Brilinta is a blood thinner used in the treatment of coronary heart disease, angina pectoris which is commonly called as heart attack. Brilinta prevents the blood clots and maintains the blood flow in the body to help reduce the risk of another cardiovascular event.

AstraZeneca is a London-based pharmaceutical company, who owns five patents 6,251,910, 6,525,060, 7,250,419 7,265,124 and 8,425,934 and approved to sell the drug Brilinta in 90 and 60 milligram tablets.

AstraZeneca sued a case on Mylan Inc. a pharmaceutical company for patent infringement. Mylan has infringed five of AstraZeneca patents by filing an abbreviated new drug application with the U.S. Food and Drug Administration to make a generic version of AstraZeneca’s blood thinner Brilinta of the same dose as AstraZeneca.

AstraZeneca received letters from Mylan Inc. stating that it was seeking FDA approval to manufacture, use and sell a generic version of Brilinta, but AstraZeneca’s patent has never expired, , according to the FDA their patent extends till April 2017, July 2018, December 2019, July 2021 and April 2030. And the company warns Mylan Inc. that without court intervention it will be irreparably harmed by having a generic come to market before its patents have expired.

The patents are valid, enforceable and would be infringed if a generic form of Brilinta came to market, the company is asking for a judgment. According to the FDA  orders approval of a generic must wait until after the AstraZeneca’s patents expire, an order enjoining Mylan from making or selling the generics and monetary relief if Mylan manufactures or sells the drug before the patent expiration.
Mylan have not immediately return requests for the comments. And Mylan’s ANDA was for the same dosage amounts, according to the complaint.
News from the clinical sides states that, the trial on patients conducted by AstraZeneca had better results than those from an independent organization. It states that 18,624 patients in 43 countries taking Brilinta or clopidogrel.

Also, an international Journal of Cardiology stated that, under clinical trials patients taking Brilinta had beneficial and effects and reduced risk factors monitored by AstraZeneca with Plavix as the standard than by any other independent clinical research organization

AstraZeneca’s so-called Plato trial studied the outcomes of, the active ingredient in the blood thinner Plavix. AstraZeneca said. Results from the study were first reported at a medical meeting in 2009.

This clinical trial opened a great path for winning the patent and getting approval by U.S. and European regulators.

AstraZeneca thus hit Mylan with a patent over a generic version of AstraZeneca’s blood thinner Brilinta.

 

Keywords: AstraZeneca, Mylan, Brilinta, generic drug, Patent infringement.