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USPTO to Reexamine Roche Nucleic Acid Amplification and Detection Patent

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By Ben Butkus

Intellectual property watchdog firm Troll Busters has requested a reexamination of a patent owned by Roche Molecular Systems and related to nucleic acid amplification and detection methods used in clinical research and diagnostics, according to documents filed recently with the US Patent and Trademark Office.

The patent reexamination is part of a broader strategy on the part of Troll Busters to challenge a "PCR patents duopoly" enjoyed by Roche and Life Technologies, Troll Busters representative Jeff Oster told PCR Insider this week. The firm is also trying to dismantle this alleged duopoly through a false patenting lawsuit it filed against the companies and several of its licensees earlier this year; as well as an ongoing patent reexamination regarding Life Technologies' thermal cycler technology.

And, Oster suggested, the organization has only just begun in its quest to discredit PCR-related patents that are owned by Roche, Life Tech, and others, and that Troll Busters sees as stifling innovation and driving up the cost of healthcare.

"You can say that Troll Busters is getting busy," Oster said. "Some of these patentees certainly are aware that I am on the case."

In the most recent patent reexamination request, filed last month, Troll Busters has asked the USPTO to reexamine all claims of US Patent No. 5,804,375, assigned to Roche Molecular Systems and entitled "Reaction mixtures for detection of target nucleic acids;" and on which David Gelfand and others are listed as inventors.

According to its abstract, the patent protects a process of detecting a target nucleic acid using labeled oligonucleotides, in which the 5'-to-3' nuclease activity of a nucleic acid polymerase is used to cleave annealed labeled oligonucleotide from hybridized duplexes and release labeled oligonucleotide fragments for detection. "This process is easily incorporated into a PCR amplification assay," the patent's abstract states.

According to Troll Busters' request, the claims of the patent are invalid under 35 USC 102 and 35 USC 103, which cover novelty and loss of right to patent and non-obvious conditions for patentability; and under the equitable doctrine of obviousness type double patenting.

"By demanding significant (up to 20 percent royalty payments) financial consideration before allowing research to be performed or diagnostic tests to be run, the '375 patent owner (Roche Diagnostics, the parent of Roche Molecular Systems) is attempting to limit essential clinical diagnostic tests into an artificial monopoly," the reexamination request states.

"This not only harms scientific advance here in the US, but also has a harmful economic impact on Americans by diverting taxpayer dollars in Medicare and Medicaid and private insurance dollars to pay off unworthy monopolies," the request adds.

Troll Busters notes in its request that the '375 patent was filed as US patent application 08/425,941 on April 25, 1995, as a continuation of US Patent No. 5,487,972; which in turn was a continuation-in-part of US Patent No. 5,210,015 filed on August 6, 1990.

Troll Busters claims that the '375 patent is "an improper extension of patent term over the grandparent '015 patent that has already expired," and should therefore be invalidated under the doctrine of obvious type double patenting. In total, the request lists 17 "substantial new questions of patentability" based upon the claims of the '375 patent having a priority date of Aug. 6, 1990, which is the filing date of the grandparent '015 patent.

"When you're prosecuting a patent and you have an [obviousness type double patenting] rejection, it means that [your] patent claims are not distinct from patent claims of another patent in your family or also owned by the patentee," Oster told PCR Insider.

"Here you have improper extension of monopoly of the original grandparent Gelfand patent, the '015 patent," Oster said. "On one level, the first two [substantial new questions of patentability] are improper extension of monopoly. Therefore, you can either argue that no, these claims are distinct from the grandparent or parent Gelfand patents; or you can file a terminal disclaimer," which would result in the immediate expiry of the '375 patent. "And that's the Hobson's choice that Roche faces here," he added.

A Roche spokesperson declined to comment on the reexamination. According to Oster, the USPTO has informed him that Roche also declined to file a statement in response to the reexamination request; thus, "the next action from the patent office will be the first office action" and is expected in a matter of weeks, he said.

