- Two small-molecule drug patents expired the week of August 3, 2014.
- One patent relates to UCB’s Vimpat, which was filed late last year as a monotherapy for epileptic seizures; UCB has filed several recent suits to protect IP related to Vimpat.
- The second patent relates to Nutropin Depot, a drug developed by Alkermes and marketed jointly with Genentech until the companies withdrew it from the market in 2004.
Vimpat launched in 2009 as an adjunctive therapy to treat partial-onset seizures in epilepsy patients 17 and older. It is marketed by UCB, a Brussels-based biopharmaceutical company with 3.4 billion euros in 2013 revenue.
According to UCB, in 2013 Vimpat had global sales of 411 million euros and North America sales of 314 million euros, meaning North American sales of Vimpat accounted for around 9 percent of UCB’s total revenue.
This week’s expiration
U.S. patent number 5,654,301, titled “Amino acid derivative anticonvulsant,” relates to “compounds and pharmaceutical compositions having central nervous system (CNS) activity which are useful in the treatment of epilepsy and other CNS disorders. More specifically, the compounds of this invention can be characterized as protected amino acid derivatives of the formula: ##STR2## or the N-oxides thereof or pharmaceutically acceptable salts thereof.”
The object of the patent, filed Jan. 12, 1995, was to:
“Provide novel compounds exhibiting CNS activity, particularly anticonvulsant activity.”
“Provide pharmaceutical compositions useful in the treatment of epilepsy and other CNS disorders.”
“Provide a method of treating epilepsy and related convulsant disorders.”
In November 2013, UCB announced a filing for Vimpat as a monotherapy for partial onset seizures in epileptic patients. During 2013, UCB has sued Mylan (NASDAQ:MYL) and Actavis (NYSE:ACT) over their production of generic versions of Vimpat.
Per NIH, Nutropin Depot is a “long-acting dosage form of recombinant human growth hormone” that has been studied in young children with growth hormone deficiency (GHD) and is indicated for “the long term treatment of growth failure due to a lack of adequate endogenous GH secretion.” It was originally developed by Alkermes and approved by the FDA in 1999. Alkermes and Genentech partnered in the manufacture and marketing of Nutropin Depot until 2004, when the companies announced that they would discontinue marketing the drug. Roche later bought Genentech for around $47 billion after owning a majority of its shares since 1990. (Presumably Nutropin Depot was not the chief motivation for that acquisition.)
This week’s expiration
U.S. patent number 5,654,010 relates to “composition, and methods of forming and using said composition, for the sustained release of biologically active, stabilized human growth hormone (hGH).”
The patent application lists several advantages of a sustained-release form of hGH:
“Longer, more consistent in vivo blood levels of hGH, lower initial bursts of hGH, and increased therapeutic benefits by eliminating fluctuations in serum hGH levels.”
“Increased patient compliance and acceptance by reducing the required number of injections.”
“The ability to use smaller amounts of hGH compared to bolus injection regimen because serum hGH levels are maintained closer to therapeutical thresholds.”
Here is a table of this week’s patent expirations. This table of patent expirations and additional biotech-related IP information is available at DrugPatentWatch.com.
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.
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