Why is a foetal genetic test’s patentability being questioned?

Find out how a recent lawsuit demonstrates the complexity of patenting medical innovations if they involve biological material.

Are specific biological inventions eligible for patent protection? It's not a simple matter to determine, as shown by a recent patent infringement lawsuit filed over a test for detecting genetic problems in foetuses.

With the complexity involved in determining the patentability of an invention – particularly in the field of medicine and life sciences, which can have implications across national borders – it's important to get advice from a parent attorney in Australia. We'll take a look at that patent infringement lawsuit and examine the lessons it holds for Australian patent registration.

The lawsuit over an invention that revolutionises prenatal care 

On June 7, a patent infringement case was filed by Sequenom Laboratories (a developer of molecular technologies and highly sensitive laboratory genetic tests) against Sonic Healthcare, Australian Clinical Labs and Ariosa Diagnostics, Inc. (providers of laboratory, pathology and radiology services) in the Australian Federal Court. The patent involves the detection of cell-free foetal DNA for the risk of certain genetic conditions like Down syndrome. It's inventive in that it is a non-invasive form of testing, thereby revolutionising prenatal care. 

Sequenom is trying to protect its invention that revolutionizes prenatal care. Sequenom is trying to protect its invention, which revolutionises prenatal care.

The suit accuses Australian companies that have used the prenatal test supplied by Ariosa of infringing Sequenom's Australian Patent. Sequenom is seeking every available remedy like orders of restraint and damages.  

Sequenom and Ariosa's dispute comes amid Sequenom taking the case to the US Supreme Court to reverse a lower court's finding that its patent is not protection-eligible subject matter. 

What determines if its patent ineligible?

Sequenom may not win its patent infringement case for many reasons, but we will focus on the recent issue of social and ethical considerations.

Patents directed to biologically based inventions have been successfully challenged.

Inventions that  would threaten public morality and methods of treating humans and animals may be excluded from patents, according to IP Australia. Lexology states that it is notable that in the last five years, patents for biological  inventions have been successfully challenged in both the U.S. and Australia on the basis of lack of patentable subject matter.  

There is still much debate surrounding whether the court has the ability to evaluate social and ethical issues like the one involved in this case, which could safely test for genetic conditions.

The law currently requires a consideration of whether the invention would be generally inconvenient, but it remains unclear if a social and ethical consideration falls under this principle.

There are also many other reasons beyond the scope of this article that determine patent subject material, which only highlights how complex the determination of patent eligibility can be. In the age of high-tech biological inventions, developments in intellectual property law in Australia may occur, which makes matters much more tricky for inventors. Consult with Alder IP to get advice on the patentability of your invention and how to proceed.