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


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

BioPharm International
Volume 26, Issue 8, pp. 22-27

US Patent Law and Myriad'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.

On the Road to the Supreme Court
The ACLU filed suit in the US District Court for the Southern District of New York (SDNY) in May 2009 asking the court to invalidate Myriad's patents for failing to satisfy 35 U.S.C. 101. The ACLU also challenged the diagnostic method claims but these were not appealed to the Supreme Court (8). The ACLU also argued that the USPTO's policy of granting patents on isolated human genes violated the First Amendment of the US Constitution.

Myriad sought to dismiss the suit, arguing that the patent claims were valid because the difference in the structural and functional properties of isolated DNA rendered its claims patent-eligible. Additionally, the USPTO had been granting similar patents on this technology for decades, and the biotechnology industry had relied on patents to support research and investment.

The ACLU prevailed (9). Judge Sweet of the SDNY held that Myriad's challenged patent claims were invalid. Judge Sweet opined that DNA represents the physical embodiment of biological information and that Myriad's focus on the chemical nature of DNA failed to acknowledge the unique characteristics of DNA that differentiate it from other chemical compounds. Judge Sweet concluded that the preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition of matter claims are directed to unpatentable products of nature (9).

Myriad appealed to the US Court of Appeals for the Federal Circuit, where the judges twice reversed Judge Sweet's ruling. The first appeal was returned to the district court after the Supreme Court granted ACLU's petition for certiorari, vacated the Federal Circuit's prior decision, and remanded the case to the Federal Circuit for further consideration in light of its decision in Mayo Collaborative Services v. Prometheus, Inc., 566 U.S. __, 132 S.Ct. 1289 (2012) (10).

A three-judge panel, led by Judge Lourie, held that all claims were valid but the opinions of the other judges on the panel varied with the claims. Judge Lourie opined that all appealed claims were patentable and Judge Moore agreed, but on different grounds. Judge Lourie reasoned that: "[t]he isolated DNA molecules before us are not found in nature. They are obtained in the laboratory and man-made, the product of human ingenuity. While they are prepared from products of nature, so is every other composition of matter. All new chemical or biological molecules, whether made by synthesis or decompositions, are made from natural materials" (11). Judge Lourie also cautioned that Congress, not the courts have the appropriate mandate to categorically exclude subject matter such as isolated genes from patenting. Congress, he noted, was aware of the controversial issue when it recently enacted the comprehensive patent reform act, and it is ultimately for Congress to act if it wishes to overturn case law and the long practice of the USPTO to determine that isolated DNA must be treated differently from other compositions of matter.

Judge Bryson opined that only the synthetic man-made "cDNA genes" were patent-eligible and agreed with Judge Sweet that claims to isolated naturally occurring genes and fragments are invalid. The ACLU appealed to the Supreme Court.

blog comments powered by Disqus



Lundbeck CEO Resigns Due to Code of Conduct Breach
November 24, 2014
GPhA Issues Statement on Generic Drug Costs
November 20, 2014
Amgen Opens Single-Use Manufacturing Plant in Singapore
November 20, 2014
Manufacturing Issues Crucial to Combating Ebola
November 20, 2014
FDA Requests Comments on Generic Drug Submission Criteria
November 20, 2014
Author Guidelines
Source: BioPharm International,
Click here