ViiV Healthcare Co. filed a patent infringement suit against Lupin Ltd. in Delaware on Wednesday in an effort to block the Indian drugmaker's planned generic version of HIV drug Trizivir.
U.K.-based ViiV claims that a Lupin abbreviated new drug application infringes the patent covering Trizivir, an anti-retroviral treatment that uses three different types of drugs to better treat resistant strains of HIV.
"ViiV will be irreparably harmed by Lupin's infringing activities unless those activities are enjoined by this court," the complaint said. "ViiV does not have an adequate remedy at law."
A representative for Mumbai, India-based Lupin could not be immediately reached for comment.
The U.S. Food and Drug Administration granted ViiV approval in 2002 to sell a tablet that contains 300 milligrams of abacavir sulfate, 150 milligrams of lamivudine and 300 milligrams of zidovudine, which is marketed in the U.S. as Trizivir, according to the complaint.
The ANDA, which Lupin filed in May, seeks FDA approval to manufacture a tablet with the same three drugs in the same dosages before the patent expires, the suit says.
Lupin notified ViiV in a letter that it planned to make its own version, and included a Paragraph IV certification asserting that the patent claims are invalid or not infringed by its proposed product, according to the suit.
The plaintiff asserts U.S. Patent Number 6,417,191, which covers the combination of three HIV drugs that together "provide synergistic antiviral effects, more complete viral suppression [and] viral suppression over a longer period."
Zidovudine has long been recognized as a useful treatment for HIV patients, helping to prolong the disease-free interval in individuals without symptoms and to delay death in individuals with symptoms, according to the patent abstract. However, the widespread use of zidovudine has made the HIV virus resistant to the drug, it said.
The suit seeks a judgment of infringement, a court order postponing the effective date of the Lupin ANDA until after the patent-in-suit expires, a permanent injunction, treble damages, attorneys' fees and court costs.
ViiV is a joint venture between Pfizer Inc. and GlaxoSmithKline PLC established to focus on developing drugs to treat HIV. Since its founding in November 2009, the company has developed 10 different drugs that it claims generate £1.5 billion ($2.4 billion) in annual sales.
The patent-in-suit is U.S. Patent Number 6,417,191.
ViiV is represented by Joseph J. Farnan Jr. and Brian E. Farnan of Farnan LLP and F. Christopher Mizzo, Charles A. Fernandez and Craig T. Murray of Kirkland & Ellis LLP.
Counsel information for Lupin was not immediately available.
The case is ViiV Healthcare UK Ltd. et al. v. Lupin Ltd. et al., case number 1:11-cv-00576, in the U.S. District Court for the District of Delaware.
REPRINTED WITH PERMISSION FROM THE JUNE 30, 2011 EDITION OF LAW360 © 2011 PORTFOLIO MEDIA INC. ALL RIGHTS RESERVED. FURTHER DUPLICATION WITHOUT PERMISSION IS PROHIBITED