SOUTH AFRICA— The Court of Commissioner of Patents in Gauteng, South Africa, has recognized Bayer South Africa’s patent claim against Clicks, South Africa’s largest pharmacy chain, effectively stopping them from selling a generic blood-thinning drug in South Africa.

More than a year after pharmaceutical giant Bayer brought an urgent application to the court, Judge Colleen Collis has finally handed down her ruling that confirms pharmaceutical giant Bayer’s patent rights.

Pharmaceutical giant Bayer had previously obtained an interdict to stop the import of generic blood thinning tablets.

The ruling now effectively stops Clicks from selling the cheaper generics.

The hearing was about just 2,963 packs of blood-thinning pills worth less than US$106,112 still in Clicks stock rooms­ which Click noted was only a fraction of 1% of Bayer South Africa’s annual turnover.

Bayer South Africa’s legal team, in turn, responded that ditching those 2,963 packs of pills would cost Clicks just 0.005% of the Clicks Group’s turnover.

The applicants were Bayer Intellectual Property GMBH, Bayer AG, and Bayer (Pty) Ltd which form part of a multi-billion-dollar multinational group listed on all of Germany’s stock exchanges.

It has a market capitalization of over US$50.4 billion and publicly disclosed assets of perhaps double that value.

The respondent, New Clicks SA, through its United Pharmaceutical Distributors division, supplies pharmaceuticals to 650 Click pharmacies, major private hospital groups, and over 1,300 independent pharmacies.

Clicks South Africa is a Johannesburg Stock Exchange-listed parent company, with an annual turnover of US$1.98 billion in 2021.

In 2007, Bayer was granted a South African patent that covers the manufacture and use of an oral, rapid-release formulation of rivaroxaban, an anticoagulant medication to be taken as a pill once a day, sold under the brand name Xarelto.

Xarelto is prescribed for the treatment of patients prone to develop blood clots that cause disorders such as pulmonary thrombosis, deep vein thrombosis, stroke, and hip & knee replacements, making it Bayer’s highest-selling pharmaceutical product globally.

Subsequently, its first sale in 2008, more than 83 million global patients have been treated using Xarelto.

It is also Bayer South Africa’s biggest-selling pharmaceutical product by a considerable margin and in 2022 its sales of the product totalled US$16.5 million and accounted for more than 25% of its pharmaceutical division’s turnover.

In the case of rivaroxaban, the patent was due to expire in December 2020 and 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.

After news broke that pharmacies had sufficient stocks of Dr. Reddy Pharmaceutical’s generic to last for years, in February this year, Bayer launched an urgent Patent Court application.

This time it wanted to stop the three pharmacy groups from selling Dr. Reddy’s generic pills they still had in stock.

Bayer argued that if the pharmacies were allowed to continue selling the generics until the main action is finalized, the harm caused to Bayer South Africa would be substantial, irreparable, and unquantifiable.

Dis-Chem and Alpha Pharm reached a settlement with Bayer, leaving Clicks with its 2,963 unsold packs of pills alone in opposing Bayer’s interim interdict application in the Patent Court last week.

Clicks opted not only to continue opposing the interim interdict application but also announced that, in the public interest, they would be joining Dr. Reddy in defending the still-pending main patent case.

In terms of section 27 of South Africa’s Constitution, citizens have the right access to healthcare services.

The state has a positive obligation to take reasonable legislative and other measures, within its available resources, to achieve that right’s progressive realization, since cost is the main inhibitor of access the medicine.

“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.

Judge Collis granted the interdict and ordered Clicks to pay the costs of the application.

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