Bills Digest no. 159 2005–06
Intellectual Property Laws Amendment Bill
2006
WARNING:
This Digest was prepared for debate. It reflects the legislation as
introduced and does not canvass subsequent amendments. This Digest
does not have any official legal status. Other sources should be
consulted to determine the subsequent official status of the
Bill.
CONTENTS
Passage History
Purpose
Background
Main Provisions
Endnotes
Contact Officer & Copyright Details
Passage History
Intellectual
Property Laws Amendment Bill 2006
Date introduced: 30 March 2006
House: House of
Representatives
Portfolio: Industry, Tourism and Resources
Commencement: The formal provisions commence on Royal Assent. The
substantive provisions commence on various dates. Details are
provided in the Main provisions section of this Digest.
The purpose of this Bill is to:
- amend the Patents Act 1990 in order to:
- broaden the springboarding regime for pharmaceutical
patents
- allow for awards for exemplary damages in patent infringement
actions
- clarify prior users rights in the granting of patents
- amend provisions of the Trade Marks Act 1995 relating
to revocation of trade marks and public access to trade mark files,
and
- make minor technical amendments to the Patents Act
1990, Trade Marks Act 1995, Designs Act
2003, and Plant Breeder s Rights Act 1994.
Background
As there is no central theme to the Bill, the background to the
various measures will be described below.
The amendments in Schedules 1, 2, 4 and Part 2
of Schedule 3 commence six months after Royal
Assent unless commenced earlier by proclamation. Part
1 of Schedule 3 commences the day after
Royal Assent (clause 2).
A trade mark is a 'sign' which signifies a connection to
particular goods or services and which distinguishes it from
similar goods or services. It can be a letter, number, word,
phrase, shape, logo, picture, aspect of packaging, sound or even a
smell. A mark can become a very valuable commercial asset and trade
mark disputes are common.
To obtain the property and other valuable rights on offer under
the Trade Marks Act, the owner of a trade mark must secure
registration from the Trade Marks Office. The owner of a registered
trade mark has the exclusive right to use it for the nominated
goods and services and can sue those who infringe his or her
rights. Registration lasts 10 years but can be endlessly renewed if
fees are paid on time and basic conditions about use of the trade
mark are met. A registered trade mark is an item of property and
the associated rights can be bought and sold.
The registration system is similar for patents, trade marks and
designs. The applicant lodges details of the trade mark and
specifies with which goods and services the mark is associated. The
Trade Marks Office checks the application against statutory
criteria and exclusions. If accepted, the application is advertised
in the Official Journal of Trade Marks. Opponents have three months
to object to registration on specified grounds, but if there is no
successful opposition the trade mark is registered from the date of
filing the application.
Revoking acceptance of a trade
mark
If a trade mark has been accepted in error by the Trade Marks
Office, and this is realised before the trade mark proceeds to
registration, the Registrar has the power to revoke that acceptance
under section 38 of the Trade Marks Act. Item 1
repeals and replaces subsection 38(1) with the effect of expanding
the grounds on which the Registrar may revoke acceptance of a trade
mark. New subsection 38(1) allows the Registrar to
revoke the acceptance of a trade mark if he or she is satisfied
that it is reasonable to do so taking into account all of the
circumstances. The Explanatory Memorandum states that the intention
of this provision is to focus attention on the reasonableness of
the Registrar s actions, and not on whether or not an error or
omission or a special circumstance preceded the acceptance of the
trade mark.
Revoking a registered trade mark
Trade marks can be mistakenly registered due to administrative
oversight or error.(1) Under the current law, if an
error is not realised until after the trade mark has been
registered, there is no administrative remedy. Instead, legal
action would have to be pursued through the courts in order to
rectify the situation.(2)
Item 7 proposes amendments (new
sections 84A 84D) that will give the Registrar, in certain
circumstances, the power to revoke the registration of a trade mark
on his or her own initiative. The Registrar may revoke registration
if satisfied that:
- the trade mark should not have been registered, taking account
of all the circumstances that existed when the trade mark became
registered (whether or not the Registrar knew then of their
existence) (new paragraph 84A(1)(a)), and
- it is reasonable to revoke the registration, taking account of
all the circumstances (new paragraph
84A(1)(b)).
