Pharmaceutical companies.

Medical technology (devices and diagnostics) and digital health companies.

Research institutes.

Government and regulatory bodies.

Funding bodies.

Support services.

Investigator grants. This provides fellowship and research support, providing funding for high-performing researchers consisting of funding for their salary and a research support package.

Synergy grants. This provides AUD5 million per grant for outstanding multi-disciplinary research teams to work together to answer complex questions.

Ideas grants. This is provided to fund innovative and creative research projects.

Strategic and leveraging grants. This is more targeted and focuses on supporting projects that address identified national needs.

Subsidies for pharmaceuticals listed on the Pharmaceutical Benefits Scheme (PBS).

Free or subsidised treatment by medical practitioners (classified as "bulk billing").

Substantial grants to state and territory governments, contributing to the cost of providing free access to public hospitals.

Specific purpose grants to state and territory governments and other bodies.

Schedule 2: medicines that can only be sold by pharmacies and licensed persons (pharmacy medicines).

Schedule 3: medicines that can only be sold by pharmacists personally (others are not licensed to sell them) (pharmacist only medicines).

Schedule 4: medicines that can only be supplied on prescription from a medical professional (prescription only medicines).

Schedule 8: controlled drugs.

Buildings and grounds for medicine storage.

Training and policies for distribution personnel.

Stock handling and stock control.

Transportation of medicines.

Managing complaints, return of unused or damaged goods, and product recalls.

Unapproved therapeutic goods for experimental purposes.

Therapeutic goods for personal use.

Marketing approval from the TGA to sell the pharmaceutical product in Australia (through inclusion of the product on the ARTG).

A PBS listing, if it wants the product to qualify for government reimbursement.

Schedule 3 (pharmacist only medicine).

Schedule 4 (prescription only medicine).

Schedule 8 (controlled drugs).

Restricted representations (those that refer to serious forms of a disease, condition, ailment, or defects). These require approval from the TGA to be used in advertising. Section 28 of the Advertising Code specifies what is meant by "serious form" in this context.

Prohibited representations (those that refer to cancer, sexually transmitted diseases, HIV/AIDS, Hepatitis C virus, mental illness, or an abortifacient action). These must not be used unless expressly permitted by the TGA. The prohibited representations are set out in Part 1, Schedule 2 of the Therapeutic Goods Regulations 1990.

The price information of prescription and pharmacist-only medicines can only be lawfully advertised under certain conditions to:

(Section 92, National Health Act 1953.)

For medicines under the PBS scheme, section 36 of the Advertising Code provides that pharmacy marketing groups can publish price information where it includes the PBS price, the group's own generic medicine, and one other benchmark price brand for that medicine.

Mandatory statements.

Health warnings or links to health warnings.

Other statements required by a legislative instrument (such as complementary medicines, vitamins and minerals, and weight management).

A visual statement easily read from a reasonable viewing distance for the particular media type in the context in which the advertisement is intended to be viewed.

A spoken statement that can be clearly heard and understood.

In either case, the statement being repeated as often as is necessary to be noticed by a viewer or listener.

Labels of therapeutic goods.

Consumer medicine information.

Instructions for use.

Patient information leaflets.

Advertisements that do not refer, expressly or by implication, to a claim relating to therapeutic use and that only contain one or more of the:

Therapeutic goods only available from a pharmacist must include: "ASK YOUR PHARMACIST ABOUT THIS PRODUCT".

Short form advertisements must include: "ALWAYS FOLLOW THE DIRECTIONS FOR USE".

Medicines must include: "ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE".

Suggest that the comparator goods or services are harmful or ineffectual, either directly or by implication.

Exaggerate the efficacy of the goods or encourage their inappropriate or excessive use.

The comparison is accurate.

The products or services being compared are reasonably similar.

The comparison is valid for the life of the promotion.

Be accurate, truthful, and not misleading.

Use substantiated claims.

Promote safe and proper use of the goods.

A "relevant person," defined as a person engaged in the product's production, marketing, or supply (such as a CEO of a pharmaceutical company, a paid influencer, or direct seller of the product).

A member of a relevant person's immediate family, unless the relationship is disclosed in the advertisement.

A government or government authority.

A hospital or health care facility other than a community pharmacy.

An employee or contractor of a government, government authority, hospital, or health care facility.

A current or former health practitioner, health professional, or medical researcher.

A person who represents themselves as being qualified or trained to diagnose, treat, or prevent disease, ailment, defect, or injury in persons.

A corporation.

Cash payment.

Provision of services.

Gifts.

Free products.

Accommodation.

Promises of future benefits.

