13. What are the restrictions on marketing practices such as gifts, sponsoring, consultancy agreements or incentive schemes for healthcare establishments or individual medical practitioners?
Despite the TGA's broad powers in relation to advertising, in practice much of the regulation of the advertising of prescription products is through a self-regulatory scheme operated by Medicines Australia (which is the main industry body representing innovator pharmaceutical companies). For medical devices and technologies, the relevant industry body is the Medical Technology Association of Australia (MTAA).
The TGA, in its marketing approval, requires the promotion of all prescription products to comply with the Medicines Australia Code of Conduct (Code). The current edition of the Code (Edition 16) sets out standards of conduct relating to the marketing of prescription products. In particular, it contains detailed provisions relating to:
- The form and content of adverts directed at doctors for prescription pharmaceuticals.
- Promotional activities carried out by pharmaceutical companies.
No item or offer can be given or made to healthcare professionals (HCPs), their families or employees, except (Code):
- Brand name reminders of a low monetary value, which are educational or directly related to the practice of medicine or pharmacy.
- Competitions based entirely on medical knowledge or the acquisition of medical knowledge, provided that:
- entry is not dependent on prescribing, ordering or recommending a product;
- the prize is directly relevant to the practice of medicine or pharmacy;
- prizes are of a low monetary value or educational;
- there are appropriately documented processes for determining the winner(s).
- Sponsorship for educational events, which are strictly prescribed by the Code.
- Hospitality offered by companies to HCPs, provided it is simple, modest, secondary to the educational content and provided in an environment that enhances education and learning.
- Medical educational material that complies with the Code.
If the Code has been breached, the Code Committee can impose a range of sanctions, depending on the nature of the breach. The Committee can also recommend to the Medicines Australia Board that a member be suspended or expelled.
Edition 16 of the Code commenced on 1 January 2010, following a lengthy and detailed consultation process. Edition 16 introduced the following changes to the Code:
- Additional training requirements for company representatives and employees involved in preparing or approving promotional material.
- Additional restrictions on advertising, including a general prohibition on giving brand reminders to HCPs unless they are educational and/or directly related to the practice of medicine or pharmacy, and provisions dealing with 'social media' such as Facebook, YouTube, MySpace and Twitter for the promotion of prescription medicines.
- Further measures seeking to improve transparency and increase accountability of industry conduct.
- An increase in the maximum fines for moderate, severe and repeat breaches of the Code.
Medicines Australia reviews the Code no less than every three years. A new version of the Code is currently under development and is expected to be released in early 2013. Similar requirements exist under the MTAA Code of Practice. The most recent version, edition 7, was released on 1 November 2011.
The increased emphasis on anti-bribery and corruption in recent years has led to significant pressure on pharmaceutical and medical device and technology companies in Australia. Under the Criminal Code Act 1995 (Cth) it is an offence to influence a foreign public official in the exercise of the official's duties by offering, providing, promising (directly or indirectly through an intermediary) a benefit to another person that is not legitimately due to that person.
A 'benefit' includes any advantage and is not limited to property. The definition of 'foreign public official' is broad and:
- Includes, for example, members of a legislature of a foreign country and individuals who perform work for a public international organisation under a contract.
- Applies to a person who is incorporated in Australia, a citizen, or a resident at the time of the conduct, even if the conduct occurs wholly outside Australia.
- Does not apply to foreign nationals or companies unless the conduct occurs wholly or partly in Australia, or wholly or partly on board an Australian aircraft or ship.
The UK Bribery Act 2010 and the US Foreign Corrupt Practices Act 1977 also have a significant impact on pharmaceutical companies operating in Australia as those with head offices, bank accounts or other business operations in the UK and the US are subject to the extraterritorial operation of those acts.
14. What are the restrictions on marketing medicinal products on the internet, by e-mail and by mail order?
The advertising of prescription products to the general public is prohibited. Therefore, pharmaceutical products cannot be advertised on Australian-based internet sites that are accessible by the public. While the internet can be used as a means of providing accurate and scientifically reliable information on prescription products, this information must be non-promotional. However, it should be noted that the Medicines Australia Code of Conduct and TG Act both define promotion and advertising very narrowly. It is therefore unadvisable to use this medium without legal review.
Non-prescription pharmaceutical products can be advertised to the public where they are listed on the ARTG. Therefore, these OTC products can be advertised on Australian-based internet sites that are accessible by the public. These advertisements are strictly regulated by law and industry standards such as the Therapeutic Goods Advertising Code.
