Association for Molecular Pathology v. Myriad Genetics, Inc. The decision and its implications

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1 Association for Molecular Pathology v. Myriad Genetics, Inc. The decision and its implications November 1, 2013 Scott D. Miller, J.D., Ph.D. IP Counsel Leader Life Technologies Corporation

2 DNA Can Be Better Understood If You Picture Salt in a Chocolate Chip Cookie Super Microscope Capable of Seeing Individual Nucleotides Leaf Cut From a Tree Compound Isolated From Leaf Gold Extracted From the Earth Gold Made Into Earring Using Some Method Drug made by reacting known molecules Organ Taken From A Body Piece of Organ Cut From An Organ Baseball Bat Made From Tree 2 Electricity Isolating a Chromosome

AMP Challenged Select Claims to Isolated DNA Sequences And Methods for Their Use COMPOSITION CLAIMS United States Patent 5,747,282 1.

3 AMP Challenged Select Claims to Isolated DNA Sequences And Methods for Their Use COMPOSITION CLAIMS United States Patent 5,747, An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2. 5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1. United States Patent 5,837, An isolated DNA molecule coding for a mutated form of the BRCA2 polypeptide set forth in SEQ ID NO:2. 9. An isolated DNA molecule comprising at least 15 contiguous nucleotides of the DNA of claim 6. METHOD CLAIMS United States Patent 5,709, A method for detecting a germline alteration in the BRCA1 gene... 3 comprising analyzing a sequence of a BRCA1 gene or RNA...

The Evolution of a Holding District Court NY Held:

and BRCA2 gene sequences are not patent eligible;

BRCA2 sequences to correlate to disease are not

4 YRS remand Federal Circuit Supreme Court Held: We

DNA molecules are patent ineligible products of

Screening cancer therapeutics via changes in cell

decision that claims to comparing or analyzing DNA

segment is a product of nature and not patent

4 The Evolution of a Holding District Court NY Held: (1) isolated DNA containing all or portion of BRCA1 and BRCA2 gene sequences are not patent eligible; (2) methods for comparing or analyzing BRCA1 and BRCA2 sequences to correlate to disease are not patent eligible. 4 YRS remand Federal Circuit Supreme Court Held: We reverse the district court s decision that isolated DNA molecules are patent ineligible products of nature under 101. Screening cancer therapeutics via changes in cell growth rates is also patent eligible. We affirm the district court s decision that claims to comparing or analyzing DNA sequences is not patent eligible. Held: A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. cdna is patent eligible because (or to the extent) it is not naturally occurring. 4

5 35 U.S.C. 101 Inventions Patentable 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 therefore, subject to the conditions and requirements of this title. Subject to conditions = subject to 35 U.S.C. 102, 103, : The invention must be novel 103: The invention must not be obvious 112: The invention must be clearly described in writing and include at least one claim that particularly points out the invention 105: Inventions in outer space Process: series of steps Machine: a concrete thing consisting of parts or devices Manufacture: an article produced from raw or prepared materials Composition of matter: a composition of substances or composite article 5

Diamond v. Chakrabarty & Anything Under the Sun Made by Man (with Some Notable Exclusions) Anand Chakrabarty created a genetically engineered bacterium capable of breaking down crude oil.

Chakrabarty is distinguished from categories of invention that are not patent eligible: Laws/Products of Nature (e=mc 2 or naturally occurring) Natural Phenomenon (wind, gravity) Abstract Ideas (i.

6 Diamond v. Chakrabarty & Anything Under the Sun Made by Man (with Some Notable Exclusions) Anand Chakrabarty created a genetically engineered bacterium capable of breaking down crude oil. Held: Engineered bacterium is patent eligible because it has markedly different characteristics from any found in nature. Chakrabarty is distinguished from categories of invention that are not patent eligible: Laws/Products of Nature (e=mc 2 or naturally occurring) Natural Phenomenon (wind, gravity) Abstract Ideas (i.e. mental processes) Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc 2 ; nor could Newton have patented the law of gravity. -Supreme Court (Chakrabarty) 6

7 7 USPTO Saves the Day with a Flow Chart?

8 Recent Supreme Court Decisions Have Addressed The Three Exceptions Abstract Idea: Bilski v. Kappos Claim to a method for managing risk comprising applying the concept of hedging to a market transaction. Additional claim limitations (i.e. specifying the energy market) considered merely token post-solution activity. Natural Phenomenon (or Law of Nature): Mayo v. Prometheus 1. A method of optimizing therapeutic efficacy... comprising: a) administering a drug providing 6-thioguanine to a subject...; and b) determining the level of 6-thioguanine in said subject..., wherein the level...indicates a need to increase... [or] decrease the amount of said drug subsequently administered to said subject. Held: The claims do not do significantly more than simply describe the natural relation between concentration of certain metabolites and dosage amounts. To be patent eligible one must do more than simply state the law of nature while adding the words apply it. Law of Nature: AMP v. Myriad Court s decision also echoed Bilski by describing snipping DNA as token post solution activity. This creates some tension with 103 (obviousness). 8

BRCA gene is isolated product of nature cdna is not a product of nature Myriad s Contribution Was Limited (and So Is This Holding) Myriad s principal contribution was uncovering the precise location

Central to the question of patent eligibility is whether this resulted in a DNA sequence with markedly different characteristics from any found in nature.

9 BRCA gene is isolated product of nature cdna is not a product of nature Myriad s Contribution Was Limited (and So Is This Holding) Myriad s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes. Central to the question of patent eligibility is whether this resulted in a DNA sequence with markedly different characteristics from any found in nature. Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them... Myriad s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes... [However,] groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the 101 inquiry. cdna is not a product of nature, so it is patent eligible under This case, it is important to note, does not involve method claims, patents on new applications of knowledge about the BRCA1 and BRCA2 genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.

