GlaxoSmithKline Consumer Healthcare Investments (Ireland) (No 2) Ltd v Apotex Pty Ltd

GlaxoSmithKline Consumer Healthcare Investments (Ireland) (No 2) Ltd brought an action against Apotex Pty Ltd in the Federal Court, alleging infringement of its patent for paracetamol bilayer tablets with sustained release and immediate release layers, and unique in vitro paracetamol dissolution profiles. The dispute centred on the interpretation of the patent claims, particularly the dissolution testing apparatus referred to as “the USP type III apparatus, reciprocating basket,” and whether the term “reciprocating basket” was a mistake or error in the claims and specification. The applicant argued that the term should be construed as “reciprocating cylinder.” The court also had to consider the meaning of “matrix forming polymer” and whether the respondents’ products were within the claimed dissolution profile and contained the matrix forming polymer within the claims.

The court found that the respondents’ arguments on lack of inventive step were unsuccessful, as they failed to establish that the invention lacked a fair basis, sufficiency, clarity, or inventive step. The court concluded that the patent was valid and enforceable, as it met all the statutory requirements. The court also held that the applicants’ infringement case failed because the term “basket” in claim 1 meant a basket, not a cylinder. The court noted that the dissolution apparatus was not critical to the invention, and that the patent claims were clear and unambiguous.

The respondents’ cross-claims for invalidity were dismissed, as none of their arguments on invalidity were successful. The applicants’ proceeding was also dismissed, as the court found that the respondents’ products did not infringe the patent. The court made no order for costs in favour of any party, but gave the parties an opportunity to make submissions thereon, including on any consequential orders. The time for filing any notice of appeal or cross-appeal was extended until 21 days after all final orders, including on costs and ancillary orders, had been made.

The court ordered that the applicants’ proceeding be dismissed, the respondents’ cross-claim be dismissed, and that the parties file written submissions on costs and any consequential orders sought. The court also extended the time for filing any notice of appeal or cross-appeal until 21 days after all final orders had been made. The court granted liberty to apply for further orders.