New Forms of Evergreening in Australia: Misleading Advertising, Enantiomers and Data Exclusivity: Apotex vs. Servier and Alphapharm vs. Lundbeck
Journal of Law Medicine, Vol. 12, No. 2, pp. 220-32, October 2008
13 Pages Posted: 18 May 2009
Date Written: May 15, 2008
Two recent decisions of the Federal Court of Australia have provided interesting insights into the ongoing struggle between originator drug manufacturers and the public interest in Australia. In Apotex Pty Ltd. (formerly GenRx Pty Ltd.) vs. Les Laboratoires Servier (No. 2)  FCA 607 the court held that an advertising campaign by an originator pharmaceutical company, which sought to persuade doctors to issue prescriptions prohibiting substitution of "a-flagged" generics, constituted misleading and deceptive conduct under s 52 of the Trade Practices Act 1974 (Cth). The decision of the court in Alpharm Pty Ltd vs. H Lundbeck A/S (2008) 76 IPR 618;  FCA 559 limits the ability of the manufacturer of a drug based on a purified racemate enantiomer to claim a later registration date on the Australian Register of Therapeutic Goods and subsequently obtain an extension of its intellectual monopoly privileges as well as an exclusivity period for the data it had submitted to safety regulators. Importantly, this case is one of the first to consider recent allegedly pro- and anti-"evergreening" changes to the Therapeutic Goods Act 1989 (Cth) and Patents Act 1990 (Cth) as impacted by the intellectual property chapter (Ch.17) of the Australia-United States Free Trade Agreement.
Keywords: Evergreening, data exclusivity, generic medicines, pharmaceutical regulation, direct to consumer advertising
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