This case involves the same verdict of Patent infringement as AstraZeneca sued on various Pharmaceutical companies, and this case is the fight for Nexium which is a drug used in treatment of GERD.
Since, AstraZeneca received a notice saying that Zydus had filed an abbreviated new drug application(ANDA) with the U.S. Food and Drug Administration requesting to manufacture esomeprazole magnesium trihydrate, as Nexium which is known generically, which would be prior to the expiration of AstraZeneca’s patents on the drug’s compounds and manufacturing process of AstraZeneca holding the three patents from U.S. patent numbers 6,369,085, 7,411,070 and 8,466,175.
AstraZeneca approached New Jersey federal court claiming that Zydus’ plans to manufacture generic Nexium which would be an act of infringement on AstraZeneca’s patents on the popular heartburn drug.
The complaint says that Plaintiffs will be substantially and irreparably harmed by the infringing activities described above unless those activities are precluded by this court and they have no adequate remedy at law. And AstraZeneca holds the patent until May 25, 2018 and pediatric patent extends till Nov. 25, 2018
The defendants failed to allege the invalidity or unenforceability of the three patents in their ANDA, AstraZeneca claims that they effectively accepted the statutory presumption the patents are both valid and enforceable.
AstraZeneca also demands for a judgment enjoining the manufacture, use or sale of the esomeprazole magnesium product described in the ANDA prior to the expiration of the patents-in-suit, in addition to attorneys’ fees and costs. Fighting over the propriety of a ruling allowing the case, which focuses on reverse-payment settlements for AstraZeneca’s blockbuster heartburn medication Nexium, to proceed as a class action, even though some buyers may not have overpaid.
Nexium is the second-biggest selling drug worldwide, behind Pfizer Inc.’s cholesterol medication Lipitor, according to court filings. Nexium is used in the treatment of Gastroesophageal reflux disease (GERD) is one of the most common chronic illnesses in the United States today, affecting more than 60 million Americans. Many have experienced, NEXIUM provide relief for who experience persistent heartburn caused by acid reflux disease. NEXIUM can also heal possible damage to the esophagus that may be caused over time by acid reflux disease. Most erosions heal in 4 to 8 weeks with varying Individual results.
AstraZeneca’s statistics shows that revenue from the top product Nexium between 2006 and 2015. AstraZeneca is one of the top 10 pharmaceutical companies worldwide. The multinational company is headquartered in London, UK. AstraZeneca is focused on products for following major disease areas: cancer, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation. In 2006, revenue from Nexium amounted to around 5.18 billion U.S. dollars.
Efforts to produce generic versions of the blockbuster acid reflux drug have prompted other litigation in federal courts.
This kind of cases has become very common and AstraZeneca had sued a lot of Patent infringement cases. And it has become very necessary to know that filing abbreviated new drug application on a drug before its patent expires is an act of infringement.
And AstraZeneca hits the Zydus Pharmaceuticals USA Inc., an American subsidiary of Indian drugmaker Zydus Cadila.
Keywords: AstraZeneca, Zydus Pharmaceuticals, Nexium, GERD, Patent infringement.