15. What are the restrictions on advertising medicinal products?
Legislation and regulatory authority
The TGA regulates and enforces restrictions on advertising medicinal products. Additionally the Therapeutic Goods Advertising Code Council regulates the Therapeutic Goods Advertising Code.
The Australian Consumer and Competition Commission enforce breaches of the Competition and Consumer Act 2010 (Cth) (CC Act), which deals with offences relating more broadly to advertising, for example advertisements which are misleading.
An advertisement of a medicinal product can only refer to the indications that have been included in the ARTG for that specific product.
Advertising prescription products directly to consumers is prohibited.
Advertising of certain medicinal products that can only be supplied by a pharmacist is also prohibited. However, there are some exceptions to this. OTC products available without prescription from pharmacies, health food stores, supermarkets and by direct marketing can be advertised to the general public, subject to:
- The TG Act.
- The TG Regulations.
- Relevant state and territory legislations.
- The Therapeutic Goods Advertising Code which sets out specific requirements on the content of advertisements for medicinal and other products.
In addition, advertising non-prescription products must not infringe the CC Act. Any representations made in advertisements must be documented, genuine and not misleading.
The internet can be used to promote pharmaceutical products to HCPs, provided that the advertisement complies with the regulatory scheme (see above, Restrictions), and the internet site can only be accessed through a secure system designed to prevent access by members of the general public.
PACKAGING AND LABELLING
16. Outline the regulation of the packaging and labelling of medicinal products.
Legislation and regulatory authority
Requirements for the packaging and labelling of pharmaceutical products vary according to whether the product is a medicinal product (prescription or non-prescription), device or poison.
The TGA is the regulator that enforces the legislation and requirements regarding packaging and labelling of therapeutic goods.
Packaging must comply with the following (depending on the product):
- The TG Act.
- The TG Regulations.
- The Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) (TG (MD) Regulations).
- Relevant state and territory medicinal products legislation.
- TGO 69 on General Requirements for Labels for Medicines.
- TGO 37 on General Requirements for Labels for Therapeutic Devices.
- TGO 87 on General Requirements for Biologicals Labelling (commencing 31 May 2012).
- TGO 80 on General Requirements for Child Resistant Packaging.
- The Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) No. 24 and its amendments, incorporated in the Poisons Standard 2009. This contains all mandatory warning statements to be included on the packaging or labelling of therapeutic drugs (prescription and nonprescription) and poisons.
- The Therapeutic Goods Advertising Code (for non-prescription medicines).
- Code of Practice for Tamper Evident Packaging.
The requirements for the packaging and labelling of medical devices were amended in 2002. The new requirements are contained in the TG (MD) Regulations. The new requirements complement TGO 37. Information that must be provided is similar to that for listed medicinal products.
Prescription only or pharmacist only medicines must have a Product Information (PI) document and a Consumer Medicine Information (CMI) document. The PI contains technical information intended for HCPs. The CMI contains general information about the medicine for the patient and must be in plain English.
The Minister for Health and Ageing can, by legislative instrument (on commencement of the relevant provisions), require specified advisory statements to be incorporated on the labelling of particular medicines or classes of medicines.
The following main items of information must be included on the labels of all therapeutic goods:
- The product name.
- The name(s) of all the active ingredients in the goods.
- The quantity or proportion of all active ingredients in the goods.
- Warning statements, where applicable.
- Expiry date of the goods preceded by the expiry date prefix.
- If the goods are included on the Australian Register of Therapeutic Goods, the registration or listing number.
- The name or address of the manufacturer or sponsor of the goods.
If the therapeutic good is a therapeutic device and that device is within a package that contains two or more identical or different therapeutic devices, additional requirements must be met.
If the therapeutic good contains blood, cells or tissues collected from a donor the labelling must contain the following main information:
- The unique identification number/alphanumeric linked to the donor.
- Date and time of collection.
- Additives and/or antimicrobial agents (if applicable).
- Suspending solution (if applicable).
- Instructions for return (if applicable).
All particulars that are contained on labelling for therapeutic goods must be written:
- In the English language.
- In durable and legible character and:
- for all registration and listing numbers must not be less than one millimetre in height; and
- in all other cases not less than 1.5 millimetres.
- In metric measurements for all active ingredients in therapeutic goods.
Any medicines that present significant risk of toxicity to children if accidently ingested must be contained in child resistant packaging. The packaging must retain these child-resistant properties for the necessary number of openings and closing necessary to fully use the contents.
