Both Sides Claim Victory in Clear Aligner Patent Case

Dentistry Today


Recent decisions in an ongoing case before the United States Patent and Trademark Office (USPTO) between Align Technology and ClearCorrect LLC have left both sides claiming victory. The case began in 2011 when Align alleged that ClearCorrect infringed the claims of 9 Align patents. The case was stayed in 2012 pending resolution of a concurrent proceeding in the International Trade Commission, but the stay was lifted in January 2017. 

Align’s Position 

On February 22 and March 22, the USPTO issued re-examination certificates confirming the patentability of all challenged claims of Align’s US Patent Nos. 5,975,893 and 6,398,548. Align was not required to amend or narrow any of the challenged patent claims, which all were confirmed based on the existing claim language. Align is asserting both confirmed patents in its pending patent infringement lawsuit against ClearCorrect in the Federal District Court, Southern District of Texas.

These patents are in addition to 3 Align patents—6,217,325; 6,722,880; and 8,070,487—that the USPTO issued re-examination certificates for confirming the patentability of all challenged claims, as announced by Align on February 16. The USPTO confirmed as valid all of the claims in these 5 patents, 4 of which are asserted by Align against ClearCorrect, in 2017.

Also, Align provided an update on the Patent Trial and Appeal Board (PTAB) inter partes review (IPR) of its US Patent No. 6,699,037 instituted in May 2016 based on a petition filed by ClearCorrect. Align did not assert the patent against ClearCorrect. On March 24, the PTAB issued its final written decision finding that claims one, 2, 9, and 10 of the patent are invalid. The other unchallenged claims remain valid and enforceable.

Although unrelated to the Southern District of Texas infringement litigation against ClearCorrect, Align believes the PTAB erred in its decision and intends to appeal to the Court of Appeals for the Federal Circuit.

“We are pleased that, after reviewing 4 of the 9 patents asserted against ClearCorrect in the Southern District of Texas infringement action, the Patent and Trademark Office has now issued re-examination certificates confirming that all the claims of those 4 asserted patents are valid and enforceable,” said Roger E. George, Align vice president and general counsel.

“While the PTAB’s ruling regarding the ’037 patent is disappointing, it is important to note that Align is not asserting the ’037 patent against ClearCorrect in the Southern District of Texas infringement litigation or in any other current patent litigation, and we do not expect this decision to impact our infringement case against ClearCorrect.”

ClearCorrect’s Position 

ClearCorrect regards the PTAB’s cancellation of all challenged claims of Align’s ’037 patent as a victory, noting that the patent contained key concepts and claims similar to those featured in the pending patent infringement case that Align filed against ClearCorrect in 2011. This ruling was the final result of the IPR that ClearCorrect initiated in 2015, as the panel of administrative patent judges found that ClearCorrect demonstrated that Align’s claims were unpatentable because they were obvious combinations of known technology.

Also, ClearCorrect claims, this decision directly contradicts the recent ex parte re-examinations of related Align patents at the USPTO. Although those re-examination decisions found in favor of Align, ClearCorrect says, they featured the same claim terms and prior art discussed in the IPR. All re-examination proceedings, unlike IPRs, are one-sided, so the USPTO did not have the benefit of a rebuttal from ClearCorrect, the company states. 

“The PTAB’s decision completely unravels the one-sided record of the re-examinations. With the complete story in hand, the PTAB correctly concluded, like many others in the industry, that the MBA students who founded Align Technology simply leveraged off-the-shelf components,” said Scott A. McKeown, ClearCorrect’s lead counsel and a partner with the law firm of Oblon, McClelland, Maier & Neustadt in Washington, DC.

“Although the reviews and re-examinations were conducted concurrently, it appears that Align did not provide the patent examiners with ClearCorrect’s IPR trial brief. The IPR decision highlights the fact that the re-examinations would not have concluded in Align’s favor except for the missing review briefing. These missing briefs, in addition to the IPR undermining the flawed reasoning expressed in the re-examinations, will likely result in the re-examined patents being rendered unenforceable,” said McKeown.

Several Align patents will expire in October, but there is one remaining US lawsuit between ClearCorrect and Align at the United States District Court for the Southern District of Texas. ClearCorrect expects the PTAB’s decision to directly affect Align’s claims in court as the bulk of the arguments hinge on the art and claims presented during the review, ClearCorrect says. The ruling from the PTAB also will demonstrate that Align did not provide the necessary documents to the USPTO examiners, so the enforceability of these re-examined patents in court will be in jeopardy, ClearCorrect says.

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