Posts Tagged ‘gene patents’

Patentable subject matter reform

Thursday, August 8th, 2013

IP Australia has issued an Issues Paper on the proposed amendments to the Patents Act:

(1) to insert an “objects” clause; and

(2) to exclude from patentable subject matter inventions which it would be “offensive” to commercially exploit.

These plans arise out of a recommendations made by ACIP which the Government announced it accepted. The consultation now is on the wording to implement those policies.

An objects clause

The consultation paper proposes 2 alternative “objects” clauses:

Option 1

…. the purpose of the legislation as being to provide an environment that promotes Australia’s national interest and enhances the well-being of Australians by balancing the competing interests of patent rights holders, the users of technology, and Australian society as a whole.

Option 2

the purpose of the patent system is to provide an environment that enhances the well-being of Australians by promoting innovation and the dissemination of technology and by balancing the competing interests of patent applicants and patent owners, the users of technology, and Australian society as a whole.

Now, one could very well wonder what possible help either of these statements might give a court if they were enacted. The consultation paper even notes that the Parliamentary Draftsman is rather ambivalent about the value of objects clauses in general:

Some objects provisions give a general understanding of the purpose of the legislation…Other objects provisions set out the general aim or principles that help the reader to interpret the detailed provisions of the legislation.

The first option is what ACIP proposed. ACIP considered its proposal a simplified version of the Objects identified in art. 7 of TRIPS:

The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

The consultation paper thought that Option 1 does not sufficiently recognise the economic and social welfare concerns of patent law and did not sufficiently recognise the interests of patent applicants as well as patent owners (formerly known in Olde English as patentees). As the consultation paper explains:

The economic goals of the patent system are to promote economic growth, trade and investment by encouraging innovation and the dissemination of knowledge and technology.

The patent system encourages innovation by giving patentees a period of market exclusivity in which to recoup their development costs through commercialisation of their inventions. In exchange, patentees are required to disclose the details of their inventions to the public. The patent system contributes to social welfare by providing Australians with access to new technologies and developments that otherwise would not have occurred and that improve our quality of life (for example new pharmaceuticals and medical technologies and improvements to safety and waste management technologies).

However, the patent system will only meet its economic goals if the positive effects of the patent system in stimulating investment in innovation and providing society with access to new technology are balanced against the potential negative effects of patents restricting access to follow-on innovation and increasing costs, and so restricting supply of new patented technologies.

This is better, at least the first 2 paragraphs (if one bears in mind that economists – to the extent they accept the role of patents – think of the market exclusivity as providing an incentive rather than a “reward”). The third paragraph is rather more ambivalent.The danger the third paragraph raises is that it could be used as a basis for excluding something from patentability because someone might use the patent to raise prices or the other evils identified. But, while there are some provisions in the Patents Act that address, or attempt to deal with, these issues, in many respects they seem more properly the territory of (take a deep breath) competition law.

Offensive commercial exploitation

What the consultation proposes is a new exclusion to be added to s 18:

…  for an invention the commercial exploitation which would be wholly offensive to the ordinary reasonable and fully informed member of the Australian public.

Wholly offensive?

Apparently, the test of the ordinary reasonable and fully informed member of the Australian public is intended to ensure that the exclusion is “applied in a consistent, predictable and neutral manner”. However, it is also proposed to assist the Commissioner by explicitly empowering the Commissioner  in his or her discretion to seek “non-binding” advice on ethical matters.

What seems to trigger the exclusion commercial exploitation in an wholly offensive way rather than at the specific subject matter itself. At what point is the appropriateness of the commercial exploitation determined? Will it be enough that the invention could be exploited in an wholly offensive way? The BRCA controversy erupted when Myriad announced it was going to start charging licence fees for its products. Would the ordinary, reasonable and fully informed Australian have considered its patent wholly offensive before that announcement? This rather suggests that the problem falls within the second type issue identified by ACIP: about how the patent is used, are better dealt with through Crown Use and other compulsory licence arrangements.

 

If you have views you want to inflict, they should be submitted by 27 September 2013.

Find the issues paper here.

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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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Gene (no)patenting bill going down

Friday, September 23rd, 2011

The Senate’s Legal and Constitutional Affairs Committee has, by majority, recommended that the Senate should not pass the Patent Amendment (Human Genes and Biological Materials) Bill 2010.

The Bill is a private members’ effort and, perhaps not surprisingly, the three of its sponsor still in the Senate dissented.

(At the time of writing, it is proving difficult to get a working link to the text of the Bill itself.) According to the EM it was considered desirable to expand the ban in s 18(2) on patenting human beings and the biological processes for their generation:

The purpose of this Bill is to advance medical and scientific research and the diagnosis, treatment and cure of human illness and disease by enabling doctors, clinicians and medical and scientific researchers to gain free and unfettered access to biological materials, however made, that are identical or substantially identical to such materials as they exist in nature.