The kind of circumstances that the Registrar must take into
account under paragraph 84A(1)(a) include:
- any errors (including errors of judgment) or omissions that led
directly or indirectly to the registration;
- any relevant obligations of Australia under an international
agreement, and
- any special circumstances making it appropriate not to register
the trade mark or to register it subject to conditions or
limitations (new subsection 84A(2)).
The kind of circumstances that the Registrar must take into
account under paragraph 84A(1)(b) include:
- any use that has been made of the trade mark
- any relevant legal proceedings or other action taken in
relation to the trade mark
- any special circumstances that make it appropriate to revoke or
not revoke the registration (new subsection
84A(3)).
In order to revoke registration, the Registrar must notify the
owner or approved user within 12 months of registration
(new subsection 84A(4)) and must provide such
persons with an opportunity to be heard (new subsection
84A(5)). Revocation outside that 12 month time frame would
still be available via the courts. A decision to revoke
registration under section 84A is appealable to the Federal Court
of Australia (new section 84D).
New section 84B sets out a circumstance in
which the Registrar is obliged to revoke the registration
of a trade mark. The Registrar will be obliged to revoke
registration if the Registrar has failed to take account of a
notice of opposition which has been filed within the appropriate
time and the Registrar becomes aware of the failure within 1 month
of filing of the notice. A revocation under section 84B is not
appealable to the Federal Court, although administrative law
remedies would be available.
Items 1 and 2 of
Schedule 2 amend section 223 of the Trade Marks
Act in order to provide that many of the fee payment requirements
of trade mark registration will be set out in the Trade Marks
Regulations 1995. The Explanatory Memorandum states that these
amendments will bring the fee payment provisions of the Trade Marks
Act into line with the fee payment provisions in section 227 of the
Patents Act and section 130 of the Designs Act.(3)
A trade mark is essentially about branding. It is a 'sign' which
signifies a connection to particular goods or services and which
distinguishes it from similar goods or services.
In contrast, a certification trade mark (CTM) shows that goods
meet a particular standard or accuracy or have a particular origin
or composition etc. For example, the Woolmark is a certification
trade mark indicating that a garment uses 100% pure new wool.
Part 16 of the Trade Marks Act sets out the requirements for the
registration of a CTM. The process for obtaining a CTM involves
both the Trade Marks Office and the Australian Competition and
Consumer Commission (the Commission).
In order to obtain a CTM the trade mark owner must make an
application to the Registrar for a CTM and provide a copy of the
rules regarding its use (subsection 173(1)). Once the Registrar is
satisfied with the application, he or she forwards it with the
rules to the Commission (subsection 174(1)) If the Commission finds
that the rules are acceptable and are not detrimental to the public
interest, a certificate is issued (subsection 175(2)). The
Registrar, upon notification, must accept the CTM (section 176) and
advertise the decision in the Official Journal (subsection
176(3)).
The Explanatory Memorandum states that the proposed amendments
to this process are not aimed at changing the requirements an
applicant for a CTM must fulfil, the documentation they must
provide, or the rights that a CTM gives to the registered owner.
Rather the changes are targeted at the administrative aspects of
how applications for CTMs are processed, and affect only the
internal workings of the Trade Marks Office and the Commission.
(4)
Item 1 repeals subsection 173(2) of the Trade
Marks Act and substitutes new subsections 173(2) to
173(4). New subsection 173(2) provides
that the rules governing a CTM must specify the following:
- the certification requirements that the goods and/or services
must meet (e.g. specific ingredients, method of production)
- the process for determining whether goods and/or services meet
the certification requirements (e.g. specific method for
determining the strength of the material used)
- the attributes of an approved CTM certifier (e.g. specific
qualifications)
- the requirements that an owner or approved user of a CTM must
meet (e.g. annual fees)
- the use of the CTM by the owner or an approved user of the CTM,
and
- the procedure for resolving disputes relating to the CTM.
The rules must also include any other matters the Commission
requires or permits to be included (new subsections 173(3)
and (4)).
Section 175 deals with the Commission s role in certification.
