Somebody Else’s Medicine could be a Poison to You
Federal Court gives Pharmacor a headache over bio-equivalence claim...
In GlaxoSmithKline Australia Pty Ltd v Pharmacor Pty Ltd the Federal Court considered whether claims of bio-equivalence contravened Australian Consumer Law.
Pharmacor had obtained approval for its Osteomol 665 Paracetamol products from the Therapeutic Goods Administration (TGA), who found that they were bio-equivalent to GSK’s modified release paracetamol products that included Panadol Osteo.
GSK submitted that the bio-equivalence claim could contravene consumer law as it would amount to misleading or deceptive conduct by omission or silence in concealing the differences between the products. The Judge held that GSK had not sufficiently demonstrated that the products were not bio-equivalent and that there was no material omission in Pharmacor’s application to the TGA.
However, the Judge noted that there is an inherent imprecision in the TGA’s concept of bioequivalence as it can be satisfied by a 90% confidence interval. The Judge noted that satisfaction of the confidence interval test does not guarantee that all consumers will experience the same clinical and therapeutic effects. This imprecision in conjunction with the finding that Pharmacor’s product does not fall within claim 1 of GSK’s patent were sufficient for the Judge to hold that GSK established a reasonable belief that the products may have different clinical effects. The Judge upheld GSK’s consumer law argument on this basis. End users may assume that bioequivocal means interchangeability or substitutability as they may not appreciate that there is any imprecision in the TGA’s use of that concept. The Judge held that GSK was entitled to preliminary discovery concerning the proposed promotion and supply of the Pharmacor Products to pharmacists or consumers to establish whether it amount to misleading or deceptive conduct by omission or silence.