These biological materials even if they have been isolated, purified or synthetically made have not been transformed from products of nature into products of humankind.

Thus the Bill (a) reinforces the applicability of the proviso in section 6 of the Statute of Monopolies within the meaning of section 18(1)(a) and section 18(1A)(a), (b) reinforces the applicability of the distinction between discovery and invention and (c) applies that distinction by expressly excluding from patentability, biological materials which are identical or substantially identical to such materials as they exist in nature, however made.

Notwithstanding this, it is rather difficult to find an Australian research institute researching genes etc. which supported the idea.

The ALRC of course had previously recommended leave well enough alone.

The issue doesn’t seem likely to go away. Apart from whatever the Bill’s sponsors and their allies may get up to, the majority concluded:

5.26 Like many of those who gave evidence, the committee prefers the solutions offered in the proposed amendments of the Raising the Bar Bill. However, the committee does not consider that the amendments in the Raising the Bar Bill will resolve all of the issues in the patent system. In the opinion of the committee, serious consideration should also be given to the proposals for legislative enactment of the patentable subject matter test and the general ‘ethical’ exclusion made in the ACIP report on patentable subject matter. Other reforms may also be necessary in the future, particularly in relation to ensuring equitable access to healthcare. In this context, the committee recognises that the Senate Community Affairs References Committee has indicated it will maintain a ‘watching brief’ in relation to the impact of gene patents in Australia.[5] Despite the need for further reform to the patent system, the committee agrees that removing an area of patentable subject matter, as proposed by the Bill, is not an appropriate solution to this complex set of issues. (emphasis and hyperlink supplied)

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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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Patentable subject matter in Australia

Wednesday, February 16th, 2011

The Minister has released ACIP’s report into what should be patentable subject matter under Australian law.

At the moment, s 18 defines a ‘patentable invention’ and the Dictionary in Sch. 1 defines and “invention” as:

“invention” means any manner of new manufacture the subject of letters patent and grant of privilege within section 6 of the Statute of Monopolies, and includes an alleged invention.

and, from NRDC (for example) :

Section 6 of the Statute of Monopolies provides that the declarations of invalidity contained in the preceding provisions of the Act “shall not extend to any letters patents and graunts of privilege . . . hereafter to be made of the sole working or makinge of any manner of new manufactures within this realme, to the true and first inventor and inventors of such manufactures, which others at the tyme of makinge such letters patents and graunts shall not use, soe as alsoe they be not contrary to the lawe or mischievous to the state by raisinge prices of comodities at home, or hurt of trade, or generallie inconvenient”

From the Key Points and recommendations:

We recommend changing the Patents Act 1990 to codify the principles of inherent patentability (as developed by the High Court in the NRDC case and in subsequent Australian court decisions). …

Consequently:

These reforms envisage amending the legislation by:
  • replacing the words ‘is a patentable invention’ in subsections 18(1) and18(1A) with the words ‘is patentable’;
  • replacing the words ‘if the invention, so far as claimed in any claim’ in subsections 18(1) and 18(1A) with the words ‘if it’;
  • replacing the current words of paragraphs 18(1)(a) and 18(1A)(a) with the words ‘an artificially created state of affairs in the field of economic endeavour’;
  • changing the definition of ‘invention’ in Schedule 1 to be ‘the subject matter of any claim’; and
  • deleting the definition of ‘patentable invention’ in Schedule 1.

So far, so good. These proposals would keep the teleological approach adopted in NRDC that was (and is) so forward looking and which has served us so well. It looks like they would also do away with all the problems of the “threshold” requirement introduced by Phillips v Mirabella (the nature of the problem is laid out at paragraphs 19 to 27 of Bristol-Myers Squibb v Faulding).

Then, things start to get a bit hairy:

Because the principles of inherent patentability address only the economic goals of the patent system, we also recommend specific and general exclusions to address certain ethical concerns that may arise. The current specific exclusion preventing the patenting of human beings and biological processes for their generation should be retained. Instead of the general inconvenience proviso, a general exclusion would preclude the patenting of inventions the commercial exploitation of which would be wholly offensive to the ordinary reasonable and fully informed member of the Australian public. (my emphasis)

Now, I would be happy with the recommendation insofar as it gets rid of the “general inconvenient proviso” as no-one knows what it means, or is intended to mean. But to replace it with an exclusion of “something wholly offensive to the ordinary reasonable and fully informed member of the Australian public”? That will be “fun”.

In Bristol-Myers Squibb, Finkelstein J pointed out (especially at 140 to 142) that courts are not particularly happy hunting grounds for that type of inquiry; still less so, one might have thought, the Commissioner (whomever he or she might be). For example, in a different field, Lady Chatterley’s Lover was famously offensive, although apparently no more. Today, we have controversy over whether or not to fly some people at taxpayer’s expense to funerals (here vs here and here). Which side of that debate represents the ordinary reasonable and fully informed member …?

