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Biotech News IP law update Regular intellectual property news from Australia and overseas. |
- Government accepts ACIP recommendation that the innovation patent exclusion for plant & animal subject matter remain
- Federal Court decision allows for 'de facto opposition' by generic pharmaceutical companies in some circumstances
- Patentee has no right to insist on maintenance of 'incorrect' Register
Government accepts ACIP recommendation that the innovation patent exclusion for plant & animal subject matter remain
27 February – Federal Industry Parliamentary Secretary Warren Entsch MP announced the Government has accepted the recommendation of the Advisory Council on Intellectual Property (ACIP) that the exclusion of plant and animal subject matter (including the biological processes for the generation) from innovation patents should remain. ACIP's recommendation was contained in a report released in November 2004 called 'Should plant and animal subject matter be excluded from protection by the innovation patent?' (the Report). The Report followed a four year process where ACIP considered whether the plant and animal subject matter exclusion was in the national interest. ACIP released an issues paper and sought submissions from interested parties, followed by a round-table discussion with interested parties for this purpose.
[Source: ACIP]
Federal Court decision allows for 'de facto opposition' by generic pharmaceutical companies in some circumstances
Pfizer Corp v Commissioner of Patents [2006] FCA 164 (Bennet J, 1 March 2006)
Spirit Pharmaceuticals Pty Ltd (Spirit) sought to be joined as a second respondent in a proceeding brought by Pfizer Corp (Pfizer) to appeal a decision of the Commissioner of Patents. The Commissioner's decision resulted in the Register of Patents being amended to record the term of Pfizer's patent as expiring on 14 April 2007, rather than 26 February 2008.
Spirit had not opposed the extension of patent term under s75 of the Patents Act 1990 (Cth) (the Act) as it was not incorporated at the relevant time.
Spirit led evidence that its commercial interests in launching a product within the scope of the claims of the Pfizer's patent would be affected by the expiry of the patent term. If Pfizer's appeal against the Commissioner's decision was successful, Spirit could lose AU$5.5 million. Pfizer argued that Spirit should not be joined as a party as this would achieve a de facto opposition which was not envisaged by the Act.
Bennett J held that Spirit should be joined as a party to the proceeding even though it had no cause of action unless and until Pfizer's appeal succeeded. Bennett J accepted the Commissioner's argument that Spirit should be joined because it was in a position to present evidence from a commercial perspective which the Commissioner was unable to present. Bennett J noted that the joinder of Spirit would 'achieve a just resolution of the disputes … with minimum costs, delay and use of Court time' (at [40]) and that Pfizer had not established any unfairness should Spirit be joined.
Patentee has no right to insist on maintenance of 'incorrect' Register
H Lundbeck A/S v Commissioner of Patents [2006] FCA 163 (Lindgren J, 1 March 2006)
The proceeding concerned three other related proceedings regarding the validity of a Lundbeck Australia Pty Ltd (Lundbeck) patent for Citalopram (a selective serotonin reuptake inhibitor). Lundbeck contended that regulation 10.7(7) of the Patents Regulations 1991 was invalid. Regulation 10.7(7) requires the Commissioner to amend the Register where, among other things, the first regulatory approval date is earlier than that submitted with the application for grant of an extension of patent term. Lindgren J held that a patentee is not entitled to the benefit of an extension of term merely by virtue of its entry on the Register (ie the Register does not grant an indefeasibility of title). Rather, it is by operation of s77 of the Patents Act 1990 that the extension takes effect.
