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 - 27 October 2023 - is below:
MHRA issues guidance on the new requirement that valproate-containing medicines be supplied in the manufacturers’ original full packaging
On 11 October 2023, the Medicines and Healthcare Regulatory Authority (MHRA) issued a guidance note outlining changes to legislation made pursuant to the Human Medicines (Amendment Relating to Original Pack Dispensing) (England and Wales and Scotland) Regulations 2023 (SI 2023/1015) (the Regulations). The Regulations amend the Human Medicines Regulations 2012 (SI 2012/1916) (HMR). The changes do not apply to Northern Ireland, where they should be considered as good practice.
Valproate, a drug for the treatment of bipolar disorder and epilepsy, is a known teratogen (an agent that causes an abnormality following foetal exposure during pregnancy). The manufacturers’ original full pack for medicines containing valproate alerts patients of the teratogenic risk if valproate is taken during pregnancy. The MHRA had in the past asked manufacturers to produce smaller pack sizes of valproate containing medicines, however as a consequence of repackaging, there were concerns from patient groups that such warnings were not always being provided to patients, and that some patients taking the medicine were unaware of the teratogenic risk.
Accordingly, the HMR were amended to ensure that all patients (male and female) would receive information on the risks and be made aware of the conditions of the Valproate Pregnancy Prevention Programme. The amendment adds a new regulation which requires valproate containing medicines to be given to the patient in the manufacturer’s original full pack as of 11 October 2023.
UPC Court of Appeal issues its first order and Nordic-Baltic regional Division rules on file inspections
On 13 October 2023, the UPC Court of Appeal issued an order in favour of Sanofi indicating that the time limits in Rules 19.1 and 23 of the Rules of Procedure (“RoP”) should be extended by the period during which the annexes were not available. In the case between Sanofi v Amgen, Amgen failed to upload annexes to their Statement of Claim onto the Case Management System which raised the question as to when the Statement of Claim should be deemed to have been served and whether there should be an extension of time for Sanofi to file any Preliminary Objection and Statement of Defence.
As Amgen had not supplied a copy of the documents referred to in the Statement of Claim pursuant to Rule 13.2, the Court concluded that these extensions of time should be granted to Sanofi.
On 17 October 2023, the Nordic-Baltic Regional Division handed down an Order in relation to an application by a third party requesting access to the Statement of Claim in a case, along with any Orders that had been made and, if possible, any Orders that had been made in cases between the same parties at the local divisions in Düsseldorf and Milan (those proceedings, based on other patents, had been initiated and were withdrawn). The applicant wished to see how the claim filed in the Nordic-Baltic division was framed, particularly since it was filed in parallel with cases in other divisions, and argued that there would be a broad public interest in this information being made available for public scrutiny and discussion as the new court system develops.
The Court ruled that the applicant had provided a credible explanation for why it wanted access to the Statement of Claim. None of the parties had submitted a request for confidentiality pursuant to Rule 262.2 and therefore it was not necessary to make the document confidential in the interests of other affected persons, or in the general interest of justice or public order. Access was granted to the Statement of Claim, after redaction of personal data within the meaning of Regulation (EU) 2016/679. The Court ruled that if a person has made an application under Rule 262.1(b) for access to pleadings or evidence and provided a credible explanation for why they would like access, the application shall be approved unless it is necessary to keep the information confidential. This is in contrast to the earlier decisions of the Munich Local Division. The application in relation to the Order in this action was rejected as it had already been published on the UPC website. The application for Orders in the related cases was also rejected on the basis that it was not for the instant Court to take a view on the Orders in those cases. Permission to appeal was granted.