The Trans Pacific Partnership (TPP) Agreement was finally concluded on 5 October, 2015 with the full text of the Agreement made public on 5 November. The Agreement is yet to be ratified by signatory countries, although at this stage there is nothing to suggest that ratification will not take place. Signatories to the TPP include Brunei, Chile, New Zealand, Singapore, Australia, Canada, Japan, Malaysia, Mexico, Peru, United States and Vietnam.
The main aims of the TPP are to lower trade barriers such as tariffs and also to help establish a common framework for intellectual property laws amongst the member countries.
PCT and Madrid Protocol
The TPP requires that signatories join the Patent Cooperation Treaty (PCT) for International Patent Applications, and the Madrid Protocol for the International Registration of Trade Marks. All of the TPP countries are already PCT member countries. However, Brunei, Chile, Canada, Malaysia and Peru will need to become Madrid Protocol members. This should make obtaining trade mark registrations in these jurisdictions simpler and more cost-effective.
Grace period for patents
The TPP specifies that a grace period will be afforded to patentees for any self-disclosure within the 12 months prior to filing a patent application in a signatory country. The US, Australia and Canada already offer such a grace period, however other TPP countries, notably Japan, Singapore and Vietnam, will have to expand their grace period provisions to include any prior self-disclosure within the 12-month period.
Patentable subject matter and innovation patents
The TPP includes a requirement regarding patentable subject matter which provides that subject matter that may be excluded under national laws includes: plants, animals, diagnostic, therapeutic and surgical methods as well as biological processes for the generation of plants and animals. There is nothing in the TPP to suggest that Australia will need to alter the Patents Act to cater to the patentable subject matter requirements.
Pharmaceuticals and biologics
The TPP requires signatories to adopt a regulatory review exception that permits generic pharmaceutical manufacturers to make small batches of a patented pharmaceutical to apply for marketing approval before the patent expires without risk of liability for infringement.
This provision allows for what is known as ‘springboarding’, enabling generics to enter the market immediately upon the expiry of the relevant patent, preventing a de facto extension of term. Australia already has these provisions.
It is understood that the US pushed for changes to the rules regarding IP protection for biologics, which are a type of medicine comprised of complex molecules such as proteins isolated from plants, animals and micro-organisms. They can include vaccines, oncology medications and other therapies such as insulin. Biologics are not always patentable because they can include naturally occurring products such as insulin or other blood components. As such, another form of regulatory protection available for biologics is known as ‘data exclusivity’.
Data exclusivity refers to the protection of clinical trial data submitted to regulatory agencies from use by competitors, which is a different type of monopoly protection to patents. The TPP requires that signatories establish data exclusivity provisions. The TPP requires that signatories should provide 5 years of data exclusivity from the date of marketing approval in the relevant country. An equivalent period of data exclusivity is already provided for in Australia in the Therapeutic Goods Act, pursuant to Australia’s FTA with the US, so no change to Australian law should be required. There is some doubt as to whether the TPP may enable the term to be renegotiated in the future as there is a provision for review in 10 years. It is understood that the US pushed for the ’data exclusivity’ term to be extended to, perhaps eight years or more. However, the text of the TPP suggests only a minimum five-year term, meaning no change to Australia’s current law in the area.
The TPP also requires that signatories institute a ’Patent Linkage’ procedure whereby patent holders must be notified prior to the marketing of a competing product so that they can decide whether to assert their patent rights and perhaps, seek an injunction. Australia already has such a provision.
The term of copyright in Australia for films and sound recordings is 70 years from the year in which the recording or film was first published. For literary, dramatic and musical works published during the lifetime of the author, copyright lasts for 70 years from the end of the year in which the author died. The previous terms were generally 50 years and were altered as a result of Australia’s accession to the Australia-US FTA in 2005. The 70-year terms now part of Australian Copyright law are also mandated by the TPP. A number of signatory countries may be required to amend their copyright laws to extend the term of copyright protection to be equivalent to the terms applicable in Australia and the US.
According to the Department of Foreign Affairs and Trade, the TPP agreement requires parties to introduce strong enforcement systems including civil procedures, provisional measures, border (customs) measures and criminal procedures and penalties for commercial scale trade mark counterfeiting and copyright or related rights piracy. TPP parties will be required to institute legal procedures for the prevention of stealing of trade secrets and establish criminal procedures and penalties for trade secret theft including by way of cyber-theft.
The TPP agreement’s provisions regarding intellectual property appear to be an attempt to mould the IP laws of signatory countries in the image of the US’s IP laws. Having already been through a process of negotiating and ratifying an FTA with the US in 2005, Australia’s IP laws already reflect the IP provisions of the TPP. The most significant changes to IP laws resulting from the TPP will be in other countries which, at least to some extent, should make international IP protection and enforcement a simpler and cheaper proposition for Australian clients.