DNA Patent Law 101:

The Myriad Decision and its Impact on Patenting Genes

© 2014 Michael A. Cicero

Southern Polytechnic State U.

EE 3903 – Introduction to BME

April 9, 2014

Who is this guy, and what does he know about patent law?

• Juris Doctor (law degree), U. of SC, 1990• Member, GA & SC Bars

• Registered to practice before U.S. Pat. & TM Office, Apr. 1991, Reg. No. 34,562

• Worked 22+ years as an IP attorney

Why should I care about patents?

• “One study demonstrated that biotech firms expect to earn between 45–79% more on patented inventions than they would earn on those inventions if they had not been patented.” Buck, Nikki, “Greed is Good, for Patients: How the Biotechnology Industry Saves Lives, One Gene Patent at a Time,” 11 NW. J. TECH. & INTELL. PROP. 61, 78 (2013).

• Between 1997 and 2013, Myriad Genetics, Inc. earned more than $2 BILLION from sales of its patented test for presence of mutations in BRCA1 and BRCA2 genes. In re BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litig., 2014 U.S.Dist.LEXIS 31345, at *9 (D. Utah Mar. 14, 2014).

Patent Basics

“The patent system added the fuel of interest to the fire of genius.” - Abraham Lincoln

What is a patent?

A grant from the federal government to an inventor, conveying the right to exclude others in the U.S. from making, using, selling, offering for sale, or importing into the U.S., the invention for a term of years. 35 U.S.C. § 154(a)(1).

Term of U.S. utility patent = 20 years from earliest effective filing date. (Design patents: 14 years from patent issue date.)

What does a patent protect?

• “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.” 35 U.S.C. § 101.

• Put another way: “anything under the sun that is made by man.” Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).

• Examples: computer programs, golf balls, medical devices.

§ 101 – General Principles

• “[T]his provision [§ 101] contains an important implicit exception. ‘[L]aws of nature, natural phenomena, and abstract ideas’ are not patentable.” Mayo Collaborative Svcs. v. Prometheus Labs., Inc., 132 S.Ct. 1289, 1293 (2012).

• “‘[T]hey are the basic tools of scientific and technological work’ that lie beyond the domain of patent protection.” Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107, 2116 (2013) (Myriad) (quoting Gottschalk v. Benson, 409 U.S. 63, 67 (1972)).

§ 101 – General Principles

“The rule against patents on naturally occurring things is not without limits, however, for ‘all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas,’ and ‘too broad an interpretation of this exclusionary principle could eviscerate patent law.’” Myriad, 133 S.Ct. at 2116 (citations omitted)).

Technical Principles Underlying Myriad Patent Litigation

Transcription (Fig. 2 from Myriad Appellate Opinion)

Exons:DNA sequence necessary for protein creation

Introns:DNA sequence interspersed b/t exons; they do not code for a protein

Translation (EE 3903 PowerPoint #5, Slide 10)

Translation (Fig. 3 from Myriad Appellate Opinion)

(Genetic Code Table - annotated excerpt fromEE 3903 PowerPoint #5, Slide 11)

SNP (EE 3903 PowerPoint #7, Slide 12)

Genomic DNA

“Genomic DNA can be extracted from its cellular environment using a number of well-established laboratory techniques. A particular segment of DNA, such as a gene, can then be excised or amplified from the DNA to obtain the isolated DNA segment of interest.” Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 689 F.3d 1303, 1313 (Fed. Cir. 2012).

Complementary DNA (“cDNA”)

Source: http://blogs.scientificamerican.com/guest-blog/2013/07/09/new-supreme-court-decision-rules-that-cdna-is-patentablewhat-it-means-for-research-and-genetic-testing/

Facts in Myriad Case

Discovery of BRCA-1 & -2 Genes

• 1980s: Breast cancer patients mobilize to raise awareness of breast cancer epidemic. This caused the federal gov’t to increase funding for breast cancer research, which would grow from $90M in 1990 to $2.1 billion by 2008.

In re BRCA1- and BRCA2, 2014 U.S.Dist.LEXIS 31345, at *49.

• 1990: Group from U. of Cal., 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.”

Discovery of BRCA-1 & -2 Genes

• 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.

In re BRCA1- and BRCA2, 2014 U.S.Dist.LEXIS 31345, at *50-52.

• 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.

Significance of BRCA-1 & -2 Genes

• “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.” In re BRCA1- and BRCA2, 2014 U.S.Dist.LEXIS 31345, at *52.

• “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 now know which genes were associated with those cancers.” Myriad, 133 S.Ct. at 2112.

