Biotechnology · Legal News · Patents

NIH Stem Cell Injunction Vacated by the U.S. Court of Appeals for the D.C. Circuit

The federal government can continue funding research using human embryonic stem cells, the U.S. Court of Appeals for the D.C. Circuit ruled today, reversing a lower court injunction against the National Institutes of Health.

Two scientists who work with adult stem cells sued NIH to stop embryonic stem cell research, charging that revised 2009 guidelines violated the 1996 Dickey-Wicker Amendment that bars federal funding for research in which a human embryo is destroyed.

This ruling is hailed by scientists as a victory for medical progress.

Stem cells from embryos are believed to hold great promise for treating hard-to-treat illnesses or conditions, such as Parkinson’s disease or spinal cord injuries. But the research itself remains controversial because it makes use of cells from early-stage embryos.

“I am delighted and relieved to learn of the decision,” said Dr. Francis Collins, director of the National Institutes of Health. “This is a momentous day — not only for science, but for the hopes of thousands of patients and their families who are relying on NIH-funded scientists to pursue life-saving discoveries and therapies that could come from stem cell research.”

In August, Judge Royce Lamberth granted their motion for a preliminary injunction, concluding they were likely to succeed at trial. Judge Royce Lamberth surprised scientists by ordering a temporary halt to new research grants. He said this funding appeared to violate a 15-year-old congressional ban on using federal money for research in “which embryos are destroyed.”

Since 1999, the NIH had interpreted this ban more narrowly. Its lawyers said stem cells are not “embryos.” No federal funds may be used to destroy embryos while extracting stem cells, they said, but the funds may be used for research on stem cells that already exist.

The U.S. court of appeals in Washington, which blocked Lamberth’s injunction while it considered an appeal, called this an “entirely reasonable” interpretation of the law. And when in doubt, the judges say they defer to an agency’s long-standing view. The 2-1 decision reversed Lamberth and said the research funding may continue.

Several states, including California, Connecticut, Illinois and Maryland, have used their own money to fund embryonic stem cell research. But leaders in those states say steady federal funding is important.

For more information on issues related to stem cell research and biotechnology patents, please feel free to mail us at rd (at) patentbusinesslawyer (dot) com.

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