Pronova BioPharma ASA: Files Second Patent Infringement Action in Response to Par and Teva's Paragraph IV Notifications related to Lovaza(TM)

Pronova BioPharma ASA (OSE:　 PRON.OL) ("Pronova
BioPharma") announces that Pronova BioPharma Norge AS filed two individual lawsuits; one
against Par Pharmaceutical, Inc. and Par Pharmaceutical Companies, Inc. (collectively
"Par") and one against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries
Ltd. (collectively "Teva") in the United States District Court for the District of
Delaware asserting infringement of Pronova BioPharma's U.S. Patent No. 7,732,488 ("the
'488 Patent", entitled "Pharmaceutical Composition Comprising Low Concentrations of
Environmental Pollutants"). The '488 Patent was listed in the FDA Orange Book on 2 July
2010 and expires in 2025.　 The lawsuits are in response to Par and Teva's Paragraph IV
Certification Notices to Pronova BioPharma related to the '488 Patent.

Pronova BioPharma files lawsuit against Teva Pharmaceuticals

Norway-based biotechnology company Pronova BioPharma has reported that Pronova BioPharma Norge AS has filed a lawsuit against Teva Pharmaceuticals USA and Teva Pharmaceutical Industries Ltd in the US District Court of Delaware asserting infringement of the company's US patents relating to omega-3-acid ethyl ester compositions and methods of using omega-3-acid ethyl esters. 

These patents are listed in the FDA's Orange Book and expire in 2013 and 2017, respectively.

The lawsuit is in response to Teva USA's Paragraph IV Certification notice to Pronova BioPharma advising that Teva USA has submitted an abbreviated new drug application to the FDA seeking approval to engage in the commercial manufacture, use, or sale of generic versions of Pronova BioPharma's omega-3-acid ethyl esters capsules which are marketed in the US as Lovaza.

Omacor/Lovaza is reported to be the first and only EU- and FDA-approved omega-3 derived prescription drug. The drug is prescribed as an adjunct to diet for the treatment of elevated levels of triglycerides in humans, a condition known as hypertriglyceridemia, a form of dyslipidemia.