Statistics Regarding BRCA-1 & -2 Genes

Normal risk (breast cancer): 12% - 13%

Risk with BRCA mutations:• Breast cancer: 50% - 80%• Ovarian cancer: 20% - 50%

Source: Myriad, 689 F.3d at 1314.

Myriad’s Patents

• Myriad’s applications issued as patents, owned by Univ. of Utah Research Foundation, and exclusively licensed to Myriad. Myriad, 689 F.3d at 1324.

• 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. Myriad, 133 S.Ct. at 2113.

• Claim 2 asserts a sequence of cDNA that codes those amino acids.

• Method claims - Myriad, 689 F.3d at 1333-37.• Methods of “comparing” and “analyzing” BRCA sequences• Method of screening potential cancer therapeutics via “changes

in cell growth rates of transformed cells.”

Myriad Threatens Lawsuit, Gets Hit with Preemptive Strike

• 1998-99: Myriad sends cease-and-desist letters to U. of PA’s Genetic Diagnostic Laboratory (“GDL”), claiming that GDL’s BRCA1/2 diagnostic services for women violated Myriad’s patents. Sends similar letter to Dr. Harry Ostrer, NYU researcher. Ostrer had sent patient samples to GDL for testing. Myriad, 689 F.3d at 1314-15.

• Sept. 1999: GDL informs Dr. Ostrer that GDL can no longer accept patient samples for BRCA testing, due to Myriad’s threats. This made Myriad the only provider of such services in the U.S. Id. at 1315.

• 2009: Dr. Ostrer, other researchers, and the ACLU file a declaratory judgment action vs. Myriad, alleging that 15 claims in 7 Myriad patents were invalid as drawn to patent-ineligible matter under § 101.

Procedural History and Judicial Rulings

2010: U.S. District Ct. for Southern District of NY: Invalidates all of Myriad’s challenged claims under § 101.

Myriad files appeal

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.

Researchers file petition for Supreme Court review

2012: Supreme Court of the United States: Grants the petition, agreeing to review the Federal Circuit’s decision.

The Supreme Court’s Decision

• Authored by Justice Clarence Thomas

• “Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Myriad, 133 S.Ct. at 2117.

• Issued by the Court on June 13, 2013

• Unanimous decision – no dissenting opinions

• “[E]xtensive effort alone is insufficient to meet the demands of § 101.” Id. at 2117.

• “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.” Id.

The Supreme Court’s Decision

• “cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments.” Myriad, 133 S.Ct. at 2119.

• “[T]he lab technician unquestionably creates something new when cDNA is made.” Id.

• “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.” Id. (emphasis added).

The Aftermath of the Supreme Court’s Myriad Decision

Thousands of Unexpired Genomic DNA Patents Vulnerable to Invalidity Attack . . .

• “It is estimated that the PTO has issued 2,645 patents claiming ‘isolated DNA’ over the past [29] years . . . and by 2005, had granted 40,000 DNA-related patents relating to, in non-native form, genes in the human genome.” Myriad, 689 F.3d at 1333.

• “Existing patents that claim only isolated genes are ‘probably pretty worthless’ now, according to Thomas Engellenner of Pepper Hamilton LLP, but the ruling did not broadly foreclose any patents involving genes, leaving applicants plenty of options.” Davis, Ryan, “High Court’s Ruling Will Spur Novel Patent Claims,” LAW360 (June 13, 2013).

. . . But Door to DNA Patents Not Totally Closed . . .

“Leaving the door open to other types of claims ensures that patent protection will remain available for inventions involving natural products that cannot themselves be patented, according to Dalila Argaez Wendlandt of Ropes & Gray LLP.

‘The Myriads of the world still have the incentive to do this research because there are other types of claims that are still out there,’ she said.

The thousands of patents that have already been issued on isolated DNA are now vulnerable to invalidation, but many of them may include the types of claims that the Supreme Court found acceptable, [Mark] Janis said.” Davis, R., supra.

. . . But Just How Narrow Might that Opening Be?

“[T]he [Supreme] Court well understood that isolated DNA could encompass synthetic DNA, as the lower court opinion made clear.”

* * *For these reasons, this court concludes that Plaintiffs are incorrect in contending that the [Supreme] Court found all synthetic DNA to be patent eligible. Rather, this court interprets [Myriad] to stand for the proposition that even synthetic, non-cDNA , isolated DNA is patent ineligible where it reflects the same nucleotide sequence as the genomic DNA.”

In re BRCA1- and BRCA2, 2014 U.S.Dist.LEXIS 31345, at *140.

USPTO Memo to its Examiners – March 4, 2014

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ANY QUESTIONS?

THE END