17. Outline the regulation of the manufacture and marketing of alternative or complementary medicinal products.
The manufacture and marketing of alternative or complementary medicine is regulated by the TG Act, TG Regulations and SUSDP. Due to the complexity of regulation in this area, a number of other rules also apply. The Australian regulatory guidelines for complementary medicines (ARGCM) may also be of assistance to sponsors of complementary medicines in meeting their obligations under therapeutic goods legislation.
The following are referred to as complementary medicines:
- Medicinal products containing herbs, vitamins, minerals, and nutritional supplements.
- Homoeopathic medicines.
- Certain aromatherapy products.
- Traditional medicines including:
- Chinese medicines;
- Ayurvedic medicines; and
- Australian indigenous medicines.
Complementary medicines can be listed or registered. Whether a complementary medicine is listed (low risk) or registered (higher risk) depends on:
- The indications granted for the product by the TGA.
- The product's ingredients.
- The claims made by a sponsor on the product's labelling.
By default, if a therapeutic good such as a complementary medicine is not listable or exempt, it is registrable. Therefore, while most complementary medicines are listed in the ARTG, some must be registered.
In July 2011, the TG Act was amended to introduce a new regulation for Homeopathic and Ayurvedic medicines.
The amendments to the TG Act:
- Include new definitions and standards for homeopathic and Ayurvedic preparations.
- Seek to ensure that Homeopathic and Ayurvedic preparations meet the appropriate standards for safety quality and efficacy.
The TGA Office of Complementary Medicines (OCM) regulates the manufacture and marketing of complementary medicines in consultation with the Advisory Committee on Complementary Medicines (ACCM). The ACCM replaces the Complementary Medicines Evaluation Committee and was formed to advise and make recommendations to the OCM on the inclusions, variation and retention of complementary medicines on the ARTG.
The OCM's primary role is to:
- Evaluate new complementary medicinal substances and products.
- Undertake post-market reviews.
- Maintain and support the Electronic Listing Facility, Version 3.0 (ELF3).
The ELF3 system provides a browser-based electronic facility for lodging applications to list complementary medicines in the ARTG. Notice must be first given to the OCM in writing of the intention to lodge the application before an application can be submitted to the TGA to list a complementary medicine in the ARTG. The application must then be posted on the ELF3 system. Once an electronic application for listing of a complementary medicine is lodged on the ELF3 system, the TGA usually makes a decision about listing within ten working days.
18. What are the legal conditions to obtain a patent and which legislation applies? Which products, substances and processes can be protected by patents and what types cannot be patent protected?
Conditions and legislation
Australian patent law is governed by the Patents Act. The Patents Act provides for the grant of two main types of patent in Australia:
- Standard, which is the traditional form of patent protection under Australian law.
- Innovation, which is a recently introduced second form of patent protection intended to provide protection for a shorter term to inventions that cannot satisfy the inventiveness requirement for a standard patent.
While there are significant differences between these two types of patents, they have much in common. Unless specifically referring to one type of patent or the other, the following applies to both types of patents.
For an invention to be protected by an Australian patent, it must satisfy the requirements for a 'patentable invention' under section 18 of the Patents Act. Section 18 provides that a patentable invention is one that:
- Is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies 1623 (a threshold test requiring the invention to be the appropriate subject matter for the grant of a patent).
- Is novel relative to the prior art base.
- Involves an inventive step (standard patent) or an innovative step (innovation patent) relative to the prior art base. The inventive step requirement for a standard patent means that the invention must not be obvious to a person skilled in the relevant art. This assessment is made in light of 'common general knowledge' as either:
- it existed in Australia before the priority date of the claim considered separately; or
- together with prior art information that a person skilled in the art could reasonably be expected to have ascertained, understood and regarded as relevant before the priority date.
The innovative step requirement for an innovation patent assesses whether the invention differs from the prior art in a manner that makes a substantial contribution to the working of the invention. It does not consider whether the invention is obvious.
- Is useful (at least one embodiment of the invention must achieve the result promised in the specification).
- Has not been commercially exploited in secret by, or with the authority of, the patentee in Australia before the priority date of the patent.
To be valid, a patent must also satisfy the requirements of section 40 of the Patents Act, which requires that the complete specification:
- Describes the invention fully, including the best method known to the applicant of performing the invention. This full description requirement encompasses an enablement requirement, which has been held to be satisfied if the specification enables a single embodiment falling within the scope of the claims, regardless of their breadth.
