What the Raising the Bar research exemption means for biotech

One of the triumphs of the recent Intellectual Property Laws Amendment (Raising the Bar) Bill 2012 heralded by the scientific community was the research exemption allowing experimentation on inventions protected by patents.

However, there is still some uncertainty over precisely how the exemption will be work and what will qualify as research and what might infringe existing patents, says Joe Seisdedos, Patent Attorney and Senior Associate at Wrays, a Perth-based intellectual property law firm.

“As with any new law, the legislation can be read in a number of ways, and until we get a court decision, we never know exactly how the courts will interpret the legislation,” he told ALS.

The precise text in the legislation states that “a person may, without infringing a patent for an invention, do an act that would infringe the patent apart from this subsection, if the act is done for experimental purposes relating to the subject matter of the invention.”

One key term is “experimental purposes”, which is stated to include “determining the properties of the invention; determining the scope of a claim relating to the invention; improving or modifying the invention; determining the validity of the patent or of a claim relating to the invention; determining whether the patent for the invention would be, or has been, infringed by the doing of an act.”

Another key term is “relating to the subject matter of the invention.” This latter term specifically limits free experimentation which is related to exploration of the invention itself, but not wholesale permission to use the invention for other experimental purposes, says Seisdedos.

“The experimentation has to be related to the patented invention, such as looking at the properties of the process or the drug,” he says. “It’s not a blanket exemption that says you can build the product and or use the method in the course of doing something unrelated.”

For example, a patented assay that detects the presence of some disease could be experimented upon by someone other than the patentee to determine how it works or the limits of its function, without infringing the patent.

An improved assay could then be patented by someone other than the original patentee, although in order to use the improved assay in a commercial environment, it’s likely that a license would have to be acquired for the original assay on which it was developed.

However, the assay could not be freely used in research on the disease in question if that research does not involve looking at the function of the assay itself.

“Having said that, I believe that this is an important freedom that has been provided to researchers,” he says. “This is because the law, as it previously stood, did not make a distinction between use of a patented method for experimental reasons as opposed to any other reason.

"The old law allowed, at least in theory, the ability of a patentee to stifle research into new improvements by arguing that the very act of using a method, even in a research or experimental context, would result in infringement of the patent. This has a chilling effect that prevented researchers from experimenting with the particular drug or the patented method for producing the drug.”

Things get a little more blurry when the subject of the invention can potentially be used to produce a great number of potentially therapeutic compounds. Research on the invention could, quite incidentally, reveal a new and attractive compound that could be the subject of a new patent. Whether commercialising this new compound would represent a breach of the research exemption is yet to be fully determined, says Seisdedos.

“It depends on how integral use of the patented method is to the new invention. Lets’ say it’s a compound that could be produced by any number of methods – and is not anticipated by the original method – then no licence would be required.

“But if the patented process is the only known way to produce the compound, then if someone was to commercialise that compound, they would likely have to license the original patented method.”

While the research exemption opens up more possibilities for genuine exploratory research involving patented subject matter, it will take some time before we know precisely where the lines are drawn, and it will likely take the courts to do just that, he says.