Patentable Subject Matter

1. Patentable Subject Matter Prof Merges 1.10.12

2. Agenda • Current § 101 Controversies • Intro to patentable subject matter • Chakrabarty and Parke-Davis

3. Supreme Court • Mayo Collaborative Services v. Prometheus Laboratories, Inc., Supreme Court, No. 10-1150; decision below, 581 F.3d 1336 (Fed. Cir. 2009) • Oral argument: Dec. 7, 2011 • Summary at PatentlyO blog, Dec. 8, 2011

4. Patent in Prometheus • Medical correlation or observation • Process: “Step 1: Measure X. Step 2: If level below __, administer drug. If level above __, decrease drug dosage.”

5. Purified gene patent case • Association for Molecular Pathology v. U.S. Patent and Trademark Office, 653 F.3d 1329 (Fed. Cir. 2011) • Questions Presented: 1. Are human genes patentable? • Cert petition filed 12/7/2011

6. Introduction to the Patent System • Quick history: see casebook • Purpose of system: “to promote the progress of science and the useful arts” • Importance of claims in understanding how patents work

7. Basic patent procedure • File for patent in Patent and Trademark Office (PTO) • Examiner assigned to application; 2-4 year process to obtain patent (on average) • Final rejections can be appealed to administrative board in PTO

8. Court review of PTO • Can appeal adverse ruling of PTO Board of Appeals to an appellate court • Before 1982: Court of Customs and Patent Appeals (CCPA) • 1982 and after: US Court of Appeals for the Federal Circuit (unified patent appeals court)

9. Who is Chakrabarty? • Ananda Chakrabarty, PhD is a distinguished professor of microbiology and immunology at the University of Illinois College of Medicine. His most notable creation is a biology-based solution for cleaning up toxic spills using the generically engineered Pseudomonas (today classified as Burkholderia cepacia or B. cepacia).

10. Ananda Chakrabarty

12. Chakrabarty: Claims • Process claims • “Inoculum” including a carrier (combination claim) • “the bacteria themselves”

13. Chakrabarty Claims: p. 129 1. A bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.

15. Chakrabarty • How many different types of claims?

16. Chakrabarty • How many different types of claims? • WHY?

18. Chakrabarty • Process claims – never a problem • Why not? • Process comprising steps of (1) , (2), (3), where (2) involves living subject matter

19. Combination claims • “An inoculum” . . . • Also allowed • Why?

20. Combination claims

21. SUBJECT MATTER § 101 Inventions Patentable 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.

22. Subject Matter: Overview § 101 Categories • Process • Machine • Manufacture • Composition of Matter • Improvements

23. History of Section 101 • 1793 Act – “authored by Thomas Jefferson” -- ? • Edward C. Walterscheid, The Use and Abuse of History: The Supreme Court’s Interpretation of Thomas Jefferson’s Influence on the Patent Law, 39 IDEA 195 (1999).

24. Section 101 Categories in Chakrabarty • Manufacture • Composition of Matter • “chemical union or mechanical mixture”

25. The now-famous punch-line • Legislative history  statutory language, 1952 Act • “Anything under the sun that is made by [humans]”

26. What are the limits? • Laws of nature • Physical phenomena • Abstract ideas

27. The Court’s examples of unpatentable things “a new mineral discovered in the earth, or a new plant found in the wild” Einstein’s “law” (E=mc2) Newton’s law of gravitation

28. How is Chakrabarty’s oil-eating bacterium different? • “His claim is not to a hitherto unknown natural phenomenon, but to a nonnaturally ocurring manufacture or composition of matter – a product of human ingenuity . . .”

29. Contrast (?) with Kalo • Combining species into convenient plant-root inoculant • How is this different from Chakrabarty’s invention?

30. What are the limits? • “not nature’s handiwork, but his own” • How does this limit the scope of patent law? • Is it predictable? Too open-ended?

31. Counter-arguments • Plant-specific Acts • Congress should make IP policy, not the courts

32. What about plant-specific Acts? • Implicit argument: • Expressio unius/exclusio alterius?

33. Utility Patents PPA/PVPA Chakrabarty Patent

34. Utility Patents PPA/PVPA X Chakrabarty Patent

35. “Expressio Unius/Exclusio Alterius” All Utility Patents PPA/PVPA Chakrabarty Patent

36. Second argument: Congress ought to make policy • History of patents on living subject matter • Comparative Institutional Competence

37. The Life Sciences and § 101 • A Brief history • Plant-specific acts, 1930 & 1970 • Early biotech – 1973-1980 • Early animal modification: Ex parte Allen, 1987 • Gene patents: 1990-today • Gene therapy: mid-1990s-today • Dolly the sheep: late 1990s • Stem cell research: late 1990s-today

38. Commoncouragepress.com

39. Somebody owns your genes. Through the U.S. patent system, corporations and universities have claimed property rights not just on the rice and corn at your dinner table but also on you. Moving beyond patenting and "owning" diseases like staph, tuberculosis, and SARS, one American corporation owns the genetic heritage of the entire population of Iceland. A university has property rights on all human clones-even though human cloning is still being debated in Congress. Another company claims to have invented "junk" DNA. Through its patents, it stakes a claim to the research on 95% of human DNA.

40. Though we are only at the earliest stage of the establishment of patent monopolies over genes, cell lines, and even organisms, the current struggle over access to AIDS drugs is a harbinger of problems ahead. AIDS drug costs are a clear example of the use of patent monopolies to drive up the price of therapy.

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

42. Jokichi Takamine

43. Jokichi Takamine Jokichi Takamine was born on November 3, 1854 in Takaoka, Japan. He graduated 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.

44. Takamine (cont’d) He worked 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.

45. 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

46. Takamine: The Legend

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

48. Takamine’s patents (cont’d) • ‘177 Patent • “Salt” (acid) form of isolated hormone • Usually “salt” is applied to an ionic compound produced by reacting an acid with a base. • Why not at issue here? Claims were amended during prosecution. • How could it have been valid? • Prior art

49. Judge Hand’s Decision

50. 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.”