Enzo Says Hologic Infringes Genetic Testing Patent

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By John T. Aquino

Oct. 5 — Hologic's products for detecting the presence of cancers and HIV/AIDS in clinical samples infringe an Enzo Life Sciences Inc. patent, Enzo alleged Oct. 3 in federal district court ( Enzo Life Sciences, Inc. v. Hologic, Inc., D. Del., No. 1:16-cv-00894, filed 10/3/16 ).

Enzo, which is based in New York, asserted in the U.S. District Court for the District of Delaware that Hologic's “capture” technology in its Progensa PCA3, Aptima and Procleix products infringes Enzo's U.S. Patent No. 6,221,581. Enzo asked the court for a jury trial, damages, “enhanced” damages because the infringement was willful, attorneys' fees and costs and an order that Enzo get a compulsory ongoing licensing fee.

The lawsuit is the latest in a series of both court and agency litigation between Enzo and Hologic in the competitive market of genetic testing, in one of which Enzo sued Hologic and 10 other life sciences companies. Depending on how the market is defined, analysts such as Grand View Research Inc. and Mordor Intelligence estimate that the global value of the genetic testing market will range from $10 billion to $25 billion by 2022.

Both Enzo and Hologic declined Bloomberg BNA's request for comment about Enzo's Oct. 3 lawsuit. In response to a question as to whether the new litigation might grow to resemble that of 2012, an Enzo spokesman told Bloomberg BNA in an Oct. 5 e-mail: “We have not as yet filed similar suits, and are not commenting as to whether the company plans to do so.”

Background of Other Litigation

While Enzo's new lawsuit is for infringement of a patent for finding genetic mutations and defects, Enzo sued 11 life sciences companies, including Hologic, in separate 2012 lawsuits for infringement of its patents for genetic identification and testing (10 LSLR 15, 7/22/16). Five of the 11 companies have reached settlements with Enzo. Six, including Hologic, haven't, and the lawsuits against them are ongoing.

Enzo also filed litigation in 2015 in the federal district court in Delaware alleging that Hologic's Progensa PCA3, Aptima and Procleix infringed a different Enzo patent, U.S. Patent No. 7,064,197. The litigation has been stayed pending the outcome of the 2012 lawsuit. On March 30, 2016, Hologic filed a petition for the Patent and Trademark Office's Patent Trial and Appeal Board to potentially invalidate the '197 patent.

Alleged Willful Infringement

Hologic's global diagnostic product revenue was $1.2 billion in its FY 2015, according to its annual report, and $903 million for the first nine months of FY 2016, according to its July 27 filing with the Securities and Exchange Commission. The life sciences segment of Enzo's parent company Enzo Biochem had global 2015 annual revenues of $15 million, according to Enzo Biochem's annual report.

Enzo Life Sciences wrote in its complaint that its '581 patent discloses novel processes useful for separating or isolating nucleic acids of interest from samples. One such process comprises forming a multi-hybrid complex comprising a nucleic acid strand of interest, a second nucleic acid strand that is fixed or immobilized to a solid support, and a third nucleic acid strand that is capable of forming hybrids with both the nucleic acid of interest and the nucleic acid fixed or immobilized to the solid support.

According to Enzo's complaint, the result of the Hologic “target capture” approach that is used in Progensa PCA3, Aptima and Procleix is a multihybrid complex that is fixed to a magnetic microparticle and comprises three nucleic acid strands: the nucleic acid of interest or target, the capture oligomer, and the oligonucleotide fixed on the magnetic microparticles.

Enzo alleged that Hologic knowingly infringed the '581 patent. Hologic clearly knew about that patent because it referenced it in applications for five subsequently issued patents, Enzo stated.

The complaint was filed by Farnan LLP, Wilmington, Del., with Desmarais LLP, New York, of counsel.

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story: Randy Kubetin at rkubetin@bna.com

For More Information

The complaint is at http://src.bna.com/i9Q.

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