Item 3 repeals and replaces paragraph 175(2)(a)
with the effect that before issuing a certificate, the Commission
must be satisfied that the attributes that the rules require an
approved certifier to possess are of a suitable standard. The
proposed amendment is intended to clarify that the CTM owner (and
not the Commission) is responsible for determining whether an
approved certifier meets the criteria set out in the rules.
Item 8 repeals and replaces section 174 with
the effect that the regulations rather than the Act will specify
the conditions for sending of prescribed documents relating to a
CTM application to the Commission.
Item 10 repeals and replaces subsection 176(1)
with the effect of clarifying how to apply for CTM registration.
New subsection 176(1) specifies that the Registrar
must accept an application for registration of a CTM if:
- the application has been made in accordance with the Act
- there are no grounds for rejection, and
- the Commission has issued a certificate.
If these criteria have not been met, the Registrar must reject
the application, although not before giving the applicant the
opportunity to be heard.
Section 178 of the Trade Marks Act deals with procedures for
varying the rules governing CTMs. Items 12 and
13 propose amendments to section 178 with the
effect that certain administrative aspects of variation will be set
out in the regulations rather than the Act.
Item 15 repeals and replaces section 179 with
the effect that the Registrar must publish the rules governing the
use of a CTM in accordance with the regulations.
The purpose of Schedule 4 is to amend the Trade
Marks Act so as to make documents relating to trade marks publicly
available. The Explanatory Memorandum states that this amendment is
in line with section 55 of the Patents Act and section 60 of the
Designs Act which provide for certain documents to be publicly
available.
Item 1 inserts new section 217
with the effect that all prescribed documents on a trade mark file
will be available for public inspection from the time they are
received and processed by the Trade Marks Office. New
section 226A (item 3) limits this provision to the extent
that the Registrar may specify information in a document that has
to be held confidentially in the Trade Marks Office.
Commencement: The amendments in
schedules 5-6 and 8-9 commence the day after Royal
Assent. Schedule 7 commences 28 days after Royal
Assent and Schedule 10 commence six months after
Royal Assent unless commenced earlier by proclamation
(clause 2).
Commencement: 28 days after Royal Assent.
Australia s patent scheme Patent extensions and
springboarding
Under the Patents Act 1990 holders of a standard patent
are granted exclusive rights to make, hire, sell or otherwise
dispose of their invention for up to twenty years. The Act also
grants an exclusive right to manufacture a potential product in
Australia for sale in Australia or for export.
The Intellectual Property Laws Amendments Act
1998 that came into effect on 27 January 1999 amended the
Patents Act in two important respects relevant to the
pharmaceuticals industry. Firstly, it provided for the extension of
the effective patent life by up to five years, and secondly it
introduced springboarding for the manufacturers of generic or
off-patent pharmaceuticals in cases where an extension of the
patent life has been granted.
The introduction of a five year extension was largely in
recognition of the lengthy regulatory approval process required
before pharmaceuticals can be marketed, which can leave limited
patent life in which to recoup the investment. Only patents which
over an active pharmaceutical ingredient (API) are currently
eligible for patent extension in Australia. The Explanatory
Memorandum at page 19 explains that there are broadly four types of
pharmaceutical patents: patents on the active pharmaceutical
ingredient (API), patents on the formulation of the medication,
patents on the process for making the API, and patents on the
methods of use of the medication.
Springboarding is an activity that allows
manufacturers of generic drugs(5) to undertake certain
activities prior to the expiry of the patent solely for the
purposes of meeting pre-marketing regulatory approval requirements.
The 1999 amendments to the Patents Act allowed for limited
springboarding activity to be undertaken by generic
manufacturers.(6) The purpose of the amendment was to
allow earlier regulatory approval for generic pharmaceuticals,
faster market entry upon patent expiry and to prevent originator
companies from receiving further de facto extensions of patent
terms. However the provision is limited because it only applies to
pharmaceutical substance (i.e. API) patents once an extension is
granted. Pharmaceutical products are frequently the subject of
multiple patents which cover different aspects of the products.
These patents are potentially of different types, some of which may
not be eligible for extension. In some cases the most important
patent may not be extended and thus the most important
springboarding work cannot be done until this patent expires in
Australia.
