[Ip-health] Gilead License on Promising Cancer Treatment Goes to Court

Claire Cassedy claire.cassedy at keionline.org
Mon Apr 23 10:53:56 PDT 2018


https://news.bloomberglaw.com/pharma-and-life-sciences/gilead-license-on-promising-cancer-treatment-goes-to-court

Gilead License on Promising Cancer Treatment Goes to Court

Posted April 20, 2018, 4:39 PM

By Greg Langlois

 -  Nonprofit group says NIH didn’t follow law when awarding exclusive
CAR-T license
 -  Gilead, Novartis charging hundreds of thousands for breakthrough cancer
treatments

The NIH didn’t follow the law in awarding Gilead Sciences Inc. a lucrative
license to a breakthrough cancer treatment technology—its second of only
three handed out so far, a new lawsuit says.

The exclusive license of a new chimeric antigen receptor T-cell (CAR-T)
therapy the National Institutes of Health granted to Gilead Sciences Inc.'s
Kite Pharma Inc. will stifle competition and likely lead to continued
“excessive” prices for a government-funded cancer treatment, an attorney
for the nonprofit organization that brought the suit told Bloomberg Law.

“The whole root of this is the fact that there’s significant amounts of
taxpayer money going every day to the research and development of new
medicines, new treatments, new medical technologies,” but no “safeguards on
excessive pricing” after products go on the market, Knowledge Ecology
International Policy and Legal Affairs counsel Andrew Goldman told
Bloomberg Law in an April 20 interview. “Taxpayer money went into this, but
on the back end, we get prices that approach half a million dollars for the
CAR-T treatments, and we don’t think that that’s fair or reasonable.”

An NIH spokesperson told Bloomberg Law the agency doesn’t comment on
pending litigation.
High Hopes, High Prices

CAR-T therapies are cutting-edge, one-time cancer treatments that involve
extracting immune-system cells from a patient, modifying them to make them
capable of attacking cancer cells, and then re-injecting them into the same
patient.

“By most accounts, CAR-T treatments are among the most important new
treatments for cancer,” Goldman said. “Immunotherapy is the new frontier
for cancer treatment.”

But only two CAR-T treatments have been approved by the Food and Drug
Administration so far, and they come at a high cost. Novartis AG priced its
Kymriah (tisagenlecleucel) leukemia treatment at $475,000, and Gilead set
Yescarta (axicabtagene), a B-cell lymphoma treatment approved in October,
at $373,000.

Knowledge Ecology International’s (KEI) April 19 lawsuit against the NIH
and its National Cancer Institute filed in a federal court in Maryland
asserts it costs as low as $15,000 to produce the treatments.

“We’re very concerned about an exclusive license of another CAR-T treatment
to Gilead, when Gilead already owns one of the other two,” Goldman said.
“And the prices for the two products on the market now are approaching
$500,000 per treatment, so there’s serious concerns about excessive prices.”
Group’s Appeal Dead on Arrival?

The NIH announced its plans to grant the exclusive license for the new
CAR-T therapy, which treats various lymphomas, in late December, and asked
for public comments by Jan. 4 of this year. KEI submitted a response
objecting to the proposed exclusivity and advocating for safeguards on
excessive pricing and other issues, Goldman said.

After the agency declined to accept KEI’s recommendations, the group tried
to file an appeal. KEI noted that the NIH hadn’t posted instructions on its
website on how to file an appeal, and a link to a page that might have
explained it was broken, Knowledge Ecology International’s lawsuit says.

KEI emailed the agency about where to send it, and in response, an NCI
official told the group it already had determined the group wouldn’t be
harmed by the government’s decision and therefore didn’t have standing to
appeal, Goldman said. KEI filed it anyway, including arguments about how it
and those it represents would be harmed, he said.

“We were shocked that the NIH refused to entertain our appeal even before
receiving our appeal,” Goldman said. “I think that sends a really
horrendous signal about accountability to the public and having a
responsive government, and taking seriously the concerns of public interest
organizations representing patients, consumers, and taxpayers,” he said.

This is the first time KEI has filed a lawsuit against the NIH on a
licensing decision, he said.
Antitrust Obligations

The NIH also failed to follow a statutory requirement that it obtain advice
from the U.S. attorney general about antitrust issues before disposing of
federal property, including the disposal of patents, the lawsuit said.

The NIH has said the law doesn’t apply in these situations, but “that’s a
black-letter obligation in the law,” Goldman argued.

“There’s no exemption. So that’s something we would like the court to
resolve here.”

The case is Knowledge Ecology Int’l v. Nat’l Insts. of Health, D. Md., No.
18-cv-1130, 4/19/18.


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