Patents and 'wild' organisms

Question

This question was prompted by a discussion I overheard recently at a scientific conference about a specific example (background given below), but ideally I would like the answer to explain the legal principles involved in this general area if feasible. If the answer varies by region, please assume either the US or Australia (since the most recent article I could find on the subject described a field release in Australia).

Bacteria in the genus Wolbachia naturally occur in a large number of insect species. It was discovered a few years ago that putting some species of Wolbachia into some species of insect reduced their ability to transmit viruses causing human disease such as dengue (sample US patent) - they are rendered 'refractory'. The use of Wolbachia-transfected mosquitoes is increasingly suggested as a possible method of controlling mosquito-borne disease. It is my understanding that the process to transfer one strain of Wolbachia into a new mosquito population is time-consuming, requires specialist equipment and training and has a high risk of failure, but once it is accomplished the bacterium spreads vertically to all descendants of the modified mosquitoes.

Field trials of transfected mosquitoes are happening in various parts of the world (for example in Australia, as reported this week). To be clear, these are not GMOs (in fact that is part of the reason they are popular, from a regulatory perspective): they are mosquito strains taken from nature, transfected with bacteria that naturally infect other insect species, and then mass-reared before release, where they freely breed with the natural population which allows the bacterium to spread.

My question is this: In a situation like this, if a researcher went out and collected mosquitoes from a region where field releases were occurring, what restrictions would exist on what they could do with them?

For example (ordered in what I would guess is decreasing order of likelihood of permission), could they:

1. 'observe' the collected mosquitoes (e.g. measure their survival or immune response under various conditions compared to unmodified mosquitoes)?
2. establish their own breeding colony of the collected mosquitoes?
3. share the mosquitoes or their descendants freely with international collaborators (assuming Nagoya compliance)?
4. attempt to further modify the collected mosquitoes or their descendants?
5. mass-rear modified mosquitoes for commercial sale or to release freely (assuming no regulatory barriers to this)?

How would any of these answers change if the researchers genuinely had no idea they had collected modified mosquitoes (for instance, were not aware of the trials), or if they had reason to suspect the collection included some modified mosquitoes but never actually tested to confirm it? (In many parts of the world where mosquito-borne diseases are common, surveillance programmes are operating that routinely collect thousands or millions of mosquitoes to monitor abundance or test for pathogens).

By my limited understanding of IP, patents cover processes, not products, so in this case might cover the process of modifying the mosquitoes, and maybe the process to confirm their modification status, but could not cover the mosquitoes themselves. Is this correct? I also understand there are more restrictions on patenting natural organisms than there used to be, but I've not kept up to date on this since my (biology) undergrad reading on it.

Answer 1

Things and processes can both be patented.

35 U.S.C. 101 Inventions patentable Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof may obtain a patent therefor, subject to the conditions and requirements of this title.

In the U.S. you can't patent anything that includes a person, although you can patent a process that is applied to a person. A mosquito is not a human and you can patent a modified mosquito. Regarding the patentability of living things. In Diamond v Chakrabarty, the SCOTUS ruled

"A live, human-made micro-organism is patentable subject matter under 35 U.S.C. § 101. Respondent's micro-organism constitutes a "manufacture" or "composition of matter" within that statute.

As one commenter said, it may of may not be obvious to combine two naturally occurring things together. If that never happens in the wild, it might take some inventing to determine that it would solve the problem and some inventing to get the mosquitos to become infected and to breed.

The closest case is the GMO seeds sold to farmers. They are not allowed to plant anything other than the seeds they bought. see Monsanto v Bowman

In the US a patent allows the patent owner to control making, selling, offering for sale, using and importing the patented item. I do not know the answer to which activities you are asking about constitute "using". I guess breeding would be "making". The fact that they were let out into the world rather than sold probably makes a difference in your favor.

Answer 2

Naturally occurring organisms are not patentable in either the US or Australia. See http://ipwire.com/stories/patentability-living-organisms/