AstraZeneca Secures Injunction Blocking Pharmacor's Generic Diabetes Drug Launch in Australia

AstraZeneca has secured a Federal Court ruling that blocks local generics maker Pharmacor Pty Ltd from selling its cheaper versions of the diabetes drug dapagliflozin until a full trial can be heard. Justice Kylie Downes of the Federal Court on Monday granted an interlocutory injunction restraining Pharmacor from selling, supplying or otherwise disposing of multiple dapagliflozin products in Australia before the expiry of AstraZeneca's patent, or further order of the Court.

The patent at issue, AU 2003237886, relates to dapagliflozin — the active pharmaceutical ingredient in AstraZeneca's blockbuster diabetes drug Forxiga — and is due to expire on October 22, 2027. Pharmacor had been preparing to launch multiple products containing dapagliflozin this year, including through the Pharmaceutical Benefits Scheme, eyeing a dramatic reduction in price and a share of Australia's lucrative diabetic medicines market.

The order also requires Pharmacor to withdraw or adjust its pending Pharmaceutical Benefits Scheme (PBS) listing applications for its generic products.

At the interlocutory stage, the Court found that AstraZeneca has established a prima facie case of infringement by Pharmacor because there was no "factual debate" that Pharmacor's products fall within the scope of the patent's claims and would be used in a way covered by those claims. Justice Downes found that Pharmacor's principal defence — that the patent is invalid — was arguable but not sufficiently strong at this preliminary stage to outweigh AstraZeneca's case.

She noted that if Pharmacor were left free to proceed with sales and PBS listings, AstraZeneca's patent monopoly would effectively be destroyed, causing "irreparable harm" to the company. That harm, the judge found, outweighed Pharmacor's loss of first-mover advantage from an earlier market entry.

As part of the ruling, AstraZeneca must provide usual undertakings to compensate any party harmed by the injunction, and both sides have been tasked with proposing a timetable to bring the substantive case on infringement and invalidity to trial — currently eyed for later this year.

Pharmacor wants to amend its defence in AstraZeneca's suit so that it can argue a patent extension for the drug should not have been granted. Pharmacor's case turns on familiar battlegrounds in pharmaceutical patent litigation: whether the claims are novel and involve an inventive step in light of earlier published material, and whether the patent specification properly supports the breadth of the monopoly claimed. The company argues that prior art relating to SGLT2 inhibitors — the drug class to which dapagliflozin belongs — anticipated or made obvious the particular compound claimed in AstraZeneca's patent.

It has also raised arguments about the way the patent claims are framed, contending that they extend beyond what was truly disclosed or enabled in the original specification.

Justice Downes assessed those questions only to the extent necessary to decide whether Pharmacor had shown a sufficiently strong case that the patent was likely to be invalid. Her conclusion was that, while the arguments warranted a full trial, they did not displace AstraZeneca's prima facie case of infringement at this interlocutory stage.

Dapagliflozin has been a key revenue driver for AstraZeneca globally, and entry of a generic competitor via the PBS would typically trigger steep price reductions across the board. For now, the injunction preserves the status quo. Pharmacor must hold off on launch, while AstraZeneca maintains exclusivity pending the outcome of the substantive proceedings.