enablement

ToolGen’s CRISPR/Cas9 patent application rejected

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Nicholas J has ruled that ToolGen’s application for a patent, AU 2013335451, for “what is now a well-known gene editing system known as the CRISPR/Cas9 system” for editing target DNZ sequences in eukaryotic cells. His Honour has allowed ToolGen until 11 August 2023 to bring any application for leave to amend pursuant to s 105(1A).

As the complete specification was filed after 15 April 2013, the Patents Act in the form amended by the Raising the Bar Act applied.

The matter came before his Honour on ToolGen’s “appeal” from an opposition in which the Commissioner’s delegate found that all but one of the claims should be refused but allowed ToolGen 2 months to amend.

At [13], Nicholas J summarised his Honour’s findings:

For the reasons that follow I have concluded:

(a)          None of the claims are entitled to priority based on P1 (s 43(2A)). 

(b)          All of the claims lack novelty or do not involve an inventive step (s 18(1)(b)).

(c)          The complete specification does not provide an enabling disclosure of the invention (s 40(2)(a)).

(d)          The claims are not supported by matter disclosed in the specification (s 40(3)).

(e)          Claim 19 lacks clarity (s 40(3)).

More detailed consideration will have to wait for another day.

ToolGen Incorporated v Fisher (No 2) [2023] FCA 794

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Draft Intellectual Property Laws Amendment (Raising the Bar) Bill 2011

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A few weeks back now, IP Australia released a draft Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (pdf) and draft Explanatory Memorandum (pdf).

You can probably guess its overall objective from the exposure draft bill’s longer short title. The range of matters covered extends across 6 schedules:

  • Schedule 1- Raising the quality of granted patents
  • Schedule 2– Free access to patented inventions for research and regulatory activities
  • Schedule 3– Reducing delays in resolving patent and trade mark applications
  • Schedule 4- Assisting the operations of the IP profession
  • Schedule 5- Improving mechanisms for trade mark and copyright enforcement
  • Schedule 6 – Simplifying the IP system

Of the many things that struck my eye, the proposals:

  • seek to introduce the diligent searcher standard for testing the obviousness of patents;
  • seek to have patent applications and oppositions (but not, so far, trade mark oppositions) tested on the balance of probabilities instead of being practically certain not to be valid
  • introduce the new statutory experimental use defence;
  • seek to introduce a presumption of registrability for trade mark applications;
  • introduce the patent opposition “pleading” system to trade mark oppositions; and
  • confer original jurisdiction in trade mark and registered design mattters on the Federal Magistrates Court.

As IP Australia’s announcement says:

Bill does not deal with gene specific issues, rather it seeks to raise patentability standards across all technologies. Gene specific issues are being considered separately by the Senate Legal and Constitutional Affairs Legislation Committee, and by the Government in its response to the Senate Community Affairs Committee’s Gene Patents report.

Over at Patentology Dr Mark Summerfield gives very detailed consideration to the pros and shortcomings of the obviousness reform, the changes to the requirement that patents be useful,  the attempt to fix the law of fair basis (at least insofar as provisional specs are concerned), the new enablement requirement. Dr Summerfield seems to be on a roll, so there may well be more to come.

Comments and submissions should be provided by 4 April 2011.

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