The document discusses the Supreme Court case Myriad Genetics v. Ambry regarding patents on the BRCA1 and BRCA2 genes. It summarizes that Myriad discovered the location and sequence of these genes linked to breast and ovarian cancer. Myriad obtained patents covering the isolated DNA and cDNA of these genes. In 2013, the Supreme Court ruled that isolated DNA is not patent eligible, but cDNA created in a lab is patent eligible. The decision narrowed the scope of gene patents but allowed patents on synthetically created DNA.

1. By
Aathilakshmi.U
1st year M.tech Biotechnology

2. Introduction
 The general rule towards Patent law is that anything and everything
made my man could be Patented which should have a practical use in the
welfare of the society and it should not merely be an idea.
 This rule is sometimes overlooked and confused among the scientist and
researchers and they end up getting confused between Invention and
Discovery.
 Patent law encourages researchers and inventors to contribute more to
the society by providing security to their invention which prevents from
exploitation of their hard-work and also provides certain monopoly
rights to the inventor.

3. Patentable Subject Matter
Whoever invents or discovers a 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.

4. Patent Eligible Subject Matter
Exclusions
 Laws of Nature
 Natural Phenomenon (Products of Nature)
 Abstract Ideas
 Naturally occurring orgaanisms
 Legal contract

5. Discovery of BRCA-1 & -2 Genes
 1980s: Breast cancer patients mobilize to raise awareness of breast
cancer epidemic. This caused the federal goverment to increase
funding for breast cancer research, which would grow from $90M in
1990 to $2.1 billion by 2008.
 1990: Group from University of California., Berkeley announces
that the Breast Cancer Susceptibility Gene (BRCA1) was located on
chromosome 17. “With this discovery, research teams from around
the world intensified efforts to be the first to sequence the BRCA1
gene.”

6.  Sept. 1994: Group led by Dr. Mark Skolnick, co-founder of Myriad,
announces that it had sequenced the BRCA1 gene. Myriad files
patent applications related to that gene.
 Dec. 1995: Dr. Skolnick‟s group announces that it found the
sequence of a BRCA2 gene, which had recently been located on
chromosome 13. That gene was linked to ovarian cancer, as well as
female and male breast cancer. Myriad files patent applications
regarding the BRCA2 gene in the U.S. and in Europe.

7. Significance of BRCA 1 & 2 Genes
 “Before Myriad‟s discovery of the BRCA1 and BRCA2 genes,
scientists knew that heredity played a role in establishing a woman‟s
risk of developing breast and ovarian cancer, but they did not know
which genes were associated with those cancers.”
 “The sequencing of the BRCA1 and BRCA2 genes were landmark
events in genetics, as mutations in these genes are responsible for
many breast and ovarian cancer cases.”

8. Statistics Regarding BRCA-1 & -2 genes
 Normal risk (breast cancer): 12% - 13%
 Risk with BRCA mutations:
• Breast cancer: 50% - 80%
• Ovarian cancer: 20% - 50%

9. Myriad's Patents
 Myriad's applications issued as patents, owned by University of
Utah Research Foundation, and exclusively licensed to Myriad.
 Nine “composition” claims at issue before Supreme Court.
Examples:
 Claim 1 of “the 282 Patent” asserts a claim on the DNA code that tells a cell to
produce the 1,863 amino acids that the typical BRCA1 gene encodes.
 Claim 2 asserts a sequence of cDNA that codes those amino acids.
 Method claims
 Methods of “comparing” and “analyzing” BRCA sequences .
 Method of screening potential cancer therapeutics via “changes in cell
growth rates of transformed cells.”

10. Procedural history and judicial rulings
2010: U.S. District Ct. for Southern District of NY: Invalidates all of
Myriad's challenged claims under 101.
2012: U.S. Court of Appeals for the Federal Circuit: Mostly reverses
district court; upholds validity of all claims except for the “comparing
and analyzing” method claims.
2012: Supreme Court of the United States: Grants the petition, agreeing
to review the Federal Circuit's decision.

11. The Supreme Court's Decision
 “Extensive effort alone is insufficient to meet the demands of 101.”
 “Myriad found the location of the BRCA1 and BRCA2 genes, but that
discovery, by itself, does not render the BRCA genes „new . . .
composition[s] of matter,‟ 101, that are patent eligible.”
 “cDNA does not present the same obstacles to patentability as
naturally occurring, isolated DNA segments.”
 “The lab technician unquestionably creates something new when
cDNA is made.”
 “As a result, cDNA is not a „product of nature‟ and is patent eligible
under 101, except insofar as very short series of DNA may have no
intervening introns to remove when creating cDNA. In that situation, a
short strand of cDNA may be indistinguishable from natural DNA.”

12. Biotech after Myriad Genetics
 cDNA is still patent eligible. Thus, practitioners can direct cDNA
claims to sequences that are derived from genes that naturally
contain introns.
 Nucleotide sequences, proteins and peptides that are not identical
to naturally-occurring genes and proteins may be patent eligible.
 New methods of using old or known compositions may be
patented.

13. Reference
 https://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf
 In re BRCA1- and BRCA2- Based Hereditary Cancer Test Patent
Litig., 2014 U.S.Dist.LEXIS 31345, at *9 (D. Utah Mar. 14, 2014).
 https://truthandyouth.com/the-myriad-patent-case-a-critique/
 https://www.wipo.int/wipo_magazine/en/2006/04/article_0003.html

14. Thank You!