A US District Court earlier this month settled the interpretations of eight patents at the heart of a 4-year-old lawsuit pitting Enzo Biochem against defendants GE Healthcare, Affymetrix, PerkinElmer, Sigma Aldrich, Orchid Biosciences, Molecular Probes, and Roche.
Since it first filed the suits in 2002 and 2003, Enzo has alleged that the defendants, by selling its reagent kits improperly, are infringing 15 claims of eight different patents. The parties participated in a Markman hearing to define the interpretations of those claims in July 2005.
In the order, handed down July 10, Judge John Sprizzo of the US District Court in the Southern District of New York ruled that Enzo could indeed proceed with its litigation against the seven biotech firms. However, Sprizzo rejected many of Enzo’s interpretations of the eight patents, causing both Enzo and one of its opponents to claim a victory.
Enzo issued a statement last week arguing that “the ruling supports Enzo’s position that hundreds of defendants’ products infringe certain Enzo patents” and “opens the door for Enzo to not only pursue its patent infringement claims, but, as importantly, to also aggressively pursue its claims that defendants breached their contractual obligations to Enzo.”
A person familiar with Enzo’s position who wished to remain anonymous because he didn’t want to comment on ongoing litigation told BioArray News this week that, although the court constructed many of the claims in a manner that could be seen as favorable to Enzo’s opponents, Enzo sees the ruling as positive to itself. This is particularly the case because the ruling left mostly intact a key patent in its suit, US Patent No. 4,994,373, entitled “Method and structures employing chemically-labelled polynucleotide probes.”
Enzo officials could not be reached for comment.
What Did the Court Say?
According to the court, the ‘373 patent “relates to a method for quantifiably detecting a targeted polynucleotide sequence in a sample of biological and/or non-biological material employing a probe capable of generating a soluble signal.”
Although the court constructed many of the claims in a manner that could be seen as favorable to its opponents, Enzo sees the ruling as positive, particularly because a key patent in its case was left mostly intact.
During the Markman hearing, the court sought to settle disputes over whether the patent contemplates conducting the test by attaching the probe to the solid surface, as well as to better define “soluble signal.” In both cases, the court limited the scope of Enzo’s claims, prompting Roche Diagnostics to say last week that the court had ruled in its favor.
“Among its allegations, Enzo contends that Roche's AmpliChip CYP450 Test infringes Enzo's US Patent No. 4,994,373. However, Judge Sprizzo's order rejected Enzo's interpretations of both the testing format and the ‘soluble signal’ claimed by this patent, and instead agreed with interpretations by Roche Diagnostics and its co-parties,” Roche said in a statement released soon after Enzo‘s announcement.
“The Court adopted virtually all of the interpretations proposed by Roche Diagnostics and its co-parties relating to seven Enzo patents covered by the order,” the firm added.
Melinda Griffith, senior vice president and general counsel of Roche Molecular Diagnostics, said that the "order will allow [the company] to request a further ruling from the Court, declaring that Roche does not infringe on this patent."
None of the other parties in the case commented publicly on the ruling.
No Trial Date and No Word on Affy
While the court settled disputes between Enzo and the defendants over the claim construction in the case, it did not schedule a trial date for the litigation, now in its fourth year. Nor did the court discuss the separate litigation between Enzo and Affymetrix over a contract the two parties signed eight years ago.
According to Affymetrix’s most recent 10-K filing with the Securities and Exchange Commission, Enzo sued the company in the same US District Court in October 2003 for breach of contract, injunctive relief, and declaratory judgment after the firm claimed Affy violated a 1998 distribution agreement by improperly selling Enzo’s reagent kits. Enzo is also seeking to have some of Affy’s patents transferred into its own IP portfolio. Enzo terminated the agreement in November 2003.
Affy fired back with a complaint one month later alleging that “Enzo has engaged in a pattern of wrongful conduct against it and other Enzo labeling reagent customers by … asserting improperly broad rights in its patent portfolio, improperly using the 1998 agreement and distributorship agreements with others in order to corner the market for non-radioactive labeling reagents, and improperly using the 1998 agreement to claim ownership rights to [Affymetrix’s] proprietary technology.”
Affy also filed a notice of related case stating that its complaint against Enzo is related to the complaints against the other former Enzo distributors. A trial date for the litigation specific to Affy and Enzo has yet to be set.