In 2002 an interdepartmental Committee, established by the
Minister for Industry, Tourism and Resources, examined the impact
of the patent extensions and springboarding provisions on generic
manufacturers. The Committee concluded that Australia s
springboarding provisions were limited compared to those in
competing markets (e.g. USA, Canada and New Zealand) and that under
the current springboarding provisions, Australian manufacturers of
generic drugs were prevented from competing in export markets on
equal terms with their overseas competitors.(7) The
Government has concluded that this disadvantages the Australian
generics industry and provides an incentive for companies to move
their development activity offshore. (8) The purpose,
therefore, of the amendments in Schedule 7 is to
address this problem by implementing a wider springboarding scheme
for generic pharmaceuticals than is currently provided under the
Patents Act.
Item 2 repeals subsection 78(2), the current
springboarding provision.
Item 3 inserts new section
119A. Its effect is to allow springboarding on any
pharmaceutical patent at any time for purposes related to
generating information necessary to support an application for
regulatory approval of a pharmaceutical product in Australia or
foreign country. Regulatory approval of a pharmaceutical product in
Australia means obtaining inclusion in the Australian Register of
Therapeutic Goods(9) (new paragraph
119A(1)(a)). Where the purpose of the generics
manufacturer is approval overseas, the rights of the manufacturer
do not extend to export unless the patient is of a particular type
and an extension has been granted (new subsection
119A(2)). The Explanatory Memorandum states that Australia
s international obligations including AUSFTA and TRIPS limit
Australia s capacity to implement this provision more
broadly.(10)
The new springboarding provisions will apply to the exploitation
(11) of patents that occurs after the Schedule commences
(item 4).
The Parliamentary Secretary to the Minister for Industry,
Tourism and Resources, Bob Baldwin, in his Second Reading Speech
said the changes would stimulate greater competition in the
generics market and encourage companies to develop generic
pharmaceuticals in Australia rather than offshore.
The objective [ ] is to encourage generic
pharmaceutical development in Australia, consistent with the
National Medicines Policy objective of maintaining a responsible
and viable medicines industry.(12)
The Generic Medicines Industry Association has welcomed the
Bill, and has been reported as saying it would increase the
international competitiveness of Australia s generic medicines
industry and bring Australian patent law in line with other
countries especially the US and Europe.
"The widening of springboarding provisions enables the local
industry to compete more fairly with overseas players," GMIA chair,
John Montgomery, said.(13)
AusBiotech, in its submission to the Interdepartmental Review
mentioned above, supported the existing springboarding provisions
and argued that broadening the provisions would shorten the
effective patent life of pharmaceutical patents and negatively
impact investment by pharmaceutical companies in
Australia.(14) The Explanatory Memorandum also confirms
that submissions by pharmaceutical companies to the Review (10
companies and the industry association) were all in favour of the
status quo and argued that springboarding should remain linked to
the extension of patent term scheme.(15)
Paul Jones, a partner in the patents and trademarks practice of
Freehills, says the changes may make innovator pharmaceutical
companies more willing to litigate to protect their market share.
He has been reported as saying:
Clearly this new provision favours generic
companies over innovators. The springboarding amendment will raise
the stakes for innovators with generic pharmaceutical products
likely to be on the market sooner after patent expiry and in
greater numbers. Consequently, innovators may be more willing to
litigate to protect their market share.(16)
Media reports have suggested that the proposed amendments will
mean generic drugs worth millions of dollars could be ready for the
market as soon as medicines patents expire.(17) The
Explanatory Memorandum does state that to the extent that a broader
springboarding regime would enable generic medicines to enter the
market more quickly, this proposal has the potential to increase
competition and lower Pharmaceutical Benefits Scheme costs .
However the EM appears to downplay this potential effect and
actually states that there are unlikely to be significant costs or
benefits to Government from the proposed changes.(18) It
acknowledges that competition from generic drugs produced overseas
already happens as soon as a patent expires.(19) The
Government s rationale for the change seems to focus more on the
benefits of encouraging the retention and growth of a competitive
generic pharmaceuticals R&D industry in Australia than on
immediate savings to Government and consumers in the form of
cheaper pharmaceuticals.