Oster told PCR Insider that some aspects of the '375 reexamination are similar to that of another reexamination initiated by Troll Busters in 2008 against US Patent No. 6,814,934 entitled "Instrument for monitoring nucleic acid amplification," assigned to Applied Biosystems (now Life Tech) and naming as an inventor Russ Higuchi, among others (PCR Insider, 12/3/2009).

In three "non-final actions" issued in December 2009, November 2010, and May of this year, the USPTO rejected the claims of the patent because they were "not patentably distinct" from those of another Higuchi invention that was awarded a patent in 2001 — US Patent No. 6,171,785, entitled "Methods and devices for homogeneous nucleic acid amplification and detector," and assigned to Roche Molecular Systems. Oster said that the '785 reexamination is still ongoing due to a set of "extraordinary circumstances" involving a separate challenge from another law firm that may have delayed the reexamination process.

Nevertheless, "from a legal standpoint, there are some similarities between the Higuchi and the Gelfand [re-exam] … in that in Gelfand it's extending the monopoly beyond its term. And that's why the first two substantial new questions of patentability … are obviousness-type double patenting."

One difference between the two cases, however, is "the notion of forcing the patentee to file a terminal disclaimer," which would give the later patent the same expiration date of the parent patent, and was "something you could not do because of the way the PCR tech was divided between Roche and ABI."

Particularly telling evidence in the '375 patent re-exam is a declaration by Fred Kramer, a researcher at the Public Health Research Institute Center at the University of Medicine and Dentistry of New Jersey and New Jersey Medical School, who has filed for and been awarded several patents related to so-called "molecular beacons" technology for PCR and real-time PCR assays.

Kramer's declaration outlines how he and colleagues first filed for their earliest patent covering molecular beacons in November 1993, prior to business dealings with Roche Molecular Systems that began in 1995.

The declaration also provides a timeline of business meetings and seminars culminating in an April 1998 meeting in which Kramer was allegedly informed by a Roche patent agent that "all the claims that will issue in the '375 patent (which was filed in April 1995) both covered the making, using, or selling of molecular beacons, and that the converse was also true that the soon-to-issue claims were anticipated by my molecular beacons patent having a priority date of November 12, 1993."

Essentially, Oster said, Kramer's declaration is a record of "what Roche knew and when they knew it. By interweaving the ['375 patent] file history with Kramer's meetings with Roche, it allowed the story to be told. If I were Roche I would not be proud of that history at all. It's out there for the world to see, it's factual, and people can draw their own conclusions."

Regardless of what happens with the '375 patent reexamination, Oster said that it is likely the first of several such patent challenges that Troll Busters is working on in the PCR space; and that it represents a larger problem in the industry underscored by a lawsuit filed earlier this year by Troll Busters against Roche, Life Tech, and several other firms accusing them of marking products or services falsely because they are based on expired patents.

Of the 12 defendants named in that lawsuit, "they're divided between two licensors — that would be Roche and Life Tech — and 10 licensees," Oster said. "Focusing on the licensors, they represent what has become a PCR patents duopoly. We've been looking at abuses of that power … both from the standpoint of this particular re-exam of one of the Roche patents; but also in terms of the false marking and how the licensors force the licensees to mark their product, and then continue to try and collect royalties falsely beyond the term of the patents."

According to the re-exam request, a review of PCR licensing that Troll Busters carried out as part of its false marking suit found that the '375 patent "is not licensed independently." Rather, Roche "groups together patents and requires that a licensee take all the patents in such a group as part of a license in order to practice any form of PCR procedures."

This grouping, the re-exam request states, is "designed to include (perhaps unnecessary) patents that have longer terms such that the royalty paid under such a license continues for a longer term than the patent claims that, perhaps, would be infringed."

Oster said that the overall theme was one of "anti-competitive behavior going back to the notion that the original Kary Mullis PCR patents have expired, and yet the price of PCR reagents, and the cost of healthcare to you and me as taxpayers, has not come down."


Have topics you'd like to see covered in PCR Insider? Contact the editor at bbutkus [at] genomeweb [.] com.

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