Patent Law Prof. Merges

1. Patent LawProf. Merges Intro to Section 101 1.15.08

2. Main Themes • Living Subject matter • Therapeutic correlations • Intro to Software and business methods

3. Chakrabarty: Questions • 1. Why are “discovered” things not patentable? • 2. Why are newly discovered laws of nature not patentable?

4. Chakrabarty (cont’d) • 3. Why isn’t Chakrabarty’s invention just a newly discovered law of nature? • 4. Why don’t the Plant Patent Act and the PVPA show that Congress assumed living things to be unpatentable?

5. Chakrabarty (cont’d) • 5. Why is this decision so important if Chakrabarty could have obtained process claims anyway? • 6. Would a cloned human be patentable under this decision? How broad is this holding?

6. Page 72 “Congress thus recognized that the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions.”

7. Thesis/antithesis The Committee Reports accompanying the 1952 Act inform us that Congress intended statutory subject matter to “include anything under the sun that is made by man.” S. Rep. No. 1979, 82d Cong., 2d Sess., 5 (1952) . . . -- casebook p. 70

8. This is not to suggest that § 101 has no limits or that it embraces every discovery. The laws of nature, physical phenomena, and abstract ideas have been held not patentable.

9. 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 = mc2; nor could Newton have patented the law of gravity. Such discoveries are “manifestations of . . . nature, free to all men and reserved exclusively to none.”

10. Lab Corp of America v. Metabolite Labs, Inc.

11. Metabolite v. Lab Corp. Am. 13. A method for detecting a deficiency of cobalamin or folate in warmblooded animals comprising the steps of: assaying a body fluid for an elevated level of total homocysteine; and correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate. ’658 patent, col. 11, ll. 58-65.

12. The ’658 patent claims methods for detecting cobalamin or folate deficiency. Cobalamin and folate are both B vitamins, commonly known as B12 and folic acid, respectively. A deficiency in these vitamins can cause serious illnesses in humans, including vascular disease, cognitive dysfunction, birth defects and cancer. If detected early enough, however, vitamin supplements readily treat the deficiency.

13. Because these B vitamins assist in metabolizing the amino acid homocysteine, scientists directly or indirectly assay homocysteine to screen for cobalamin and folate deficiency.

14. Proceedings below The jury found that LabCorp breached its license agreement with Metabolite, that LabCorp willfully infringed the ’658 patent, and that the claims at issue are not invalid. The jury assessed damages against LabCorp of $3,652,724.61 for breach of contract and $1,019,365.01 for infringement. . . . In light of the finding of willfulness, the district court doubled the jury’s infringement award to $2,038,730.02.

15. “The correlating step is a simple conclusion that a cobalamin/folate deficiency exists vel non based on the assaying step.” – 370 F.3d at 1367.

16. Supreme Court • Drafted its own cert question: “First, measure the level of the relevant amino acids using any device, whether the device is, or is not, patented; second, notice whether the amino acid level is elevated and, if so, conclude that a vitam in B deficiency exists. Is the patent invalid because one cannot patent “laws of nature, natural phenomena, and abstract ideas”?

17. Official disposition • Writ of certiorari dismissed as improvidently granted.

18. Breyer et al. dissent • “laws of nature, natural phenomena, and abstract ideas” excluded from § 101 • “[T]he reason for the exclusion is that sometimes too much patent protection can impede rather than “promote the Progress of Science and useful Arts” . . . . Casebook p. 100

19. Metabolite v. Lab Corp. Am. 13. A method for detecting a deficiency of cobalamin or folate in warmblooded animals comprising the steps of: assaying a body fluid for an elevated level of total homocysteine; and correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate. ’658 patent, col. 11, ll. 58-65.

20. Back to claim 13 • because the natural relationship between homocysteine and vitamin deficiency was now well known, such “correlating” would occur automatically in the mind of any competent physician . . .

21. But one can reduce any process to a series of steps. The question is what those steps embody. And here, aside from the unpatented test, they embody only the correlation between homocysteine and vitamin deficiency that the researchers uncovered. In my view, that correlation is an unpatentable “natural phenomenon,” and I can find nothing in claim 13 that adds anything more of significance. . . . -- casebook p. 105

22. Natural substance patents • “Purified and isolated” claims • § 101 Issues • Practical advantages

23. Jokichi Takamine Jokichi Takamine was born on November 3, 1854 in Takaoka, Japan. His father, Seichi, was a physician like many of his ancestors in the Takamine family. Unlike his contemporaries, Takamine learned English at an early age. He attended schools in Osaka, Kyoto, and Tokyo, graduating from the college of science and engineering at the University of Tokyo in 1879. That year the Japanese government selected Takamine as one of 12 scholars to pursue graduate studies in Scotland at Glasgow University and at Anderson College. He returned to Japan in 1883 and joined the department of agriculture and commerce.

