A judgment in an urgent matter about the sale of generic blood-thinning tablets in South Africa has not been delivered, more than a year after the matter was heard – with GroundUp reporting that it is astonishing for a judge to take 12 months over any judgment, let alone an urgent one.
The judicial norms and standards state that judgments, in non-urgent matters, should be handed down within three months of being reserved.
The case deals with the extension of pharma giant Bayer’s patent on a drug called rivaroxaban from December 2020 to January 2026.
In 2000, Bayer obtained a patent on rivaroxaban. Patents are granted for 20 years and so the patent was to expire in December 2020. The patent-holder of a medicine, in this case Bayer, has exclusive control over it. No other pharmaceutical company may sell the medicine in South Africa during the patent period, at least not without Bayer’s permission.
In 2007, Bayer obtained a patent for rivaroxaban to be dosed once daily (the original patent was silent on dosing). This extended the patent to 19 January 2026. This kind of patent extension is widely criticised by health activists and is called evergreening.
After the initial patent expired in December 2020, two pharmaceutical companies, Austell and Dr Reddy’s, launched generic versions of rivaroxaban. In short, there followed a series of court actions resulting in Austell and Dr Reddy’s being interdicted from selling their versions of rivaroxaban in South Africa.
But the interdicts did not yet stop the big three pharmacy groups, Dis-Chem, Alpha Pharm and Clicks, selling the stock they had of both generic products.
Dis-Chem and Alpha Pharm reached a settlement with Bayer in respect of Dr Reddy’s product, Rivaxored, but Clicks did not. According to its court papers, the company was sitting with about 3 000 boxes of the generic. The generics are about 40% cheaper than Bayer’s pills.
Bayer then applied to the court of the commissioner of patents to interdict Clicks from selling rivaroxaban and obtained an urgent interim interdict in March 2022.
Shortly after that, in April 2022, the main (and still urgent) hearing for this application took place and Judge Colleen Collis reserved judgment.
That is where matters stand, more than a year later.
As of 13 May, OpenUp’s medicine price website gives the price of a pack of 42 Xarelto (Bayer’s rivaroxaban product) 15mg tablets as R1 532 Austell’s equivalent product, Rezalto, is R 931.26. Dr Reddy’s product, Rivaxored, is a little higher priced than Rezalto (at 15mg) but considerably lower than Bayer.
There’s also iXarola, Bayer’s “authorised generic”, which they brought to market just before the expiry of the 2000 patent. It’s priced at R1 285. (These prices exclude the dispensing fee.)
One year and counting
There are a number of court cases dealing with the issue. One of these is that between Bayer and Clicks and was heard in the court of the commissioner of patents in Gauteng.
But what is clear is that in April 2022 Judge Collis reserved judgment in this urgent matter about the sale of the tablets. More than a year later, she has failed to hand down her ruling.
GroundUp previously reported that the last available list of late judgments on the judiciary’s website is 31 December 2021. The judiciary has stonewalled our requests for an updated list.
We asked for comment from Chief Justice Raymond Zondo and Collis but received no response.
See more from MedicalBrief archives:
Research into popular blood thinner drug under scrutiny
Mortality benefit to adding rivaroxaban to aspirin in coronary artery disease — COMPASS trial
AHA recommendation on newer type of blood-thinning medications