Maintaining and driving commercial success in the current economic climate, particularly in the Chemical/Biotechnological/Life Sciences sectors, requires more than just innovative thinking. Innovative patenting strategies are essential to protect market share. These days, there are few innovators who can afford not to obtain patent protection for their new products. This has meant in-house Intellectual Property Counsel coming under increasing pressure to balance the urgent demand for enforceable patents with the practicalities of research delays and budgetary constraints.
Outdated patenting strategies worth avoiding
Until very recently, it was standard practice to protect an invention in the Chemical/Biotechnological/Life Sciences fields by filing a Provisional Patent Application generally describing preliminary data. Typically, such preliminary data would be obtained from limited in vitro experiments, which showed a degree of promise sufficient to justify the continuation of the project, so as to enable in vivo data to be obtained. Until 15 April 2013, a Patent Specification, which generally and fairly described the nature of the invention, was considered in Australia to be sufficient disclosure on which to base a claim for a priority date. The disclosure requirement for a Provisional Application in Australia was less stringent than that of other countries and required neither an enabling description of the invention, nor a description of the best method of performing the invention.
During the subsequent twelve months, further information could be gathered and then added to the Specification when filing a Complete Patent Application. In practice, a description of a single embodiment falling within the scope of the claims was all that was required to meet the sufficiency requirement. If the invention was described fully in the Specification for the Complete Application, including the best known method known to the Applicant of performing the invention, this was considered sufficient for the purposes of the Patents Act 1990.
Prior to 15 April 2013, the early filing of Provisional Patent Applications for many halfformed inventions was the norm in Australia. Many Applicants made use of a shotgun approach by filing many less expensive Provisional Applications describing the preliminary data of various projects in order to secure a priority date. Then, the more successful projects would later be chosen to continue to completion. While this shotgun strategy was previously effective in securing a priority date, it is now not likely to meet the more stringent requirements of the effect of the amended Australian Patent Law.
Dovetailing the new patenting requirements with research project timelines
The recent Intellectual Property Laws Amendment Act (Raising the Bar) 2012 requires that the description of an invention that is included in a Specification for a Complete Application be "clear and complete". Furthermore, the disclosure included in a Provisional Specification must now reach the same level as that required for a Complete Application.
This is a significantly more stringent requirement. In the UK, this requirement has been interpreted as requiring disclosure of enough information to enable a skilled person to perform the invention across the full scope of each Claim. In the absence of any Australian precedent of what "clear and complete" actually means, we expect the Australian Patent Office and Courts to follow the same path as the UK Courts.
Accordingly, a brief description of preliminary data is no longer likely to be sufficient to effectively secure a priority date and obtain valid patent protection in Australia. In contrast to the full description of a single embodiment of the invention previously required, a more comprehensive description of several embodiments of the invention across the full scope of the anticipated claims will now be required in order to meet the higher standard.
Effectively securing a priority date under the new law
Before filing a Provisional Application for an invention under the new law, a comprehensive description of the invention must now be collated. The following practical considerations are worth bearing in mind for Chemical/Biotechnological/Life Sciences inventions:
- A complete set of data or at least a comprehensive description of how to perform the invention for at least one embodiment of the invention is needed. A complete set of data for more than one embodiment of the invention is definitely preferable, in order to provide sufficient disclosure over the breadth of the Claims. To meet this higher standard, it may be prudent to plan and integrate various different Examples of the proposed invention into the experimental design of a research project. This approach may delay costs associated with filing patent applications.
- While in vitro data arguably provides sufficient disclosure for Claims relating to in vitro applications, it may now be very difficult to argue that such data provides sufficient disclosure for later Claims relating to in vivo applications. If in vivo applications are envisaged, then it may be necessary to delay filing a Provisional Patent Application directed to both in vitro and in vivo applications, until sufficient in vivo data has been collated. Alternatively, if the Provisional Patent Application cannot be delayed, it may be necessary to pursue patent protection for in vitro applications separately to patent protection for in vivo applications. While this approach may increase initial filing costs, it is likely to decrease prosecution costs and facilitate a more rapid grant of enforceable patents.
- The filing of a Provisional Patent Application may by necessity only be possible at a later point in the timeline of a research project once a more complete set of data is available. While such delay bears the risk of not obtaining the earliest priority date for an invention, it has the advantage of delaying costs associated with filing the application. The timing of project funding and disclosures of the invention, such as at conferences or by way of academics’ publications, will need to be planned accordingly. In light of anticipated longer project timelines, it may also be prudent to watch the activities of competitors and search for and monitor their patent filings.
The previous strategy of filing many Provisional Patent Applications describing only preliminary data may now be a false economy and may need to be replaced with a more considered approach. Similarly, the hasty drafting and filing of a Provisional Patent Application before an unexpected disclosure deadline may need to be considered carefully. Rather than filing many inexpensive Provisional Patent Applications, which may ultimately become abandoned, resources could be more cost effectively directed into the filing of a select number of quality applications. It is worth regarding the disclosure requirement of a Provisional Application as now equating to that required for a Complete Application.
The take-home lesson is to engage in careful forward planning of research projects, so as to direct available resources into collating sufficient information derived from select projects in order to successfully prosecute more patent applications through to grant and reduce associated patenting costs. Moreover, a patent granted under the new Australian law is considered to have undergone more rigorous examination than under the previous regime, and may thus be in a more enforceable form against competitors. Ultimately, employing a directed approach in filing Provisional Patent Applications may result in a stronger and more enforceable Patent Portfolio.