Relate to an annual compliance priority and part of the associated compliance operation.

Relate to a compliance operation arising during the year.

Of higher risk and selected as an individual case for investigation.

Selected for action from a lower risk report stored in the TGA database.

Issue warning letters.

Suspend or cancel goods from the ARTG, manufacturing licences, and quality management certificates.

Recall goods under the Uniform Recall Procedure for Therapeutic Goods where they may be deficient or defective.

Issue a directions notice.

Issue infringement notices.

Negotiate an enforceable undertaking with the entity, and if necessary, apply for Federal Court orders.

Seek an injunction from the Federal Court against the entity's non-compliant activity.

Enforce civil penalties of up to 5,000 penalty units (AUD1.1 million) for an individual and 50,000 penalty units (AUD11 million) for a body corporate.

Pursue criminal proceedings where there is serious non-compliance.

The TG Act.

The TG Regulations.

Relevant state and territory legislation.

The Advertising Code, which sets out specific requirements for the content of adverts for medicinal and other products (see Question 10).

Benefits, performance characteristics, or composition of a product (including where an inaccurate comparison is drawn between different products).

Sponsorship of a product.

Need for the product.

Condoms.

Goods that are or contain sunscreen.

Stoma devices for self-management.

Continence catheter devices for self-management.

Disinfectants.

Face masks and gloves for preventing the transmission of disease in persons.

Hand sanitisers.

Lancets and blood glucose strips for use in connection with measuring blood glucose.

Nicotine replacement therapies administered by oromucosal or transdermal means, including sprays, patches, gums, lozenges, sachets, and tablets.

Oral hygiene goods, such as toothpaste, mouthwash, and interdental brushes.

Oral rehydration goods.

Stoma devices for self-management.

Sunscreens and other therapeutic goods containing sunscreen.

Tampons and menstrual cups.

Wound care dressings for superficial wounds, including first aid items and antiseptics.

"Health care professional" means a health care professional registered to practise in Australia who, in the course of their professional activities, can prescribe, dispense, recommend, supply, or administer a prescription medicine in Australia.

"Health care organisation" is not defined, but is understood to include organisations such as hospitals and medical clinics.

The form and content of advertising directed at health care professionals for prescription pharmaceuticals.

Promotional activities carried out by pharmaceutical companies.

Educational items that do not bear the name of any medicine or product, and that otherwise comply with the Conduct Code.

Sponsorship for educational events (which are strictly prescribed by the Conduct Code).

Hospitality offered by companies to health care professionals, provided it is simple, modest, secondary to the educational content, and provided in an environment that enhances education and learning.

A retraction statement in the form of a corrective letter or advertising.

A fine according to the Schedule of Fines in the Conduct Code, up to AUD300,000 per complaint.

Standard patents granted before 15 April 2013.

Innovation patents certified before 15 April 2013.

Patent applications filed before 15 April 2013 for which examination was requested by 15 April 2013.

Innovation patent applications filed before 15 April 2013 that the Commissioner of Patents decided to examine before 15 April 2013.

Is a "manner of manufacture" (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.

For a standard patent, is not obvious to a person skilled in the relevant art, assessed in light of "common general knowledge" and relevant "publicly available" information. Common general knowledge is limited to that existing in Australia before the priority date of the claim. Publicly available information is limited to that which a person skilled in the art could reasonably be expected to have ascertained, understood, and regarded as relevant before the priority date.

For an innovation patent, satisfies the "innovative step" requirement. This involves assessing whether the invention differs from the prior art in a way that makes a substantial contribution to the working of the invention. It does not consider whether the invention is obvious.

Is useful, meaning that at least one embodiment of the invention must achieve the result promised in the specification (commonly known as the "utility" requirement).

Has not been commercially exploited in secret by, or with the authority of, the patentee in Australia before the priority date of the patent.

Describe the invention fully (known as "sufficiency"), including the best method known to the applicant (at the time of filing) of performing the invention (known as the "best method" requirement).

For a standard patent, end with a claim or claims defining the invention.

For an innovation patent, end with at least one and no more than five claims defining the invention.

Be clear and succinct and fairly based on the matter described in the specification.

Relate to one invention only.

Inventive step. The reforms removed the limitations about the scope of "common general knowledge" and "publicly available" information, meaning that a greater breadth of prior art is considered in determining whether an invention involves an inventive step.

Utility. An invention is not considered "useful" unless "a specific, substantial, and credible use" for the invention is disclosed in the complete specification.

Sufficiency. A specification must disclose the invention in a way that is sufficiently clear and complete for it to be performed by a person skilled in the relevant art.

