Chapter 7.E.4 Intellectual Property and the Ownership of Genetic Discoveries

Notes on Ownership

2. Developments in the United States, Canada, and Internationally.

For European developments, see Laura Bonetta, European Stem Cell Patents: Taking the Moral High Road?, 132 Cell 514 (2008), Joshua Whitehill, Note: Patenting Human Embryonic Stem Cells: What Is So Immoral?, 34 Brook. J. Int’l L. 1045 (2009), and Adam Inch, The European Patent Convention: A Moral Roadblock to Biotechnological Innovation in Europe, 30 Hous. J. Int’l L. 203 (2007).

3. Human Gene and Stem Cell Patents.

On March 29, 2010, a federal district court in New York struck down patents on two genes relating to breast and ovarian cancer held by Myriad Genetics. Ass’n for Molecular Pathology v. U.S. Patent and Trademark Office, 2010 WL 1233416 (S.D.N.Y.). The court held that the patents were “improperly granted” because they involved a “law of nature.” Judge Invalidates Human Gene Patent, http://www.nytimes.com/2010/03/30/business/30gene.html. The case, often referred to by the name of the patent holder Myriad Genetics, is on appeal to the Federal Circuit Court of Appeals. If the decision is upheld, there could be significant repercussions, as the patents were similar to thousands of other genetic patents, and 20% of the human genome is currently patented. Id. See also, Aaron S. Kesselheim & Michelle M. Mello, Gene Patenting—Is the Pendulum Swinging Back?, 362 N. Eng. J. Med. 1855 (2010)(discussing implications of the Myriad Genetics decision). The Federal Circuit court’s decision in the appeal will be influenced by the Supreme Court’s recent decision in Bilsky v. Kappos, 130 S.Ct. 3218 (2010). See, William J. Simmons, Bilski v. Kappos: The US Supreme Court Broadens Patent Subject-Matter Eligibility, 28 Nature Biotech 801 (2010) (discussing implications of Bilsky for biotechnology patent cases).

Attempts to patent human genes may also fail for obviousness. See, e.g., In re Kubin, 561 F.3d 1351 (C.A. Fed. 2009).

For important new scholarly commentaries on human gene and stem cell patents, see Symposium, Who Owns Your Body?, 84 Chicago Kent L. Rev. 3-224 (2010); David E. Winickoff et al., Opening Stem Cell Research and Development: A Policy Proposal for the Management of Data, Intellectual Property, and Ethics, 9 Yale J. Health Pol’y, L. & Ethics 52, 59 (2009); Christopher M. Holman, Trends in Human Gene Patent Litigation, 322 Science 198 (2008).

New Note 3.5. Patenting Chimeras.

“Chimeras” in mythology were a combination of three different animals. Modern day chimeras are combinations of two or more different species. The U.S. Patent Office rejected a patent application for a human-animal chimera in 2005, citing among other things, the 13^th Amendment prohibition against slavery. See Mary Ann Liebert, No Patent on Embryonic Human-Animal Chimera, 24 Biotechnology L. Rep. 290 (2005). For more recent developments, see Ryan Hagglund, Patentability of Human-Animal Chimeras, 25 Santa Clara Computer & High Tech. L.J. 51 (2008); Gregory R. Hagen & Sébastien A. Gittens, Patenting Part-Human Chimeras, Transgenics and Stem Cells for Transplantation in the United States, Canada, and Europe, 14 Rich. J.L. & Tech. 11, 16 (2008).

Problem: Patenting Human Genes

See generally, Symposium, Who Owns Your Body?, 84 Chicago Kent L. Rev. 3-224 (2010).