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Qiagen, NeuMoDx Lose Patent Appeal in BD/HandyLab Dispute

NEW YORK – The United States Court of Appeals for the Federal Circuit on Friday terminated an appeal and thereby upheld a ruling against NeuMoDx parent company Qiagen regarding two of Becton Dickinson's HandyLab patents.

After an appeal to the United States Patent and Trademark Office, administrative patent judges affirmed a prior judgement that HandyLab patents 7,998,708 and 8,323,900 were not unpatentable due to obviousness.

The original lawsuit was filed by BD in 2019. It alleged that NeuMoDx had infringed on US patent numbers 8,273,308, 8,703,069, 7,998,708, 8,323,900, 8,415,103, and 8,709,787 which cover technologies surrounding the use of microfluidic cartridges for molecular diagnostic assays and instruments.

NeuMoDx — a startup that signed a merger agreement with Qiagen in 2018 and became a wholly owned subsidiary of Qiagen last year — filed counterclaims noting that it had a prior agreement with BD concerning the development and commercialization of the technology. It also filed an affirmative defense, namely that the patents were invalid and unenforceable under US patent laws due to prior art and other evidence that anticipates or renders obvious the claims.

The Patent Trial and Appeal Board previously ruled that the challenged claims of the '708 and '900 patents would have been non-obvious, specifically that a multi-lane microfluidic device would have been obvious at the time.

Qiagen appealed, and on Friday the USPTO responded and affirmed the original ruling.

Specifically, the board determined that Qiagen failed to demonstrate by a preponderance of the evidence that the challenged independent claims were obvious, or that a person skilled in the art would have had a reasonable expectation of success in creating a similar technology.

In contrast, the board viewed HandyLab's evidence as well as testimony from expert Allen Northrup as credibly demonstrating that the development of microfluidic PCR devices was a complex endeavor, and upheld the dismissal of the motion to dismiss.

"The board agreed with HandyLab that 'the development of microfluidic PCR devices was not routine and predictable by March 2006, but rather a very complex endeavor that presented challenges with regard to uniform heating, detection of small volume reactions, contamination, design, and configuration of a microfluidic network, and functionally interfacing the reaction instrument with control machinery,'" court documents state.