Isolated Genetic Sequences: Altered Enough for Patent?

Patenting a DNA structure may seem silly or trivial to the everyday person because it is widely known as being a natural and organic phenomenon. Prior to the Molecular Pathology v. Myriad Genetics case in June of 2013, isolated but altered genetic sequence patents are allowed under the category of a patent on a composition of matter section of a utility patent (Molecular Pathology). Trying to patent a genetic sequence without substantial alteration is not viable for patent, however in Molecular Pathology v. Myriad Genetics, Myriad Genetics somehow managed to do just that.

One of the sparks of controversy arose under the American Invents Act. Section 27 provides information on genetic diagnostic testing, however semantically the controversy lies with section 33 which states “notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism” (H.R. 1249 (112th): Leahy-Smith America Invents Act). This section concludes that unless previously patented, human organisms cannot be further patented.  General human genetics are naturally occurring and therefore cannot be patentable. Dan Hunter’s Intellectual Property provides an example: “Einstein could not have patented the formula E=mc2 because it is a law of nature, and Sir Humphry Davy, the first isolator of potassium, barium, and calcium, could not have obtained a patent over these elements because they are naturally occurring […] a genetically engineered bacterium or mouse is patentable subject matter, as is a purified form of adrenaline, because these things have taken human ingenuity to create, not merely uncover” (Hunter, 91). In this case, genetic patents serve the purpose that other patents do- allow a limited monopoly on invention in order to foster innovation and allow the inventors monetary gains during that period. Unfortunately, not all companies or organizations claiming genetic patents are “using them for good” in that sense and rather are establishing a corner market in genetic diagnostics regarding their genetic discovery.

Interestingly enough, The Economist wrote an article segment about the Molecular Pathology v. Myriad Genetics case which was sponsored by General Electric, the famous employer of Ananda Chakrabarty in the 1980 court case Diamond v. Chakrabarty (Diamond). This landmark case in gene patentry allowed a genetically engineered oil-eating bacterium to be patented because of its non-obviousness and novelty, regardless of whether or not it was alive. In the instance of the Economist article cited above, General Electric has an interest in genetic patents and may include some bias positively towards allowing them. Although in GE’s court case the bacterium was not isolated genes and rather only derived from a previously established organism and thus abides by the correct assertion of a genetic patent as outlined by Hunter.  This potential bias however, does not scream clear in the article because it presents both sides equally.

Myriad Genetics had rights established by patents to two genes BRCA1 and BRCA2 that when mutated increase ovarian and breast cancer probability in woman (Why Are Gene Patents Controversial?”). The Association of Molecular Pathology brought suit against Myriad Genetics on the grounds that merely isolating a genetic sequence should not constitute innovation enough for a patent grant. Because of Myriad’s patent for the gene sequencing, diagnostic testing for mutations in those genes were also controlled by Myriad along with the right “to synthetically create BRCA cDNA” (Molecular Pathology). The claims by either side indicate a stronger pull for the discontinuing patents of isolated, basically unaltered, genetic sequences.

Myriad claims that because the isolated gene sequenced was chemically altered for lab use it was altered enough to not be simply an organism already existing in nature. In terms of defense, Myriad claims little else. In the Supreme Court holding, this defense does not make Myriad the victor under the grounds of their DNA claims fall “within the law of nature exception” and goes further to state that “Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes” (Molecular Pathology).  The Association of Molecular Pathology counter claims by saying that the alterations are minimal and irrelevant to the genetic material scientifically used for medical purposes and that genetic patents of this nature actually hinder innovation (Why Are Gene Patents Controversial?”).

Molecular Pathology’s arguments are arguably more logical and thought provoking compared to Myriad’s defense that their alterations to make the sequence lab accessible was enough to constitute an innovation.  By simply altering any organism to make it lab appropriate would, to any person even in the genetics field, seem like a necessary alteration for further innovation not the end result. While Myriad did isolate a difficult and new sequence that a PHOSITA (Person Having Ordinary Skill in the Art) would not necessarily be able to figure out from prior knowledge, the lab alterations Myriad made would certainly be able to be figured out from stated prior knowledge. The counter claim is neatly condensed and partially agreed upon by the Supreme Court’s holding statement that  Myriad “found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not itself satisfy the section 101 inquiry” (Molecular Pathology). However, whether or not genetic patents generally hinder innovation was not addressed in the holding documents.

The holding against Myriad Genetics is a crucial decision that elaborates upon the definitions in American Invents Act and helps clear genetic patents that should not have been given in the first place. Isolated relatively unaltered genetic sequences are no longer allowed to be patented after the Supreme Court decision and for good reason. Myriad Genetics used their discovery to control testing and research based around their “basic” discovery which could hinder an actual innovation involving the gene’s mutation.  Genetic patents are still allowed and around to cause more controversy but at the very least, the Supreme Court decision to discontinue the abuse of patenting isolated genetic sequences is still a victory to help curb the declaration of innovation, without actual innovation occurring. Moral of the case is, double check that the alterations to a gene are- in fact -altered enough.

Diamond v. Chakrabarty – 447 U.S. 303 (1980). Justia US Supreme Court Center. N.p., n.d. Web. 29 Mar. 2014. <http://supreme.justia.com/cases/federal/us/447/303/case.html>.

“H.R. 1249 (112th): Leahy-Smith America Invents Act.” GovTrack.us. N.p., n.d. Web. 29 Mar. 2014. <https://www.govtrack.us/congress/bills/112/hr1249/text>.

Hunter, Dan. “Patent.” Intellectual Property. Oxford: Oxford UP, 2012. 90-91. Print.

Molecular Pathology v. Myriad Genetics. 569 U.S. 398 (2013). Supreme Court of the United States. Web. 29 Mar. 2014. <http://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf>.

“Why Are Gene Patents Controversial?” The Economist. The Economist Newspaper, 18 Apr. 2013. Web. 29 Mar. 2014. <http://www.economist.com/blogs/economist-explains/2013/04/economist-explains-why-gene-patents-controversial>.

Shannon

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