24. Takamine (cont’d) In 1884 Takamine made his first trip to the United States to attend a Cotton Centennial Exposition, where he met his future wife, Caroline Field Hitch. They married in 1884 and had two children. The family moved to Japan, and continued to work for the department of agriculture and commerce as chief of the division of chemistry until 1887. At that time he formed his own company, the Tokyo Artificial Fertilizer Company, where he later isolated a starch-digesting enzyme, Takadiastase, from a fungus.

25. Takimine (cont’d) In 1894 Takamine moved permanently to United States, settling in New York City. He opened his own private laboratory but allowed Parke, Davis & Company to produce Takadiastase commercially. In 1901 he isolated and purified the hormone adrenalin in his laboratory, becoming the first person to accomplish this for a glandular hormone. --- Am Chem Soc’y, J. Chem Ed Online

26. Takamine’s patents • ‘176 Product patent • Why was this valuable? • Why not a process patent (see Chakrabarty) • See p. 107

27. What is the value of a product patent? • Mulford used a different process to precipitate out the final adrenaline product • Might not have infringed a detailed process patent if Takamine had claimed narrowly • See p. 107

28. Takamine’s patents (cont’d) • ‘177 Patent • “Salt” (acid) form of isolated hormone • Why not at issue here? • Why claim it? • How could it have been valid? • Prior art

29. Hand’s decision “While it is of course possible logically to call this a purification of the principle, it became for every practical purpose a new thing commercially and therapeutically.” -- p. 108

30. Hand’s Pragmatism • “Practical differences” Vs. • “Scholastic distinctions” -- p. 108

31. Two additional points • Evidence of patentability: Takamine’s product displaced the prior products • “I cannot stop without calling attention to the extraordinary condition of the law which makes it possible for a man without any knowledge of even the rudiments of chemistry to pass upon such questions as these . . . .” -- p. 109

32. Demaine and Fellmeth (cont’d) Science, Vol 300, Issue 5624, 1375-1376 , 30 May 2003 The challenge is to craft a test to distinguish products of nature from patentable inventions. A parsimonious solution is a variant of the "substantial transformation test“ (STT) used in customs law, in which a product is considered to have undergone a substantial transformation when it has a "new and distinct name, character, or use.“ Because name is highly mutable, the real focus of the test is a change of character or use.

33. Recent Commentary • Eileen M. Kane, Splitting the Gene: DNA Patents and the Genetic Code, 71 Tenn. L. Rev. 707, 707 (2004) By scientific and historical criteria, the genetic code can be characterized as a law of nature and as an essential component of the public domain in molecular biology. The Article concludes that the patenting of genes results in constructive preemption of the genetic code, a result that is contrary to the Supreme Court's dictate that the laws of nature are not patentable. This outcome undermines the legitimacy of genes as patentable subject matter.

34. In re Comiskey Claim 1: A method for mandatory arbitration resolution regarding one or more unilateral documents comprising the steps of: • enrolling a person and one or more unilateral documents associated with the person in a mandatory arbitration system at a time prior to or as of the time of creation of or execution of the one or more unilateral documents;

35. incorporating arbitration language, that is specific to the enrolled person, in the previously enrolled unilateral document wherein the arbitration language provides that any contested issue related to the unilateral document must be presented to the mandatory arbitration system, in which the person and the one or more unilateral documents are enrolled, for binding arbitration wherein the contested issue comprises one or more of a challenge to the documents, interpretation of the documents, interpretation or application of terms of the documents and execution of the documents or terms of the documents;

36. requiring a complainant to submit a request for arbitration resolution to the mandatory arbitration system wherein the request is directed to the contested issue related to the unilateral document containing the arbitration language; • conducting arbitration resolution for the contested issue related to the unilateral document in response to the request for arbitration resolution;

37. providing support to the arbitration; and determining an award or a decision for the contested issue related to the unilateral document in accordance with the incorporated arbitration language, wherein the award or the decision is final and binding with respect to the complainant.

38. “Product” or system claims Claim 17: A system for mandatory arbitration resolution regarding one or more unilateral documents comprising: • a registration module for enrolling a person . . . ; • an arbitration module . . .

39. Comiskey, 499 F.3d at 1374 State Street Bank explicitly held that business methods are “subject to the same legal requirements for patentability as applied to any other process or method.” Id. at 1375. We must then consider the requirements of § 101 in determining whether Comiskey's claims 1 and 32 for a method of mandatory arbitration for unilateral and contractual documents claim statutory subject matter.