The Review of Intellectual Property Legislation under the
Competition Principles Agreement (the Ergas Report) was delivered
to the Government on 30 September 2000. It was produced by the
Intellectual Property and Competition Review Committee (IPCRC)
chaired by Mr Henry Ergas.
The IPCRC saw intellectual property laws and competition policy
as 'largely complementary', on the basis that the former promote
innovation, 'which is a key form of competition'. It acknowledged
however that the two are also in tension because intellectual
property laws usually confer exclusive rights:
While conferring intellectual property rights
encourages investment in creative effort, it can allow the owners
of the results of this effort to unduly restrict the diffusion and
use of these results.(20)
The Ergas Report went on:
It must also be recognised that the rights granted
by the intellectual property laws can be used for anti-competitive
ends. This occurs when the rights are used to claim for the creator
not merely a share of the efficiency gains society obtains from the
creation, but also super-normal profits that arise from market
power unrelated to the creation.(21)
Two questions guided the IPCRC in trying to better harmonise the
interests of competition and innovation:
- whether exclusive rights available under intellectual property
laws need to be reined in because they go beyond what is needed 'to
encourage an efficient level of investment in creative effort'
and
- whether adequate enforcement remedies are available under those
laws, as 'the community's interest in competitive markets needs to
be protected by ensuring that abuse of those rights is
prevented'.(22)
In the area of patents, the IPCRC concluded that it should be
harder to obtain a patent in the first place. Its rationale was
that inventions which are not genuinely innovative should not
obtain the monopolistic rights available under the Patents Act,
because it excessively restricts competition. The IPCRC recommended
making the threshold test for obtaining a patent more demanding and
the examination process by the Patents Office more rigorous.
The Patents Amendment Act 2001 and the regulations
implemented some of these recommendations, particularly in relation
to a more stringent threshold test. However some recommendations
for legislative change made in the IPCRC report were not adopted in
the 2001 legislation the Government s rationale being that the
initial changes were fast tracked ahead of any formal government
response to the recommendations of the IPCRC review.(23)
The Government s formal response to the IPCRC report was finally
released in January 2003. Schedules 6 and
8 of the Bill represent the Government s response
to two further recommendations of the IPCRC
report.(24)
Not everyone who duplicates a patented invention will infringe
the patent. One exemption, known as 'prior use', permits someone to
continue using a process or making a product, where they were doing
so (or about to do so) at the time a patent application was lodged
by someone else, but that prior use was not publicly known.
The prior use exemption (found in section 119) is currently
unavailable if the person derived information about the invention
from the patentee or they had abandoned use or intention to use
before the date of lodgement by the patentee.
The IPCRC considered the exemption and heard from a number of
parties, some of whom alleged that prior users who have sunk a lot
of investment into a product over a long period of time were not
adequately protected. It recommended against allowing a prior user
to assign, licence or sell their right under section 119. A
majority thought that 'extending the exemption might tilt the
benefits too far toward a de facto right for the prior secret
user'.(25) The IPCRC did however make 2 recommendations
for amendment of section 119:
- prior use be confined to use within the patent area (ie
Australia), and
- prior use include experimental use.
The Government accepted these recommendations in
part(26), agreeing that the prior use should be limited
to use in the patent area, but rejecting the idea that it was
necessary to clarify that the prior use included experimental use.
The Government also considered that assignees, but not
licensees(27), of the prior user should also have the
benefit of the prior use defence. The Government further considered
that the prior use exception should not be limited to the making of
a product or the use of a process but that prior use should also
encompass other acts such as selling, hiring or otherwise disposing
of the product.
Schedule 6 of the Bill implements the
Government s response to the IPCRC recommendations regarding prior
use.
Item 1 repeals and replaces section 119 of the
Patents Act. The effect of new section 119 is that
if a person had, before the relevant priority date,(28)
been exploiting a product, method or process (for example, if they
had been making a particular product, or using a particular method
or process), then even when the patent has been granted, they would
have a right to continue to do that, but in addition, they would
have the right to do any other act that would constitute an
exploitation of that product, method or process (such as a right to
sell the product they had been making, or to sell a product
resulting from using the method or process).