Fair basis. The fair basis requirement is replaced by a "support" requirement, to align with the law of other jurisdictions. An appropriate "basis" is required in the body of the specification for each claim. The scope of a claim must not exceed what is justified by the extent of the information provided to "support" that claim.

Standard patent (the traditional form of patent protection).

Innovation patent, providing shorter term protection for inventions not meeting the inventive threshold requirement for a standard patent. The innovation patent has been abolished and is being phased out.

Biological materials (such as chemical molecules, monoclonal antibodies, synthesised/modified isolated polypeptides, proteins, and micro-organisms) and the processes for identifying, purifying, and isolating them and methods of using them. However, isolated naturally occurring DNA or RNA (coding and non-coding, probes and primers, interfering RNA, isolated interfering/inhibitory nucleic acids, and synthetic nucleic acids) are not patentable if they merely replicate the genetic information of naturally occurring organisms (D'Arcy v Myriad Genetics Inc.& Anor [2015] HCA 35, High Court of Australia).

Medical devices.

Methods of medical treatment involving a new use of a pharmaceutical product, as confirmed by the High Court of Australia in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50. However, methods of medical treatment not involving use of a pharmaceutical product, such as surgical and other physical procedures used by doctors to treat patients, may still fall outside the scope of patentable subject matter.

Diagnostic methods have been confirmed as patent-eligible subject matter by the Federal Court of Australia in Ariosa Diagnostics Inc v Sequenom Inc [2021] FCAFC 101.

A title.

A description to fully describe the invention, so that others can reproduce it from the information given and provide the best method of performing the invention.

Up to five claims for innovation patents and any number of claims for standard patents. The claims should clearly define what patent protection is being sought and must set out the essential features of the invention to establish its inventiveness.

Drawings or figures (if applicable). These should help describe the invention and must be clearly labelled and described in the body of the specification.

An abstract. A brief summary of the invention to identify the key features.

Application forms and filing fee.

The application is published about 18 months after the application's earliest priority date.

A request for examination can be made by the applicant within five years of the filing date. 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. The applicant will then have two months to request examination.

Following the request for examination, the patent examiner will 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 then respond to the adverse report. Further reports may 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. For Old Applications (see Question 24), the application will lapse if it is not accepted within 21 months of the first adverse report. Applications under the new regime will lapse if it is not accepted within 12 months of the first adverse report.

Within a couple of weeks of filing the application, IP Australia will conduct a simple formalities check to ensure the application is in order. IP Australia does not assess whether the patent is valid. If the application passes the formalities check, the innovation patent will be granted. However, 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 will either issue a notice that the innovation patent has been certified or an adverse report. The patentee can respond to the adverse report. Further reports may 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 commence opposition proceedings and if successful, the innovation patent may be revoked.

20 years.

Up to 25 years for particular standard patents relating to pharmaceutical substances.

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 produced by a process involving the use of recombinant DNA technology.

Goods containing, or consisting of, the pharmaceutical substance are included in the ARTG.

The first regulatory approval for the pharmaceutical substance occurred more than five years after the effective filing date of the patent.

The term of the patent has not previously been extended.

The patent is not a Swiss-form patent (which cannot be extended).

Where the invention is a product:

Where the invention is a method or process, using the method or process, or any action above relating to a product resulting from the method or process.

WIPO Madrid Agreement Concerning the International Registration of Marks 1891.

Paris Convention for the Protection of Industrial Property 1883.

The mark contains or consists of certain prohibited or prescribed signs (section 39, TM Act).

The mark cannot be represented graphically (section 40, TM Act).

The mark is not capable of distinguishing the applicant's goods or services for which the trade mark is sought from the goods or services of other persons (section 41, TM Act).

The mark contains or consists of scandalous matter or its use would be contrary to law (section 42, TM Act).

Use of the mark in relation to the goods or services for which it is sought would be likely to deceive or cause confusion because of some connotation of the trade mark (section 43, TM Act).

The 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).

The other party is passing off their goods as the goods of the trade mark owner.

Use of the trade mark by the other party is misleading or deceptive conduct, or makes false representations prohibited under Australian consumer protection law.

The exclusive right to use the trade mark and to authorise other persons to use the trade mark.

The right to obtain relief (including declaratory, injunctive, and compensatory relief) under the TM Act if the trade mark has been infringed.

A medicinal brand.

The appearance of the medicinal product itself, including any distinctive shape or colour or colour combination of a tablet or capsule, or other delivery system such as a syringe or inhaler.

The distinctive aspects of packaging.

It is identical or deceptively similar to a notified International Non-proprietary Name (INN) or a notified INN Stem and is therefore not distinctive.

