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Institut Pasteur, Bio-Rad Sue Abbott for Patent Infringement, Breach of Contract

NEW YORK (360Dx) – Institut Pasteur and Bio-Rad Laboratories are suing Abbott, alleging infringement of a patent covering technology for diagnosing HIV-2, as well as breach of contract.

The lawsuit filed this week in US District Court, Northern District of Illinois Eastern Division, relates to US Patent No. 6,544,728, titled "Methods and Kits for Diagnosing Human Immunodeficiency Virus Type 2 (HIV-2), Proteins of HIV-2, and Vaccinating Agents for HIV-2," and assigned to Institut Pasteur in April 2003.

According to the patent abstract, the technology relates to a method for detecting HIV-2 infection, which includes reagents such as cDNA probes that can hybridize to at least a portion of the HIV-2 genome. "In one embodiment, the DNA probes are capable of hybridizing to the entire genome of HIV-2," the abstract states, and the reagents include polypeptides encoded by some of the DNA sequences.

Bio-Rad is the exclusive licensee of the patent and has the right to grant sublicenses, the plaintiffs said in their complaint. Abbott, meanwhile, was a licensee of the '728 patent until its license was terminated on March 7, 2017.

Specifically, the plaintiffs allege that Abbott infringes claims 4 and 6 of the '728 patent. Claim 4 relates to an in vitro diagnostic method for detecting the presence of antibodies to HIV-2 by contacting a biological sample with at least one isolated polypeptide expression product of HIV-2 "from the group consisting of polymerase and env protein," as well as detecting the formation of antigen-antibody complex between the polypeptide expressing products and antibodies present in the biological sample.

Claim 6 relates to an IVD kit used for detecting HIV-2 and comprises one or more isolated polypeptide expression product of HIV-2 selected from the group consisting of polymerase and env protein; reagents for detecting the formation of antigen-antibody complex between the polypeptide expression products and antibodies present in the biological sample; and a biological reference sample "lacking antibodies recognized by" the polypeptide expression products.

Institute Pasteur and Bio-Rad accuse Abbott of infringing the '728 patent through the sale of the two Abbott kits used for detecting antibodies to HIV-2 — Prism HIV O Plus and the Architect HIV Ag/Ab Combo — after its license to the patent was terminated in March.

The plaintiffs also accuse Abbott of breaching a contract, which granted it rights to Pasteur-owned patents, including the '728 patent. Another party granted Abbott a sublicense to the Pasteur patents in late 1991, and Bio-Rad eventually came to hold those predecessor-in-interest rights.

The 1991 licensing deal authorized Abbott to make and sell diagnostic kits "whose use or sale would infringe one or more valid claims of the licensed patents." In exchange, Abbott would pay royalties based on the sale of the licensed products.

According to the lawsuit, Abbott paid such royalties up to June 30, 2015. In December 2016, Bio-Rad notified Abbott that it was in breach of the licensing deal and gave Abbott 60 days to "cure its breach." In March, after Abbott failed to do so, Bio-Rad terminated the license, effective immediately.

The plaintiffs are seeking a jury trial, as well as unspecified damages.

On deadline, Abbott did not respond to a request for comment.