New subsection 119(4) allows the prior user to
assign his or her prior use right. The assignee may then have the
full benefit of the prior use exemption. There is no provision for
the prior user to licence his or her prior use right.
A patent grant is, in essence, a right to stop others from doing
certain things and a patentee may decide not to work the patent.
The decision may be due to lack of resources, unavailability of raw
materials or similar reasons. However it is also possible that the
patentee s failure to work the patent is due to a desire to exploit
a different patent, or promote a different product or simply to
stifle the inventions. The Patents Act recognises that failure to
work an invention may be contrary to the interests of the public
and provides for the granting of compulsory license and for the
revocation of a patent on the grounds of non working. Section 133
of the Patents Act provides that a prescribed court can order a
patentee to grant a licence to work their patented invention in
certain circumstances. Subsection 133(2) allows the court to
make the order if the reasonable requirements of the public with
respect to the invention have not been satisfied and the patentee
has given no satisfactory reason for failing to exploit the
invention. Subsection 135(1) provides that the reasonable
requirements of the public have not been satisfied if:
- an existing trade or industry in Australia is unfairly
prejudiced by the patentee s failure to work the invention, or an
essential part of the invention, or to grant licences on reasonable
terms
- an Australian trade or industry is unfairly prejudiced by
conditions imposed by the patentee on the working of the patent,
or
- the patent is not being commercially worked in Australia but is
capable of being worked.
The IPCR Committee considered the conditions currently
prescribed for the grant of a compulsory licence to be outdated,
poorly aligned to achieve their purpose and deficient, in that they
do not include an explicit competition test and do not sufficiently
take the legitimate interests of the patentee into account.
However, the IPCR Committee acknowledged that the threat of a
compulsory licence may lead to innovations being worked sooner and
more widely than they would otherwise have been and that the
current provisions have a continuing impact on licence
negotiations, notably between foreign rights owners and potential
users of patents in Australia .(29)
The IPCR Committee goes on to say, that the conditions for grant
of a compulsory licence should be stringent and has recommended
that the existing compulsory licensing provisions be replaced with
a stringent competition test.(30)
The Government in its response to the IPCR Committee report
supported in principle the recommendation to make the compulsory
licensing of patents subject to a competition test but argued that
a competition test alone is not sufficient as:
(a) the recommended test may be more stringent in
some circumstances than the existing tests and may result in the
compulsory licensing provisions ceasing to act as an incentive to
negotiate a voluntary licence; and
(b) a competition test will not cover some
situations where the non-working of the invention, or other
effective denial of reasonable access to it, has some negative
effect on the public interest which is not dependant on competition
in the market.(31)
Accordingly, the Government believes that the existing tests
should be retained and a competition test be added as an additional
ground on which a compulsory licence can be obtained. The
amendments in Schedule 8 implement this response.
In particular, items 2 and 3 repeal and replace
the existing test for grant of compulsory licences for patents. The
existing limbs of the test are now contained in new
subparagraphs 133 (2)(a)(ii) and (iii). New
paragraph 133(2)(b) represents the additional competition
test for compulsory licences. Under this test, if the patentee
contravenes Part IV of the Trade Practices Act or an application
law in connection with a patent, then a compulsory licence is
available as a remedy for that contravention. The Trade Practices
Act is part of a national scheme of legislation restricting
anti-competitive conduct. An application law(32) refers
to the various State and Territory Competition Policy Reform
Acts.
The effect of item 1 is that applications for
compulsory licences will only be made in the Federal Court.
Currently applications can be heard by the Federal Court and State
and Territory Supreme Courts.
Exemplary damages are damages, over and above those necessary to
compensate the plaintiff, that are awarded to punish the defendant
and provide retribution, to act as a deterrent to the defendant and
others minded to behave in a similar way, and to demonstrate the
court s disapproval of such conduct.
Item 1 of Schedule 5 inserts a
new subsection 122(1A) into the Patents Act to
allow for exemplary damages to be awarded by a court in patent
infringement actions, for example, in the case of flagrant or
wilful infringement of a patent (new paragraph
122(1A)(a). This amendment represents part of the
Government s response to the recommendations of the Advisory
Council on Intellectual Property review of patent enforcement
report, 2002.
