Posts Tagged ‘experimental use’

Myriad wins Down Under

Sunday, February 17th, 2013

Nicholas J has ruled that Myriad’s patent for isolated gene sequences relating to BRCA1 are patentable subject matter for the purposes of Australia’s Patents Act 1990.

Claim 1 of the Patent (No. 686004 entitled “In vivo mutations and polymorphisms in the 17q-linked breast and ovarian cancer susceptibility gene”) is for:

An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:l one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19.

At [70], Nicholas J explained the scope of this claim:

Claim 1 extends to isolated DNA, RNA and cDNA that has a BRCA1 polypeptide encoding sequence as shown in SEQ ID No.1 with one or more of the mutations or polymorphisms specified in the relevant tables.

To qualify as patentable subject matter in Australia s 18(1)(a) prescribes that the claimed invention must be a “manner of manufacture”.

This term, much to the chagrin of modernising law reformers, derives from s 6 of the Statute of Monopolies 1623. In the “watershed” NRDC ruling in 1959, Dixon CJ, Kitto and Windeyer JJ declared that the meaning of “manner of manufacture” is not to be derived as a matter of mere etymology. Rather it poses a question:

“Is this a proper subject of letters patent according to the principles which have been developed for the application of s. 6 of the Statute of Monopolies?”

and in answering that question, it must be recognised that the concept has a “broad sweep” intended to encourage developments that are by their nature unpredictable. Hence, their Honours indicated the processes at issue in that case were patentable subject matter because they led to, or resulted in, an artificially created state of affairs, that had some discernible effect, which had economic significance.  A very teleological approach from the supposed patron saints of strict legalism!

Nicholas J found that the isolated gene sequences claimed in Myriad’s patent were an artificially created state of affairs having economic significance.

His Honour at [105] rejected Myriad’s first line of defence claiming that there was a change in chemical structure simply by the process of isolating the gene sequence. Rather, more generally, the nucleic acid or gene sequence in its isolated form was sufficient to qualify as an artificially created state of affairs:

First, the concept of patentable subject matter is expressed in very expansive language.

Secondly, at [108] the nucleic acid did not exist in isolated form in the cell:

in the absence of human intervention, naturally occurring nucleic acid does not exist outside the cell, and “isolated” nucleic acid does not exist inside the cell. Isolated nucleic acid is the product of human intervention involving the extraction and purification of the nucleic acid found in the cell. Extraction of nucleic acid requires human intervention that necessarily results in the rupture of the cell membrane and the physical destruction of the cell itself. And purification of the extracted nucleic acid requires human intervention that results in the removal of other materials which were also originally present in the cell. It is only after both these steps are performed that the extracted and purified product may be properly described as “isolated” in the sense that word is used in the disputed claims.

Thirdly, at [109] isolating the substance could require “immense research and intellectual effort”.

In that case, it was only as a result of an intensive research effort that the isolated micro-organism in question could be made available for use in the manufacture of the new antibiotic. It was fortuitous for the patentee that it was its employees who were first to isolate the new micro-organism and first to deploy it in the manufacture of the new drug. That will not always be so. It would lead to very odd results if a person whose skill and effort culminated in the isolation of a micro-organism (a fortiori, an isolated DNA sequence) could not be independently rewarded by the grant of a patent because the isolated micro-organism, no matter how practically useful or economically significant, was held to be inherently non-patentable. In my view it would be a mistake, and inconsistent with the purposes of the Act, not to give full effect in such situations to the broad language used by the High Court in NRDC.

His Honour had earlier noted at [75] that, while the isolated substances contained genetic information, the patent did not claim information per se, rather, it was for a substance. Furthermore, at [76] because the claim was limited to the gene sequences in isolated form, it did not cover or extend to the naturally occurring DNA or RNA.

Nicholas J also noted that it was longstanding practice for the Commissioner to grant patents over gene sequences. Both ACIP (pdf) and the ALRC had recommended that this not be changed. The Government had announced (pdf) it accepted those recommendations and Parliament had implemented a different range of measures through the Raising the Bar Act, especially by introducing an explicit experimental use exception in s 119 C and the extension of the usefulness requirement by the introduction of new s 7A which was likely to affect the patentability of ESTs or expressed sequence tags.

 

Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65

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Raising the Bar Act

Tuesday, April 17th, 2012

Apparently, the Governor-General signed the Royal Assent to the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 on 15 April 2012.

According to IP Australia, most of the amendments will not come into force until 15 April 2013, but the exceptions to patent infringement for (1) regulatory use or (2) experimental use are now in force.

Many of the changes yet to come into force do relate to patents. There are, however, important changes to trade mark registrability (amongst other things) and conferral of original jurisdiction (from 15 April 2013) on the Federal Magistrates Court in matters concerning registered designs, trade marks or PBR , including appeals from the Registrar, infringement and revocation proceedings.

The Act (AUSTLII doesn’t have a link at the time or writing).

IP Australia’s announcement. Links to some previous commentary here.

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

Sunday, March 20th, 2011

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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Working a patent for regulatory approvals

Wednesday, May 6th, 2009

Patently-O considers a new Federal Circuit case in the USA dealing with the scope of s 271(e)(1) – a defence to infringement by working the patent to prepare regulatory data.

It would appear that the defence should now apply in proceedings against imports before the ITC.

Patents Act 1990 (Cth) s 119A (introduced with effect from 25 October 2006 following ACIP’s report) permits such activity where the working:

  • is for purposes of having a therapeutic pharmaceutical product included in the Australian Register of Therapeutic Goods;
  • or a similar foreign regulatory approval.

Although working for a foreign regulatory approval may take place only in the supplementary protection period (see e.g. ACIP on experimental use p. 44 (pdf)).

See now Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559 at [643]ff.

IP Australia is considering extending this: see paragraphs 9 and 17 of IP Australia’s Consultation Paper on experimental use (pdf) [NOTE: submissions should be in by 8 May 2009. Submissions on the Getting the Balance Right paper (pdf) are also due by then.]

WIPO’s Standing Committee on Patents has a study paper on exceptions and limitations as an area of increased focus.

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