Chemical, biotech and 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

Chemical	AU Patent # 2018203740 Chemical inhibition of pitting corrosion in methanolic solutions containing an organic halide Baker Hughes, a GE company, LLC
Materials	AU Patent # 2019100244 Textile and garment comprising a dual-weave of composite materials Saint IP Pty Ltd
Medical materials	AU Patent # 2014292503 Biomimetic collagen–hydroxyapatite composite material Geistlich Pharma AG
Nano-materials	AU Patent # 2006225095 Rare earth nanorods Antaria Ltd
Polymers	AU Patent # 2018100854 An additive for polymer and preparation method thereof Guangzhou Bobei Info-tech Ltd
Chemical and industrial processes	AU Patent # 2015299202 Energy-efficient and environmentally friendly process for the production of target chemical compounds from cellulosic material Clariant International Ltd
Hydrocarbon extraction and refining	AU Patent # 2014265950 Methods for separating hydrocarbon gases Linde Engineering North America, Inc
Mining processes and mineral extraction	AU Patent # 2017203383 Beneficiation process for enhancing uranium mineral processing Uranium Beneficiation Pty Ltd
Organic chemistry	AU Patent # 2014367284 WNT pathway modulators Agency for Science, Technology and Research
Pharmaceutical formulation	AU Patent # 2018101116 Vitamin drug intermediates diketone guluronic acid synthesis method Chengdu Ka Di Fu Technology Co. Ltd
Molecular biology	AU Patent # 2013269536 High-capacity storage of digital information in DNA European Molecular Biology Laboratory
Genetics	AU Patent # 2017201900 Association of rare recurrent genetic variations to attention-deficit, hyperactivity disorder (AFHD) and methods of use thereof for the diagnosis and treatment of the same The Children’s Hospital of Philadelphia
Antibody technology and characterisation	AU Patent # 2017203225 A monoclonal antibody inhibiting immunosuppressive functions of pathogens, antigen-binding fragment thereof, and hybridomas producing such antibody Sagabio Co., Ltd
Gene silencing and RNA interference	AU Patent # 2013257445 Conserved HBV and HCV sequences useful for gene silencing Alnylam Pharmaceuticals, Inc
Infectious diseases, particularly viral infectious diseases such as HIV and hepatitis	AU Patent # 2015371255 Fused pyrimidine compounds for the treatment of HIV Gilead Sciences, Inc.; Institute of Organic Chemistry and Biochemistry of the AS CR, v.v.i.
Stem cell isolation and culture	AU Patent # 2017239554 Stem cell factor inhibitor The Regents of the University of Michigan
Protein structure and function	AU Patent # 2013220749 Nucleic acid comprising or coding for a histone stem-loop and a poly(A) sequence or a polyadenylation signal for increasing the expression of an encoded therapeutic protein CureVac AG
Cancer biology and genetics	AU Patent # 2017258877 DNA vaccine for use in pancreatic cancer patients Vaximm AG

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:

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.

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:

“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.