Natural Substance Patents

1. Natural Substance Patents Patent Law Prof Merges 8.30.04

2. Themes for today • “Purified and isolated” claims • § 101 Issues • Practical advantages • Plant-specific Acts • Relationship to “utility” patents • Consequences of utility patents

3. Jokichi Takamine

4. 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.

5. 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.

6. 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

7. Takamine: The Legend

8. Takamine’s patents • ‘176 Product patent • Why was this valuable? • Why not a process patent (see Chakrabarty) • See p. 98

9. 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

10. Judge Hand’s Decision

11. 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. 99

12. Hand’s Pragmatism • “Practical differences” Vs. • “Scholastic distinctions”

13. Critiques “Reinventing the double Helix: a novel and nonobvious reconceptualization of the biotechnology patent” • 55 Stanford Law Review 303 (2002); Demaine, Linda J. Fellmeth, Aaron Xavier

14. Demaine and Fellmeth In the current patent law, then, there is an important and rarely discussed lacuna. Courts have failed to interpret the Patent Act in a manner that captures the prerequisite of human ingenuity to patentability where the claimed product is based on a newly discovered, natural substance. It is inappropriate,however, to examine whether the other, more often discussed, requirements of patentability, such as novelty, utility, and nonobviousness, are satisfied before properly determining that applicants are claiming more than a trivial modification of a natural substance.

15. 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.

16. J.E.M. Ag Supply v. Pioneer Hi-Bred • Plant-specific patent acts • Expressio unius/exclusio alterius? • Practical consequences • PVPA/PPA Filings • Farmers • Industry

17. PPA/PVPA Pioneer Hi-Bred Patents

18. “Expressio Unius/Exclusio Alterius” All Utility Patents PPA/PVPA

19. Recent Research - Example Research Confirms Benefits of Potato Leafhopper Resistant Alfalfa Varieties DES MOINES, IOWA., Aug. 10, 2004 - Alfalfa growers no longer need to question the yield performance of potato leafhopper (PLH) resistant varieties compared to standard susceptible varieties. New research from The Ohio State University shows the yield gap has been closed thanks to genetic advances of new PLH resistant varieties. Additional management advantages of highly resistant varieties include less worry about scouting or the accurate timing of insecticide application.

20. Practical impacts • Reduction in PVPA filings? • Reduction in PPA Filings? • “Power” issues in agriculture • Part of a larger story!