Judge Sarah Evans Barker with the US District Court for the Southern District of Indiana rejected Teva's challenges to four patents – the '086, '968, '049 (the ‘bone loss’ patents) and the '050 patent (the ‘low dose’ patent) – barring Teva from selling its product in the US before Lilly's patents have expired.

The ‘bone loss’ and ‘low dose’ patents cover the oral administration of raloxifene for prevention or treatment of postmenopausal osteoporosis. In April 2009, Judge Barker issued a preliminary injunction to prevent a launch of a Teva product until she reached a final decision. At that time she said that she did not agree that raloxifene was just an obvious extension of previously known work, and indicated that the company was “likely to prevail in demonstrating the non-obviousness” of the patent.

In her opinion of 23 September 2009, Judge Barker also invalidated Lilly's two particle-size patents, for lack of description. Lilly says that it is reviewing this aspect of the ruling to determine whether or not to appeal.

Judge Barker stated that Teva had failed to prove “by clear and convincing evidence” that certain claims of the four patents are invalid as obvious, invalid for lack of enablement, or are unenforceable due to inequitable conduct.

Teva had previously informed Lilly that it planned to launch its product following expiration of the 30-month stay; however, over the past year (2008-2009) the case took an unusual turn.

In February 2009, the Federal Circuit affirmed a lower court's ruling extending the 30-month stay of Teva's raloxifene Abbreviated New Drug Application (ANDA). (The action relates to the 12 patents in the Orange Book for Evista, with expiry dates ranging from 2012 to 2017.) As explained by authors of the Orange Book Blog, in May 2006, Teva notified Lilly of its paragraph IV certifications on at least some of the patents, and Lilly sued in June 2006.

Teva had previously informed Lilly that it planned to launch its product following expiration of the 30-month stay; however, over the past year (2008-2009) the case took an unusual turn.

In February 2009, the Federal Circuit affirmed a lower court's ruling extending the 30-month stay of Teva's raloxifene Abbreviated New Drug Application (ANDA). (The action relates to the 12 patents in the Orange Book for Evista, with expiry dates ranging from 2012 to 2017.) As explained by authors of the Orange Book Blog, in May 2006, Teva notified Lilly of its paragraph IV certifications on at least some of the patents, and Lilly sued in June 2006.

Thus, the 30-month stay was originally set to expire in November 2008. The district court set a trial date of 9 March 2009. In February 2007, Lilly amended its complaint to assert that Teva infringed three more patents ('811, '719, and '064), covering raloxifene particle size and formulations, all expiring in 2017.

In July 2008, Teva amended its ANDA to include a new particle-size measuring methodology for the raloxifene in its generic drug product. Shortly thereafter, Lilly filed a motion to extend the 30-month stay, arguing that Teva “failed to reasonably co-operate in expediting the action…as evidenced by Teva's last-minute alteration of its proposed drug product and its multiple delays in producing critical discovery (which have) adversely affected Lilly's infringement case and trial preparation”, Orange Book Blog stated. Thus, the district court granted Lilly's motion and extended the 30-month stay to 9 March 2009. Final approval was stayed until that date.

References:
Scrip News 25 September 2009. US court upholds Evista patents through 2014, blocking Teva generic.