An Invitrogen official said that the firm will seek damages under willful infringement as its patent case against Clontech Laboratories was sent back to the US District Court by an appellate court last month.
The patent-infringement litigation dates back nine years, and Invitrogen has claimed that Clontech infringes three of its US patents numbers 6,063,608; 5,244,797; and 5,668,005 all of which cover embodiments of the firm's reverse transcriptases. The intellectual property relates to mutations that disable the RNase H activity of native reverse transcriptase, the company said.
In this particular decision, the US Court of Appeals for the Federal Circuit found that Clontech's PowerScript products infringed Invitrogen's '608 patent, which was issued on May 16, 2000. However, also that year, the district court had consolidated the claims of all three patents, with the '608 patent taking priority.
Invitrogen said in a statement last week that Clontech's PowerScript products and their customers' use of them "are not licensed under these patents."
"This case has been going on for nine years, and this is not the first appeal. There have been a number of challenges that Clontech has raised, and quite frankly, they've lost on all of those validity challenges they've raised to date."
Specifically, the appellate court made three determinations all in Invitrogen's favor.
The first ruling overturned the district court's verdict that Invitrogen's patent is invalid, saying that two scientists at Columbia University had conceived Invitrogen's claimed invention first and had "diligently reduced it to practice." Invitrogen claimed in its appeal that the district court had "misread the facts and misapplied the law to award … [one of the Columbia University researchers] priority of invention." The appellate court agreed.
The appellate court also affirmed two partial summary judgments made by the district court that had favored Invitrogen and were challenged by Clontech: that the claims in the suit were enabled and satisfied written description requirements, and Clontech's PowerScript RT product literally infringes claims in the '608 patent.
The appeals court remanded the case back to the US District Court for the District of Maryland for further proceedings, which is likely to include claims of willful infringement by Invitrogen as well as a request for an injunction against Clontech.
"From our perspective, what we are going to address with the district court will be damages, willfulness, and injunction," said Alan Hammond, chief intellectual property counsel for Invitrogen. "Perhaps there will be consideration of infringement of the other patents that are part of the suit as well."
Hammond told BioCommerce Week that the firm had not yet asked for a specific amount in damages. But, if the district court finds that Clontech willfully infringed Invitrogen's patents, Invitrogen could seek triple the amount in damages as well as attorneys' fees.
"This case has been going on for nine years, and this is not the first appeal," Hammond said. "There have been a number of challenges that Clontech has raised, and quite frankly, they've lost on all of those validity challenges they've raised to date."
Clontech officials did not respond to a request for comment. The business was recently sold by Becton Dickinson to Japanese firm Takara Bio for $60 million (see BioCommerce Week 7/7/2005).
Invitrogen said that it sells "more than 100 different products" based on the reverse transcriptase technology, including its SuperScript RT and ThermoScript. Hammond said he could not disclose the annual revenue of the products infringed by Clontech, as that information is confidential under a protective order.
Are Stratagene and Incyte Next?
Invitrogen still has two legal actions pending against Stratagene and Incyte for infringement of its reverse transcriptase patents. Hammond said that those two cases have been stayed by the court due to "procedural issues."
However, it is possible Invitrogen will pursue those cases once the litigation with Clontech is finalized. "We preserved our rights in those other cases," he said.
The case against Stratagene claims infringement of Invitrogen's patents through the sale of its StrataScript reverse transcriptase products. Incyte is developing a reverse transcriptase inhibitor against HIV that is currently in Phase II studies.
Edward Winnick ([email protected])