[Ip-health] US Federal rights in patents on Probuphine, to treat opioid addiction

Kim Treanor kim.treanor at keionline.org
Wed Aug 30 08:21:03 PDT 2017


US Federal rights in patents on Probuphine, to treat opioid addiction
Kim Treanor on 30 August 2017

Probuphine is an expensive medication used to treat opioid dependence by
providing maintenance treatment and lessening withdrawal symptoms. The U.S.
federal government also has considerable leverage over the pricing of this
product, because of the federal funding of the the research that lead to
the sole Orange Book patent on the product, and phase 3 trials that were
used the register the product.

Probuphine consists of four rods which are implanted under the skin of a
patient’s arm. These four rods work for six months to provide a continuous
supply of buprenorphine, a partial opioid agonist, into the patient’s
system. While buprenorphine is available in generic form, Probuphine is
patented. The medication is protected by only one patent, for the delivery

The benefits of an implant are numerous. While buprenorphine is available
as a tablet and a sublingual form, these forms require frequent dosage and
compliance from a patient. The subdermal implant requires only a visit to a
doctor’s office every six months. Additionally, the implant is more
difficult to abuse or resell than other forms of buprenorphine. One study
in the Journal of the American Medical Association found that patients
receiving the implant were more likely to maintain opioid abstinence than
those receiving sublingual buprenorphine.[1]

While the treatment has the potential to provide important benefits to
patients, its price places it out of reach of many of those in need.
Drugs.com lists a price of $5,175.80 for the 6 month supply, creating a
price per patient of $10,351.60.[2] This figure does not include
implantation costs.

The sole patent listed in the FDA Orange Book for Probuphine is 7,736,665,
which provides exclusivity until 2024. The inventors were Rajesh Patel and
Louis Bucalo, and the patent was assigned to Titan Pharmaceuticals. But the
patent also disclosed the invention was conceived on a federal grant.

This invention was made in part during work supported by a grant from the
National Institute of Mental Health (1R43 MH60037-01). The government has
certain rights in the invention.”

Under the Bayh-Dole Act. and specifically 35 U.S.C. § 202(c)(4), the
funding Federal agency retains “a nontransferable, irrevocable, paid-up
license... to practice the invention or have the invention practiced
throughout the world by or on behalf of the Government of the United
States.” The royalty-free right can be used by the government or on its
behalf at any time, without payment of royalty.

As the invention was partially or fully federally funded, the United States
Government also retains “march-in” rights under 35 U.S.C. § 203, which
allows the government to force the rights holder of a federally-funded
invention “to grant a nonexclusive, partially exclusive, or exclusive
license in any field of use to a responsible applicant or applicants, upon
terms that are reasonable under the circumstances,” or, if the rights
holder refuses, the government may itself grant the license. Utilizing
these march-in rights requires a determination that at least one of four
conditions (section 203(a)(1-4)) are met, but most relevant to the
amendment is the requirement for “practical application” of the invention,
which is defined in 35 U.S.C. § 201(f) as making the benefits of the
invention “available to the public on reasonable terms.”

In addition to its initial funding, the National Institute on Drug Abuse
provided $7,586,848 in funding for Phase 3 clinical trials for the
medication. While Probuphine is protected by test data exclusivity until
May 26th, 2019, the government may have rights to the test data. KEI has
requested copies of any cooperative research and development agreements and
copies of the grants related to this funding.

The United States is in the grip of an opioid addiction epidemic. Kaiser
Family Foundation has found that only 40 percent of adults with opioid
addiction have private insurance, while 30 percent rely upon Medicaid and
20 percent are uninsured.[3] For many of those suffering from addiction,
the costs of this medication must be borne out of pocket.

This is a medication which has been proven to be effective. The government
can use its existing rights to expand access and affordability. Earlier
this month, President Donald Trump said that he would declare the opioid
crisis a national emergency, and the President’s Commission on the opioid
crisis recommended expanding access to medication assisted treatment in its
report.[4] Action on expanding access to Probuphine is one important tool
which the government already has at its disposal.

1 http://jamanetwork.com/journals/jama/fullarticle/2533504#Discussion
2 https://www.drugs.com/price-guide/probuphine
3 http://www.kff.org/uninsured/fact-sheet/6-things-to-know-about-uninsured.


Kim Treanor
Knowledge Ecology International
kim.treanor at keionline.org
tel.: +1.202.332.2670

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