10 Everything is inside something else. Justice Breyer Salt in a Chocolate Chip Cookie Super Microscope Capable of Seeing Individual Nucleotides Compound Isolated From Leaf Gold Extracted From the Earth Baseball Bat Made From Tree If the body is somehow different, Anything that you snip out of the body and isolate is patent eligible? - Breyer Isolated Chromosome? Organ Taken From A Body? Piece of Organ Cut From An Organ? 10 Myriad attorney argued (unsuccessfully) that these examples are the same thing when removed from body while a DNA segment is not the same thing when snipped from its normal context.

the different things that patients now have as a result of this human ingenuity attorney for Myriad arguing that ingenuity consistent with patent eligibility

quality found in Amazon jungle required great ingenuity to find yet is not patent eligible Examples of Patent Eligible Subject Matter Gold made into earring

11 the different things that patients now have as a result of this human ingenuity attorney for Myriad arguing that ingenuity consistent with patent eligibility Electricity required great ingenuity yet is not patent eligible (alternatively, applications of electricity may be patent eligible) Tree leaf with medicinal quality found in Amazon jungle required great ingenuity to find yet is not patent eligible Examples of Patent Eligible Subject Matter Gold made into earring using some method Drug made by reacting know molecules 11 Patent eligible means subject to further conditions of 35 U.S.C. including novelty and nonobviousness

12 Implications for the Research Community and Industry Consumers Academics THE DECISION & THE REACTIONS 12 Law Firms Lobbyists Companies -Large -Small -Generic Investors

13 MYRIAD: Business As Usual Supreme Court "upheld its patent claims on complementary DNA, or cdna," but also "ruled that five of Myriad's claims covering isolated DNA were not patent eligible." Myriad indicated that despite the Court's decision suchisolated DNA were not patent eligible, the company still had "more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis test," and that "[i]mportantly, the Court noted that many of Myriad's unchallenged claims are method claims applying knowledge about the BRCA 1 and BRCA 2 genes." 13

14 ACLU: Diagnostic Testing is Now Patent Free The Court "unanimously invalidated patents on two genes associated with hereditary breast and ovarian cancer," which "made it difficult for women to access alternate tests or get a comprehensive second opinion about their results." Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued. The "[b]ottom line, diagnostic genetic testing is now free from any patent threat, forever, and the poor can now have their genes tested as freely as the rich." 14

15 USPTO: merely isolating DNA is not enough The United States Patent Office gave guidance to its Examiners: As of today, naturally occurring nucleic acids are not patent eligible merely because they have been isolated. Examiners should now reject product claims drawn solely to naturally occuring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter under 35 U.S.C Claims clearly limited to non-naturally-occurring nucleic acids, such as a cdna or a nucleic acid in which the order of the naturally occuring nucleotides has been altered (e.g., a man-made variant sequence), remain eligible. Other claims, including method claims, that involve naturally occurring nucleic acids may give rise to eligibility issues and should be examined under the existing guidance in MPEP 2106, Patent Subject Matter Eligibility. 15

16 Jones Day: BRCA Tests Still Patent Protected Myriad Genetics obtains Supreme Court patent victory on synthetic DNA molecules relating to its breast and ovarian cancer test The court upheld the four cdna claims, which are vital to the tests Myriad has developed for diagnosing cancer risk and used to test more than one million patients since the patents issued in the 1990s. Although the Court struck down five claims directed to isolated genomic DNA, Myriad's many other patent claims directed to methods of use and applications of what Myriad learned about the BRCA1 and BRCA2 genes are not affected by the Court's ruling on claims to isolated genomic DNA. 16

17 ACMG: Court Did Not Go Far Enough American College of Medical Genetics and Genomics, one of the plaintiffs in the suit, called the result "a thrilling victory for patients." However, a "preferred outcome would have gone even further and found that any form of a gene is not patentable because it is the information content that is naturally occurring regardless of whether its genomic or cdna." 17

18 BIO: Troubling Departure Creates Business Uncertainty The Biotechnology Industry Organization Stated that the Court's decision "offers urgently-needed certainty for research-driven companies that rely on cdna patents for investment in innovation." However, the decision "represents a troubling departure from decades of judicial and Patent and Trademark Office precedent supporting the patentability of DNA molecules that mimic naturally-occurring sequences," and "the Court's decision could unnecessarily create business uncertainty for a broader range of biotechnology inventions." 18

19 AIPLA: Weakening of Patents Hurts Scientific Research The American Intellectual Property Law Association stated that the Court "continued to cut back on the scope of technologies eligible for patent protection." The decision "may even backfire on its proponents, leading to increased secrecy in research and reduced collaboration, so critical in today's research environment." 19

20 Scalia and Science (and an odd disclaimer) Part 1-A of Supreme Court Decision: "Genes form the basis for hereditary traits in living organisms." Genes are "encoded as DNA, which takes the shape of the familiar 'double helix,'" and describes the chemical structures of DNA. "the study of genetics can lead to valuable medical breakthroughs." 20 I join the judgment of the Court, and all of its opinion except Part I A and some portions of the rest of the opinion going into fine details of molecular biology. I am unable to affirm those details on my own knowledge or even my own belief. It suffices for me to affirm, having studied the opinions below and the expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA (cdna) is a synthetic creation not normally present in nature.

21 THANKS! Scott Miller 21

Biomedical Diagnostic Patents Post Prometheus

Biomedical Diagnostic Patents Post Prometheus JPO / U.S. Bar Liaison Council Meeting June 27, 2012, Washington, D.C. Presented by Joerg-Uwe Szipl Griffin and Szipl, PC Delegate of the Virginia Bar Association