Australia Federal Court finds against APVMA on confidential commercial information

In a much anticipated decision, the Federal Court last week found in favour of a manufacturer of generic veterinary products in its action against the Australian Pesticides and Veterinary Medicines Authority (APVMA). Partner, Dr Teresa Nicoletti and Lawyer, Sebastian Tonkin discuss this decision further.

The case arose out of a change in policy in 2014, when the APVMA decided to require applicants proposing to register generic products to obtain written consent to the use of confidential commercial information about reference products from the owners of that information.

We analysed the policy change in an article published last year, and expressed the view that the policy was anti-competitive, since innovator companies would be under no obligation to (and indeed would find it commercially beneficial not to) support generic companies’ registration applications. It was also our view that the policy seemed to misapply the Agricultural and Veterinary Chemicals Code Act 1994 (Cth) (Act).

That view has now been affirmed by the Federal Court in Abbey Laboratories Pty Ltd v Australian Pesticides and Veterinary Medicines Authority [2016] FCA 704.

Read the entire article.