Clinical OMICS

JUL-AUG 2019

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

Issue link:

Contents of this Issue


Page 47 of 51

46 Clinical OMICs July/August 2019 Whose Genes Anyway? Congressional action on Section 101 of U.S. patent law could reopen path to patenting genes By Chris Anderson I n early-to-mid June, the Intellectual Property Subcommit- tee of the U.S. Senate Judiciary Committee held three days of hearings on proposed legislation to reform Section 101 of the U.S. Patent Act. The hearings are the latest step in a pro- cess that began late in 2017 as a series of roundtable discus- sions with legal experts, trade groups, biotechs, and other technology companies intended to examine whether Section 101 is hindering commercial investment due to uncertainty in its interpretations by the courts. The draft legislation was released in late May by Senators Chris Coons (D-Del.) and Thom Tillis (R-N.C.), the rank- ing member and chair, respectively, of the Senate Judiciary Committee's intellectual property subcommittee, along with Rep. Doug Collins (R-GA), the ranking member of the House Judiciary Committee, Sen. Hank Johnson (D-GA), and Sen. Steve Stivers (R-OH). Proponents of the leg- islation argue that rulings by both the U.S. Supreme Court and lower courts have created significant uncertainty about patent enforcement which is sti- fling innovation, invest- ment, and the development of potentially life-saving drugs and other technolo- gies. Opponents of the draft legislation point to there being more innovation in the field than ever before, and further, that the patent laws as cur- rently applied have promoted competition and innovation, and benefited healthcare consumers via lower prices. Among the handful of decisions by the U.S. Supreme Court that proponents contend established precedent and prove the patent statute as currently written and interpreted is the 2013 ruling in The Association for Molecular Biology v. Myriad Genetics, which threw out Myriad's patents for the BRCA1 and BRCA2 genes. Kate Ruane, senior legislative counsel of the American Civil Liberties Union (ACLU), testified before the subcom- mittee that rewriting the patent statute would once again open the door for companies to patent specific genes. It was the ACLU that originally brought the lawsuit against Myr- iad on behalf of 20 other plaintiffs. "We argued that human genes are products of nature and that genes and other naturally occurring matter and rela- tionships should never be granted to anyone as intellectual property," Ruane said in her testimony before the Subcom- Sean George, CEO, Invitae Steve Heap / Alloy / Getty Images

Articles in this issue

Links on this page

Archives of this issue

view archives of Clinical OMICS - JUL-AUG 2019