- For a standard patent, ends with a claim or claims defining the invention.
- For an innovation patent, ends with at least one and no more than five claims defining the invention.
- For both standard and innovation patents the claim or claims:
- must be clear and succinct and fairly based on the matter described in the specification; and
- must relate to one invention only.
Scope of protection
Pharmaceutical and biotechnology products, processes and methods are all patentable, provided they meet the conditions for patentability (see above, Conditions and legislation). This includes:
- Biological materials such as isolated or purified gene sequences, proteins and micro-organisms and the:
- processes for identifying, purifying and isolating them; and
- methods of using them.
- Medical devices.
- Methods of medical treatment.
Human beings, and the biological processes for their generation, are not patentable inventions. Also, plants and animals, and the biological processes for the generation of plants and animals, are not patentable inventions for an innovation patent unless the invention is a microbiological process or a product of such a process.
19. How is a patent obtained?
Application and guidance
Applications are made to IP Australia (www.ipaustralia.gov.au). IP Australia provides guidance on the application process at www. ipaustralia.gov.au/get-the-right-ip/patents/apply-for-a-patent/.
IP Australia's fees are available at www.ipaustralia.gov.au/ get-the-right-ip/patents/time-and-costs/fees/.
Process and timing
The application process can begin by filing either a complete application or a provisional application (in which case a complete application must be filed within 12 months).
An application for a standard patent then proceeds through the following process:
- The unexamined standard application is published about 18 months after the application's earliest priority date.
- A request for examination must be made within five years of the filing date. However, if a request for examination has not been made by about 55 months from the earliest priority date, IP Australia will direct the applicant to request examination. A request for examination must then be filed within six months of receiving the direction or the application will lapse.
- Following submission of the request for examination, the Patent Examiner may issue either a notice that the standard patent application has been accepted or an adverse report identifying any lawful grounds of objection. The applicant can respond to the adverse report. Further reports can be issued to which further responses can be filed. Once the Patent Examiner is satisfied that there are no outstanding issues, the application is accepted. If the application is not accepted within 21 months of the first report, it lapses.
After a complete application is accepted by IP Australia, interested third parties can oppose the grant on certain specified grounds within three months of publication of the advertisement of acceptance of the application in the Australian Official Journal of Patents (AOJP). If an opposition is pursued, a Hearing Officer at IP Australia will hold a hearing to decide whether or not the opposition succeeds.
An appeal against a decision of the Hearing Officer on an opposition must be made to the Federal Court of Australia (Australia's principal court for dealing with patent litigation). If no opposition is filed or the opposition is unsuccessful, the accepted standard application is granted.
The application process for an innovation patent is quite different to that for a standard patent and is as follows:
- Within a couple of weeks of the filing of an innovation patent application, IP Australia will conduct a simple formalities check to ensure the application is in order. This is not a substantive examination and IP Australia does not assess whether the patent is valid as part of this formalities check. If the innovation patent application passes the formalities check, the innovation patent will be granted. Note that although granted, an innovation patent cannot be enforced until it has been examined and certified.
- The unexamined innovation patent is then published at grant.
- The patentee or a competitor can request examination of the innovation patent.
- Following a request for examination, the Patent Examiner may issue either a notice that the innovation patent has been certified or an adverse report identifying any lawful grounds of objection. The patentee can respond to the adverse report. Further reports can be issued to which further responses can be filed. Once the Patent Examiner is satisfied that there are no outstanding issues, the innovation patent is certified. If the innovation patent is not certified within six months of the first report, it ceases.
- Once an innovation patent is certified, interested third parties can then start opposition proceedings as for a standard patent application. If the opposition proceedings are successful, the innovation patent may be revoked.
Applications are usually examined to see if they meet the substantive requirements for patentability (see above, Process and timing).
20. How long does patent protection typically last? Can monopoly rights be extended by other means?
Duration and renewal
The term of a standard patent from its effective filing date is either (sections 67 and 70, Patents Act):
- 20 years.
- Up to 25 years for particular standard patents relating to pharmaceutical substances (see below, Extending protection).
The term of an innovation patent is eight years from its effective filing date (section 68, Patents Act).
Annual renewal fees are payable from the fifth anniversary of the filing date for a standard patent and from the second anniversary for an innovation patent. Renewal fees are detailed at www. ipaustralia.gov.au/get-the-right-ip/patents/time-and-costs/fees/).
