment claims. Neurim’s product covered by the patent is Circadin®, which is indicated for the treatment of primary insomnia characterised by poor quality sleep in patients 55 and over. Neurim brought infringement proceedings against Generic Partners and Apotex in relation to their generic product, Melotin, which had the same approved indication as Circadin®. The Patent expired on 12 August 2022.

Infringement was alleged under s. 117(2)(b) and s. 117(2)(c) of the Patents Act for the method of treatment claims 4-7, and under s. 13(1) of the Patents Act for the Swiss-style claims 1-3. Further or alternatively, infringement was alleged by authorisation and common design. The issues arising under s. 117 included whether (i) Melotin is a staple commercial product (s. 117(2)(b)), (ii) if not, whether the respondents have reason to believe Melotin will be prescribed or recommended by medical practitioners for use by patients as a treatment for primary insomnia characterised by non-restorative sleep to improve the restorative quality of their sleep (also s. 117(2)(b), and (iii) whether the respondents provided any instructions or inducement to use Melotin as a treatment for primary insomnia characterised by non-restorative sleep to improve the restorative quality of sleep (s. 117(2)(c)).

In regard to the first question, the Judge considered that the question was not whether the product has non-infringing uses, but whether it is supplied commercially for various uses. It was held that sleep disorders are a narrow field of use, and melatonin was not a staple commercial product.

In regard to the second and third questions, expert evidence on the interpretation of “non-restorative sleep” was central to the outcome, along with the fact Circadin® was approved for use in accordance with the approved indication only, and Melotin was approved for the same indication. The Judge was satisfied on the evidence that a reasonable person supplying a prescription medicine (Melotin) approved for treatment of primary insomnia characterised by poor quality sleep would have reason to believe that the medicine would be prescribed by a not insignificant number of psychiatrists for primary insomnia where the patient complained of non-restorative (or unrefreshing) sleep. Claims 4-7 were therefore infringed under s. 117(2)(b). In contrast, as the product information document for Melotin referred to “poor quality sleep” and not “non-restorative sleep”, the Judge was not persuaded that there was explicit instruction in the product information document (nor the approved indication) to use Melotin as a treatment for the claimed use. The requirements under s. 117(2)(c) were not therefore met for infringement of claims 4-7.

The analysis of infringement of Swiss-style claims 1-3 was concerned with what the allegedly infringing manufacturer had done, not what it intended to do. The bioequivalence of Melotin to Circadin® and the fact that it was suitable for use as a treatment for primary insomnia characterised by non-restorative sleep was not determinative of infringement, rather the product information document and approved indication were of greater significance. The approved indication was not the same as the claimed use, and it was determined from the expert evidence that “quality of sleep” (the approved indication) was broader than “non-restorative sleep” (the claimed use). The Judge therefore concluded that, although it is reasonably foreseeable that Melotin will be used by some clinicians for the therapeutic purpose specified in the claims, it is also reasonably foreseeable and highly likely that Melotin will mostly be used for other, non-infringing therapeutic purposes. On this basis, the Judge was not persuaded that Melotin is a medicament manufactured for the therapeutic purpose specified in the Swiss-style claims. Claims 1-3 were not therefore infringed.

The Respondents cross-claimed for invalidity of the Patent, relying on lack of clarity and full description, lack of fair basis, lack of novelty and lack of inventive step. The Judge was not persuaded by the lack of clarity and description arguments, considering that the term “non-restorative sleep” and related terms could be understood and interpreted in accordance with DSM-IV criteria and in the context used. The specification as a whole makes the nature of the invention and how to perform it clear to the person skilled in the art. The novelty and inventive step attacks also failed, the Judge finding that the features identified in the claim have a technical effect directly related to the claimed advantage of the invention and were not a narrower use fitting within a broader use for the old product already described in the prior art. The cited prior art considered alone or in various combinations along with the common general knowledge would not have led the skilled person to try melatonin in the expectation that it may provide a useful treatment for primary insomnia characterised by non-restorative sleep.

The Patent was therefore found valid and infringed (claims 4-7 only), an outcome which is in line with the UK Courts’ findings on the corresponding EP parent and divisional patents. Finally, the Judge opined that, had the patent not expired, this was not a case where a blanket injunction would have been appropriate, given the extent to which Melotin is likely to be used for non-infringing purposes.

UPC

Court of Appeal dismisses PI appeal in SES-Imagotag v Hanshow and considers the correct approach to claim interpretation.

On 13 May 2024, the UPC Court of Appeal handed down an Order upholding an earlier decision of the Munich Local Division that the preliminary injunction requested by SES-imagotag SA Electronics (recently renamed VusionGroup SA) (SES) against Hanshow Technology Co. and the Hanshow Group (Hanshow) should be refused. In doing so, the Court declined to address the question of whether the file wrapper should be consulted when construing patent claims, which will come as a disappointment to many readers as this aspect of the case was one of the most interesting parts of the first instance decision; the first instance court considered the file wrapper (the original version of the claim) when interpreting the granted claims. The Court of Appeal was chaired by President Klaus Grabinski and consisted of three legally qualified and two technically qualified judges.

SES claimed that Hanshow was infringing its patent EP 3883277 (EP 277) and applied to the UPC on 4 September 2023 for interim measures. EP 277 relates to an electronic labelling system used in retail spaces and the dispute focused on the positioning of a printed circuit board in relation to an antenna and electronic chip. According to the wording of the granted claims, the printed circuit board should be placed “on the back of the housing” and the antenna placed “on or in the housing on the side of the front of the electronic label”. The first instance court looked at the version of the claim originally filed which established a direct link between the chip arranged on the printed circuit board and the antenna such that they were required to be “at a distance” from each other. Hanshow’s allegedly infringing products had a substantial part of the antenna resting on the rear side of the housing. By interpreting the claim in the context of the amendments made during examination, the Court held that the antenna could not be arranged on the front and rear sides of the electronic label at the same time. Therefore, infringement could not be established and no interim measures were granted.

On appeal, SES argued that the Court had incorrectly interpreted the features of the patent claims. In its decision, the Court of Appeal cited the principles set out in 10x and Harvard v Nanostring (UPC_CoA_335/2023 App_576355/2023) for interpreting patent claims in accordance with Art.69 EPC, including the following:

• The patent claim is not only the starting point, but the decisive basis for determining the scope of protection of a European patent.
• The interpretation of a patent claim is not solely dependent on its exact wording in the linguistic sense. Rather, the description and the drawings of must always be consulted as explanatory aids for the interpretation of the patent claim and not only be used to resolve any ambiguities in the patent claim. However, this does not mean that the patent claim merely serves as a guideline.
• The patent claim is to be interpreted from the perspective of the person skilled in the art.
• When applying these principles, appropriate protection for the patent proprietor should be combined with sufficient legal certainty for third parties.

In light of the patent description and the general knowledge of the skilled person, the Court of Appeal came to the conclusion that the Court of First Instance had correctly construed the claims and agreed with its finding that infringement could not be established with a sufficient degree of certainty. The Court held that documents from the examination proceedings before the European Patent Office cited by the parties shed no new light on the interpretation of the patent claims. Therefore, it was not necessary for the Court of Appeal to address the question of whether the grant history should be taken into account when determining the scope of protection of a European patent.

The Court of Appeal found, following the standard for interim relief set out in 10x and Harvard v Nanostring, that there was not a sufficient degree of certainty that Hanshow’s products infringed the patent. As a consequence, SES’s appeal was dismissed and SES were ordered to pay the costs of the appeal proceedings.