Nucleonics, Ambion, and GenScript have come out swinging in their defense against a patent infringement lawsuit filed by Benitec, according to court documents.
In the suit, filed in April in the US District Court for the District of Delaware, Benitec has alleged that the three companies all have infringed on its US patent — number 6,573,099 — entitled “Genetic Constructs for Delaying or Repressing the Expression of a Target Gene” (see RNAi News, 4/2/2004). The patent essentially covers the knocking down of gene expression in plants, as well as animals, using DNA that transcribes double-stranded RNA, one strand of which has a sequence complementary to that of the target gene.
In its claim, Benitec is asking the court to find that Nucleonics, Ambion, and GenScript have infringed the ‘099 patent, and to permanently enjoin the three companies from engaging in further infringing activities. Benitec is also seeking treble damages from Nucleonics and Ambion for willful infringement.
As might be expected, the three companies named in the lawsuit have all denied the charges put forth by Benitec, but on top of this, the companies are charging that Benitec’s patent is invalid and unenforceable based on US patent law.
“They raised the standard objections to the validity of the patent, which is what everybody should be doing,” Richard Warburg, an IP lawyer and partner at the San Diego office of Foley & Lardner, told RNAi News. “In the biotech area, validity of the patent … is always challenged. There may be a few circumstances where you don’t challenge it, but that’s the main defense to an allegation of patent infringement — one, you don’t infringe; and two, the claims are invalid,” he said.
According to the court documents, the companies are challenging Benitec’s patent based on a handful of statutes under Title 35 of the United States Code. One of the allegations made by the defense under Title 35 is that Benitec was not the first to describe the invention. In part of its official response to Benitec’s legal complaint, GenScript states that Benitec’s invention “was known or used by others in this country, or patented or described in a printed publication in this or a foreign country” beforehand.
Another allegation against Benitec, being put forth by all three defendants, is that the ddRNAi technology is inadequately detailed in the ‘099 patent. According to Warburg, this charge suggests that a patent holder has “described an invention, but [not] enabled it — you’ve described what it is you want to do, but you haven’t told anybody how to do it [with] success.”
All three companies are also claiming that Benitec’s patent is an obvious one and failed to be novel to anyone with ordinary skill in the field of the invention, while Ambion alone has raised a jurisdiction issue by alleging that Benitec’s complaint fails to state a claim on which the Delaware District Court can legally act or for which relief can be granted.
Not all the defenses of the defendants, however, are completely run of the mill. For instance, Nucleonics is claiming that its activities fall under the “safe harbor” provided by Title 35, USC, section 271. This statute states in part: “It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product) … which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site-specific genetic manipulation techniques solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”
This defense, said Warburg, stems from a relatively new statutory exemption tied to the court decision in a case called Integra LifeSciences v. Merck. This ruling, which was recently affirmed by a Federal court, said that “if you are performing your infringing activity … to develop a drug to get FDA approval … it won’t be an act of infringement,” he said. Warburg noted, however, that the court ruling determined that this exemption will be “narrowly construed [and] won’t cover everything people are doing for FDA approval.”
Nucleonics, Ambion, and GenScript are all requesting the court find them not in infringement, and Nucleonics and Ambion are asking for a judgment that Benitec’s patent is invalid. Additionally, all three are seeking to recoup attorneys’ fees, which Warburg said is out of the ordinary.
“The statute [being claimed seeking legal fees] is rarely applied,” he said. “It’s only in very exceptional cases. In patent cases, you can get enhanced damages if you are the patentee and can prove that the actions by the infringer … [were] in a willful manner — and even then the judge may or may not enhance the damages,” Warburg said. “The [seeking of] attorneys’ fees is a rare circumstance and it’s usually based on behavior during the litigation that is way above and beyond the normal behavior that goes on at these things.”
In what might be indicative of some of Benitec’s bad behavior possibly going on during the court proceedings, GenScript has also charged that Benitec’s patent is unenforceable because it was “obtained directly or indirectly through inequitable conducts.”
GenScript did not elaborate on these “inequitable conducts” in its answer to Benitec’s complaint and stated that it was not required to do so. Benitec has filed a motion to dismiss this charge.
Further, Ambion has filed counterclaims asking for attorneys’ fees and to have Benitec’s patent invalidated. As opposed to simply seeking a ruling of patent invalidity and damages through its defense, Warburg characterized the counterclaim as “a lawsuit coming from the other side,” which would proceed even if Benitec dropped its own suit. Benitec has asked the court to dismiss Ambion’s counterclaims with prejudice.
Requests to Benitec, Ambion, Nucleonics, and GenScript for comment were not returned as of press time.