US court ruled in favour of Bayer the German drugs and chemicals maker, in a case in Dr Reddy's Laboratories had challenged the validity of two US patents for antibiotic Avelox.
The US District Court for the District of Delaware has issued a ruling in its lawsuit against Dr. Reddy's Laboratories in which Dr. Reddy's challenged the validity and enforceability of two US patents covering Avelox (moxifloxacin HCl), the company's fluoroquinolone antibiotic for the treatment of respiratory tract and other infections. The court ruled in Bayer's favour, rejecting all of Dr. Reddy's challenges to the validity and enforceability of both Bayer patents.
Dr Reddy's had filed an Abbreviated New Drug Application (ANDA) for approval of a generic version of Avelox prior to the expiration of Bayer's patents, the German drugs and chemicals maker said in a statement. Under US law, the filing of the ANDA is an act of patent infringement,' Bayer said, adding it is nonetheless not unusual for generic drug companies to file ANDAs on successful pharmaceutical products prior to the expiration of the relevant patents.
In the US, Avelox is approved to Acute Exacerbations of Chronic Bronchitis (AECB), Acute Bacterial Sinusitis (ABS), Community Acquired Pneumonia (CAP), Uncomplicated Skin and Skin Structure Infections (uSSSI), Complicated Skin and Skin Structure Infections (cSSSI) and Complicated Intra-Abdominal Infections (cIAI).
In Europe, Avelox Oral is approved to treat Community Acquired Pneumonia (CAP) – except severe cases, Acute Bacterial Sinusitis (ABS) where adequately diagnosed, and Acute Exacerbations of Chronic Bronchitis (AECB). Avelox IV (+ oral sequential therapy) is approved to treat Community Acquired Pneumonia (CAP), and Complicated Skin and Skin Structure Infections (cSSSI). In Germany, Avelox is known as Avalox.
Avelox was launched in the US in 1999 and is currently marketed in more than 80 countries worldwide. In the US, Avelox is marketed by Bayer's partner, Schering-Plough Corporation.
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany.