[Ip-health] Following KEI request for investigation, Cold Spring Harbor Labs says 7 patents require correction to disclose federal funding

James Love james.love at keionline.org
Fri Oct 20 06:12:45 PDT 2017

We are waiting for a letter from the NIH on the Cold Spring Harbor
Labatory/Spinraza patent disclosures, but apparently the NIH has done an
investigation, and Cold Spring Harbor has corrected its none disclosure on
several patented inventions.   The Cold Spring Harbor Lab corrections were
made after the KEI letter to the NIH.



Following KEI request for investigation, Cold Spring Harbor Labs says 7
patents require correction to disclose federal funding


* After KEI filed a complaint with the NIH, Cold Spring Harbor Laboratory
(CSHL) corrected a failure to disclose funding of at least 7 patented
inventions, including one patent for the drug Sprinraza.

* Since 2012, when federal funding was relevant to an invention, CSHL
failed to make a disclosure on a filed patent more than half the time.

Cold Spring Harbor Laboratory (CSHL) is a private, nonprofit institution,
focusing today on cancer, neuroscience, plant genetics, genomics, and
quantitative biology. Tracing its history to the founding of a lab in 1890,
the storied history of the institution includes a role promoting eugenics
and limitations on immigration a century ago. In more recent years, CSHL
has been an important center for medical research, employing 600
researchers, and has employed eight scientists who have been awarded the
Nobel Prize in Physiology or Medicine, including James Watson, who directed
the institution and later served as President and then chancellor until

In January 2017, KEI asked the Department of Health and Human Services to
investigate a failure to disclose federal government funding for two
patents listed in the FDA Orange Book for the drug nusinersen, marked by
BioGen under the tradename Spinraza for the treatment of spinal muscular
atrophy, a rare and often fatal neuromuscular disorder. (More here)

The initial price of Spinraza was $125,000 per injection, and had cost of
$750,000 for the first year of treatment, and $375,000 for maintenance
doses. The FDA Orange Book listed four patents. Two of the patents were
assigned to the University of Massachusetts, and declared federal funding
on the patent. Two patents were assigned to CSHL and Isis Pharmaceuticals
(now known as Ionis Pharmaceuticals), and neither one had disclosed federal

Following the KEI complaint to HHS, CSHL filed an amendment to the patent
application, and received a “certificate of correction” for patent
8,361,977, disclosing NIH grants GM42699 and NS041621, and government
rights in the invention. No such amendment has been issued for the second
patent, 8,980,853, even though the patents share two inventors and the same
subject matter.

The NIH has been handling the investigation into the failure to disclose,
and it appears to have led to a larger review. KEI has identified seven
different CSHL patents that were granted certificates of correction on
federal funding since the KEI letter was sent in January of 2017.

The NIH identifies 13 patents granted to CSHL since 2012 that the NIH
itself says benefited from NIH funding. Of these 13 patents, CSHL had
originally disclosed federal funding on 6 patents.

>From May to August of this year, CSHL was issued certificates of correction
that provided disclosures of federal funding for 7 additional patents.

  ... there is a table in the web page version

James Love.  Knowledge Ecology International
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love

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