Schedule 9 commences the day after Royal Assent.
Schedule 10 commence six months after Royal Assent
unless commenced earlier by proclamation (clause
2).
Innovation patents are a type of second tier patent for
minor or incremental innovations. They have a lower inventive
threshold than standard patents, do not require a substantive
examination before grant, have a maximum possible term of 8 years
(compared to 20 years for a standard patent) and provide the
ability to make up to 5 claims in the specification.
Item 1 of Schedule 9 is a technical amendment
to clarify that claims of an innovation patent define the
invention.(33)
Schedule 10 makes technical amendments to
correct ambiguities in wording relating to divisional applications
for innovation patents. Divisional applications are later-in-time
applications made from within the four corners of the specification
in an earlier parent application. In other words, the later
invention must be disclosed in the earlier specification.
Items 1 and 2 clarify that a
divisional application from a granted parent innovation patent must
be made in accordance with the regulations and may only be made
between the period starting when the examination of the parent
patent begins and ending when the parent patent either ends, ceases
or is revoked.
Schedules 11, 13 15 commence the day after
Royal Assent, Schedule 12 commences six months
after Royal Assent unless commenced earlier by proclamation, and
Schedule 16 commences retrospectively
(clause 2).
The Trade Marks Act 1995 and Plant Breeder s Rights
Act 1994, like other intellectual property laws are concerned
with obtaining property and other valuable rights. For this reason,
filing dates, priority dates and time periods generally assume
importance. For example, the filing date of a trade mark
application(34) is important because the term of
registration of any mark is generally counted from that date.
The effect of the amendments in Schedule 11 is to allow
regulations to be made to determine priority and filing dates of
plant breeder s right applications and trade mark applications. The
Explanatory Memorandum states that this is to overcome problems
that may arise where only partial applications have been filed or
where on-line lodgement fails due to disruption of online services.
In these cases filing dates could be affected, thus jeopardising
applicants rights. These amendments are consistent with similar
provisions in other intellectual property laws, specifically the
Designs and Patents Acts.
As stated above, intellectual
property laws are concerned with obtaining property and other
valuable rights and for this reason, filing dates, priority dates
and time periods generally assume importance. Items 2
4 and 7-8 make identical amendments to
the Patents Act 1990, Trade Marks Act 1995,
Designs Act 2003 and Plant Breeder s Rights Act
1994 to provide clarification regarding the effect of offices
not being open for business. For example, in the case of trade
marks, if a person wishes to object to registration of a trade mark
and lodges their opposition on the final day of the three month
objection period and the Trade Marks Office is closed on that date,
then lodgement could be done on the next day of business
(item 8).
Schedule 13 makes a
minor amendment to the Trade Marks Act to clarify the effect of
subsection 224(7). This subsection provides that applications may
be made to the Administrative Appeals Tribunal requesting review of
certain decisions of the Registrar not to grant extensions of
time.
The Plant Breeder s Rights Act 1994 provides for
approved forms, such as application forms, plant description forms
and plant breeder s rights certificates. These are forms approved,
by instrument in writing, by the Departmental Secretary. These
forms are currently disallowable instruments meaning that they must
be tabled in Parliament and are subject to disallowance by the
House of Representatives or the Senate. Item 2
repeals section 7 of the Plant Breeder s Rights Act with the effect
that these forms will no longer be legislative instruments or
disallowable instruments for the purposes of the Legislative
Instruments Act 2003.
Item 1 amends the Designs Act to clarify that
the delegation of the Registrar s powers and functions under the
Designs Act include those powers and functions provided in the
Designs Regulations 2004.
Item 2 amends the Plant Breeder s Rights
Act 1994 to enable a wider delegation of the powers of the
Minister, Departmental Secretary and Registrar. Its effect will be
to allow delegation to prescribed employees, such as Australian
Public Service employees. The Explanatory Memorandum states that
this brings the Plant Breeder s Rights Act into line with similar
provisions in the Patents, Trade Marks and Designs
Acts.(35)
Schedule 16 makes minor retrospective technical
amendments to the Patents Act and the Trade Marks Act.
