By James DeGiulio --
Mirapex Case Ends, Mylan Found to Infringe Boehringer Patent
On August 18, Boehringer's long-running case against Mylan over the drug Mirapex came to a close after Mylan was found to infringe Boehringer's patent and an injunction was issued prohibiting Mylan from producing generic pramipexole dihydrochloride.
In 2005, Boehringer brought suit against Mylan and Barr in the U.S. District Court for the District of Delaware over infringement of U.S. Patent Nos. 4,843,086 and 4,886,812 covering Mirapex. In September 2008, Judge Farnan determined that the ANDAs filed by Barr and Mylan infringed Boehringer's '812 patent, but that the patent was invalid. Boehringer appealed, and brought an additional suit in the District of New Jersey against Mylan in January 2009, claiming that Mylan had infringed the invalidated claims as well as two similar claims (see "Court Report," February 8, 2009). In May 2009, Mylan successfully obtained a dismissal due to the District of Delaware's finding that the patent was invalid. In January, the Federal Circuit reversed the District of Delaware's ruling that invalidated the '812 patent, holding that the patent was shielded from invalidity by a safe harbor (see "Boehringer Ingelheim Int'l. v. Barr Laboratories, Inc. (Fed. Cir. 2010)"). The Federal Circuit declined to review its decision, and on June 7, the District of Delaware entered a final judgment of infringement in favor of Boehringer. Earlier this month, the Federal Circuit vacated the District of New Jersey ruling and remanded the case for further proceedings.
On August 18, Judge Hochberg signed off on a consent judgment in favor of Boehringer, finding that Mylan infringed the '812 patent. The judgment ends the case and enjoins Mylan from selling generic Mirapex until October 2010. Judge Hochberg's consent judgment can be found here.
Eli Lilly Granted 14-Day Injunction Prohibiting Production of Generic Strattera
Just days after its U.S. Patent No. 5,658,590 for Strattera was invalidated, Eli Lilly successfully obtained a 14-day injunction prohibiting a generic version of the drug from being introduced.
On August 9, 2007, Lilly brought suit against Actavis in the U.S. District Court for the District of New Jersey for infringement of the '590 patent (see "Court Report," August 19, 2007). One month later, Lilly amended its complaint, including Glenmark, Sun, Sandoz, Mylan, Teva, Apotex, Aurobindo, Synthon, and Zydus as defendants. In the months that followed, Lilly settled with Zydus, Glenmark, Synthon, Teva, and Actavis. On December 29, 2009, Judge Dennis Cavanaugh determined the remaining defendants had induced infringement of the '590 patent by filing ANDAs for generic versions of Strattera. The judge declined to grant summary judgment motions to either side at that time, saving questions on the patent's validity for trial. On August 12, Judge Cavanaugh found that Lilly's '590 patent was invalid due to lack of utility (see "Biotech/Pharma Docket, August 19, 2010"). Lilly immediately appealed the decision to the Federal Circuit and moved for a temporary injunction to prevent generic market entry until the decision on appeal.
On August 19, Judge Cavanaugh enjoined the defendants from entering the market for 14-days, which was time granted for Lilly to attempt to secure an injunction from the Federal Circuit. Despite Lilly's arguments, Judge Cavanaugh refused to issue a temporary injunction that would have prohibited generic versions of Strattera until the resolution of Lilly's invalidity appeal. Lilly's motion for injunction can be found motion.
Aurobindo and Torrent Pharma Found to Infringe Sanofi-Aventis' Uroxatral Patent
Following a ruling upholding Sanofi-Aventis' Uroxatral patent in early August, defendants Aurobindo Pharma and Torrent Pharma were both found to infringe Sanofi's patent covering the prostate drug.
Sanofi brought an infringement suit against Aurobindo, Torrent, Mylan, and others in 2007 following their ANDA filings, alleging Mylan's generic alfuzosin hydrochloride infringes U.S. Patent No. 4,661,491 (see "Court Report," October 14, 2007). Sanofi, Aurobindo, and Torrent stayed their claims, with Aurobindo and Torrent agreeing that if the District Court found for Sanofi and against any defendant, a judgment would also be issued against both defendants. Mylan moved forward with its invalidity case, asserting that the '491 patent was obvious in view of three pieces of prior art. However, in May, Mylan's contention that the patent was invalid for obviousness was rejected, and the U.S. District Court for the District of Delaware found for Sanofi (see "Biotech/Pharma Docket," May 27, 2010). On August 3, the Court upheld the validity of the '491 patent and enjoined Mylan from entering the market.
On August 16, Judge Gregory M. Sleet honored the May 2009 stipulation of the parties, where both Aurobindo and Torrent agreed to become subject to the judgment against any defendant. Judge Sleet, following the earlier ruling in favor of Sanofi in its case against Mylan, lifted the stay on the litigation and found the '491 patent infringed by both Torrent and Aurobindo. Judge Sleet's order can be found here.
James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a graduate of Northwestern University School of Law. Dr. DeGiulio is a member of MBHB's 2010 associate class and he can be contacted at [email protected].
Comments