Bits and Bytes No. 128: BRCA Gene Patents

• Patentable Subject Matter During Prosecution: The PTO has asked for public comments on its interim examination instructions for evaluating patent subject matter eligibility. [PTO Request][Patently-O Discussion]
• Breast Cancer Gene Patent Challenge:
  • The ACLU, PUBPAT, and others continue their fight against patents covering the breast cancer genes BRCA1 and BRCA2 held by Myriad and the University of Utah. The federal lawsuit argues (1) that the genes should not be patentable as "products of nature" and (2) that the patentee's use of patent rights to limit scientific research on the genes violates constitutional First Amendment protections.
  • A key to ACLU's argument is to look at what the patent prevents – i.e., making or using the isolated gene. The organization argues that "human genetic sequences and the scientific inquiry of looking at a gene or comparing two human genes constitute natural phenomena, laws of nature, and abstract ideas and thus are not patentable subject matter under 35 U.S.C. § 101.
  • The First Amendment argument has some merit because of the Supreme Court's penchant for sharing principles between patent and copyright law. In copyright law, the idea-expression dichotomy is often used to ensure that First Amendment rights are protected. See Harper & Row v. Nation, 471 U.S. 539, 555-560 (1985). In patent law, the ACLU argues that "there can be little doubt that patenting of abstract ideas or thought or an entire body of knowledge would violate the First Amendment" protections of freedom of thought and speech. There are many interesting issues here – one in particular is a question of whether the bare patent could create a first-amendment violation, or does it also require aggressive enforcement.
  • Downside of eBay: Unfortunately, the cancer cells continue to ignore Myriad's repeated warnings to stop making and using the gene. [joke]
  • Links: [ACLU Discussion][ACLU Summary Judgment Motion][Sarnoff's Discussion][Holman's Discussion]