Lilly has a patent in Australia for “difluro nucleoside antivirals”. In January 2000, it was granted an extension of term for the patent until March 2009. In March 2008, Interpharma brought proceedings to have the extension of term revoked.
One of the grounds for Interpharma’s action was that Lilly had engaged in misleading or deceptive conduct contrary to the Trade Practices Act 1974 to secure the extension of term. (For those interested in the technicalities, the application for an extension was said to claim that the substance claimed in claims 1 to 4 of the patent was a substance listed on the Australian Register of Therapeutic Goods – see Patents Act s 70.)
Sundberg J granted summary judge against this claim on the grounds that, even if it were misleading or deceptive, Lilly’s application to and communications with the Commissioner were not conduct in “trade or commerce”. Lilly was of course engaging in trade and commerce, but what needed to be shown was that the representations were made in the course of a trading or commercial relationship between Lilly and the Commissioner.
Lilly also obtained summary judgment against Interpharma’s remaining claims on the basis of Interpharma’s delay.
The extension was granted in 2000 and by s 75 (and the regulations) anyone wishing to challenge must file an opposition within 3 months.
Interpharma did not come into existence until 2 years after the extension of term was granted. Sundberg J was particularly critical of Interpharma’s delay after it became aware of the extension of term – a period of 7 months including 5 months after obtaining the complete file from the Commissioner and the institution of proceedings. However, his Honour’s reasoning would appear to be much broader:
40 I agree with Lilly that once the opposition period has expired and an extension is granted, the patentee and third parties are prima facie entitled to proceed on the basis of the extension. Admittedly, one must take into account that the applicant was not incorporated until nearly two years after the extension. Nevertheless, the public interest to which I have referred is relevant notwithstanding that. As a matter of fairness in the administration of the patent system, it would be extraordinary if extensions could be challenged some eight years after grant. Even taking into account the applicant’s date of incorporation, it would still be extraordinary that a challenge could be made six years after that.
The case is Interpharma Pty Ltd v Commissioner of Patents [2008] FCA 1283.