New Gene Patent Rules - Pharmaceutical Technology

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New Gene Patent Rules
The US Supreme Court's Myriad decision satisfied both patient groups and patent holders. Includes bonus online coverage.

Pharmaceutical Technology
Volume 37, Issue 8, pp. 14-16

US Patent Law and Myria's Patents
Patents on isolated genes and gene fragments similar to the Myriad patents have been granted by the USPTO since the 1980s. The USPTO will grant a patent on discoveries or inventions if it satisfies three criteria for patentability: novelty (codified in 35 U.S.C. 102), non-obviousness (codified in 35 U.S.C. 103), and utility (codified in codified in 35 U.S.C. 101). The novelty requirement ensures that the discovery is "new"—that the discovery is not a copy of an existing or prior discovery or invention. The non-obviousness requirement ensures that the discovery or invention is a significant advancement over prior known discoveries. The utility requirement ensures that the invention is useful and is of a class for which the USPTO is authorized to grant patents.

The ACLU challenged Myriad's patent claims on the ground that the subject matter of the claims (isolated genes, synthetic "man-made" genes, gene fragments, and methods for using them) should not be patented because the patent claims do not qualify for patentability under Section 101 of the Patent Act. This argument was highly unusual. Most patents are challenged on other grounds such as that patent claims are not novel (failing to satisfy Section 102 of the Patent Act) or that they do not embody a significant advancement over prior knowledge (failing to satisfy Section 103 of the Patent Act). Section 101 of the Patent Act (utility) provides that "Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title."

The courts have determined that certain subject matter is outside the broad scope of 35 U.S.C. 101. Excluded subject matter includes patents on abstract ideas, laws of nature, and physical phenomena (6). While the courts had never ruled on the issue of whether human genes are excluded from patentable subject matter, the Supreme Court had decided in the seminal case of Diamond v. Chakrabarty, 447 U.S. 303 (1980) (Chakrabarty) that genetically modified bacteria were patent-eligible. The Supreme Court reasoned that the bacteria were patentable because Chakrabarty had produced "a new bacterium with markedly different characteristics from any found in nature" by introducing multiple oil-degrading plasmids into a bacterium, which itself has no capacity for degrading oil (6). The USPTO relied on this key Supreme Court precedent when it began issuing patents to isolated genes, fragments, and their uses.

The Myriad patent claims challenged by the ACLU cover the BRCA1/2 genes and certain alterations or mutations in these genes and their uses. Claims 1, 2, 5, and 6 of US Patent No 5,747,282 (the '282 Patent) are representative of the claims ultimately reviewed by the Supreme Court:
  • Claim 1—An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2
  • Claim 2—The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1
  • Claim 5—An isolated DNA having at least 15 nucleotides of the DNA of claim 1
  • Claim 6—An isolated DNA having at least 15 nucleotides of the DNA of claim 2.

Claim 1 of the '282 Patent covers the isolated human BRCA1 gene or "the DNA code that tells a cell to produce the string of BRCA1 amino acids listed in SEQ ID NO: 2" (7). Claim 2 of the patent covers an isolated synthetic form of the gene, that is manmade and does not exist in nature. This claim refers to SEQ ID NO: 1, which list only the cDNA exons in the BRCA1 gene, rather than a full DNA sequence containing both introns and exons. Claims 5 and 6 cover fragments of the genes of at least 15 nucleotides of claims 1 and 2, respectively.


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