Currently, renewal fees are:
- About A$8,500 over the 20-year term of a patent for a standard patent.
- A$2,000 for each year during the period of the extension if the term is extended.
- About A$900 over its eight year term for an innovation patent.
A patentee can apply for an extension of up to five years of the term of a standard patent where the following conditions are satisfied (section 70, Patents Act):
- The patent includes at least one claim covering one or more pharmaceutical substances per se (as distinct from a pharmaceutical substance that forms part of a method or process) or one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology.
- Goods containing, or consisting of, the pharmaceutical substance must be included in the Australian Register of Therapeutic Goods.
- The first regulatory approval for the pharmaceutical substance must have occurred more than five years after the effective filing date of the patent.
- The term of the patent has not previously been extended.
No further extensions for a standard patent are possible. Australia does not offer an additional paediatric extension like that available in Europe and the US.
The term of an innovation patent cannot be extended.
21. How can a patent be revoked?
A patent can be revoked in whole or in part by a prescribed court (usually the Federal Court of Australia) or the Commissioner of Patents. Any person can apply to a prescribed court for an order revoking a patent (section 138, Patents Act) or a defendant in infringement proceedings can apply through a counterclaim in the proceedings for the revocation of the asserted patent (section 128, Patents Act).
A standard patent can be revoked by the Commissioner on receipt of an adverse report following re-examination (section 101, Patents Act) and an innovation patent can be revoked by the Commissioner following an adverse report following examination (section 101F, Patents Act) or re-examination (section 101J, Patents Act). A request for examination or re-examination can be made by any person.
A patent can be revoked in whole or in part by a prescribed court on any of the following grounds:
- The patentee is not entitled to the patent.
- The invention is not a patentable invention under section 18 of the Patents Act (see Question 18, Conditions and legislation). That is:
- the invention is not a manner of manufacture;
- one or more claims of the patent are not novel or lack an inventive step (standard patent) or lack an innovative step (innovation patent);
- the invention is not useful;
- the invention was commercially exploited in secret by or with the authority of the patentee in Australia before the priority date of the patent;
- the patent, or an amendment of it, was obtained by fraud, false suggestion or misrepresentation;
- the specification does not comply with subsections 40(2) or (3) of the Patents Act, which require the patent specification to:
- describe the invention fully, including the best method known to the patentee of performing the invention;
- set out the claims clearly and succinctly;
- fairly base the claims on matter described in the specification.
A patent can be revoked in whole or in part by the Commissioner following re-examination on the grounds that when compared with the prior art base as it existed before the priority date the invention either:
- Is not novel.
- Lacks an inventive step (standard patent).
- Lacks an innovative step (innovation patent).
Following the examination of a patent, the Commissioner must revoke an innovation patent if he considers that a ground for the revocation of the patent has been made out and that ground has not been removed (section 101F, Patents Act). The grounds on which the Commissioner can revoke an innovation patent following examination include (section 101B):
- That the specification does not comply with section 40 of the Patents Act.
- The invention is not a manner of manufacture.
- That the invention is not novel when compared with the prior art base as it existed before the priority date of that claim.
- That the invention lacks an innovative step when compared with the prior art base as it existed before the priority date of that claim.
- That the invention is not a patentable invention as it relates to:
- a human being or the biological processes for their generation; or
- a plant or animal or the biological processes for the generation of plants and animals other than a microbiological process or a product of such a process.
- That the use of the invention would be contrary to law.
- That the patent claims as an invention a substance that is capable of being used as food or medicine (whether for human beings or animals and whether for internal or external use) and is a mere mixture of known ingredients or a process producing such a substance by mere admixture.
- That the patent contains a claim that includes the name of a person as the name, or part of the name, of the invention so far as it is claimed in that claim.
- The patent claims an invention that is the same as an invention that is the subject of a patent and is made by the same inventor and the relevant claim or claims in respect of each patent have the same priority date or dates.
- The complete specification does not comply with such other matters (if any) as are prescribed in the Patents Regulations.
For the novelty and innovative step analysis, the prior art base does not include information made publicly available only through the doing of an act (sections 98, 101G, Patents Act).
