Paul Whenman, Consulting Partner and Declan McKeveney, Senior Counsel at FB Rice, begin their series into patents. In Part 1, they consider Australian patents in a life sciences context by sharing an overview of key frameworks, innovation, litigation and more.
What are patents?
Innovation is at the core of economic development. For this reason, substantial resources are devoted to technological innovation. In order to foster innovation, the patent system exists globally to provide innovators with a period during which an innovator may exclusively exploit its innovation provided that it qualifies as a patentable invention.
By providing the patentee with a monopoly, a patentee has an opportunity to profit from its invention. In exchange for exclusivity, a patentee is required to disclose its invention in sufficient detail such that once its patent expires, third parties may exploit the invention. Generally the period of exclusivity is 20 years, calculated from the filing date of a patent application.
Innovation versus invention
A technical improvement may be regarded as innovative but it will only be regarded as a patentable invention if it satisfies the basic criteria of being patentable subject matter, novel and inventive. Only innovations that are new and non-obvious in the sense of not being disclosed or used before a patent application is filed, nor being an obvious variation of such disclosed subject matter, will be regarded as novel and inventive.
Not all technical subject matter is patentable. For example, the High Court of Australia has confirmed in D’Arcy v Myriad Genetics Inc  HCA 35 that naturally occurring genes were not patentable, even if in isolated form.
Patents are granted on a national basis. This means that to gain effective patent protection internationally, patentees must obtain patent grant in each country of interest. To facilitate this, a number of international treaties and agreements exist to ensure inventions protected in an originating country may be protected internationally.
The Paris Convention is an international agreement on the protection of industrial/intellectual property which became effective in 1884 and continues to underpin global patenting. As of January 2019, there were 177 contracting states, also referred to as convention countries, to this convention. Australia is a contracting state.
An important feature of this convention is the establishment of a “priority right”. Such a right is established when an initiating patent application is filed in a convention country. Once a priority right is established, it allows an applicant 12 months to file a corresponding application in any other convention country. The effective date or priority date of such patent applications becomes the date of the initiating patent application.
When it becomes necessary to evaluate a patent application for novelty and obviousness, it is generally only those disclosures and uses made before the priority date that may be considered. An exception to this is patent applications having an earlier priority date than an application being evaluated. If such patent applications are published after the priority date of a patent application under evaluation, they may affect the novelty only of that application.
Patent Cooperation Treaty (PCT)
An important improvement to the global patenting process occurred when the PCT came into force on 1 June 1978. As of 17 October 2019, there were 153 contracting states to the PCT. Australia is a contracting state.
One of the global patenting challenges is the time taken to commercialise an invention. If an applicant is confident of its commercialisation strategy, then the 12 months provided by the Paris Convention may be an adequate time frame to proceed with global filings. However, this time frame is generally inadequate.
To address this inadequacy, the PCT provides a process by which an applicant may file an international application within the 12 month priority period. This filing automatically covers all contracting states for a period (referred to as the international phase) of at least 30 months from the priority date. By the end of the international phase, an applicant is required to file its patent applications in those contracting states of interest. This is referred to as entering the national phase.
Another desirable feature of the PCT is that an application will be searched and examined for novelty and obviousness. The examination results are provided to an applicant thereby allowing an applicant to evaluate the likelihood of a patent being granted.
For these reasons, the majority of globally important patents are filed using the PCT. In Australia, the majority of patent applications filed are national phase entries of PCT applications.
The Australian Patent Office is responsible for the administration of the Patents Act 1990. A primary function of the Patent Office is the examination and grant or refusal of patent applications.
Once the national phase is entered and examination requested, an examiner will prepare a report on all aspects of patentability. An applicant will have an opportunity to respond to any issues raised by an examiner in a report. If all issues are resolved, then the patent application will be accepted for subsequent patent grant. If any issues remain, a further report will allow the applicant to again respond.
The process of examination report and response may be repeated. However, if an application is not accepted within a 12 month time period after the first report, it will lapse. Although there are variations in the patent examination process throughout the world, in principle, Australia is representative.
During the international phase and many national phase states, a third party may file information that impacts the validity of a patent application. Such information is considered by patent examiners in evaluating the patentability of an invention.
Subsequently, validity may be challenged, for example, by opposing the grant of a patent on an accepted application. Such a procedure is quasi-judicial in nature. Completion of an opposition results in a patent application being refused or granted, possibly in a form amended to overcome matters raised in the opposition procedure.
Once granted, patents may still be challenged for validity. In Australia, this may be in a re-examination process in the patent office or a revocation action in the Federal Court.
Life sciences patents
A broad range of technologies lies within the scope of life sciences, many of which are of considerable importance to the Australian economy. Fortunately, the Australian patent system provides the possibility of obtaining patents for many such inventions.
Within the fields of human and animal health, patents are available for inventions including:
- small molecules
- monoclonal antibodies
- stem cells
- medical devices.
It is also possible to obtain patents for therapeutic methods and procedures. However, surgical procedures are excluded.
Life sciences patents – litigation
Australia has an advanced health care system which is underpinned by the Pharmaceutical Benefits Scheme (PBS). Thus although the population of about 25 million people is relatively low, the value of pharmaceutical products is relatively high. This has resulted in a high level of pharmaceutical patenting.
In order to provide a patented pharmaceutical with an effective term of patent protection, the usual 20 year patent term may be extended by a further five years. This contributes to the attractiveness of Australia as a pharmaceutical patent filing destination.
The relatively high value of the pharmaceutical market has had the effect of encouraging the entry of generic products. However, when a product is patented and prior to expiry of the patent term, a successful generic entrant must invalidate the patent by a Federal Court initiated revocation procedure.
Examples of such litigation include:
Invalidation of rosuvastatin patent: AstraZeneca AB v Apotex Pty Ltd; AstraZeneca AB v Watson Pharma Pty Ltd; AstraZeneca AB v Ascent Pharma Pty Ltd  HCA 30
Invalidation of clopidogrel patent: Apotex Pty Ltd v Sanofi-Aventis  FCAFC 134
Invalidation of vaccines against streptococcus pneumoniae patents: Merck Sharp & Dohme Corporation v Wyeth LLC (No 3)  FCA 1477
Future articles will feature
- Patent term extension – what is extendible, procedure and examples.
- Challenging patent rights – opposition, re-examination and revocation procedures and examples.
- Generics and biosimilars – regulatory procedure and its intersection with patent rights.
- South East Asia and New Zealand – an overview of life sciences patents in these countries.
Paul Whenman is a consulting partner in FB Rice’s Sydney chemistry team. As a qualified patent attorney, Paul has had a distinguished career with the firm with over 35 years’ experience in chemically related patents, including pharmaceuticals, animal health products, surface coatings and water related technologies. He has an enviable reputation for his knowledge and expertise in the chemical patent space, with an ability to instantly identify issues and develop management strategies to work around them, particularly in the scientific and R&D sectors where he has an in-depth understanding of business practices. Connect with Paul via email or LinkedIn
Declan McKeveney is a senior counsel in FB Rice’s Brisbane chemistry team. He has a PhD in chemistry and research experience in the fields of organic, biological and medicinal chemistry and pharmacology, with particular expertise during his PhD in the design, synthesis and screening of combinatorial compound libraries. Declan practices in all areas of chemistry, with a focus on pharmaceutical compounds and drug technologies. He assists clients with the construction and ongoing management of local and international patent portfolios with an eye to adding value to his client’s businesses and ensuring alignment of their IP strategy with the broader business objectives. Connect with Declan via email or LinkedIn