[Ip-health] Trump administration is urged to override patents on pricey muscular dystrophy drug

[Kim Treanor]

https://www.statnews.com/pharmalot/2018/04/05/trump-patents-muscular-dystrophy-drug/

Trump administration is urged to override patents on pricey muscular
dystrophy drug
Ed Silverman in Stat News on 5 April 2018

Six advocacy groups have asked the federal government to sidestep a handful
of patents on a pricey drug used to treat a rare form of muscular dystrophy
as part of an ongoing campaign to provide wider access to high-cost
medicines.

In a letter sent on Wednesday to the Department of Health and Human
Services, the groups argued that the patents — which are either owned or
licensed by Sarepta Therapeutics (SRPT) — failed to disclose federal
funding for grants that were used to develop a drug known as Exondys 51 for
treating Duchenne muscular dystrophy.

[snip]

If the groups are correct, such a failure could have implications for the
company and patients because federal law permits the government to take
title to a patent. The government could then, presumably, pursue
alternative arrangements for making the drug available at a lower cost. The
annual price tag is about $300,000, although this can rise dramatically
depending upon patient weight.

“The Sarepta price for Exondys 51 is excessive, and the high cost has
created significant access barriers and hardships for patients,” the groups
wrote to HHS Secretary Alex Azar. “The failure by inventors to disclose NIH
funding provides the U.S. government with an opportunity to take title to
at least five relevant Exondys 51 patents, and to use the ownership of the
patents as leverage to lower the price.”

Under a federal law known as the Bayh-Dole Act, as well as federal
regulations, a grant recipient is required to disclose federal funding that
contributed to a patented invention, and include language in patent
applications and any patent describing the role the funding played. The
groups contended that the University of Western Australia, which licensed
four patents to Sarepta, failed to take this step for the patents, and the
same issue was raised in connection with a patent owned by the company.

[snip]

The move to push the HHS to sidestep the patents is part of a broader
effort by Knowledge Ecology International, which led this effort, to widen
access to high-priced medicines in the U.S. This is, in fact, the fourth
time in the past month the group has asked the White House, HHS, or the
National Institutes of Health to either investigate or sidestep drug
patents over a purported failure to disclose government funding. The other
efforts targeted hepatitis C drugs, an opioid overdose treatment and a
cholesterol medication.

[snip]

...by taking title to a patent, Sarepta effectively becomes an infringer,
unless it can obtain a license from the new owner of the patent, which
would be the U.S. government, according to Jamie Love, who heads Knowledge
Ecology International. “It is that leverage which is useful, even during
the period of orphan exclusivity, and the leverage is not dependent upon
the U.S. to obtaining an alternative supplier” of the medicine.

[snip]

-- 
Kim Treanor
Knowledge Ecology International
kim.treanor at keionline.org
tel.: +1.202.332.2670 <(202)%20332-2670>