22. How is a patent infringed? How is a claim for patent infringement made and what remedies are available?
Conditions for infringement
The Patents Act does not define infringement. However, a patentee is granted the exclusive right to exploit the patented invention and to authorise another person to exploit that invention in Australia (section 13, Patents Act). 'Exploit' is defined to include:
- Where the invention is a product:
- making, hiring, selling or otherwise disposing of the product;
- offering to make, sell, hire or otherwise dispose of it;
- using or importing it;
- keeping it for the purpose of doing any of those things.
- Where the invention is a method or process, using the method or process, or doing any action mentioned immediately above in respect of the product resulting from the method or process.
Therefore, generally, a patent is infringed when a person exploits a patented invention or authorises another to do so in Australia without the licence or authority of the patentee. However, the exclusive rights of a patentee are limited during the extended term of a pharmaceutical patent. More specifically, if the term of a pharmaceutical patent has been extended, it is not an infringement during the extended term to exploit:
- A pharmaceutical substance per se or a pharmaceutical substance when produced by a process that involves the use of recombinant DNA technology for a purpose other than therapeutic use.
- Any form of the invention other than that pharmaceutical substance (section 78, Patents Act).
A patent claim can also be infringed indirectly or contributorily by a supplier (section 117, Patents Act). More specifically, the supplier of a product will be liable for contributory or indirect infringement if, without the licence of the patentee, it supplies a product either:
- That is capable of only one reasonable use, being the infringing use.
- That is not a staple commercial product and the supplier had reason to believe that the recipient would put the product to an infringing use.
- Together with inducement or instructions to use the product in an infringing manner.
A patent can be infringed by conduct after the publication date of the complete specification although proceedings can only be instituted after the patent has actually been granted (section 57, Patents Act).
Claim and remedies
Patent infringement actions for pharmaceutical and biotechnology products, processes and methods are common in Australia. Patent infringement proceedings can be commenced in any prescribed court but the Federal Court of Australia is the most common jurisdiction (it has many judges that are experienced in patent matters).
A first instance decision can be appealed to the Full Federal Court of Australia (comprised of three judges). There is a further right of appeal, with leave, to the High Court of Australia.
In infringement proceedings all trials are judge trials (juries have no role in patent litigation). Over the course of the proceedings, the parties will discover documents and will exchange evidence, both lay and expert. There are no pre-trial depositions. The court will hold a single hearing where it hears evidence regarding infringement (including claim construction) and invalidity, and possibly also remedies.
A patent is infringed if the accused product, process or method includes all of the essential features (integers) of the asserted claim. In assessing whether the accused product, process or method includes all of the essential integers of the asserted claim, the court employs a purposive approach to construing the claim. The doctrine of equivalents is not part of Australian law and does not play a role in the court's assessment of infringement.
Remedies available to a patentee include:
- Interlocutory injunction orders temporarily preventing infringement pending trial, provided that the patentee:
- establishes that there is a serious question to be tried such that if the evidence remains as it is, there is a probability that at the trial of the action the patentee will be held entitled to relief;
- establishes that it will suffer irreparable harm for which damages will not be an adequate remedy unless an interlocutory injunction is granted;
- establishes that the balance of convenience favours its grant;
- gives a cross undertaking as to damages, which becomes enforceable if it is ultimately held that the interlocutory injunction order should not have been granted.
- A final injunction preventing infringement during the life of the patent (including any extended term).
- Either of the following, at the election of the patentee:
- damages (compensating the patentee for the loss which it can prove to have suffered as a result of the infringement). Additional (non-compensatory) damages are also available for flagrant infringement of a patent;
- an account of profits (requiring the infringer to disgorge all profits made by it as a result of the infringement).
- Delivery up orders requiring the infringer to deliver up the infringing product.
23. Are there non-patent barriers to competition to protect medicinal products?
A period of data exclusivity to protect particular medicinal products exists under section 25A of the TG Act. Under that regime, the Secretary of the Department of Health and Ageing (Secretary) must not use 'protected information' about another therapeutic good when evaluating a new therapeutic good for registration. Information is 'protected information' if it meets the following criteria (section 25A(2)):
- It concerns an active component that is contained in an application to register a therapeutic good (not being a therapeutic device) ('new good').
- It is not in the public domain and the sponsor has not given written permission for the Secretary to use the information.
- When the application to register the new good was lodged, no goods containing that active component were (or had ever been) included in the ARTG.
- Five years have not passed since the day the new good became registered.
An 'active component' is a substance that is, or one of the substances that together are, primarily responsible for the biological or other effect identifying the goods as therapeutic goods (section 25A(3)).
No additional data exclusivity periods are available, such as for information relating to a new indication.
