By James DeGiulio --
Validity of Allergan Lumigan Patents Upheld
Allergan has successfully defended its patents covering the glaucoma drug Lumigan from an invalidity attack by alleged infringers Teva and Sandoz. In May 2009, Allergan filed the suit in the District of Delaware against Teva and Barr Laboratories, alleging infringement of U.S. Patent Nos. 6,403,649 and 5,688,819 after Barr filed an ANDA for generic Lumigan (see "Court Report," May 17, 2009). Allergan also filed a similar suit against Sandoz (see "Court Report," January 17, 2010), which was consolidated with the Teva suit in April 2010. A bench trial on the issues of infringement and validity was held between January 31 and February 4, 2011. At trial, defendants' defense focused mainly on the claim that the two patents were invalid for anticipation and obviousness. The defendants did not dispute that their ANDA products infringe three claims of the '649 patent, and conceded that the generics infringed the other asserted patent after trial was completed.
On September 8, Judge Sue L. Robinson issued an opinion finding Allergan's patents valid and determiningb that the defendants had failed to prove otherwise. Of key importance was Judge Robinson's finding that the credibility of the defendants' expert witness, Dr. Ashim K. Mitra, had been "eviscerated" on cross-examination. Dr. Mitra had testified that the compound bimatoprost, the active ingredient in Lumigan, was anticipated by a patent that described a method for treating glaucoma with derivatives from a class of compounds known as prostaglandins. The prior art patent did not explicitly name bimatoprost, but describes a compound that may result from the breakdown of bimatoprost and a compound that can be converted to bimatoprost. However, the law on inherent anticipation requires convincing evidence that bimatoprost itself is necessarily present in the prior art, which the defendants did not prove. Further, at trial, Allergan's attorneys discredited Dr. Mitra by establishing that he had incorrectly drawn the bimatoprost molecule during his deposition and disparaged the anticipatory prior art in a previous trial in 2008. After trial, the defendants tried to raise a different theory of obviousness 
that did not rely on the prior art patent, but Judge Robinson prohibited the defendants from pursuing this new theory.
Sanofi Secures Injunction Blocking Sun from Marketing Generic Eloxatin
In settling its patent dispute with Sun Pharmaceuticals over the colon cancer drug Eloxtin, Sanofi has successfully secured a ruling that will keep generic versions of its drug off the U.S. market until August 2012. In June 2007, Sanofi brought suit in the District of New Jersey against Sun and other generics makers, alleging infringement of U.S. Patent No. 5,338,874 (see "Court Report," July 30, 2007). By June 2009, Sanofi and Sun had reached a settlement agreement that included a consent decree and license agreement in which Sun would not market its generic drug until August 2010, the date of patent expiry, but would be permitted to market the drug before that date if the other drugmakers launched their own generics at-risk. Before the agreement was signed, the District Court granted summary judgment of noninfringement of the '874 patent that allowed the other generics makers to market their versions of Eloxatin, but the Federal Circuit vacated this order. Sanofi then reached a settlement agreement with the other generics makers that enjoined them from selling their versions of Eloxatin as of June 30, 2010. Sun began selling its generic version of Eloxatin at-risk in January 2010, and Sanofi submitted a revised consent decree expanding the injunction to cover Sun, which was granted over Sun's objections. Sun then appealed to the Federal Circuit, which ruled that the District Court should conduct an evidentiary hearing on the new language of the agreement.
On September 15, Judge Joel A. Pisano issued an opinion reinstating the April 2010 consent decree that prevented Sun from selling its generic Eloxatin from June 30, 2010 through August 9, 2012. Sun argued at the evidentiary hearing that the consent decree between Sanofi and the other generics makers did not qualify as an enjoining decision because it was merely entered by a judge, not decided by one. However, Judge Pisano found that an enjoining decision should be interpreted broadly and is not limited to decisions on the merits. Thus, his ruling is a judicial act that results in an injunction. In his ruling, Judge Pisano noted that the new language of the agreement intended to provide a mechanism by which Sanofi could regain exclusivity after at-risk launches are enjoined. According to the judge, interpreting the term "decision(s) enjoining" to require a decision on the merits would be inconsistent with the intent of the new language of the agreement.
Medicis Secures Permanent Injunction, Settling Solodyn Dispute with Aurobindo
Medicis successfully resolved its latest patent dispute over the acne drug Solodyn, when it reached an agreement with Aurobindo which permanently enjoins the generic drugmaker from entering the market absent a Medicis license. In December 2010, Medicis filed suit in the District of Delaware, alleging that Aurobindo infringed U.S. Patent Nos. 5,908,838 and 7,790,705, which cover the anti-acne oral antibiotic (see "Court Report - Part II," December 13, 2010). Aurobindo notified Medicis in an October 2010 notice letter that it was seeking approval from the FDA for a generic version of Solodyn before the patents covering it expired. In addition to infringement, the suit alleged that the notice letter did not provide a detailed statement of the legal basis for the claims that Aurobindo's version would not infringe the patents.
On September 14, Judge Stark entered a consent judgment that, in the absence of a Medicis license, permanently enjoined Aurobindo from manufacturing, using, offering to sell, selling, importing, or distributing any current or future products having the same strength and dosage form as Medicis' Solodyn products. Under the terms of a settlement and license agreement between the parties, Judge Stark dismissed all claims and counterclaims without prejudice, thus ending the suit. Aurobindo acknowledged that the patents were valid and enforceable as part of the settlement. Judge Stark noted that final settlement of the litigation will help Medicis and defendants avoid the substantial uncertainty and risks involved with prolonged litigation, save litigation costs, and conserve judicial resources. Medicis has reached settlements with numerous generics over Solodyn, including Lupin, Teva, Mylan, Ranbaxy, Sandoz, and Impax.
Comments