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Saturday, 15 June 2013

Are Human Genes Patentable?

Copy Kat, the first kitten clone
Washington – On Thursday, the Supreme Court delivered its eagerly awaited judgment in the Myriad case (Association for Molecular Pathology v. Myriad Genetics), putting an end to 20 years of USPTO practice and overruling what had appeared to be settled since the Court’s landmark decision in Diamond v. Chakrabarty: the patentability of human genes. Gone are the days when biotechnology companies could obtain patents for isolated human DNA [although they may still obtain a patent for isolating it].

The Supreme Court had to decide on two issues: (1) Are DNA sequences eligible for patent protection? (2) If not, what about complementary DNA sequences (cDNA)?

In an unanimous ruling, the nine Justices came to the conclusion that DNA sequences are products of nature; isolating them from their natural environment does not create anything with markedly different characteristics. Isolated human genes are therefore not considered patentable. However, cDNA is deemed patent eligible, because its chemical composition is different from that of naturally occurring DNA.

With regard to genomic DNA, the Supreme Court notes:
It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myriad create or alter the genetic structure of DNA. Instead, Myriad's principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes […]. The question is whether this renders the genes patentable. […]  
Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention. Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry. […]. Myriad found the location of the BRCA1 and BRCA2 genes, but that discovery, by itself, does not render the BRCA genes "new . . . composition[s] of matter," § 101, that are patent eligible. […]  
Many of Myriad's patent descriptions simply detail the "iterative process" of discovery by which Myriad narrowed the possible locations for the gene sequences that it sought. Myriad seeks to import these extensive research efforts into the § 101 patent-eligibility inquiry. But extensive effort alone is insufficient to satisfy the demands of § 101. 
With regard to cDNA, the Court explains:
cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. […]. Creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring. […] The lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a "product of nature" and is patent eligible under § 101. 
Finally, the Supreme Court points out that the case 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.

Since the IPKat is a native European [the UK is still a Member of the EU, right?], it cannot hurt to draw a brief comparison with the situation in Europe. As far as genomic DNA sequences are concerned, the protection available in EU Member States is partly broader und partly narrower than in the US. It is broader because, according to Articles 3 and 5 of the Biotechnology Directive, genomic DNA can be subject to a composition claim even though it is identical to natural DNA. At the same time, protection is narrower because both genomic DNA and cDNA are only subject to purpose-bound protection. According to the interpretation of Article 9 of the Biotechnology Directive adopted by the CJEU in the Monsanto case (Monsanto Tchnology v. Cefetra et al.), the protection conferred by a patent for a gene sequence is limited to the (technical) function of that sequence, as indicated in the patent application.

This Kat will not dare to speak out on the practical implications of the Myriad ruling. But other Kats and readers are very welcome to put in their two cents.

Posted by: Matthias Lamping & Roberto Romandini

Image source: ScienceMag


שרון said...

Would someone please explain to me the difference between this "markedly different characteristics" (supposedly-)dicta from Chakrabarty and the machine-or-transformation test deemed by the same court as inconclusive "clue" 3 years ago?

Anonymous said...

Machine or transformation dealt specifically with process claims (think 'doing').

The markedly different characteristics - and it is not "supposedly" dicta - is the differentiator between what is and what is not a product of nature. This characteristic is used for products - the statutory categories of manufactures and compositions of matter claims (think 'things').

Apples and oranges.

Anonymous said...

There's a look at the decision and what it means for Myriad at

Anonymous said...

Useful substances isolated from nature are patented all the time both in Europe and in the US. In fact genomic DNA sequences which are isolated from nature are changed chemically, since they are excised from the longer genomic DNA, whereas useful compounds isolated from nature are mostly not chemically changed in the process (e.g. penicillin is a natural product and useful as such without chemical modification once isolated). A lot of work goes into isolating a gene of this kind and often the cDNA is produced before the genomic DNA is identified and isolated, since the mRNA is isolated by immonoprecipitation of the ribosome-mRNA-protein complex. This is then used to produce a primer which can be used to find the gene in the genome of the organism in question. The whole process relies not only on such standard technology, but also on a (i) becoming aware of at least the effects of the gene product (ii) raising antibodies to it (this can be very difficult) and (iii) using the cDNA to produce primers which can identify the genomic DNA. Overall it can be an inventive process leading to an inventive product or may not be. That is the point, that the PTO assesses whether or not the overall facts of the case convey patentability. Blanket ban or blanket allowance are unhelpful.

Furthermore, would this decision then bar the patenting of all natural products?

Tim Roberts said...

The question for decision was whether human genes were patentable. The decision (No) clearly isn't confined to them: it applies to all DNA sequences found in Nature. But efforts to extend it to all natural products should not succeed (and it's encouraging that the USPTO has so far read it in that sense). Don't worry too much about the legal reasoning. It doesn't bear close examination, but it doesn't have to. When Anon above says it's for the PTO to assess patentability, I suggest he or she means obviousness. This decision wasn't about obviousness.

Anonymous said...

Anonymous at 11:30 obviously has not kept up with the case, as he repeats many of the arguments that failed.

Tim Roberts at 19:35 is expressly incorrect (extension to all natural products) in that the rule of law applied to the facts of this case in order to resolve the issue presented applies to more than just DNA sequences. Further, the legal reasoning does in fact bear close examination, and is fully in line with the U.S. jurisprudence of the judicial exceptions.

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