Although Australia has an orphan drugs regime, it does not include a period of marketing exclusivity.
24. What are the legal conditions to obtain a trade mark and which legislation applies? What cannot be registered as a trade mark and can a medicinal brand be registered as a trade mark?
Conditions and legislation
Australian trade mark law is governed by the Trade Marks Act 1995 (Cth) (TM Act). To qualify as a trade mark, a sign must be used or intended to be used to distinguish goods or services dealt with or provided in the course of trade (section 17, TM Act). A sign can be a:
- Aspect of packaging.
- Sound or scent.
An application for a trade mark will be rejected if:
- The trade mark contains or consists of certain prohibited or prescribed signs (section 39, TM Act).
- The trade mark cannot be represented graphically (section 40, TM Act).
- The trade mark is not capable of distinguishing the applicant's goods or services in respect of which the trade mark is sought to be registered from the goods or services of other persons (section 41, TM Act).
- The trade mark contains or consists of scandalous matter or its use would be contrary to law (section 42, TM Act).
- Use of the trade mark in relation to those goods or services in respect of which it is sought to be registered would be likely to deceive or cause confusion (section 43, TM Act).
- The trade mark is substantially identical or deceptively similar to an earlier trade mark application or registration and the goods or services of both are the same, similar or closely related (section 44, TM Act).
Scope of protection
For what can and cannot be registered as a trade mark generally, see above Conditions and legislation. More specifically, the following can be registered, provided they satisfy the application requirements (see above, Conditions and legislation):
- A medicinal brand.
- The appearance, colour or colour combination of a tablet or capsule.
- The aspects of packaging.
The brand name of a medicinal product would likely be rejected as a trade mark, on the basis that it would be likely to deceive or cause confusion, if the following applies:
- It is substantially identical to a notified International Nonproprietary Name (INN) or a notified INN stem.
- The goods in relation to which trade mark registration is sought are not restricted to the particular substance identified by the INN or INN stem.
25. How is a trade mark registered?
Application and guidance
Applications are made to IP Australia (www.ipaustralia. gov.au). Details on the application process are available at http://www.ipaustralia.gov.au/get-the-right-ip/trade-marks/ trade-mark-application-process/.
IP Australia's fees are available at http://www.ipaustralia.gov.au/ get-the-right-ip/trade-marks/time-and-costs/fees/. Currently, the fee for filing a single mark in one or more classes is either:
- A$180 for each class.
- A$120 for each class filed through the official online application.
Process and timing
Applications must be made on the prescribed form, which must specify the goods and/or services for which the applicant wishes to register the trade mark.
Applications are examined in order of filing. The period of time taken between filing and examination varies according to the number of applications lodged. Expedited examinations are possible if there is good reason. When the application is examined, it is assessed to determine whether it satisfies the requirements of the TM Act. If the application satisfies all of the requirements, it will be accepted for registration. If not, a report is sent to the applicant setting out any requirements that need to be addressed. The TM Act allows 15 months from the date of the examiner?s first report to meet any requirements set out by the examiner and to have the application accepted, although an extension may be requested. If a trade mark application is not accepted and it runs out of time, it will lapse.
Once a trade mark is accepted for registration, the details are advertised in the Australian Official Journal of Trade Marks (AOJTR).
Any person can oppose the registration of the mark within three months from the date of advertisement of acceptance of the application in the AOJTR. The registration of a trade mark can be opposed on any of the grounds on which an application for the registration of a trade mark can be rejected other than that it cannot be represented graphically (see Question 24). Registration can also be opposed on the following grounds:
- That the applicant is not the owner of the trade mark (section 58, TM Act).
- That the opponent first used, and has continuously used, a substantially identical or deceptively similar trade mark for similar or closely related goods or services, before the applicant?s first use (section 58A, TM Act).
- That the applicant does not intend to use the mark (section 59, TM Act).
- That use of the mark may confuse or deceive due to another mark that has acquired a reputation in Australia (section 60, TM Act).
- That the trade mark contains or consists of a false geographical indication (section 61, TM Act).
- That the application or a document filed in support thereof was amended contrary to the TM Act or the Registrar accepted the application on the basis of evidence or representations that were false in material details (section 62, TM Act).
- That the application was made in bad faith (section 62A, TM Act).
If no opposition is filed or the opposition is unsuccessful the trade mark will be registered on payment of the registration fee.
