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 - 08 March 2024 - is below:

STOP PRESS

EUROPE

EU approves amendments to SPC Regulations

On 28 February 2024 the EU formally adopted, with some amendments, the SPC Regulation (Recast) and Unitary SPC Regulation proposed by the Commission in April 2023.   As many readers will know, the Commission’s proposal seeks to introduce a centralised regime for the examination of SPCs and establish a unitary SPC.  It also proposes some adjustments to the SPC Regulation in an attempt to iron out certain ambiguities in the law concerning, among other things, the holding of SPCs for the same product by two or more related entities and the need for a holder to give its consent to an SPC filed using its MA. The amended proposals approved by the European Parliament will now be scrutinised by the Commission and the Council which could propose further amendments or adopt the position of the Parliament.   It is expected that the proposals will be laid before the newly elected European Parliament following the summer elections and that the proposal could be adopted reasonably soon after that.

INDIA

The High Court of Delhi grants interim relief on the balance of convenience in India

On 6 February 2024, the Delhi High Court granted interim relief in favour of AstraZeneca AB & AstraZeneca Pharma India Limited (the Plaintiffs). The patent in suit, IN 297581 (granted in July 2018 and valid until July 2032), relates to osimertinib, a second-line treatment for non-small cell lung cancers which have underlying mutations in the Epidermal Growth Factor Receptor. The Plaintiffs have the exclusive right to manufacture, use, offer for sale, import or sell osimertinib in India.

The Plaintiffs alleged that a number of Defendants were involved in clandestine operations to manufacture, smuggle and sell infringing versions of osimertinib in India. This was based on a number of activities uncovered, and the Plaintiffs alleged the following;

(i) Defendant No.1 (Azista Industries Pvt. Ltd.) was marketing and selling the osimertinib in India, which seemed to be manufactured in Bhutan by Defendant No.2 (Azista Bhutan Healthcare).  However, the Plaintiffs argued that although the packaging stated that the drugs had been manufactured in Bhutan under the brand OSITAB, import-export data of the Defendants over the past few years revealed no imports of the impugned drug, suggesting that manufacture had actually taken place in India.  

(ii) Defendant Nos.3-5 (Hetero Group) were involved in the promotion of osimerinib in India through doctors and medical practitioners, and the medicines containing osimertinib  were readily available at retail outlets/pharmacies such as that of Defendant No. 6 (Mor Chemists Banjara Hills).

(iii) Multiple third-party entities were engaged in advertising and selling infringing versions of osimertinib under the brand name OSITAB on online platforms, e.g. that of Defendant No. 7 (IndiaMART InterMESH Ltd), with listings made by Defendant No. 8 (Hedge & Hedge Pharmaceutical LLP) and Defendant No. 9 (Celute Lifesciences Private Limited).  

(iv) Several unidentified persons were engaged in the trade and supply of infringing versions of osimertinib by facilitating smuggling across the Indo-Bhutan border, supplying further inland or distribution to various medical stores in India. 

Defendant Nos. 1-5 denied the allegations, claiming not to be involved in any infringing activities and not having any stock of the OSITAB product or any other infringing products.  These Defendants claimed that the only imports they were aware of were under Rule 36 of the Drugs and Cosmetics Rules, 1945, which allow small quantities of drugs to be imported for personal use subject to certain conditions.  In support of this, copies of permits granted by the Central Drugs Standard Control Organization in relation to such permitted imports were provided to the Court.  It was confirmed that Defendant No.2 was lawfully manufacturing OSITAB in Bhutan.  Defendant No. 8 also denied the allegations and stated that the listing on Defendant No. 7’s website had not been made or authorised by Defendant No. 8 and undertook to take appropriate action to remove said listings.  Despite receiving summons, Defendant Nos. 6 and 9 were not present at the hearing.

The Court considered that the balance of convenience lay in favour of the Plaintiffs, and found prima facie in favour of the Plaintiffs.  An ex parte interim injunction was granted against Defendant Nos. 6 and 9 and all others acting on their behalf for infringing activities directly or indirectly related to any products comprising the compound osimertinib. Defendant No. 7 was also directed to delist and delete listings on its platform relating to OSITAB. The court considered that without said interim relief, the Plaintiffs would suffer irreparable loss.

CANADA

Health Canada advises it is increasing transparency on the review process for generic drugs

On 23 February 2024, Health Canada published a notice advising that it will start disclosing more detail on its Generics Submissions Under Review List (GSUR List) regarding generic drug submissions accepted into review on or after 1 April 2024.  Currently, the GSUR List includes abbreviated new drug submissions (ANDSs) accepted into review on or after 1 October 2018 and currently discloses:

(i) the medicinal ingredients;

(ii) the therapeutic area; and

(iii) the number of ANDSs currently being reviewed with the same medicinal ingredient(s).

In addition to this, Health Canda will, from April 2024, disclose:

(iv) the year and month that the submission was accepted for review; and

(v) the company sponsoring the generic drug.  

Reasons for this additional disclosure provided in the notice include (a) reducing requests under the Access to Information (ATI) Act, which have increased significantly with few third-party objections; and (b) improving the consistency of transparency across drug classes (brand name, biosimilar and generics). 

UK

IPEC gives guidance on without prejudice communications

On 4 March 2024, Pat Treacy, sitting as a Judge of the Chancery Division, handed down a decision in Ocean on Land v Land relating to a patent licence and infringement action in which the parties had made a number of applications considering the admissibility of evidence for trial.

One particular issue of interest that was addressed by the Judge relates to the nature of “without prejudice” communications.  As many readers will know, if a communication is sent from one party to another seeking to settle an existing dispute, it may not be put before the court as evidence of admissions against the interests of the party which made them.  The “without prejudice” rule is subject to certain exceptions.  For example, it is impermissible to use the cloak of “without prejudice” to conceal unambiguously improper threats, such as threats to commence criminal proceedings.

The Judge held that, owing to the public policy rationale which underpins the without prejudice rule and the context in which it operates – often involving those who are not legally qualified and who are speaking and writing in situations of considerable tension – the rule requires broad protection for statements made when seeking to settle a dispute and the narrow application of any exceptions. Thus, conduct or statements which do not go beyond the bounds of what is to be expected in negotiation are not within the scope of the improper conduct exception.  

The take-home message is that parties cannot use the rules surrounding without prejudice communications to behave inappropriately towards each other.  However genuine attempts to compromise existing disputes will be protected, regardless of whether they are labelled “without prejudice” and the Court’s instinct will be to protect such communications if there is doubt.