Meanwhile, the Senate’s Legal and Constitutional Affairs Committee is waiting (until 25 February 2011) for your submissions on the Patent Amendment (Human Genes and Biological Materials) Bill 2010, the private Senators’ bill (introduced by Senators Coonan, Heffernan, Siewert and Xenophon) to amend the Patents Act 1990 to prevent the patenting of human genes and biological materials existing in nature.

ACIP’s report.

ACIP’s press release.

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Gene patents

Friday, December 24th, 2010

The Commonwealth Senate’s Community Affairs committee tabled its report into the patenting of genes towards the end of last month.

After commenting on the still continuing cases (in both the USA and here), the Committee noted:

The Committee will continue to monitor these important international and national legal developments, and notes that these cases may bring greater clarity to the application of the invention-discovery distinction to isolated genetic materials. As part of its watching brief on this area, the Committee may wish to revisit this issue if the area remains problematic following the outcomes of these cases.

The, after referring to the private members bill (see below), the Committee recommended:

The Committee believes that the introduction of the Bill to the Senate will provide a further, and much-needed, opportunity for the arguments and questions around the impacts and effectiveness of an express prohibition on gene patents to be considered. The Committee is of the view that a Senate inquiry into the Bill should be undertaken, with a focus on the specific terms of the proposed amendments and the implications of their implementation for human health and other potentially affected fields of innovation. The Committee notes that its inquiry into gene patents has served a valuable purpose in bringing the issue of gene patenting to the light of public interest and attention, and provides a sound basis on which a targeted inquiry into the Bill can build. Accordingly, Recommendation 3 of the report requests that the Senate refer the Bill to a relevant Senate Committee for inquiry and report.

Then, there are a bundle of recommendations:

  • increase the threshold requirements of patentability (improve patent quality);
  • reduce the scope of patent claims;
  • reinforce mechanisms and policies by which governments can and should intervene with the rights of patent holders; and
  • assist judicial interpretation of the Act and establish an external accountability and quality control mechanism for the patent system.

Recommendation 9 appears directed at the Lockwood No 1 ruling:

5.175    The Committee recommends that the Patents Act 1990 be amended to introduce descriptive support requirements, including that the whole scope of the claimed invention be enabled and that the description provide sufficient information to allow the skilled addressee to perform the invention without undue experimentation.

Recommendation 16 called for the establishment of a patent audit committee.

Patentology commented here.

In the same week, Senators Heffernan, Coonan, Stewart and Xenophon and introduced their private members’ bill, Patent Amendment (Human Genes and Biological Materials) Bill 2010, which (according to the Parliamentary bills summary) is intended prevent the patenting of biological materials which are identical or substantially identical to materials as they exist in nature.

As Patentology reports here, it has been referred to the Senate’s Legal and Constitutional Affairs Committee for inquiry. Your comments are requested by 25 February 2011 and the Committee is scheduled to report by 16 June 2011.

In a different environment, the US Justice Department, perhaps surprisingly, filed an amicus brief in the Myriad appeal supporting the District Court’s conclusion that the patent was invalid.

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Class actions and antitrust

Thursday, July 15th, 2010

Following on from the post earlier this week about the findings that AstraZeneca had misused its market power in the EU over Losec, the Full Federal Court in Australia (Moore, Jessup and Dodds-Streeton JJ) has largely upheld an appeal against the primary Judge’s decision to strike out a Statement of Claim.

Unlike the AstraZeneca case, this case does not involve allegations of misuse of market power relating to a patented product; it concerns allegations about a price-fixing cartel for rubber compounds.

One interesting aspect about the case is that the litigation in Australia derives from a European Commission finding that Bayer AG and others had engaged in a global price fixing cartel for the rubber compounds. The applicants in this case allege that that cartel had ramifications in Australia causing them damage.

Another interesting aspect is that the applicants are bringing a class action to recover damages for the impact of the alleged cartel in Australia. In the IP field, we have recently seen the class action mechanism deployed to challenge the validity of patenting genes. Incidentally, the applicants’ solicitors in that case are the same as the applicants’ solicitors in this action.

Wright Rubber Products Pty Ltd v Bayer AG [2010] FCAFC 85

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The Fortnightly Review (of IP and Media Law)

Tuesday, June 1st, 2010

Professors Megan Richardson and Andrew Kenyon and Vicki Huang edit a new online publication “The Fortnightly Review of IP and Media Law”.

So far, it is up to issue #7 and features, amongst other things, a good debate in which Ass Prof. David Brennan responds to Dr Cannold and Prof Palumbi’s opinion piece in the Age on Gene Patenting. Dr Cannold and Prof Palumbi get to reply.

Check it out here (and sign up).

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