The Baxter IP approach
In order to maximise the value that the clients can obtain from their patent applications, a strategy suitable for many circumstances involves the following approach:
- File a provisional application in Australia with numerous claims including multiple claim types
- Request an International Type Search so as to gain an independent assessment of patentability
- If international protection is required, file a PCT (international) application, or if protection in only one or two countries is required, file complete national application(s). In either case, the application(s) claim priority from the original provisional application and the specification may be amended in light of the results of the Search.
- If infringement is suspected in Australia, a divisional innovation may be filed. This leads to rapid grant of a patent so as to allow for prompt legal action against the suspected infringer. Longer term protection is then afforded by the parent complete application. Note that it is possible that the innovation system in Australia will cease in the next few years, so this aspect of the strategy may be short-lived.
- File national phase applications from the PCT application in the countries of interest, amending the claims to conform with the requirements of each separate jurisdiction and taking into account any excess claims fees that may be payable.
Depending on specific circumstances, however, other strategies may be more appropriate. It is important to discuss your particular situation with a qualified attorney to determine the best strategy in each case.
A range of different types of claims may be used in drafting chemical and pharmaceutical patent specifications. It is important to include as many of these as possible to allow for different patent conventions and rules in different jurisdictions. For example:
(i) Compound per se
It is important where possible to claim a compound or class of compounds per se. This will often be in the form of a Markush claim, which provides for various alternatives for various groups in a chemical structure. It is important that the claimed structure does not encompass known compounds and that all compounds within the scope can reasonably be expected to meet the aim of the invention. Thus, for example, if a claim is to a compound for treating liver cancer, it should be reasonably predictable that all compounds within the scope of the claim have some (not necessarily high) activity against liver cancer.
Claims to a generic process for making the compounds can also be of value. This can enable action against a manufacturer, who is generally more able to pay large damages than an individual user.
(iii) First Medical Use
Occurs when a compound is known, and the invention resides in the use of it for treating a disease. Claim forms include:
- “Compound A for use in therapy.” (this is a common claim form in Europe, where Swiss-style claims are not permitted),
- “Compound A when used in therapy.”
(iv) Second Medical Use
Occurs when compound A has been known for treating disease X, and the invention resides in the use of it for treating a different disease Y. Claim types include:
- “Compound A when used in treating Y.” (this is commonly used in Australia, where the “for use” form is considered non-limiting),
- “Compound A for treatment of Y.” (more common in Europe)
- “Use of compound A for treatment of Y.”
- “Method of treating Y comprising administering a therapeutically effective quantity of compound A to a subject in need thereof.”
(v) Swiss-style Claims
These are a form of second medical use claim which was developed in jurisdictions (particularly Europe) to:
- avoid patent subject matter exclusions to methods of treatment claims; and
- target manufacturers rather than users as infringers.
Swiss-style claims are of the form “Use of compound A for the manufacture of a medicament for the treatment of Y”. Although Swiss-style claims originated in Europe, the European Patent Office no longer allows them, preferring the “compound for use” form.
Examples of chemical, biotech and pharmaceutical patent applications filed through Baxter IP
- AU Patent #2019100134 – A plant-derived germicidal deodorant for environmental treatment and its preparation method. Beijing Hongna Luyuan Technology Development Co., Ltd
- AU Patent #2018101677 – Apparatus and method for preparing multi-component alloy film. The Academy of Opto-electronics, Chinese Academy of Sciences
- AU Patent #2015201203 – A dietary supplement composition as a prophylactic and treatment for skin diseases such as eczema and psoriasis and the like and method of treatment. Fischer, Karen
- AU Patent #2012362360 – Targeted self-assembly of functionalized carbon nanotubes on tumors. Sloan-Kettering Institute for Cancer Research
Our chemical, biotech and pharmaceutical industry experts
Warren Chandler is a highly experienced patent attorney, an applied chemist and worked at CSIRO in field of pharmaceutical and drug delivery systems for treatment of diseased states. Warren has drafted and prosecuted numerous patent applications in the medical field including nasal dilation devices, mandibular advancement devices, devices for correcting spinal column misalignment, and new drugs and compounds for treatments of diseases such as Alzheimer’s, Hepatitis C virus.
Richard Grant has 20 years of experience as a researcher in the academic sphere and at CSIRO, and as a researcher/research manager in the chemical industry. He has worked on a wide range of chemical inventions spanning organic synthesis, pharmaceuticals, nanotechnology, polymer synthesis and processing, polymer composites, solar energy, carbon sequestration, graphene synthesis, sensor technology and others.