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USPTO Rejects Life Tech's Thermal Cycler Patent in Initial Ruling; EPO Upholds European Counterpart

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By Bernadette Toner

This story was originally posted on Nov. 19.

The US Patent and Trademark Office has rejected all 12 claims in a key US patent related to real-time PCR thermal cycler technology that is assigned to Life Technologies' Applied Biosystems subsidiary.

The European Patent Office, meantime, last week issued a decision to maintain the European counterpart of the patent in an "amended form."

The US patent, No. 6,814,934, and titled, "Instrument for monitoring nucleic acid amplification," was granted on Nov. 9, 2004 to inventor Russ Higuchi and assigned to Applied Biosystems.

In a "non-final action" issued last month, the USPTO rejected the claims of the patent because they are "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 hemogeneous nucleic acid amplification and detector," and assigned to Roche Molecular Systems.

In an "obvious-type double patenting" rejection, the USPTO essentially determined that the '785 patent, which covers methods for real-time PCR, presumes the existence of the thermal cycler instrument that is described in the '934 patent.

"Although the conflicting claims are not identical, they are not patentably distinct from each other because the conflicting claims within the '785 patent require a device with detector and thermal cycler, particularly where the container vessels are operably linked" to a device. "Such linkage necessarily provides an instrument or system in which the measurement or detection of fluorescence occurs while amplification is in progress without opening the container or vessel," the USPTO added.

"Thus, '785 patented claims 1-22 render obvious claims 1-12 of the '934 patent under re-examination."

The re-examination request was filed in March 2008 by a third-party requestor called Troll Busters, an IP firm that works on behalf of its clients to secure freedom to operate against patents that it considers to be invalid or overly broad.

Last month's rejection was actually the second non-final action that the USPTO issued in this case. The first, issued in January 2009, rejected all 12 claims based on lack of novelty, noting that they were "anticipated" by three other patents, including US No. 5,210,015, entitled "Homogeneous assay system using the nuclease activity of a nucleic acid polymerase" and assigned to Roche.

Applied Biosystems filed a response on March 31 that argued that the instrument and system require "some sort of integration, coupling, or other arrangement or configuration" that is not described in the '015 patent. However, in the non-final action issued last month, the USPTO noted that the claims of the '934 patent under re-examination do not specify any structural integration, coupling, arrangement, or configuration and maintained the rejection of those claims, while adding the double-patenting rejection.

"A second non-final office action in a re-examination is highly unusual," Jeff Oster, a Troll Busters founder, told PCR Insider. "In some respects, [Life Technologies] is lucky to get a second non-final office action to improve upon their prior weak response."

Life Technologies will have two months to respond to the latest claims rejection.

Vern Norviel, an IP attorney with Wilson Sonsini Goodrich & Rosati who is familiar with the case but does not represent any of the parties involved, noted that the non-final action means that it's still "very early in the ballgame here. The football analogy would be that it's the first quarter and they're down seven-zip."

Norviel added that double-patenting rejections are "extremely common," but that in most cases both patents are owned by the same party.

In this case, the finding is "unusual" since one patent is owned by Roche and the other by ABI — a result of a longstanding agreement between the two firms to split up the PCR patent estate that originated at Cetus, which was eventually acquired by Roche.

"What is required in a double patenting rejection is not normally a big deal. They say you will agree to have the same patents owned by the same party. But here it's a big deal because in fact the two patents are not owned by the same party. The other one is owned by Roche. So they have to figure out how to deal with that," Norviel said.

Norviel said that Life Technologies could try to narrow the claims of the patent or could "just argue" its case. "We'll have to see what they decide to do."

In the meantime, nothing much will change for licensees of the '934 patent, though the fact that the USPTO has rejected it would not work in Life Tech's favor if it decided to enforce the patent in court. "A court would definitely look at the fact that it's rejected in the patent office if they were to sue someone right now, and may not want to move the case forward until the patent office finishes," Norviel said.

Another issue is the timing of the patent, Norviel said. "The patent expires in April 2012, and they need to not only do something, but they need to do it relatively soon because if this were to languish on for a long period of time, they could end up in a situation where the patent is expired or nearly expired before they're even done in the patent office."

If the USPTO's decision stands, licensees "may not have to pay a patent tax" to Life Technologies going forward.

Oster said that in anticipation of this scenario, Troll Busters has already raised an undisclosed amount of financing to support an antitrust class-action lawsuit against Life Technologies to "recover the improper royalty and license payments" made for this IP.

He noted that it will likely be difficult for Life Technologies to argue against the most recent rejection without contradicting claims it has made in its "prior extensive file history."

A Litigious History

The '934 patent has already served as grounds for a considerable amount of litigation in the life science tools market.

In 2004, Applera, Applied Biosystems' parent company at the time, filed suit against Bio-Rad, Bio-Rad subsidiary MJ Research, and Stratagene for allegedly infringing the patent.

After a federal court granted an injunction preventing Bio-Rad from making and selling thermal cycler products that infringed Applera’s patents, Bio-Rad reached a settlement with Applera and Roche in February 2006. Then, after acquiring Stratagene in the summer of 2007, Agilent later that year took a license to the real-time thermal cycler instruments in research-related fields, which settled the litigation.

In addition, Fluidigm filed a complaint against AB in June 2008 in which it sought a declaration from the court that its BioMark technology did not infringe the '934 patent. That suit was settled in January of this year. Terms of the settlement were not disclosed, but a Fluidigm spokesman told GenomeWeb Daily News at the time that the agreement did not include the exchange of any money or any licensing of products.

"As we got into the prep for the trial activity we found that the two companies had some mutually interesting product opportunities, and exploring those opportunities was difficult with litigation pending between the two of us," the spokesman said.

Across the Pond

In Europe, the counterpart to the '934 patent, EP 872562, was granted in 2002. Over the next several years, several parties filed oppositions against the patent, including Bio-Rad, the UK secretary of state for defense, Eppendorf, Cepheid, MJ Research, and Corbett Research.

However, as the case proceeded, all of these parties withdrew their opposition, with the last opposing party, UK equipment distributor Bibby Sterilin, withdrawing its opposition in January of this year.

In an "interlocutory decision" issued in July, the EPO's Opposition Division determined that the patentee had addressed all questions raised by the opposition proceedings and noted that since "there are no longer any parties left in these proceedings" apart from the patentee, the EPO is "thus left in the position of either agreeing with the [patentee] or raising arguments of its own volition."

The EPO concluded that it saw "no reason to disagree with the substantive comments" made by the patentee.

Last week, the EPO formalized this decision and officially terminated the opposition proceedings.

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