Gene patent

Section 101 lets a person who invents or discovers a new and useful composition of matter obtain a patent, subject to the conditions and requirements of the Patent Act³. On June 13, 2013, the Supreme Court held in Association for Molecular Pathology v. Myriad Genetics that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring, with a narrow exception for very short strands¹.

• Why isolated genes failed. The Court said Myriad did not create or alter the genetic information encoded in the BRCA1 and BRCA2 genes or the genetic structure of the DNA. It found an important and useful gene, but a groundbreaking discovery does not by itself satisfy the section 101 inquiry¹.
• Why cDNA qualified. Creating cDNA from mRNA results in an exons-only molecule that is not naturally occurring, and the lab technician unquestionably creates something new when cDNA is made¹. The Court excepted very short strands of DNA that have no introns to remove, because such a short strand of cDNA may be indistinguishable from natural DNA¹.
• What the Court left open. The case did 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 altered¹.

The USPTO's examination manual applies the same reasoning. It lists the isolated gene and cDNA sequences of Myriad among its examples of nature-based products, which are tested with the markedly different characteristics analysis². In that analysis the claimed full-length cDNA of the BRCA1 gene had the same function as the natural gene (it encoded the same protein) but a changed structure, a nucleotide sequence containing only exons². For a nucleic acid derived from a gene, the closest natural counterpart is the gene, not the whole chromosome². See Patent claim.

The EPC applies and interprets its provisions on biotechnological inventions in accordance with Rules 26 to 34, and uses Directive 98/44/EC as a supplementary means of interpretation (Rule 26(1))⁶. The gene rules in Rule 29 EPC repeat Article 5 of the Directive^4,5.

The EPO's Guidelines add that gene sequence applications are examined on the same patentability criteria as in all other areas of technology⁸. They say a mere nucleic acid sequence without indication of a function is not a patentable invention, and that where a sequence is used to produce a protein, the application must specify which protein and what function it performs⁷.

Other limits apply to genetic inventions. The Directive treats as unpatentable, among other things, processes for cloning human beings, processes for modifying the germ line genetic identity of human beings, and uses of human embryos for industrial or commercial purposes (Article 6(2))⁴. Rule 28(1) EPC lists these exclusions under Article 53(a) EPC¹⁰. Rule 27 EPC also keeps biological material that is isolated from its natural environment or produced by a technical process patentable even if it previously occurred in nature¹¹.

Article 9 of the Directive says the protection conferred by a patent on a product containing or consisting of genetic information extends to all material, save as provided in Article 5(1), in which the product is incorporated and in which the genetic information is contained and performs its function⁴.

The Court of Justice of the EU applied Article 9 in Monsanto v Cefetra (Case C-428/08, judgment of 6 July 2010). The patent was European patent EP 0 546 090 on glyphosate tolerant EPSPS enzymes, valid among other places in the Netherlands⁹. The Court held that Article 9 does not confer patent protection where the patented product is contained in soy meal and does not perform the function for which it is patented, even if it performed that function previously in the soy plant or might again after extraction⁹. It also held that Article 9 harmonizes protection exhaustively, so national law cannot give absolute protection to the patented product as such, regardless of whether it performs its function in the material containing it⁹. See Patent infringement.

The Supreme Court's decision is the leading US record on gene claims¹.

The Court held that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring, with a narrow exception for very short strands1.