The question as to whether isolated strands of human DNA are patent eligible subject matter has finally been answered. The Supreme Court handed down its opinion in Association for Molecular Pathology v. Myriad Genetics, Inc (1), on Thursday, June 13, 2013. Confirming what many patent practitioners anticipated, the Court held that a naturally occurring DNA segment is a product of nature and therefore is not patent eligible subject matter under 35 U.S.C. § 101 merely because it has been isolated. Moreover, and perhaps more importantly, the Court ruled that complementary DNA (cDNA), which is synthetically constructed from a DNA segment by removing the introns (the non-coding DNA segments in a gene), can constitute patent eligible subject matter because the cDNA is not naturally occurring. It is important to note that this carved-out exception protects universities, biotech companies, pharmaceutical companies, and other research institutions; without the carved-out exception, the ability for such entities to recuperate resources devoted to research and development may have been lost.
Myriad Genetics, Inc. (Myriad), discovered the precise location and sequence of two genes, BRCA1 and BRCA2(2). Mutations of BRCA1 and BRCA2 are known to increase the risk of breast and ovarian cancer.(3) Myriad used this information to develop medical tests for detecting mutations in BRCA1 and BRCA2 in order to assess a patient’s cancer risk.(4) Myriad obtained patents for both the isolated DNA and the cDNA for both BRCA1 and BRCA2.(5) If Myriad’s patents were upheld, Myriad would have possessed the exclusive right to isolate a person’s DNA for these genes, as well as the exclusive right to synthetically create BRCA1 and BRCA2 cDNA.(6)
The Supreme Court has long recognized an implicit exception to patentable subject matter: “Laws of nature, natural phenomena, and abstract ideas are not patentable.”(7) The reason for the exception is that laws of nature, natural phenomena and abstract ideas are the basic tools of scientific and technological work which lie beyond the domain of patent protection.(8) This exception recognizes the balance between fostering innovation and inhibiting future innovation by restricting the use of the basic tools of science and technological work.(9)
Myriad’s patent claims sought the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes (or any DNA strand of 15 or more nucleotides located within those genes) by breaking the covalent bonds that connect the DNA to the surrounding DNA on the relevant chromosome.(10) The Court stated that while Myriad had discovered the location and sequences of the BRCA1 and BRCA2 genes through extensive research efforts, those efforts alone are not enough to make their discovery patentable if the discovery is not a new composition of matter.(11) The Court further stated that groundbreaking, innovative, or even brilliant discovery does not, by itself, make the thing discovered patentable.(12) In denying the patentability of the claims pertaining to isolated DNA, the Court stated that Myriad “found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention” because it does not result in a new composition of matter.(13) In holding the claims for the isolated DNA unpatentable, the Court noted that Myriad’s claims were focused on the genetic information encoded in the BRCA1 and BRCA2 genes and not on the chemical composition of the isolated DNA or the chemical changes that resulted from the isolation of the DNA.(14) Therefore, there is still a question as to whether claims relating to the chemical composition of isolated DNA are patentable.
cDNA differs from natural DNA in that the introns have been removed, resulting in a molecule that is not naturally occurring except in rare instances of retrovirus activity randomly creating a similar molecule.(15) Because cDNA is distinct from the DNA from which it was derived, the Court found that the lab technician “unquestionably creates something new when cDNA is made.”(16) Accordingly, the Court held that cDNA is not a “product of nature.”(17) The Court held that the claims directed to the DNA sequences of cDNA were patentable subject matter. However, the Court limited its holding to those instances where cDNA is distinguishable from natural DNA.(18)
The Court concluded its opinion by specifically noting what is not implicated in the ruling. The Court noted that this case did not involve the patentability of any of the following three categories: 1) new and useful methods for manipulating genes 2) new and useful applications of the knowledge about discovered genes, or 3) DNA sequences in which the order of the naturally occurring nucleotides has been altered.(19) Accordingly, these categories of inventions are still patent eligible subject matter.
If you have an invention relating to DNA or other biological molecules, or if you have questions about the validity of a patent claim pertaining to DNA, you should seek the assistance of experienced legal counsel.
- 569 U.S. _______ (2013), (slip op.).
- Id. at p. 4.
- Id. at p. 4.
- Id. at p. 4-5.
- Id. at p. 5.
- Id. at p. 5.
- Id. at p. 11, quoting Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. _____, (slip. op., at p. 1) (2012).
- Id. at p. 11, quoting Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. _____, (slip op. at p. 2) (2012).
- Id. at p. 11, citing Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. _____, (slip op. at p. 23) (2012).
- Id. at p. 14.
- Id. at p. 13-14.
- Id. at p. 12.
- Id. at p. 14-15.
- Id. at 14-15.
- Id. at 16, quoting Brief for Petitioners, at 51.
- Id. at 17.
- Id. at 17.
- Id. at 17. The court recognized that in some instances, naturally occurring DNA may have no introns and in those cases the cDNA may not be patentable subject matter.
Id. at 17-18.