The US Supreme Court came down with its ruling on the Myriad case. Maybe somewhat expected, the Supreme Court ruled that as genes are considered “naturally occurring,” they are not patent eligible. This is not surprising, although quite a relief at least (a good thing). The idea of a company being able to patent genes in us is simply quite disturbing.
However, I think it is too early to celebrate. The judge, interestingly, stated that as complementary DNA (cDNA) are not naturally occurring, they will be patent eligible. According to Justice Thomas in the opinion of the court:
cDNA is not a “product of nature,” so it is patent eligible under §101. cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. Its creation results in an exons-only molecule, which is not naturally occurring. Its order of the exons may be dictated by nature, but the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA.
This, to me, feels like a very awkward decision based on my understanding of biochemistry (I do have a biochemistry degree after all!). In your cell, many processes are involved in going from the genetic code in your genome to a final protein product that will be made. This process is known as the central dogma. The DNA code is first transcribed into mRNA (“transcription”), the mRNA goes through a few additional steps (adding the 5′ cap and the poly-A tail, and “splicing” – during which parts of the mRNA called “introns” are removed), and then based on this mRNA sequence, an amino acid chain is made (“translation”). This amino acid chain goes through more modifications and eventually becomes a protein. Here is a quick video about the splicing process (please watch it before reading on if you are not familiar with the central dogma):
To generate a cDNA, an enzyme called the reverse transcriptase is used to produce the cDNA based on the sequence of the spliced mRNA (here is an infographic on making a cDNA library). This means that the cDNA contains the genetic code in your genome, except with the introns already removed (this is likely a simplification of the process, because I am sure there are exceptions, but for majority of the time this is the case).
So let’s come back to this “cDNA being patent eligible” business. Because I am not an expert in the different types of patents, I am hoping to cover the different situations I can think of – none of which sit well with me.
Situation 1: cDNA essentially contains your genetic code (well, sort of, then we probably need to define what your “gene” really means – with the introns? without the introns? complementary to the mRNA sequence?). So to allow patents for the information on cDNA doesn’t seem too different from allowing patents for your gene…at least in my opinion.
Situation 2: A few have mentioned that the judge was pointing to a “method patent,” which also seems weird to me. The technique used to generate cDNA has been around for a few decades (HT Mark Hoofnagle for mentioning this in his blog post). So, the technique itself is definitely not novel.
Situation 3: If the judge was suggesting a “method patent” for the act of technicians from Myriad generating cDNA of BRCA1 and BRCA2, then does this mean that any of us with enough knowledge of how to use reverse transcriptase, with access to equipment, and a source of mRNA, can walk into a biochemistry lab to generate cDNA and patent the “method”? (if so, we probably all should start doing this…)
Situation 4: Research labs often isolate cDNAs for many purposes, or prepare cDNA libraries. If a specific cDNA is patented, does it mean that researchers will then need to pay the company a licensing fee in order to continue isolating the said cDNA or cDNA libraries? Will it be considered that they infringed on the patent?
It was, however, noted in the court opinion that:
This case, it is important to note, does not involve method claims, patents on new applications of knowledge about the BRCA1 and BRCA2 genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.
This means there was no actual ruling about whether cDNA should be patented (yet). This case, therefore, is not the end of the patent discussion for genes – companies are already moving toward working with cDNA and there will likely be more discussions and court cases about cDNA down the road.
According to the Daily Beast:
…a cDNA patent would still have to show that its invention is “non-obvious,” says Matthew Dowd, the lawyer who filed an amicus brief on behalf of James Watson, who won a Nobel Prize for his co-discovery of the structure of DNA. “If you have human genes you almost necessarily have cDNA,” says Dowd. “Down road will be battles over whether cDNA is non-obvious.”
This brings up another issue that is burning to be discussed – how do we provide companies with enough financial incentives for investment in innovation, without prohibiting others from accessing the innovation? From this case, to the patent wars between Apple, Google, and Samsung, to the lack of drug development for rare diseases (mostly as a result of the lack of financial incentives), a bigger discussion will probably need to happen as to how we can create win-win situations. Otherwise, we will continue chase the patent tail, and fill up the pockets of corporate lawyers.
Note: I would like to thank Joyce and Jone for our discussions on this topic. I am really just brushing the surface here – Joyce provided me with a much more extensive reading list (which I unfortunately didn’t finish – sorry Joyce!)
- US Supreme Court seems unconvinced of human gene patent legality by Liat Clark for Wired.co.uk. April 16, 2013
- Background/History – Myriad Genetics: In the eye of the policy storm by E. Richard Gold, and Julia Carbone. April 1, 2013
- For those who love legal documents – Association for Molecular Pathology v. Myriad Genetics, Inc. (2013) by Kevin E. Noonan. June 13, 2013 (not the one that Joyce sent me, but an update after the ruling was out
(updated June 14 at 4pm) Joyce also wrote about this for her first blog post – if you enjoy some additional technical/legal details you will likely enjoy it.
Note 2: I met Andrea, a graduate student in Biology (Genetics), on twitter. She is collecting links about this ruling on her blog “Appetite for Awesome.” Go check it out!
Note 3: This whole patent discussion reminds me of Kevin O’Leary! If you watch Dragon’s Den or Shark Tank, you would know what I am talking about 😛 Apparently he also had some opinions about this (and I’m absolutely not surprised by his standpoint):
Note 4: No, I am not an american citizen, but at the same time rulings like this set precedence…so of course I am gonna write about it 😛