By James DeGiulio --
Novo Fails to Dismiss Suit over Validity of Prandin Patent
The five year dispute over the validity of the patent covering the diabetes drug Prandin continues, as Novo Nordisk's attempt to dismiss the case with Sun Pharmaceutical Industries and Caraco Pharmaceutical Laboratories was recently denied.
Novo originally filed suit against Caraco in 2005 in the U.S. District Court for the Eastern District of Michigan, alleging infringement of U.S. Patent No. 6,677,358 based on their ANDA covering a generic version of Prandin. Sun was later added to the lawsuit. Sun and Caraco counterclaimed that Novo's patent was invalid and would not be infringed by the sale of their generic version of the drug. In 2007, the FDA notified Caraco that it could not grant final approval of the ANDA because of the Novo lawsuit. Caraco then amended its ANDA with a Section VIII statement, but Caraco's claim was rendered moot when the FDA allowed Novo to modify the use code of the '358 patent to include the method. Novo's request for a change of its use code was contested and appealed to the Federal Circuit, which ultimately ruled in April that the change was allowed (see "Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. (Fed. Cir. 2010)"). In July, the Federal Circuit denied an en banc rehearing of the case. As a result, Novo moved for dismissal, arguing that there was no longer a controversy in the case because Caraco had dropped its Paragraph IV certification in favor of the Section VIII statement.
On October 6, Judge Avern Cohn denied Novo's motion to dismiss. Judge Cohn disagreed with Novo's argument, noting that Caraco had continued to pursue Paragraph IV certification in conjunction with the Section VIII statement. Judge Cohn also noted that Caraco's Paragraph IV certification is still pending before the FDA. Judge Cohn's Order can be viewed here.
Cobalt Pharmaceuticals and Sepracor Settle Lunesta Patent Litigation
Cobalt Pharmaceuticals has reached a settlement with Sepracor, thus ending its involvement in the multi-defendant infringement suit brought by Sepracor over the sleep drug Lunesta.
In March 2009, Sepracor brought suit in the U.S. District Court for the District of New Jersey against nine generic companies who intended to make generic versions of the sleep drug Lunesta (see "Court Report," March 29, 2009). Sepracor alleged that the generic maker's ANDAs infringed four patents covering the drug: U.S. Patent Nos. 6,319,926; 6,444,673; 6,864,257; and 7,381,724. Wockhardt and Glenmark were dismissed from the litigation in August, and Teva settled in September of this year (see "Biotech/Pharma Docket," August 12, 2010; "Biotech/Pharma Docket," September 2, 2010).
On October 12, Judge Dennis M. Cavanaugh signed off on a stipulation of dismissal without prejudice between the parties. Cobalt and Sepracor had previously informed Judge Cavanaugh that the matter had reached a resolution. Under the terms of the stipulation, the parties agreed that their claims and counterclaims were moot, following the resolution. Each party agreed to pay its own fees and costs. Judge Cavanugh's Order can be viewed here.
Warner Chilcott Settles Loestrin, Femcon Patent Suit with Lupin
Warner Chilcott and Lupin have settled a patent dispute regarding Lupin's development of generic forms of the birth control drugs Loestrin 24 Fe and Femcon Fe.
Warner Chilcott brought suit against Lupin in September 2009 in the U.S. District Court for the District of Maryland, accusing Lupin of infringing U.S. Patent Nos. 5,552,394 and 6,667,050, covering the birth control drugs Loestrin 24 Fe and Femcon Fe, respectively (see "Court Report," September 27, 2009). The case was transferred to the U.S. District Court for the District of Delaware in November 2009.
Under the settlement agreement, Lupin cannot launch generic Loestrin before July 22, 2014, or begin selling generic Femcon before Jan. 1, 2013. Warner Chilcott has also granted Lupin a nonexclusive license for Femcon, allowing Lupin to sell an authorized generic supplied by Warner Chilcott. Both parties' motions to dismiss have yet to receive court approval.
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].
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