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Appeals Court Upholds Invalidation of ABL-held Patents on Computerized Treatment Selection Methods


SmartGene said this week that the United States Court of Appeals for the Federal Circuit has upheld a favorable ruling from the US District Court for the District of Columbia that invalidates two patents held by Advanced Biological Laboratories that are at the heart of a nearly seven-year lawsuit between the companies.

According to court documents dated Jan. 24, the appellate court agreed with the lower court's summary judgment that the claims of US Patents 6,081,786 and 6,188,988 — both covering computerized methods for selecting treatment regimens for patients with known diseases — are ineligible for protection under section 101 of US patent law.

Specifically, the appellate court agreed with the district court's position that the first claim of the '786 patent, which describes the architecture of the system, the data it uses to make decisions, and the results it provides, "falls outside the eligibility standards of section 101 as that provision has been constructed," the ruling states.

The DC Court made that decision after hearing arguments from SmartGene that this particular claim was representative of all the claims of both patents and that the claim did not meet the requirements for section 101 — the implication being that all other claims in both patents are also ineligible. The DC court decided that claim 1 "does 'no more describe … an abstract mental process engaged in routinely, either entirely within a physician's mind, or potentially aided by other resources in the treatment of patients,'" according to documents,

The appellate judges also disagreed with ABL's assertion that the district court "erred" when it invalidated all of the claims of both of its patents, stating that the company's arguments have no merit.

Commenting on the court's decision, David Ellis, SmartGene's president, said in a statement that the successful litigation "removes the threat of these patents from the landscape of personalized medicine," the key motivating factor in SmartGene's decision to pursue legal action against ABL in the district court in DC after attempts to get the United States Patent and Trademark Office to invalidate the patents failed, he told BioInform this week.

According to court documents, ABL first filed suit against SmartGene in 2007 in the Eastern District of Texas alleging that the company's system infringed on claims contained in the '786 and '988 patents. Founded in the late '90s in Switzerland, SmartGene provides web application services that support genetic sequencing testing applications — primarily for infectious diseases but also human genetics — in clinical and research laboratories and academic medical centers. Its customer base includes LabCorp, Quest, and a number of teaching hospitals in Europe.

That first case was ultimately dismissed in 2008. That same year, SmartGene filed a suit against ABL asking the courts for a declaratory judgment that both patents were ineligible for protection under section 101. ABL fired back asserting that SmartGene's system infringed on two claims in both of its patents. At this point, SmartGene submitted a request for reexamination of the patents to the USPTO arguing that they were invalid on the basis of prior art, which is governed by a separate section of patent law. At about this time, Robert Schafer, a professor of medicine at Stanford University who developed an HIV database that ABL claimed violated its patents, also submitted two requests for reexamination to USPTO. Together, these requests delayed legal proceedings for over two years while USPTO reviewed the patents, Ellis said. The agency would eventually uphold the validity of the patents.

That disappointing response from USPTO prompted SmartGene to change its strategy. "We decided there are various ways we can try to tackle this problem," Ellis explained. On the one hand, "we can rely on the fact that no reasonable interpretation of these claims would cause us to be an infringer of these patents and therefore we can just follow the path of litigation and demonstrate non-infringement." However, the quicker and more broad-reaching solution would be to try to "invalidate the patents completely and just remove them from the landscape and therefore they will cease to be a threat to any organization" within the community, he said.

That’s when SmartGene decided to submit a motion for summary judgment to the DC district court where it argued that all the claims of both patents were ineligible under section 101. It was in this motion that company argued that the first claim of the '786 patent represented all other claims in both patents and that claim 1 of the '786 patent did not meet section 101 requirements. According to the appellate court document, ABL did not contest this assertion in its initial response in the DC court — which accepted the argument — but this was one of its points of contention in its appeal, which the federal circuit court ultimately rejected.

Commenting on the court's ruling, James Cuticchia, an attorney with AJC Legal Services who is not affiliated with the case, noted that although the appellate court sided with the earlier judgment, it has made clear that its decision should not be cited as precedent and so this ruling does not create a new case law. However the decision "affirms the longstanding law that you can't patent an idea," he told BioInform in an email. "The patents in question attempt to perform, using a computer, mental processes [but] 'without more significance,'" he said. In order to be patentable, the system "would have to [do] something more."

Cuticchia also noted that a successful appeal on ABL's part might have had more than a passing effect on the personalized medicine arena. "If the case fell the other way, arguably this could have been a significant blow and detriment to the development of personal medicine," he said. "It would in essence, have given the keys to the kingdom to a single company. Almost every 'personal medicine' diagnostic company could have fallen to patent infringement suits. These patents were too broad."

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