8 June 2023
More than a year after reserving judgment in an urgent application, Judge Colleen Collis has finally handed down her ruling. It confirms pharmaceutical giant Bayer’s patent rights.
Bayer has won its court challenge, preventing Clicks from selling a cheaper generic blood thinning medication, in competition with Bayer’s patented product.
Last year Bayer approached the Court of Commissioner of Patents in Gauteng to stop Clicks from selling the tablets.
The case before Judge Collis was about “evergreening”, in which pharmaceutical companies who have patents on medicines extend the life-time of the patent.
In the case of rivaroxaban the patent was due to expire in December 2020. Bayer was granted a new patent extending the expiry to January 2026 on the basis that it changed the dosage to once a day. Bayer claimed the one-day dosage was an “inventive step” as provided for in Patent law.
After the initial patent expired (i.e. in December 2020), two rival companies Austell and Dr Reddy’s, launched generic versions of rivaroxaban for sale in South Africa.
While Bayer obtained an interdict against the two companies, that interdict did not extend to the pharmacies which had stocks of the generic products, including Dr Reddy’s anticoagulant drug Rivaxored.
Dis-Chem and Alpha Pharm reached a settlement with Bayer, agreeing not to sell the generic drugs, but Clicks chose to oppose the urgent interdict application which came before Judge Collis.
The judge explained that the application was brought pending the final determination of a patent infringement action instituted by Bayer against Dr Reddy’s Laboratories.
She referred to the fact that in December 2021, Judge Raylene Keightley had granted an interim interdict against Dr Reddy’s, the company that imported Rivaxored to South Africa.
“In terms of that interdict, the court found that the patent was prima facie valid and that the sale of Rivaxored in South Africa constituted a prima facie infringement of the (Bayer) patent. This has not been taken on appeal,” Judge Collis said.
Notwithstanding this, Clicks had refused to stop selling the drug.
The judge said Bayer had contended that the very purpose of the order granted by Judge Keightley was being defeated by Clicks. That while Clicks was not bound by the order, its conduct undermined the authority of the court to prevent unlawful commercial conduct and was “showing scant regard for the findings of the court”.
In considering the merits, Judge Collis said Clicks had “baldly asserted” that the Bayer patent was invalid and that it was not prepared to accept that the change in dosage was an “inventive step”.
However, Bayer argued that in Dr Reddy’s application, the inventiveness of the patent was dealt with through expert evidence and had been “comprehensively dealt with in the Keightley judgment”.
Judge Collis said Clicks had also challenged the constitutionality of the Patents Act which permitted so-called “evergreening” through dosage changes.
However, Clicks had failed to disclose any facts relevant to this claim and Judge Collis could not make any determination of it.
She said it was “undisputed” that Bayer was losing sales as a result of the continued sale by Clicks of Rivaxored and that Bayer would find it difficult to prove the full extent of its losses should it have to launch a damages claim.
Clicks had also not argued that it would be prejudiced by the grant of the interim interdict. Instead it argued that Bayer would only lose R3 million in sales based on its current stock levels and this prejudice is outweighed by the public interest of the public being able to access a cheaper alternative.
Judge Collis said the public interest argument had been raised before Judge Keightley by Dr Reddy’s and in an unrelated patent case before the Supreme Court of Appeal, and it had been rejected in both forums.
She said that in the Supreme Court of Appeal matter “the marginal harm to a small percentage of patients in the private sector (who don’t have medical aid or who have to make a small co-payment) was not considered to be sufficient to outweigh the negative public interest effect of failing to enforce valid patents”.
Judge Collis granted the interdict, and ordered Clicks to pay the costs of the application.