1. More on Section 101 Patent Law Prof. Merges 8.30.2012

2. Main Topics Supreme Court Prometheus Opinion AMP v Myriad – the gene patent case

3. Section 101 Orientation Recapping Bilski: what is an “abstract idea”? How does this objection to patentability relate to “laws of nature”, which is the heart of Prometheus and Myriad?

4. Story - Main Idea Plot Outline Subplots General Characters and Scenes Text Specific Character Elements Levels Of Abstraction – In © Law

5. Patents for “Abstract Ideas” Claim covers broad, general idea or concept: risk hedging in energy markets; use of an algorithm in any setting or context; correlation observed in nature Specific Application

6. More abstract: broader, more general Unpatentable under section 101 Less abstract: narrower, more specific Patentable under section 101

7. Mayo v Prometheus “Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972). And monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it.

8. [The Prometheus patent] concerns patent claims covering processes that help doctors who use thiopurine drugs to treat patients with autoimmune diseases determine whether a given dosage level is too low or too high. The claims purport to apply natural laws describing the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that the drug dosage will be ineffective or induce harmful side-effects

9. We must determine whether the claimed processes have transformed these unpatentable natural laws into patent-eligible applications of those laws. We conclude that they have not done so and that therefore the processes are not patentable.

10. Basic idea behind patents Correlation between (1) level of metabolites in the bloodstream, and (2) effectiveness of thiopurine drug against autoimmune diseases (e.g., Crohn’s disease)

12. What was the invention? At the time the discoveries embodied in the patents were made, scientists already understood that the levels in a patient's blood of certain metabolites … were correlated with the likelihood that a particular dosage of a thiopurine drug could cause harm or prove ineffective…. But those in the field did not know the precise correlations between metabolite levels and likely harm or ineffectiveness. The patent claims at issue here set forth processes embodying researchers' findings that identified these correlations with some precision.

13. More specifically, the patents—U.S. Patent No. 6,355,623 (6́23 patent) and U.S. Patent No. 6,680,302 (3́02 patent)—embody findings that concentrations in a patient's blood of 6–TG or of 6–MMP metabolite beyond a certain level (400 and 7000 picomoles per 8x10 8 red blood cells, respectively) indicate that the dosage is likely too high for the patient, while concentrations in the blood of 6–TG metabolite lower than a certain level (about 230 picomoles per 8x10 8 red blood cells) indicate that the dosage is likely too low to be effective.

15. Claim 1 “A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: “(a) administering a drug providing 6–thioguanine to a subject having said immune-mediated gastrointestinal disorder; and “(b) determining the level of 6–thioguanine in said subject having said immune-mediated gastrointestinal disorder, “wherein the level of 6–thioguanine less than about 230 pmol per 8x10 8 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and “wherein the level of 6–thioguanine greater than about 400 pmol per 8x10 8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.”

16. “A method of optimizing therapeutic efficacy, comprising: “(a) administering a drug; and “(b) determining the level of 6–T “wherein the level of 6–thioguanine less than [X] indicates a need to increase the amount of said drug subsequently administered to said subject and “wherein the level of 6–thioguanine greater than [Y] indicates a need to decrease the amount of said drug subsequently administered to said subject.”

17. [T]he claims inform a relevant audience about certain laws of nature; any additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform unpaten-table natural correlations into patentable applications of those regularities.

18. Relationship to Flook and Diehr The claim before us presents a case for patentability that is weaker than the (patent-eligible) claim in Diehr and no stronger than the (unpatentable) claim in Flook. The[] [claimed] instructions add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity, previously engaged in by those in the field.

19. “A method of optimizing therapeutic efficacy, comprising: “(a) administering a drug; and “(b) determining the level of 6–T “wherein the level of 6–thioguanine less than [X] indicates a need to increase the amount of said drug subsequently administered to said subject and “wherein the level of 6–thioguanine greater than [Y] indicates a need to decrease the amount of said drug subsequently administered to said subject.”

20. Back to the policy concern [T[here is a danger that the grant of patents that tie up the[] use [of natural laws] will inhibit future innovation premised upon them, a danger that becomes acute when a patented process amounts to no more than an instruction to “apply the natural law,” or otherwise forecloses more future invention than the underlying discovery could reasonably justify….

21. Other sections of 35 USC? Novelty, nonobviousness, enablement These are separate and distinct, not meant to to do the work of section 101 But: if these other sections are easier to apply, and give a clear answer, why not use them first?

