Drug Industry Daily
July 8, 2013
The Department of Health and Human Services and the board of trustees for the University of Illinois filed a patent infringement lawsuit June 27 against Indian drugmaker Lupin over its plans to manufacture and market a generic form of the HIV drug Prezista.
The drug, as described in Lupin's ANDA filed with the FDA, infringes every limitation of at least one claim of the plaintiffs' .506 patent covering methods of use for Prezista (darunavir), the suit, filed in the U.S. District Court for the District of New Jersey, claims.
The university and HHS licensed the patent to Tibotec, Prezista's innovator. In 2011, Tibotec changed its name to Janssen Therapeutics, a division of Janssen Products, which is a Johnson & Johnson drug company.
In May, the government and University of Illinois received letters from Lupin saying it had included a Paragraph IV certification in its ANDA that the .506 patent is "invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, or sale of Lupin's Product," the suit states.
The complainants seeks to enjoin Lupin and any of its associates from commercially manufacturing, using, offering to sell or selling its generic version of Prezista in the U.S. before the .506 patent's 2019 expiration date.
HHS' attorney declined to comment. A Department of Justice spokesperson told DID Wednesday that it won't comment on ongoing cases.
Lupin also declined to comment.
Janssen and DOJ filed suit against Lupin and Mylan in the same court in 2010, also alleging patent infringement for proposed generic versions of Prezista. In March 2011, J&J and the government filed patent-infringement lawsuits against generic drugmaker Teva Pharmaceuticals for an ANDA it submitted to the FDA for a version of Prezista. These cases were subsequently consolidated under Janssen, et al. v. Lupin, et al., Civil Action No. 10-5954. That case is still pending.
The United States Department of Health and Human Services and the Board of Trustees of the University of Illinois v. Lupin Limited, can be read at www.fdanews.com/ext/files/07-03-13-lupin.pdf.
The Department of Health and Human Services and the board of trustees for the University of Illinois filed a patent infringement lawsuit June 27 against Indian drugmaker Lupin over its plans to manufacture and market a generic form of the HIV drug Prezista.
The drug, as described in Lupin's ANDA filed with the FDA, infringes every limitation of at least one claim of the plaintiffs' .506 patent covering methods of use for Prezista (darunavir), the suit, filed in the U.S. District Court for the District of New Jersey, claims.
The university and HHS licensed the patent to Tibotec, Prezista's innovator. In 2011, Tibotec changed its name to Janssen Therapeutics, a division of Janssen Products, which is a Johnson & Johnson drug company.
In May, the government and University of Illinois received letters from Lupin saying it had included a Paragraph IV certification in its ANDA that the .506 patent is "invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, or sale of Lupin's Product," the suit states.
The complainants seeks to enjoin Lupin and any of its associates from commercially manufacturing, using, offering to sell or selling its generic version of Prezista in the U.S. before the .506 patent's 2019 expiration date.
HHS' attorney declined to comment. A Department of Justice spokesperson told DID Wednesday that it won't comment on ongoing cases.
Lupin also declined to comment.
Janssen and DOJ filed suit against Lupin and Mylan in the same court in 2010, also alleging patent infringement for proposed generic versions of Prezista. In March 2011, J&J and the government filed patent-infringement lawsuits against generic drugmaker Teva Pharmaceuticals for an ANDA it submitted to the FDA for a version of Prezista. These cases were subsequently consolidated under Janssen, et al. v. Lupin, et al., Civil Action No. 10-5954. That case is still pending.
The United States Department of Health and Human Services and the Board of Trustees of the University of Illinois v. Lupin Limited, can be read at www.fdanews.com/ext/files/07-03-13-lupin.pdf.