Patent dispute over generic paracetamol on hold

Initial claims have been dismissed, but there is an opportunity to make further submissions on both sides

GlaxoSmithKline’s legal proceeding against Apotex and Generic Partners over its paracetamol products has been dismissed, as has Apotex and Generic Partner’s cross claim.

The patent claim in question covered a pharmaceutical composition comprising: “a bilayer tablet having an immediate release phase of paracetamol and a sustained release phase of paracetamol”.

Since April 2000 GSK has marketed, sold and supplied two sustained-release paracetamol products in Australia – Panadol Back & Neck Long Lasting and Panadol Osteo.

After revelations Generic Partners intended to supply bilayer sustained-release paracetamol tablets containing 665mg of paracetamol to Apotex for on-supply and sale in Australia, GSK commenced a proceeding against Apotex and Generic Partners in 2014.

The company sought to restrain the supply of the alleged infringing products by Apotex and Generic Partners.

In response, Apotex and Generic Partners brought cross-claims against GSK, seeking orders to revoke patent claims to the Panadol products based on “lack of fair basis” and “failure to define the invention” among other reasons.

In his 31 May ruling in the Federal Court of Australia, Justice Jonathan Beach rejected both GSK’s infringement case and Apotex’s and Generic Partners’ invalidity assertions.

“As is typical of patent litigation, this case has raised a plethora of issues concerning the construction of the claims of the patent, infringement and invalidity,” said Justice Beach.

However, he noted the unique nature of the product under GSK’s patent.

“In my view, in April 2000 it was not a routine step to those skilled in the art in Australia to create a bilayer tablet for a sustained release product,” he found.

During the proceeding, Justice Beach called upon a variety of witnesses – academics experts in the field of pharmacology – from across the world, although neither party failed to make a conclusive case.

“Each of the parties has had a measure of success. My tentative view is to make no order for costs in favour of any party, but I will give the parties an opportunity to make submissions thereon including on any consequential orders,” he concluded.

Any further submissions are due by the end of June.

To read the court transcript in full, click here

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