Use of the name would be misleading.

The applicant is not the owner of the trade mark (section 58, TM Act).

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). This ground is only available if the prior mark was cited by the registrar as an objection and the applicant overcame this with evidence of prior continuous use.

The applicant does not intend to use the mark (section 59, TM Act).

Use of the mark may confuse or deceive due to another mark that has acquired a reputation in Australia (section 60, TM Act).

The trade mark contains or consists of a false geographical indication (section 61, TM Act).

The application or a document filed in support of it was amended contrary to the TM Act, or the registrar accepted the application based on evidence or representations that were false in material details (section 62, TM Act).

The application was made in bad faith (section 62A, TM Act).

Mergers or acquisitions that have the effect of substantially lessening competition (section 50, CCA).

Exclusive dealing, which is the imposition of various vertical restraint practices, and is prohibited if it has the purpose, or likely effect, of substantially lessening competition (section 47, CCA).

Resale price maintenance, where a wholesaler specifies a minimum resale price to a retailer (section 48, CCA).

Contracts, arrangements, understandings, or concerted practices between corporations that have the purpose, or likely effect, of substantially lessening competition in a relevant market (section 45, CCA).

A corporation with a substantial degree of market power engaging in conduct that has the purpose, or likely effect, of substantially lessening competition (section 46, CCA).

Cartel behaviour, including price fixing, restricting outputs in the production and supply chain, market sharing, and bid rigging (section 45AD, CCA).

IP rights and competition law are not in conflict. In particular, the ACCC acknowledges that IP rights confer exclusive rights on rights holders, and that the bare exercise of these exclusive rights will not have significant anti-competitive implications.

IP rights do not always create substantial market power. Therefore, even where ownership of an IP right is a key determinant of a firm's market power, this will not of itself breach the CCA.

Licensing or assignment of IP rights usually encourages competition, and enables IP to be exploited to a greater extent than would otherwise occur.

Licensing arrangements can have the purpose, effect, or likely effect of substantially lessening competition and breach the CCA. In assessing whether conduct substantially lessens competition, the ACCC focuses on the impact of the conduct on the competitive process.

When assessing the effect or likely effect of conduct on competition, the ACCC will usually apply a with or without test. This test compares the likely state of competition with the relevant conduct in place to the likely state of competition without it (for example, comparing when a licence is in place to when there is no licence).

The ACCC will assess whether conduct has the purpose, effect, or likely effect of substantially lessening competition at the time the conduct occurs. For example, for the purposes of section 45 of the CCA, the ACCC will consider the purpose, effect, or likely effect of a provision of contract, arrangement, or understanding, both at the time it was made and at the time at which it was given effect.

Expanding section 46 to include the standard Part IV effects test (in addition to the existing purpose test). The ACCC asked for this change because it is difficult for it to prove the subjective purpose of an accused.

Removing the "take advantage" limb. This makes it more difficult for a firm with market power to defend its actions. The taking advantage limb traditionally provided comfort to firms engaging in conduct that would be a rational business strategy even for a firm without substantial market power. The removal of this limb in favour of exclusive reliance on the standard Part IV substantial lessening of competition test expands the reach of the prohibition, and places significant importance on the interpretation of that test.

Introducing the standard Part IV substantial lessening of competition test in place of proscribed anti-competitive purposes. A key issue is whether there is sufficient certainty when applying this test to misuse of market power. The Harper Review recommended requiring courts to have regard to specific factors that increase or lessen competition, including efficiency, innovation, product quality, or price competitiveness. Although those factors were included in the first version of the Bill to implement the changes, they were removed during the parliamentary process. The factors arguably do not alter the nature of the test. Existing jurisprudence establishes that the test requires a comparison of the state of competition in the relevant market with and without the conduct, including pro-competitive and anti-competitive factors.

Patent settlements. These include "pay-for-delay" strategies, where patent holders settle litigation with prospective generics over questionable patents, on terms including that generic manufacturers stay out of the relevant market. Although not yet considered by Australian courts, these are as likely to be found in breach of competition laws in Australia as they have been in other jurisdictions. The Productivity Commission recommended in its Report on Australia's Intellectual Property Arrangements of 2016 a system for reporting and monitoring settlements between originator and generic pharmaceutical companies, to detect potential pay-for-delay agreements. It has received support in principle from the Australian Government.

Deals with manufacturers of precursor materials. When patents expire, patent holders should ensure that any contracts with manufacturers of precursor materials do not lock up percentages of the market for that precursor material, thereby preventing a generic from entering the downstream market for the pharmaceutical.

