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 - 12 April 2024 - is below:

EPO

The exclusion of diagnostic methods from patentability – practising on the human or animal body.

On 16 January 2024, the EPO Technical Board of Appeal (TBA) held that a claim relating to collection of breath samples, and method steps of a technical nature to analyse the samples, was not excluded from patentability under Art. 53(c) EPC. The Examining Division had refused the main request on the sole basis that claim 1 defined a diagnostic method practised on the human body within the meaning of Art. 53(c) EPC. The claim in issue was to a method for diagnosing Helicobacter pylori infection in a patient, comprising administering an acid mixture to the patient, collecting a first breath sample, administering ¹³C-labelled urea, waiting 10-60 minutes, collecting a second breath sample and finally analysing the samples by determination of a ¹³C/¹²C ratio by spectroscopy.

Under Art. 53(c) EPC, diagnostic methods practised on the human or animal body are excluded from patentability. The scope of the exclusion was interpreted by the Enlarged Board of Appeal in G 1/04, which decided that the requirement for “practised on a human or animal body” is satisfied if the performance of the diagnostic method implies any interaction with the human or animal body necessitating the body’s presence.

In the present case, the TBA firstly considered whether claim 1 was directed to a diagnostic method within the meaning of Art. 53(c). Here, the Board agreed with the Examining Division that all the method steps were practised on a human or animal body, as the measurement of the 13C isotopes in the sample cannot be isolated from the step of collecting the sample from the patient. However, the Board disagreed with the Examining Division insofar as it considered that the further method steps of a technical nature within the claim, i.e. measuring the content of 13C in the CO2 of the first and second sample and determination of a 13C/12C ratio by spectroscopy in the respective samples, did not necessarily require the presence of the patient. The Board distinguished this case from T 125/02, which related to a method for ascertaining lung function of a human subject. In that case, the human subject was required to be connected to the device and the measurements took place during exhalation.

The Board set the decision under appeal aside and remitted the case to the Examining Division for further prosecution.

IL

Previous inconsistent ILPTO decision on the PTE eligibility of proteins overturned.

The Deputy Commissioner at the ILPTO recently overturned a decision of the Deputy Chief Examiner, regarding whether a different glycosylation pattern is sufficient to confer PTE eligibility where a protein with the same amino acid sequence was previously approved. The Deputy Commissioner held that a protein having a novel glycosylation pattern, which provides for significant differences i.e. in the pharmacokinetic properties can nevertheless be “new” for PTE purposes, despite having the same amino acid sequence.

In 2023, the ILPTO rejected a PTE petition for Nexviazyme (avalglucosidate alpha) on the basis of a previously registered drug, Myozime (alglucosidase alfa), which has the same amino acid sequence. The difference between the two was that Nexviazyme also had covalently attached glycan moieties (i.e. a different glycosylation pattern). The Deputy Chief Examiner held that different glycosylation is insufficient to confer PTE eligibility, notwithstanding that it led to superior pharmacokinetic and pharmacodynamic properties. It could not be regarded as novel because it had the same amino acid sequence and the same activity as the previously approved therapy. In previous decisions of the ILPTO, for example the Kovaltry and Ferring decisions, it was held that a new glycosylation pattern may be eligible for a PTE only if it contributes to a significant difference in the properties of the drug (e.g. pharmacodynamic, pharmacokinetic, immunogenic or adverse events profile). As such, this decision of the ILPTO Deputy Chief Examiner was appealed to the Deputy Commissioner.

In the decision, the Deputy Commissioner placed emphasis on the intentional differences in the glycosylation pattern being the result of covalently attached glycan moieties, leading to the improvement in the pharmacokinetics of the protein. This was sufficient to distinguish it from the Ferring decision, where a drug was not eligible for a PTE because the different glycosylation pattern was the result of manufacturing processes and did not alter the safety or efficacy of the drug. The Deputy Commissioner therefore overturned the decision and held that Nexviazyme was “new” for PTE purposes.

UPC

Court of Appeal Decision on Access to Documents.

The Court of Appeal has dismissed Ocado's appeal against the Nordic-Baltic division's decision to grant a member of the public access to documents in Ocado v AutoStore. This is important news for those interested in transparency at the UPC. We will publish a full analysis in due course, but in the meantime, some of the key findings are highlighted below. Decision here.

The Court of Appeal noted that when a request to make written pleadings and evidence available to a member of the public is made pursuant to r. 262.1(b) RoP, the interests of a member of the public of getting access to the written pleadings and evidence must be weighed against the interests mentioned in Art. 45 UPCA. These interests include, but are not limited to, the protection of confidential information and personal data. In this case, the balance of interest was in favour of allowing access.

Both parties agreed that a member of the public generally has an interest that written pleadings and evidence are made available and the Court of Appeal states that this “allows for a better understanding of the decision rendered, in view of the arguments brought forward by the parties and the evidence relied on. It also allows scrutiny of the Court, which is important for trust in the Court by the public at large.”

The Court also accepted that "scientific and/or educational interests" constitute a legitimate interest to request access, even if a case has been settled. An argument made by Ocado that access should not be given if proceedings have come to an end due to a settlement, as the settlement may have been made on confidential terms, did not hold.

UPC

Change of name of party permitted where the claimant had not correctly named the defendant.

The Court of Appeal issued a collection of five Orders in relation to the NJOY v Juul dispute relating to vaping products. NJOY had filed five revocation actions at the Paris Central Division, incorrectly naming “Juul Labs, Inc.” as the patent proprietor rather than the correct “Juul Labs International, Inc.” At first instance, NJOY argued that there was confusion and a clerical error and the Paris Central Division granted permission for the name change. Juul appealed.

On appeal, the Court of Appeal held that the request could be granted if the defendant is not unreasonably prejudiced by the incorrect statement of name and its rectification.

In this case, the Court of appeal stated: “Given that, despite the incorrect statement of name, it must have been clear to the appellant that the statements for revocation were directed against it, the appellant was not unreasonably prejudiced by the incorrect statement of name and by the rectification ordered by the Court of First Instance.” The Court of Appeal therefore rejected the appeal and allowed the name change.

This case demonstrates a pragmatic approach to dealing with errors at both first instance and appeal, which is welcome news for potential users of the UPC system.

Also of note from the decision are comments on how the court will approach the award of costs. In these appeals, the Court of Appeal commented “No decision on the reimbursement of legal costs will be made in this appeal, since this order of the Court of Appeal is not a final order or decision, i.e. not an order or decision concluding the revocation actions”. Therefore, there was no specific award of costs in relation to these appeal proceedings. However, the Court of Appeal did point out that these appeal proceedings should be considered in a final decision on costs (i.e. in the main action).