Tuesday, April 16, 2013

Are Gene Patentable? How the Supreme Court Decision Will Affect the Polymer Industry

The Supreme Court heard arguments yesterday about whether or not single genes are patentable. While at first glance, the only relationship this may appear to have to polymers is that genes are made of DNA which is a (bio)polymer, I would argue that these issues over patentability can and will affect the commodity plastics industry in the near future.

Before getting to how this will affect our industry, let me give some background on the issues of patenting DNA and genes. The suggestion of patenting genes hits a lot of people personally, as we all know that we have our own genes and that raises the argument "how can someone patents my genes"? Furthermore, patent law declares that "natural products" are also unpatentable and since DNA and genes are natural products, they should be unpatentable. But that is where that line of argument stops.

The longstanding recognition of the patent office and courts both high and low is that any "natural product" that has been modified, purified, altered, isolated, or otherwise processed to any form that is not found in nature is patent eligible. Your genes when they are part of your DNA and in their natural environment are not patentable, but withdrawn from you and isolated, they are potentially patentable. You may not like that line of reasoning, but that is the law of the land and it has been for 30 years. Personally, I am fine with it. It give a fairly bright line as to what is and isn't potentially patentable, and bright line tests in patent law, despite their great desirability in making issues black and white, are few and far between.

Back to our favorite subject of polymers. Algae and other single cell animals create in large quantities (up to 25 wt%!) a polymers called PHA - polyhydroxyalkanoates. These are polymers that are used as a form of energy storage. We humans store our excess energy as fat, while algae store theirs as PHA. There are extensive efforts to commercialize it as it is a biodegradable plastic. I personally think it could have great potential as a thermoplastic, much greater than that of another biodegradable plastic, PLA (polylactic acid), in that the algae can be farmed on non-arable lands. Unlike PLA, you are not taking foodstuffs (corn, sugar cane...) and using farmland to create single-use plastic. Instead, you are using waste materials and non-cropland to make the plastics. The economics are not there at present, but people are trying to change that and should eventually succeed.

But keep in mind that just like the genes in the algae, the PHA is a natural product. The algae create it biochemically as part of their natural life cycle just like they create their own DNA.

So now you should be able to see my concerns about the court ruling that genes are unpatentable. To be completely honest, this example is not perfect as we have known of the existence of PHA in algae for decades, so it is non-patentable for lack of novelty, but imagine if it had only just been discovered. If the Supreme Court rules that genes are not patentable, PHA could also become nonpatentable and that would greatly disincentivize efforts to commercialize it. But also considered researchers who genetically modify the algae to produce more or higher quality PHA. Shouldn't that product also be patentable? Or back away from the whole polymer issue and consider microbes or algae that produce a unique monomer, one that can create a (co)polymer with wonderful properties. Again, shouldn't that also be patentable?

With the bright line gone, we would unquestionably be on a undefined, slippery slope. It is an irony of the current age that civilization has spent the last millenia moving away from nature and now we are relying more and more on biobased technologies to create the materials of the future. That further highlights the importance of this future decision. Without a bright line test on patent eligibility, we will have more and more arguments and cloudiness over patents. Such chaos is the opposite of why the patent system exists - "...to promote the Progress of Science and useful Arts..." (citing the US Constitution).

While yesterday's arguments were about genes, to think that the outcome won't have an impact on the polymer industry is to not see the future.

1 comment:

Arthur Gershman said...

Very thought provoking post. Keep up the good work.