Chemical, Biotech & Pharmaceutical Patents

Claims in chemical patents may cover a composition of matter (for example a particular chemical substance or mixture of substances), a process for making a chemical substance or mixture, a product yielded by a particular process or a particular method of using a product. One of the earliest patented chemical processes, in fact the first US patent, was awarded to Samuel Hopkins in 1790 for his process to produce potash.

Biotechnology involves harnessing biological systems, substances and processes to improve daily life. Some of these systems have been utilised for centuries, even before the modern patent system arose. One such example is the use of yeast in brewing alcohol. Biotechnology patents are often awarded to the novel use of known systems to yield a new outcome or for modification of such systems to improve their performance. One of the earliest and most notable patents awarded in the biotechnology field was awarded to Louis Pasteur, who developed a way to heat-treat milk and several fruit juices so as to extend their shelf life, by destroying pathogens.

Pharmaceutical inventions can present features of both chemical and biotechnology innovations. Useful drugs can originate from new approaches to extracting naturally occurring substances, or may be modifications of natural substances, or may be entirely new synthetic compounds. For example, new anti-cancer drugs have been synthesised based on the human genetic sequence.

Benefits and challenges in filing chemical, biotech and pharmaceutical patents

Advances in the fields of chemistry, biotechnology and pharmaceuticals greatly affect the quality of life of humans, mostly for the better. However, inventors who bring about these innovations cannot benefit immediately after these technologies are revealed. Research and development place a large pressure for innovators to publish their work in journals to establish a pseudo “prior claim” over an invention of a chemical, biotech and pharmaceutical nature, but this practice results in the innovation being ineligible for patenting on the grounds of public disclosure before patent grant. Thus, a proper patent strategy should be in place, or else the inventors may end up forgoing the opportunity to maximise the commercial value of their innovations or even end up invalidating their patent applications altogether. A successful grant of a patent means exclusive rights of the patent owner over a certain innovation for 20 years in most countries.

The concept of patents in the chemical, biotech and pharmaceutical industries can be considered controversial because certain parties see patents as a way to stifle innovation and solely as a way to make a profit. However, patents are, to a certain extent, rewards to inventors for having contributed to science. How so? In return for having the patent in force, the patent owner makes the patent details public. Thus, the specifications in the patents provide background literature for future innovators to use in developing new or improved materials, processes and drugs.

Examples of granted chemical, biotech and pharmaceutical patent applications

The Baxter IP approach to filing chemical, biotech and pharmaceutical patents

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:

1. File a provisional application in Australia with numerous claims including multiple claim types
2. Request an International Type Search so as to gain an independent assessment of patentability
3. 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.
4. 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.
5. 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.

Claims Type

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.

(ii) Process

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:

1. “Compound A for use in therapy.” (this is a common claim form in Europe, where Swiss-style claims are not permitted),
2. “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:

1. “Compound A when used in treating Y.” (this is commonly used in Australia, where the “for use” form is considered non-limiting),
2. “Compound A for treatment of Y.” (more common in Europe)
3. “Use of compound A for treatment of Y.”
4. “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:

1. avoid patent subject matter exclusions to methods of treatment claims; and
2. 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

1. AU Patent #2019100134 – A plant-derived germicidal deodorant for environmental treatment and its preparation method. Beijing Hongna Luyuan Technology Development Co., Ltd
2. AU Patent #2018101677 – Apparatus and method for preparing multi-component alloy film. The Academy of Opto-electronics, Chinese Academy of Sciences
3. 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
4. AU Patent #2012362360 – Targeted self-assembly of functionalized carbon nanotubes on tumors. Sloan-Kettering Institute for Cancer Research