22. Myriad The gene The patent The controversy

23. BRCA-1

24. Gene Expression  Protein

25. Relying on a large set of DNA samples from families with inherited breast and ovarian cancers, the inventors correlated the occurrence of cancer in individual family members with the inheritance of certain marker DNA sequences. This allowed the inventors to identify, or “map,” the physical location of the BRCA genes within the human genome and to isolate the BRCA genes and determine their exact nucleotide sequences. This in turn allowed Myriad to provide BRCA diagnostic testing services to women. – p. 8

27. Myriad The isolated DNA sequence can be used in genetic testing to determine whether a person carries certain alleles of the BRCA 1 or 2 gene and is thus at higher risk for breast or ovarian cancer.

28. Claim 1 of U.S. Pat. No. 5,747,282 (issued 1998) 1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO: 2.

30. Association for Molecular Pathology v. United States PTO (The “Myriad” Case) 2010 U.S. Dist. LEXIS 35418 (Apr. 5, 2010)

31. Myriad – district court Rejects Learned Hand analysis in Parke-Davis Statement re: 101 was dicta there

32. Holding In light of DNA's unique qualities as a physical embodiment of information, none of the structural and functional differences cited by Myriad between native BRCA1/2 DNA and the isolated BRCA1/2 DNA claimed in the patents-in-suit render the claimed DNA. "markedly different." This conclusion is driven by the overriding importance of DNA's nucleotide sequence to both its natural biological function as well as the utility associated with DNA in its “isolated” form.

33. . The preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition claims are directed to unpatentable products of nature.

34. Am. Fruit Growers (1931) Manufacture implies a change, but every change is not manufacture, and yet every change in an article is the result of treatment, labor, and manipulation. But something more is necessary.... There must be transformation; a new and different article must emerge having a distinctive name, character, or use.

36. Myriad in the Federal Circuit [A]lthough the parties and the government appear to agree that isolated DNAs are compositions of matter, they disagree on whether and to what degree such molecules fall within the exception for products of nature. – p. 10

37. The distinction, therefore, between a product of nature and a human-made invention for purposes of § 101 turns on a change in the claimed composition’s identity compared with what exists in nature. [Patentable:]…. compositions that human intervention has given “markedly different,” or “distinctive,” characteristics. – p. 11

38. Fed Cir Strategy Point out the significance of the isolation Chromosomes: 80 million – 110 million base pairs Genes: 80,000 bp Coding region: 10,200 bp

39. Distinguishing Parke-Davis Purified vs. merely isolated: [I]n nature, isolated DNAs are covalently bonded to such other materials. Thus, when cleaved, an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity. In fact, some forms of isolated DNA require no purification at all, because DNAs can be chemically synthesized directly as isolated molecules.

40. Dissent: Judge Bryson No to long DNA sequences

41. P. 14 It is also important to dispute the dissent’s analogy to snapping a leaf from a tree. With respect, no one could contemplate that snapping a leaf from a tree would be worthy of a patent, whereas isolating genes to provide useful diagnostic tools and medicines is surely what the patent laws are intended to encourage and protect. Snapping a leaf from a tree is a physical separation, not one creating a new chemical entity.

42. AMP – Myriad on remand Fed Cir August 16, 2012: 103 USPQ2d 1681 Opinion re-affirms original decision: “purified” gene claims are patentable under section 101

43. Holding [O]n the limited questions before us, we conclude that the composition claims and the screening claim involving growing a transformed host cell meet the standards for patent eligibility, while the claimed methods for “analyzing” or “comparing” do not. 103 USPQ2d at 1696.

44. The isolated DNA molecules before us are not found in nature. They are obtained in the laboratory and are man-made, the product of human ingenuity. While they are prepared from products of nature, so is every other composition of matter. All new chemical or biological molecules, whether made by synthesis or decomposition, are made from natural materials. For example, virtually every medicine utilized by today's medical practitioners, and every manufactured plastic product, is either synthesized from natural materials (most often petroleum fractions) or derived from natural plant materials. But, as such, they are different from natural materials, even if they are ultimately derived from them. The same is true of isolated DNA molecules.

45. Government position Middle ground: cDNAs are patentable Isolated and purified “naturally ocurring” DNA is not Degree of human intervention

46. BRCA1 and BRCA2 in their isolated states are different molecules from DNA that exists in the body; isolated DNA results from human intervention to cleave or synthesize a discrete portion of a native chromosomal DNA, imparting on that isolated DNA a distinctive chemical identity as compared to native DNA. 103 USPQ2d at 1699

47. “Information Content” [T]he patent eligibility of an isolated DNA is not negated because it has similar informational properties to a different, more complex natural material. The claimed isolated DNA molecules are distinct from their natural existence as portions of larger entities, and their informational content is irrelevant to that fact. -- 103 USPQ2d at 1700

48. From the dissent Isolating lithium using a complex process “Snapping a leaf from a tree” Not enough human intervention