Orrick, Herrington & Sutcliffe, LLP

1. Orrick, Herrington & Sutcliffe, LLP What Role Does/Should IP Play in the GM Food Debate? Elizabeth A. Howard

2. Common Misconception #1: Patenting Genetically Modified Crops • Patents to genes and DNA sequences confer rights to what already exists in nature.

3. Patenting Genetically Modified Crops What the patent laws actually protect: • Patents are not granted to genes as they exist in nature • Patents may be granted to genes in man-made compositions e.g. isolated DNA sequences.

4. Not Protectable by Patent: Nature, Physical Phenomena, Abstract Ideas Products of nature are not protectable by patent, even “[a] hitherto unknown phenomenon of nature” - Funk Bros. Co. v. Kalo Co. 499 U.S. 340 (1948)

5. What is Protectable: “anything under the sun that is made by man.” - Diamond v. Chakrabarty, 447 U.S. 303 (1980)

6. Purification of a naturally occurring compound or organism may render it patentable: • a biologically pure culture of Streptomyces was held not a “product of nature” and hence patentable subject matter. - In re Bergy, 563 F.2d 1031 (1977) • purified prostoglandins PGE and PGF, naturally occurring in prostate glands, have been held to be patentable subject matter. - In re Bergstrom, 427 F.2d 1394 (CCPA 1970)

7. Not patentable: “a DNA sequence consisting essentially of a DNA sequence encoding human erythopoietin” Patentable: “a purified and isolated DNA sequence encoding human erythopoeitin.” - Amgen, Inc. v. Chugai Pharmaceutical Co.,13 U.S.P.Q. 2d 1737 (D. Mass. 1989).

8. Patenting Genetically Modified Crops Common Misconception #2: • A patent confers ownership rights

9. Patenting Genetically Modified Crops What the patent right actually confers: The right to exclude others from making, using, offering to sell, selling or importing the patented invention.

10. Patenting Genetically Modified Crops What the patent right does not confer: The right to exclude others from making, using, offering to sell, selling or importing unpatented technologies. The right to exclude use of the patented technology in a country in which the patent has not issued.

11. The Extent of IP Protection for Genetically Modified Crops in the United States

12. Extent of Genetically Engineered Crops in the United States

13. % Total US Acreage in Genetically Engineered Crops in the United States Transgenic Crop % total US acreage GE soybeans 84% GE cotton 76% GE corn 45%

14. Impact of IP for GE Crops in the U.S. • Stimulates investment and innovation • Encourages cross-licensing

15. What is the Global IP Story? • Traditionally widely variable • GATT Agreement on Trade-Related Aspect of IP Rights (TRIPs) intended to provide uniformity: • Article 27 (patentable subject matter – inventions must be new, involve inventive step, capable of industrial application) • Article 41 et seq. provides for enforcement of IP rights

16. What is the Effect of Weak IP on Promoting Innovation? • Local companies reluctant to set up research facilities • Leaves funding of local research to public funding sources

17. What is the Effect of Weak IP on Technology Transfer? • Companies reluctant to provide know-how • Particularly problematic in area of GMO, as easily copied, reproduced

18. What is the Consequence of Improved IP and IP Enforcement? • Increased prices? • Effect on quality • Effect on internally developed technology • Effect on access to external technology

19. IP Protection is Only One Step to Introduction of GM Crops • Need to overcome regulatory barriers • Need willing buyer/seller • Rules in a single country can have global effect

20. Do GM Crops Benefit Developing Countries • Effects on spoilage • Effects on yield • Effect on nutrition