- More than a year after pharmaceutical giant Bayer filed an urgent motion in court, the ruling has been handed down.
- Pharmaceutical giant Bayer previously secured a ban to stop importing generic blood-thinning tablets
- It also stopped Clicks from selling the cheapest generics.
More than a year after reserving judgment in a pressing question, Judge Colleen Collis has finally delivered her ruling. You confirm the patent rights of pharmaceutical giant Bayers.
Bayer won its court challenge, preventing Clicks from selling a cheaper generic blood-thinning drug that competes with Bayer’s patented product.
Bayer went to the Gauteng Court of Commissioner of Patents last year to stop Clicks from selling the tablets.
The case before Judge Collis involved evergreen, in which pharmaceutical companies that hold patents on medicines extend the patent term.
In the case of rivaroxaban the patent would have expired in December 2020. Bayer was granted a new patent extending the expiration to January 2026 on the basis that it had changed the dosage to once a day. Bayer said the one-day dosing was an inventive step as required by patent law.
After the initial patent expired (i.e. December 2020), two rival companies, Austell and Dr Reddys, launched generic versions of rivaroxaban for sale in South Africa.
Although Bayer obtained a ban against the two companies, that ban did not extend to pharmacies that stocked generic products, including Dr. Reddy’s anticoagulant drug Rivaxored.
Dis-Chem and Alpha Pharm have reached a settlement with Bayer, agreeing not to sell the generic drugs, but Clicks has chosen to oppose the urgent interdict petition filed in Judge Collis.
The judge explained that the application was filed pending the final determination of a patent infringement action filed by Bayer against Dr Reddys Laboratories.
He referred to the fact that in December 2021 Judge Raylene Keightley had granted an interim interdict against Dr Reddys, the company that imported Rivaxored into South Africa.
In terms of that interdict, the court held that the patent was prima facie valid and that the sale of Rivaxored in South Africa constituted prima facie infringement of the patent (Bayer). This was not heard on appeal, Judge Collis said.
Despite this, Clicks had refused to stop selling the drug.
The judge said that Bayer had argued that the very purpose of the order Judge Keightley granted was to be defeated by Clicks. That although Clicks was not bound by the order, her conduct undermined the court’s authority to prevent wrongful business conduct and showed little respect for the court’s findings.
In considering the merits, Judge Collis said Clicks had openly asserted that the Bayer patent was invalid and was unwilling to accept that the dosage change 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 dealt with extensively in the Keightley judgment.
Judge Collis said Clicks had also challenged the constitutionality of the Patents Act which allowed so-called evergreening through dosage changes.
However, Clicks did not disclose any facts relevant to this claim and Judge Collis could not determine.
It said it was undisputed that Bayer was losing sales as a result of Clicks’ continued sale of Rivaxored and that Bayer would have difficulty proving the full extent of its losses if it were to file a claim for damages.
Furthermore, Clicks had not argued that it would be prejudiced by the granting of the interim interdict. Instead he argued that Bayer would only lose R3 million in sales based on its current inventory levels and this bias is offset by the public interest of the public in accessing a cheaper alternative.
Justice Collis said the public interest argument had been raised before Justice Keightley by Dr Reddys and in an unrelated patent case before the Supreme Court of Appeal, and had been dismissed in both forums.
He said that in the Supreme Court of Appeals matter the marginal harm to a small percentage of patients in the private sector (who either lack medical care or have to make a small contribution) was not considered sufficient to outweigh the negative interest effect public of failure to enforce valid patents.
Judge Collis granted the interdict, ordering Clicks to pay the costs of the proceedings.
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