July 11, 2013
by Sue Tuck Richmond
The drug developer and manufacturer Pegasus Laboratories Inc. filed several lawsuits in the federal district court of Kansas on July 10, 2013, against compounding pharmacies that tailor-makes veterinary medicines. These complaint allege that the compounding pharmacy are infringing patents for a drug to treat a nervous-system disorder-- equine protozoal myeloencephalitis or EPM-in horses. The compounded medication product for treatment of EPM is compounded from bulk active sulfadiazine and pyrimethamine ingredients.
Prior to the filing the federal lawsuit, Pegasus
notified the compounding pharmacies of the three patents Pegasus held for its equine drug ReBalance and
warned the companies to stop infringing. The compounding pharmacies allegedly wrote
back denying that they produced custom-made versions of the patented
formula. Pegasus is asking for a jury trial.
These cases will be very interesting to track, especially in light of the pending legislation and reform being undertaken in the compounding world. These case represent just a small sampling of the many issues involved on the veterinary compounding side of the equation. Should manufacturers be left with no choice but to file federal lawsuits? Should state pharmacy boards and veterinary boards work together to combat this problem? Should inspections be done of veterinary clinics to see how many compounds sitting on the shelf are illegal? Aren't people with specialized knowledge of veterinary medications and compounds greatly needed to help Congress, state boards of pharmacy, state veterinary boards, and the FDA to understand this area, formulate a plan, and rein in all the abuses in this area?
Diamondback Drugs, LLC, Case No. 2:13-cv-02334, the Hon. Eric F. Melgren can be viewed here
Weatherford Compounding Pharmacy, Case No. 2:13-cv-02333-CM-KGS, the Hon. Carlos Murguia presiding, can be viewed here
by Sue Tuck Richmond
The drug developer and manufacturer Pegasus Laboratories Inc. filed several lawsuits in the federal district court of Kansas on July 10, 2013, against compounding pharmacies that tailor-makes veterinary medicines. These complaint allege that the compounding pharmacy are infringing patents for a drug to treat a nervous-system disorder-- equine protozoal myeloencephalitis or EPM-in horses. The compounded medication product for treatment of EPM is compounded from bulk active sulfadiazine and pyrimethamine ingredients.
These cases will be very interesting to track, especially in light of the pending legislation and reform being undertaken in the compounding world. These case represent just a small sampling of the many issues involved on the veterinary compounding side of the equation. Should manufacturers be left with no choice but to file federal lawsuits? Should state pharmacy boards and veterinary boards work together to combat this problem? Should inspections be done of veterinary clinics to see how many compounds sitting on the shelf are illegal? Aren't people with specialized knowledge of veterinary medications and compounds greatly needed to help Congress, state boards of pharmacy, state veterinary boards, and the FDA to understand this area, formulate a plan, and rein in all the abuses in this area?
Diamondback Drugs, LLC, Case No. 2:13-cv-02334, the Hon. Eric F. Melgren can be viewed here
Weatherford Compounding Pharmacy, Case No. 2:13-cv-02333-CM-KGS, the Hon. Carlos Murguia presiding, can be viewed here
1 comment:
It was only a matter of time before these actions by Diamondback were called out. Last month it was a "voluntary" recall of over 8,000 units of Buprenorphine injectable due to stability issues and now allegations of patent infringement. Time to recind their pharmacy license, protect the publics welfare and shut them down!
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