Category:Patents

1
Australian Patent Office Decides First Opposition Under Raising The Bar Act
2
Productivity Commission’s broad IP review in Australia – Submissions due 30 November
3
Australian Patent Office Seeks Comment on Proposed Examination Practice Arising from the Myriad Genetics High Court Decision
4
High Court of Australia Finds Claims for Isolated Genetic Material not Patentable Subject Matter
5
Australian High Court Rules Rosuvastatin Low Dose Patent Obvious
6
Is Australia’s Innovation Patent System on Borrowed Time?
7
Extension of Term for Australian Patents Relating to AbbVie’s Blockbuster Drug HUMIRA Denied
8
BPCIA Statute: Patent Dance Is Optional, But Opting Out Has Consequences
9
The Name Game: AbbVie’s Citizen Petition Regarding Biosimilar Labeling
10
BPCIA: A “Choose Your Own Adventure” Statute?

Australian Patent Office Decides First Opposition Under Raising The Bar Act

By Nigel Lokan

In the matter of CSR Building Products Limited v. United States Gypsum Company¹ the Australian Patent Office has heard and decided the first patent opposition in which the provisions of the IP Laws Amendment Act 2012 (Raising the Bar Act) apply.

The Raising the Bar Act introduced a number of changes to the Australian patent legislation with the intent of raising the standard required to support the grant of a patent and to bring Australia’s patent laws into line with those of its major trading partners. The Raising the Bar Act applies to all patent applications for which a request for examination was filed on or after 15 April 2013.

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Productivity Commission’s broad IP review in Australia – Submissions due 30 November

By Naomi Pearce

There are two weeks left to make submissions to the Productivity Commission (the Commission) on the Commission’s Intellectual Property Issues Paper published in October.

The IP Issues Paper can be found here and the process for making a submission (by 30 November) is outlined here.

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Australian Patent Office Seeks Comment on Proposed Examination Practice Arising from the Myriad Genetics High Court Decision

By Rachel Young and Nigel Lokan

The Australian Patent Office has commenced a public consultation on their proposed changes to examination practice, as a result of the recent High Court decision in D’Arcy v Myriad Genetics Inc¹.

As reported in our earlier blog² the High Court unanimously decided that claims directed to an isolated nucleic acid coding for mutant or polymorphic BRCA1 polypeptide were not patentable subject matter.

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High Court of Australia Finds Claims for Isolated Genetic Material not Patentable Subject Matter

On 7 October 2015, the High Court of Australia (High Court) issued its decision[1] in the long running dispute concerning Myriad Genetics, Inc.’s (Myriad) patent relating to an isolated nucleic acid coding for mutant or polymorphic BRCA1 polypeptide. Mutations in the BRCA1 gene can serve as indicators of a woman’s risk of developing breast cancer.

In a unanimous decision, the High Court found that claims directed to the isolated nucleic acid are invalid on the basis that they are not a ‘manner of manufacture’ and therefore not patentable subject matter. The High Court took the view that the claimed invention would extend the scope of the concept of “manner of manufacture” and that this was not something which was appropriate for courts to do. In light of the High Court’s decision, it will be interesting to see whether there is a legislative response to this issue.

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Australian High Court Rules Rosuvastatin Low Dose Patent Obvious

In an eagerly awaited decision¹ the Australian High Court has upheld a decision of a five judge bench of the Full Federal Court that AstraZeneca’s patent relating to low dosages of rosuvastatin is invalid on the basis that the claims lack an inventive step.

Section 7(3) of the Patents Act 1990 (Act) as it existed at the priority date of Astra Zeneca’s patent imposed a threshold requirement that in order to be considered for assessing inventive step a document must be “ascertained, understood and regarded as relevant” by a person skilled in the art.

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Is Australia’s Innovation Patent System on Borrowed Time?

On 5 August 2015, the Australian Patent Office (IP Australia) released a consultation paper seeking feedback from interested stakeholders on the Advisory Council on Intellectual Property’s (ACIP) recommendation that the Australian Government should abolish the innovation patent system.

Introduced in 2001 under the Howard Government, the innovation patent system is Australia’s second tier patent right having a shorter term,eight  years, and a lower threshold of invention (i.e. an ‘innovative step’ as opposed to an ‘inventive step’ required for a standard patent).

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Extension of Term for Australian Patents Relating to AbbVie’s Blockbuster Drug HUMIRA Denied

In a recent decision the Australian Patent Office has rejected applications to extend the term of three patents related to the highly successful anti-inflammatory drug HUMIRA.

The patents are part of a family in which extensions of term had been granted in connection with earlier patents. These earlier extensions were based on the initial listing of HUMIRA on the Australian Register of Therapeutic Goods (ARTG) for the treatment of rheumatoid arthritis.

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BPCIA Statute: Patent Dance Is Optional, But Opting Out Has Consequences

The Federal Circuit issued a ruling on July 21, 2015 in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499, appeal after hearing oral arguments on June 3, 2015. See BPCIA: A “Choose Your Own Adventure” Statute? (describing the parties’ oral arguments before the Federal Circuit). Amgen Inc. (“Amgen”) appealed the Northern District of California’s decision holding that the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent dance” provisions are optional and that the 180-day notice provision does not require licensure. See Dancing Not Required: District Court Denies Amgen’s Bid for Preliminary Injunction, Finds BPCIA “Patent Dance” Optional.

To read the full alert, click here.

The Name Game: AbbVie’s Citizen Petition Regarding Biosimilar Labeling

On June 2, 2015, AbbVie submitted a citizen petition to the FDA arguing against its interim labeling requirements for biosimilar products under the Biologics Price Competition and Innovation Act (“BPCIA”).  As of now, the FDA has adopted the same labeling approach as used for generic pharmaceutical drugs.  However, AbbVie argues in its petition that “[b]iosimilars are not generic drugs and should not be labeled like generic drugs.”

To read the full alert, click here.

BPCIA: A “Choose Your Own Adventure” Statute?

On June 3, 2015, the Federal Circuit heard oral argument on Amgen Inc.’s (“Amgen”) appeal of the Northern District of California’s decision holding that the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent dance” provisions are optional, and that the 180-day notice provision does not require licensure in Amgen, Inc., et al. v. Sandoz, Inc., et al., Case No. 14-cv-04741-RS (N.D. Cal. March 19, 2015).

To read the full alert, click here.

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