By James DeGiulio --
Medicis and Lupin Settle Solodyn Infringement Dispute; Agree to Drug Development Collaboration
Medicis has entered into multiple agreements with Lupin over the acne drug Solodyn, allowing the generic drugmaker to enter the market prior to the expiration of Medicis' patents. In a separate agreement, Medicis agreed to join Lupin in a drug development collaboration worth an initial $20 million to the generic company.
In November 2009, Medicis filed suit against Lupin, which had filed an ANDA intending to launch a generic version of Solodyn in three approved strengths (45, 90, and 135 mg). Medicis later amended the complaint to cover all five approved dosages and to add an additional patent. Medicis claimed Lupin infringed U.S. Patent Nos. 5,908,838 and 7,790,705 by seeking to manufacture a generic version of Solodyn before the patents expire. The '838 patent covers a slow-dissolving form of tetracycline, a class of oral antibiotics commonly used to treat acne. When tetracycline dissolves too rapidly after being swallowed, the incidence and severity of side effects such as vertigo, dizziness, and blurred vision can increase. The '705 patent relates to methods of administering the dosages.
On July 21, Judge J. Frederick Motz signed off on a consent judgment that permanently enjoined Lupin from selling generic Solodyn except under the terms of a separate licensing agreement. The licensing agreement allows Lupin to sell a generic version of Solodyn in various different doses prior to the expiration of the patents. Under the agreement, Lupin can move ahead with 45-, 90-, and 135-milligram doses in November, the 65- and 115-milligram doses in February 2018, and the 55-, 80-, and 105-milligram doses in February 2019. Under certain conditions that were not disclosed, Lupin could begin making the generic earlier.
In a separate agreement, Lupin announced it had agreed with Medicis to enter a collaborative partnership, where Lupin would use its proprietary formulation technology to develop new therapeutic compounds. As part of the development collaboration, Medicis agreed to pay out a $20 million upfront payment in exchange for Lupin's technology. The agreement gives Medicis exclusive rights to the developed products outside India, where Lupin is based. Lupin is eligible for future milestone payments of up to $38 million for certain research, development, regulatory, and other targets, while Medicis is responsible for future commercialization of the licensed products.
Asahi Award Reduced in Fasudil Licensing Dispute with Actelion
A $577 million award secured by Asahi against Actelion has been cut by $70 million. In its suit, Asahi claimed that Actelion bought CoTherix in order to undermine a licensing deal over the hypertension treatment Fasudil.
Asahi brought suit in 2008 in the Superior Court of the State of California, County of San Mateo, accusing Actelion of acquiring CoTherix and then interfering with the latter's deal with Asahi to develop Fasudil. CoTherix terminated the licensing deal for Fasudil in 2007 after being acquired by Actelion. Asahi alleged that Actelion's acquisition of CoTherix was an attempt to protect its monopoly in the market for treating pulmonary arterial hypertension. Actelion maintained that there was no commitment between Asahi and CoTherix, noting that the licensing agreement explicitly stated that there was no partnership. During a three-month trial, Asahi argued that Actelion expected a major loss in market share if competitive drugs were introduced, for Acetlion's drug Tracleer had caused 3,427 patient deaths that had gone unreported to the FDA. Actelion argued that the decision not to develop Fasudil was made due to numerous safety concerns from doctors and medical authorities as to the drug's potential side effects on the kidney and the liver. In May 2011, the jury found that Actelion and CoTherix had acted with malice in interfering with Asahi's 2006 agreement with CoTherix to develop and commercialize Fasudil, and awarded Asahi $550 million in damages for interrupting the licensing agreement.
Following the damage award verdict, Actelion asked Judge Marie S. Weiner to offset a $78.4 million arbitration payment CoTherix made in 2009 from the jury verdict. Judge Weiner ordered a $70.4 million offset. Actelion also contested part of the verdict, asking the judge for an election between lost profit and development costs. The $577 million jury award consisted of $360 million in lost profits, $187 million in development costs, and $30 million in punitive damages. Judge Weiner rejected the motion on procedural grounds, telling Actelion that it must wait until judgment before filing its motion. Actelion has stated its intention to appeal the jury verdict in due course following entry of judgment, expected after August 8, and rulings on further post-trial motions.
Pfizer Settles Relpax Infringement Suit with Apotex
Pfizer could be wrapping up its infringement lawsuits over the migraine drug Relpax, as it reached a settlement agreement with Apotex, the deal with Apotex following a settlement Pfizwer reached with Teva earlier this month. Pfizer filed suit against Apotex on July 9, 2010 in the District Court of the Southern District of New York, after Apotex filed an ANDA to manufacture a generic form of eletripian hydrobromide, which Pfizer markets as Relpax. Pfizer claimed that Apotex's generic would infringe U.S. Patent No. 6,110,940. Pfizer sought a judgment of infringement and a permanent injunction against Apotex, along with attorneys' fees and costs. Apotex asserted that its generic version did not infringe the '940 patent because it uses a different form of eletripian hydrobromide. In an answer and counterclaim filed in September, Apotex requested a declaratory judgment of invalidity and noninfringement of the '940 patent.
On July 26, Pfizer's attorneys filed a letter with Judge Lewis A. Kaplan, informing him that the companies had reached a settlement. According to the letter, the parties sought to avoid further judicial involvement, and achieve the same result as with Teva. Terms of Pfizer's settlement with Teva were not disclosed. Pfizer also asked Judge Kaplan to extend discovery deadlines in the case, in order to provide adequate time for the parties to close on a final settlement agreement.
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