26. How long does trade mark protection typically last?
Duration and renewal
The initial registration is valid for a ten-year period from the filing date. Registration of a trade mark can be renewed indefinitely for successive periods of ten years on payment of a renewal fee.
Trade marks can be renewed within 12 months before or after the expiry date of the mark. Late fees apply if the registration is renewed after the expiry date.
See above, Duration and renewal.
27. How can a trade mark be revoked?
A trade mark can be revoked by the Registrar (section 84A, TM Act) or by a prescribed court (sections 86-88, TM Act).
The Registrar is entitled to revoke the registration of a trade mark if the Registrar believes 'the trade mark should not have been registered' and it is reasonable to do so (section 84A, TM Act). Applications to remove a trade mark from the Register can be made to the Registrar on the grounds that the registered owner either:
- Has not used the trade mark in Australia.
- Has not used the trade mark in good faith in Australia, for a continuous period of three years ending one month before the day on which the non-use application is filed (section 92, TM Act).
An aggrieved person can apply to a prescribed court to rectify the Register by cancelling the registration of the trade mark, or removing or amending an entry wrongly made in the Register on various grounds, including:
- A condition or limitation entered in the Register in relation to the trade mark has been contravened (section 86, TM Act).
- The trade mark contains or consists of a sign that has become generally accepted within the relevant trade as the sign that:
- describes or is the name of an article, substance or service; or
- is the only commonly known way to describe or identify an article formerly exploited under a patent, or a service formerly provided as a patented process, where the patent has expired more than two years ago (section 87, TM Act).
- Any of the grounds on which the registration of the trade mark could have been opposed (section 88, TM Act).
- An amendment of the application for the registration of the trade mark was obtained as a result of fraud, false suggestion or misrepresentation (section 88, TM Act).
- Use of the mark is likely to deceive or cause confusion (section 88, TM Act).
- If the application is in respect of an entry in the Register, the entry was made, or has been previously amended, as a result of fraud, false suggestion or misrepresentation (section 88, TM Act).
28. How is a trade mark infringed? How is a claim for trade mark infringement made and what remedies are available?
The rights of a registered proprietor of a trade mark are infringed if, without the proprietor's authorisation, another person uses as a trade mark a sign that is substantially identical or deceptively similar to the registered trade mark for:
- Goods or services for which it is registered.
- Goods or services of the same description as those in respect of which the mark is registered.
- Services which are closely related to goods for which the mark is registered.
- Goods which are closely related to services for which the mark is registered.
- Goods or services unrelated to those for which the mark is registered, if the mark is so famous that even such use is likely to harm the interest of the registered owner (section 120, TM Act).
Claim and remedies
An action for infringement of a registered trade mark can be brought in a prescribed court. Most actions are commenced in the Federal Court of Australia, which can grant:
- Injunctions (including interlocutory injunctions orders pending final trial) and ancillary orders.
- Delivery up orders.
- Either damages or an account of profits at the election of the trade mark owner.
Patent and trade mark licensing
29. Does a patent or trade mark licence agreement and payment of royalties under it to a foreign licensor have to be approved or accepted by a government or regulatory body?
A patent or trade mark licence agreement and payment of royalties under it to a foreign licensor do not have to be approved or accepted by a government or regulatory body. However, the particulars of a licence agreement can be recorded on the IP Australia Register.
There may be taxation consequences for the remission of royalties and specific advice should be sought in this area.
Patent and trade mark conventions
30. Is your jurisdiction party to international conventions on patent and trade mark protection?
Australia is a member of the:
- WIPO Paris Convention for the Protection of Industrial Property 1883 (Paris Convention).
- Patent Cooperation Treaty 1970.
- WTO Agreement on Trade-Related Aspects of Intellectual Property Rights 1994 (TRIPS).
- WIPO Patent Law Treaty.
- Budapest Treaty.
- WIPO Strasbourg Agreement Concerning the International Patent Classification (Strasbourg Agreement).
- Australia is a member of the following international treaties:
- Paris Convention.
- WIPO Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks 1989 (Madrid Protocol).
- WIPO Nice Agreement Concerning the International Classification of Goods and Services for the Purposes of the Registration of Marks (Nice Agreement).
- WIPO Trademark Law Treaty.
- WIPO Singapore Treaty on the Law of Trademarks (Singapore Treaty).
- PLC Multi-Jurisdictional Guide 2012: Life Sciences - Part 1
- PLC Multi-Jurisdictional Guide 2012: Life Sciences - Part 3
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