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 - 3 May 2024 - is below:

UK

IPEC rejects Well Lead Medical’s application for a preliminary injunction against rival CJ Medical.

On 26 April 2024, Charlotte May KC, sitting as a Deputy Judge of the Intellectual Property Enterprise Court (IPEC), refused to grant a preliminary injunction sought by Well Lead Medical Co Limited (WLM) against CJ Medical Limited (CJM) for its product, Seplou Sheath. Seplou Sheath is an endourology device known as an ureteral access sheath (UAS) and used in a common urological procedure for the treatment of kidney stones.

WLM had applied for a preliminary injunction on the basis that Seplou Sheath infringes its patent EP (UK) 3 760 143 B1 (EP 143). EP 143 relates to a UAS with negative pressure suction functionality and a flexible tip to allow for user adjustments. WLM sells two products in the UK (ClearPetra Sheath and Flexi ClearPetra Sheath) which exploit the patent. Seplou Sheath also has a negative pressure suction and there are two versions, one of which WLM claims is the same as Flexi ClearPetra Sheath. CJM was recently granted approval to supply Seplou Sheath to NHS hospitals.

In reaching its decision, the Court applied the principles set out in American Cyanamid v Ethicon [1975] AC 396. WLM submitted that it would suffer unquantifiable damage if the injunction was not granted. It also argued that various aspects of CJM’s evidence were false and misleading but the Court concluded that the discrepancies relied on by WLM were no reason to treat CJM’s evidence with less weight. WLM stated that, by virtue of its current market exclusivity:

• it has control over how ClearPetra Sheath is introduced into the market and medical professionals are educated about the product (and the associated surgical procedure); and
• third parties are currently deterred from entering the market. Furthermore, sales had increased since the product’s launch and WLM was strengthening its efforts to establish Flexi ClearPetra Sheath “as the gold standard”.

As such, exclusivity in educating the market as to its benefits was crucial.

The Court concluded that there was no evidence that Seplou Sheath would interfere with WLM’s ability to market its products or educate the medical community. The Court also ruled that there was no specific evidence about any third parties entering the UK market, beyond a medical devices distributor that could be prevented from accessing the market through other mechanisms.

The Court considered WLM’s argument that CJM had made derogatory statements about ClearPetra Sheath to the market. WLM argued that an injunction would ensure CJM has no real motive to make such statements in the future. The Court ruled that this point was flawed and unsupported by evidence.

WLM also argued that, if a preliminary injunction was refused, there would likely be a substantial and irreversible price depression of the ClearPetra Sheath products. The Court rejected this, as there was insufficient evidence to conclude that a price war which would drive down prices was likely or that there would be a price reduction due to third party entrants. It was also not in CJM’s interest to cause a price war, particularly when it is the only other supplier of suction UAS products on the market.

Finally, WLM argued that damages in the period (hypothetically assumed) between when it succeeds in obtaining a permanent injunction after trial and the expiry of the patent (Period 2) could not be quantified adequately because it would be difficult for WLM to restore prices to their original levels after trial if a preliminary injunction is was refused. (WLM accepted it would not suffer unquantifiable harm during Period 1, the period between the date of the application for the preliminary injunction and trial as the CJM had accepted that during this period each Seplou Sheath it sold would result in a lost sale of WLM’s ClearPetra Sheath product). The Court was not persuaded that it would be difficult for WLM to raise its prices back to original levels during Period 2 if there was a price reduction. Furthermore, any price depression would be for a relatively short period of time and there was not sufficient time for the market to become entrenched in relation to pricing. Also, as WLM had given clear evidence about its sales forecasts for Period 2, the task of calculating damages, if a preliminary injunction was refused, would be relatively straightforward.

The Court therefore concluded that damages were an adequate remedy to WLM and the application was refused.
 

UPC

Preliminary injunction ordered against Curio by the Düsseldorf Local Division in 10x Genomics v Curio.

On 30 April 2024, the Düsseldorf Local Division granted a preliminary injunction in favour of 10x Genomics against Curio Bioscience. The decision relates to EP 2 697 391, covering technology for mapping the location of nucleic acids within tissue samples.

The Court's decision rested on several key findings. First, it found 10x Genomics to be the rightful owner of the patent, despite Curio's arguments to the contrary. Second, the Court performed an analysis of the patent's claims and determined that Curio's products likely infringed claim 14. Finally, despite some prior art presented by Curio, the Court found claim 14 likely to be both novel and inventive.

The Court considered the matter to be urgent, as 10x Genomics demonstrated a lack of prior knowledge among relevant “decision-makers” at 10x Genomics about the potentially infringing Curio products even though the application was made over 10 months after the launch of the products in Europe. The competitive nature of the market and the risk of long-term damage to 10x Genomics meant that a preliminary injunction was seen as necessary. Ultimately, the court ruled that the potential damage to 10x Genomics outweighed the potential risks to Curio.

The Court ordered Curio to stop infringing activities and to pay a penalty for any violations. 10x Genomics was required to provide a security deposit. This case is significant, being the third preliminary injunction granted by the Düsseldorf Local Division. More information and detail on the decision can be found here on our microsite.
 

INDIA

Delhi High Court rules on process for amending patent claims during PCT application entry into India.

On 23 February 2024, the Delhi High Court addressed critical issues in Mitsui Chemicals v Controller of Patents C.A. (COMM IPD-PAT) 196/2022), focusing on the treatment of claims during a PCT application's national phase entry into India, the patentability of methods of agriculture under s. 3(h) of the Patents Act 1970, and claim amendments under s. 59.

Mitsui Chemicals (Mitsui) filed a national application (no. 3877/DELNP/2009) claiming a method of preventing plant disease and insect damage by applying an insecticidal composition for plant seeds comprising the active ingredients penthiopyrad and dinotefuran. The Patent Office issued its First Examination Report (FER) in May 2013, objecting to the national phase claims under s. 3(h) of the Patents Act 1970 (the Act) (s. 3(h) excludes methods of agriculture or horticulture from patentability). Mitsui filed a revised set of claims later that year, which the Patent Office still considered to fall foul of s. 3(h) of the Act.

Mitsui filed a further amended set of claims in response, which claimed the penthiopyrad and dinotefuran composition rather than the method of preventing plant disease and insect damage, effectively amending the claims from process to product claims. The Patent Office ruled that these amendments were inadmissible under s. 59 of the Act for added matter.

Responding to this objection, counsel for Mitsui cited s. 138(4) of the Act, arguing that the specification and claims of the PCT application should be considered part of the complete specification of the national phase application too for the purpose of assessing whether the amendment falls within the scope of the specification. Further, counsel for Mitsui claimed that since there had been no formal application to amend the claims when filing the national phase application, the official claims on record were the claims of the PCT. The Patent Office had therefore erred in using the claims of the national phase application when assessing whether the amendments fall foul of s. 59 of the Act.

Counsel for the Patent Office argued that Mitsui had specifically narrowed its national phase application by deleting the product claims in its initial filing and therefore should not be permitted to re-introduce these claims through amendments during prosecution.

The Court accepted Mitsui’s contention, stating that s. 138(4) of the Act unmistakably indicates that the claims of a PCT application including a designation for India are inherently considered to be part of the complete specification for the purpose of the Act.

Finally, the Court ruled that the Patent Office must provide more detailed and nuanced analysis before classifying subject matter as inadmissible under s. 3(h) of the Act. The Court therefore set aside the Order of the Patent Office refusing Mitsui’s application and remitted the matter back to the Patent Office to be considered afresh.