Freedom of Information Applications as An 'Evergreening' Tactic
Australian National University - ANU College of Law
Thomas Alured Faunce
Australian National University; Australian Research Council
September 18, 2011
Journal of Law and Medicine, Vol. 19, No. 1, pp. 43-52, 2011
A recent decision of the Federal Court of Australia illustrates how patent-holding pharmaceutical companies are attempting to use Australia’s Freedom of Information Act 1982 (Cth) to force Australian safety, quality and efficacy regulators to disclose whether generic competitors are attempting to enter the market. In Secretary, Department of Health and Ageing v iNova Pharmaceuticals (Australia) Pty Ltd (2010) 191 FCR 573;  FCA 1442 a single judge of the Federal Court overturned a decision of the Administrative Appeals Tribunal (AAT) that would have compelled the Australian Therapeutic Goods Administration (TGA) to reveal whether they were in possession of an application to register generic versions of two iNova products: imiquimod and phentermine.
In its justification to the AAT for refusing to confirm or deny the existence of any application, the TGA argued that to reveal the existence of such a document would prejudice the proper administration of the National Health Act 1953 (Cth) as it could compromise the listing of a generic on the Pharmaceutical Benefits Scheme. The AAT failed to appreciate the extent to which this revelation to a competitor would have undercut 2004 amendments to the Therapeutic Goods Act 1989 (Cth) that provided penalties for evergreening tactics involving TGA notifications to drug patent-holders and 2006 amendments to the Patents Act 1990 (Cth) which protected the right of generic manufacturers to “springboard”. The decision of the Federal Court is one of the first to explore the use of freedom of information legislation by patent-holders as a potential “evergreening” technique to prolong royalties by marginalising generic competition. Because of the significant amounts of money involved in ensuring rapid market entry of low-cost generic products, the issue has considerable public health significance.
Number of Pages in PDF File: 10
Keywords: Evergreening, pharmaceutical, freedom of information, generic medicines, springboarding, patents, intellectual monopoly privilege
JEL Classification: D21, D42, D43, D41, H41, H51, I18, K21, K22. K42, L12, L41, L44, L65
Date posted: September 19, 2011