- Explanatory Memorandum, paragraph 6.
- Section 86 of the Trade Marks Act provides for the Federal
Court to cancel a registered trade mark.
- Explanatory Memorandum, paragraph 77.
- ibid., paragraph 81.
- A generic version of a drug has the same active ingredient, is
manufactured to the same standard, and has the same clinical effect
as the original version. The generic pharmaceuticals sector
worldwide is expanding rapidly, fuelled by the expiration of
patents on many high-selling medications and Government incentives
to increase usage of low cost generics.
- Subsection 78(2).
- Explanatory Memorandum, p. 19.
- ibid., p.20.
- The Therapeutic Goods Act requires that therapeutic goods
must be entered in the Australian Register of Therapeutic Goods
(ARTG) before they can be lawfully imported into, exported from,
manufactured or supplied in Australia, unless the goods are the
subject of an exemption, approval or authority under the Act.
Pharmaceutical products containing a new chemical entity are
normally considered as high risk medicines and require stringent
assessment in relation to safety, quality and efficacy. Applicants
for the entry of these goods in the ARTG are required to provide
substantial information to the Therapeutic Goods Administration
(TGA), including information relating to pre-clinical studies,
clinical or toxicological information, chemistry, quality control
and manufacturing information. Under current rules, generics may
not springboard during the first five years that the original drug
has marketing approval. This is known as the data exclusivity
period. For a fuller explanation of drug patenting, approval and
listing see the Parliamentary Library Research Note, 2004-05, no.
3, 21 July 2004, The PBS and the Australia-US Free Trade Agreement
.
- Explanatory Memorandum, p. 20.
- Exploitation is defined to mean: make, hire, sell, or otherwise
dispose of the invention [ ] use or import it (Schedule 1 of the
Patents Act).
- Bob Baldwin, MP, Second reading speech, Intellectual Property
Laws Amendment Bill 2006, House of Representatives, Hansard, 30
March 2006, p. 14.
- Generics given a new springboard , Pharma in Focus, 17 April
2006.
- http://www.ausbiotech.org/pdf/review1.pdf
- Explanatory Memorandum, p. 23.
- Generics given a new springboard , Pharma in Focus, 17
April 2006.
- Springboard for generic drugs surge , Australian Financial
Review, 8 April 2006.
- Explanatory Memorandum, p. 21.
- ibid., p. 23.
- Intellectual Property and Competition Review Committee (IPCRC),
Review of Intellectual Property Legislation under the
Competition Principles Agreement, 30 September 2000, p 6.
- ibid.
- ibid., p. 7.
- Warren Entsch, Parliamentary Secretary to the Minister for
Industry Science and Resources, House of Representatives,
Debates, 28 June 2001, p. 28951.
- Schedule 6 implements in part recommendation 15 and Schedule 8
implements recommendation 18.
- IPCRC, op. cit, p. 158.
- Government response is available at:
http://www.ag.gov.au/www/securitylawHome.nsf/Web+Pages/A6C3825011D8A8B1CA256C330000CF9A?OpenDocument
- When a patent right is assigned, the right is transferred
completely to a third party and the right owner does not retain any
interest in the right. When a patent right is licensed, the
licensee is authorised to use the right according to the terms of
the licence. However the patent owner retains the right and may
licence it to others on the same or different terms.
- The priority date of a claim is usually the date for filing the
specification of the invention with the Patent Office (section 43).
It assumes importance for a number of reasons, particularly if
someone subsequently decides to dispute entitlement to the
patent.
- IPCRC, op cit, p. 162.
- ibid., p.163.
- Government response, op. cit.
- Defined in section 150A of the Trade Practices Act.
- A specification describes the invention and innovation patent
specifications can include up to 5 claims about the
invention.
- Defined in section 6 of the Trade Marks Act.
- Explanatory Memorandum, para 237.
Mary Anne Neilsen
19 June 2006
Bills Digest Service
Information and Research Services
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Australian Parliament using information available at the time of
production. The views expressed do not reflect an official position
of the Information and Research Service, nor do they constitute
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