IP-2024-000024 - [2024] EWHC 951 (IPEC)

The following summary comes from the evidence of Ms Lijuan Shi, Sales and Marketing Director (Endourology) at the Claimant, Mr Ralph Cox, partner at the Claimant’s solicitors, Mr George Reynolds, Sales Director of the Defendant, Mr Charles Reynolds, Managing Director of the Defendant (and Mr George Reynolds’ father), and Mr Noel Akers of the Defendant’s patent attorneys.

The Claimant was founded in 1998 and became a publicly traded company in 2004 when it was listed on the Shanghai stock exchange. It is in the business of developing, manufacturing, and distributing medical devices. Its core business covers urology, anaesthesia, respiratory care, and haemodialysis. It is a substantial business with annual sales of approximately £150 million and a total asset value of approximately £262 million as at the end of 2022. Within the endourology sector, it has approximately 20 products (including UASs, ureteral stents and dilation devices) which are distributed in China and around the world.

As noted above, endoscopic renal lithotripsy is the procedure of crushing and removing kidney stones. There are two types of endoscopic renal lithotripsy: percutaneous nephrolithotomy (PCNL) where advancement of the endoscope is via an incision in the abdomen, and retrograde intrarenal surgery (RIRS) where advancement of the endoscope is via the ureter. An access sheath is often used in these procedures. An obturator or dilator is generally required for the safe insertion of the sheath (it provides sufficient stiffening to allow insertion and has a dilating effect on the urethra). Once the sheath is in position, the obturator is removed and the endoscope is inserted. Irrigation is required during the procedure (normally saline) and it is delivered through the endoscope. The outflow of the irrigation fluid is through the space between the inner diameter of the sheath and the outer diameter of the endoscope. With a conventional sheath, the outflow is passive, dependent upon intrarenal pressure and gravity. The crushed stones are generally extracted using forceps or a stone basket or by use of high-pressure irrigation to flush the stone fragments out.

The Patent relates to a UAS with negative pressure suction functionality which is provided by a side arm oblique to the main sheath and with a longitudinal slit. The person using the suction functionality can alter the negative pressure by covering more or less of the slit. The negative pressure system allows the fragmented kidney stones to be removed with the saline solution as it passes back through the gap between the sheath and the endoscope (claim 1). In addition, the Patent also provides for a UAS with a flexible tip to allow the user to adjust the direction of suction, irrigation, instrument placement or removal of a stone (claim 3). The Patent has a filing date of 27 April 2015 and a priority date of 28 July 2014.

The Claimant sells two products in the UK which are said to exploit the Patent. The first product is the “ClearPetra Sheath” which was launched in 2016 after the Claimant obtained CE certification in 2015. This is said to have the features of claim 1. The second product is the “Flexi ClearPetra Sheath” which was launched in March 2023. This is said to have the features of claim 3.

Until recently, the ClearPetra family of products were the only UASs with negative pressure suction functionality on the market in the UK. There are competitors who also market UASs, such as Boston Scientific, Cook Medical and Rocamed, but they do not offer a suction UAS. The original ClearPetra Sheath is priced at £165 per unit, whereas the Flexi ClearPetra is priced at £125. Ms Shi explained that the Flexi ClearPetra was priced lower than the original sheath so as to be more competitive with existing conventional (i.e. non suction) UASs.

Ms Shi stated that the Claimant had no intention of changing the price of the Flexi ClearPetra Sheath over the next 24 months from the date of her statement (February 2024) but that it does intend to drop the price of the original ClearPetra Sheath to a similar level to the Flexi product, so that it has better access to clinical trials and procurement. She also said that the Claimant estimates that 6000 to 9000 units will be sold in the UK between February 2024 and February 2026, of which most will be the Flexi ClearPetra sheath.

ClearPetra is distributed in the UK through a specialist medical devices distributor called BioSpectrum Ltd.

The Claimant says that the ClearPetra Sheath enables a novel suction assisted procedure for kidney stone retrieval which is safe, with minimal complications and reduced need for ancillary treatment or post operative follow up, thereby resulting in costs savings for the hospital and benefits for the patient.

The Defendant is a private company based in Truro, Cornwall. It is a distributor of a wide range of medical and surgical devices in the UK. Its profits have grown annually between 2018 and 2023, with the latest available figures at over £2.2 million.

A recent addition to the Defendant’s product portfolio is the Seplou Sheath, which is also a negative pressure suction UAS. There appear to be two different versions of the Seplou Sheath, one of which has a flexible bendable tip (which the Claimant says is the same as the Flexi ClearPetra). It is the flexible version of the Seplou Sheath which is in issue here.

The Claimant first became aware of the Defendant’s involvement with the Seplou Sheath in the UK when it exhibited the product at the Eastern Urology Ground Annual Meeting on 17 November 2023. By this time, the Seplou Sheath was already known to the Claimant, since it is one of a large number (over 60) of alleged “copy” products of the ClearPetra Sheath that are produced in China.

There are approximately 18,000 cases of endoscopic renal lithotripsy performed annually in the UK. Of these, approximately 8400 procedures each year will be carried out using a sheath. Surgeons often prefer to conduct ureteroscopies without using an access sheath as this can result in a lower likelihood of post procedural complications. However, the use of an access sheath has the advantage of enabling the surgeon to make repeated passages of the ureteroscope into the patient. It can also improve the flow of irrigation fluid and visualisation of the procedure, as well as reduce operating time. If the surgeon uses a sheath, he or she can choose to use a conventional UAS or a suction UAS.

In the UK, UASs (including suction versions) are sold to the NHS and private hospitals. Sales to the NHS are made via the NHS Supply Chain once the product is listed on the NHS Framework. The current endourology Framework started on 21June 2021 and ends on 20 June 2025. It covers “consumables used within minimally invasive endourological procedures” and gives a list of approved suppliers and product categories. The Claimant’s distributor, BioSpectrum, and the Defendant are both suppliers for the current endourology Framework.

It is possible to apply to NHS procurement to add new endourological products to the NHS Supply Chain, but this can take up to 12 weeks to approve. The Defendant applied to add the Seplou Sheath to its range of endourological products for supply to NHS hospitals on 28 November 2023. The approval took longer than expected and the Seplou Sheath “went live” on the NHS Supply Chain website on 22 February 2024. Supply of the Seplou Sheath by the Defendant to NHS hospitals could begin only once this approval had been granted.