Licensing of associated process patents. Withholding patents associated with, or necessary for, manufacturing generic products after expiry of most core product patents may be considered a misuse of market power.

The ACCC brought proceedings in the Federal Court of Australia against Pfizer Australia Pty Ltd, for alleged misuse of market power and exclusive dealing in relation to its supply of atorvastatin to pharmacies, in breach of sections 46 and 47 of the CCA.

The ACCC alleged that Pfizer offered significant discounts and payment of rebates previously accrued on sales of Pfizer's Lipitor (Pfizer's originator brand of atorvastatin) conditional on pharmacies acquiring a minimum volume of up to 12 months' supply of Pfizer's generic atorvastatin product. The ACCC alleged that the offers were first made before Pfizer's loss of patent protection for the atorvastatin molecule in 2012.

In February 2015, Justice Flick dismissed the ACCC's application. His Honour found that while Pfizer had taken advantage of its market power by engaging in the alleged conduct, Pfizer's market power was no longer "substantial" at the time the offers were made in January 2012. His Honour also found that the ACCC had failed to show that Pfizer had pursued its conduct for the purpose of deterring or preventing competitors from engaging in competitive conduct, or for the purpose of substantially lessening competition.

In May 2018, the Full Court of the Federal Court of Australia dismissed the ACCC's appeal. In October 2018, the High Court dismissed the ACCC's application for special leave to appeal the Full Federal Court decision.

Could limit the licensee's ability to effectively compete with the licensor, in particular, imposing obligations or restrictions on the licensee relating to:

Require the licensee to also purchase additional products or licences from the licensee or a third party.

The registration or listing of the therapeutic goods is suspended or cancelled.

The manufacturing principles have not been observed in the manufacture of the goods, or one or more of the manufacturing steps was carried out by a manufacturer that did not hold a valid licence.

It appears to the Secretary that the quality, safety, or efficacy of the goods is unacceptable, or that the presentation of the goods is unacceptable.

The goods are manufactured or supplied unlawfully in Australia.

The goods fail to comply with applicable standards.

Take specified steps, in the specified manner and timeframe, to recover goods that have already been distributed.

Inform the public or a particular group of persons, in the specified manner and timeframe, of the steps that have been taken.

Publish, in the specified manner and timeframe, specified information about the manufacture or distribution of the goods.

Safety alerts.

Product notifications.

Quarantine.

Product withdrawal.

Loss or damage has been suffered.

The manufacturer's conduct is in breach of the common law duty of care.

The loss or damage was caused by the manufacturer's breach of duty.

Merchantable quality.

Fitness for purpose.

Goods that do not correspond with their description.

Goods of unacceptable quality.

Goods that do not conform to a sample.

Goods unfit for a stated purpose.

Non-compliance with express warranties.

Holds itself out to be the manufacturer.

Applies its name or brand to the goods.

Permits someone to promote the goods as those manufactured by the company.

Imports the goods in circumstances where the actual manufacturer has no presence in Australia.

Indemnification clauses and exclusion clauses in contracts.

Insurance.

Causation defences, including specific causation such as the reasonable foreseeability of ingestion of the pharmaceutical causing the condition in the individual.

Voluntary assumption of risk (volenti non fit injuria).

Contributory negligence.

Goods are not reasonably fit for purpose or are not of acceptable quality because of:

In case of goods not reasonably fit for purpose, the consumer did not rely on or it was unreasonable for the consumer to rely on the manufacturer.

In case of goods not of acceptable quality, defects were drawn to the consumer's attention or the consumer examined the goods in relation to defects that the examination ought to reveal.

The defect did not exist when the goods were supplied by their actual manufacturer.

The goods only had a defect because there was compliance with a mandatory standard for them.

The state of scientific or technical knowledge at the time the goods were supplied did not enable the defect to be discovered.

In case of a manufacturer of a component used in the product, the defect is only attributable to the design of the finished product or to any markings, instructions, or warnings given by the manufacturer of the finished product, rather than to a defect in the component.

For most causes of action and most jurisdictions, the limitation period is three years.

For most causes of action and most jurisdictions, the three years start running when some appreciable (that is, more than negligible) damage occurs.

Some jurisdictions have a discoverability test to determine when time starts running.

Most jurisdictions have provisions to obtain a time extension, often based on a discoverability test.

There are some statutes of repose under the ACL.

Are in respect of, or arise out of, the same, similar, or related circumstances.

Give rise to a substantial common issue of law or fact.

General damages, including for pain and suffering, loss of amenities, and loss of expectation of life.

Special damages, including for loss of wages and earning capacity (both past and future), and medical and hospital expenses.