Is Nucleic Acid Primer a Patentable Subject Matter?
Biotechnology is any technique that uses living organisms (or parts of organisms) to make or modify products, to improve plants or animals or to develop micro-organisms for specific uses.
The 21st century is the Age of Biotechnology and most important technological breakthroughs have been occurring during the last two decades. The biotechnology revolution has put a great strain on the legal system, challenging its adaptability. In this field, the challenge pertains mostly to the patent system.
Admittedly, some legal questions were settled early by the courts such as the patentability of living organisms, and the basic equivalence of recombinant proteins with their purified natural counterpart.
However, many other legal issues have arisen concomitantly with the development of new biotechnology techniques. One such issue is whether the primers of biotechnology are patentable.
A primer is a short strand of RNA or DNA (generally about 18-22 bases) that serves as a starting point for DNA synthesis. It is required for DNA replication because the enzymes that catalyze this process, DNA polymerases, can only add new nucleotides to an existing strand of DNA.
The popular case studies associated with genes and primers are Myriad I and Myriad II where in the Myraid I case of Association for Molecular Pathology et al. V. Myriad Genetics, Inc., et al., the US Supreme Court held that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.
It was further held that cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. The creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring. cDNA differs from natural DNA in that “the non-coding regions have been removed.” 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, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.
In the Myriad II case formally titledIn re BRCA1- & BRCA2- Based Hereditary Cancer Test Patent Litigation, University of Utah Research Foundation v. Ambry Genetics Corp, the Supreme Court’s landmark decision is yet another blow to the patenting of diagnostics and personalized medicine, and biotechnology innovation in general.
The product claims in Myriad II were directed towards “pairs” of PCR primers, which are by definition synthetic molecules. In contrast, the product claims found to be patent ineligible in Myriad I were directed towards single DNA molecules, which were not necessarily synthetic.
The Supreme Court of Appeals for the Federal Circuit determined that the use of hybridization probes and PCR in genetic diagnostics is “well understood, routine and conventional,” and thus insufficient to render the claim patent eligible.
The Federal Circuit rejected Myriad’s arguments and concluded the fact that primers are synthetic and it makes no difference since synthetic primers “are structurally identical to the naturally occurring compositions” and function just like naturally occurring DNA by binding to complementary nucleotide sequences and separating DNA “from its surrounding genetic material is not an act of invention.”
The Federal Circuit further held that the synthetic nature of the claimed PCR primers was insufficient to render them patent eligible. The claims were directed towards a combination of primers, rather than to a single isolated DNA molecule. It’s one thing to declare isolated natural products patent ineligible; it’s quite another to declare combinations of natural products patent ineligible.
The primer claims at issue did not recite specific DNA sequences and were not limited to primers of any specific length.
Are the primers of limited length having a specific DNA sequence patentable?
Are the primers with new application or different function or utility of the naturally-occurring sequences qualify as an invention?
Countries around the world take different approaches to gene and primer patenting, adopting positions which are variations on those now applied in Europe, Australia or the U.S. For example, in Japan, China, Korea and Canada, isolated DNA, including human DNA, is patentable in principle, provided that function and industrial application are provided by the patent application.
What is the position of India in protecting the DNA & Primer post scenario of Myriad case?
India is similar to the U.S. and Australia whereby DNA isolated from nature is not patentable unless it has been modified by human intervention on or after the isolation procedure. Again the provision of an industrial application is essential.
The Indian Patent Office Guidelines for examination of Biotechnology Applications explicitly states that isolated gene sequence occurring in the nature will be treated as a discovery of a living thing occurring in nature and therefore not capable of patent protection under Sec. 3 (c) of the Act.
A claim directed to primers is also considered to be a scientific discovery and not a patentable subject matter under section 3(c) of the Indian Patent Act. But if the claim is based on the invention disclosed on how the primers are designed, how the sequence of the present invention primer is different from the known primers, how the characteristic feature of the primer is determined and finally indicating the industrial application or utility of the claimed primer, then the claim can be protected.
