Chief Judge Stark Issues Post-Trial ANDA Decision

September 1, 2016

Publication| Intellectual Property

In UCB, Inc. v. Accord Healthcare, Inc., C.A. No. 13-1206-LPS (D. Del. Aug. 12, 2016), Chief Judge Stark issued a post-trial decision following an ANDA trial held in December 2015. The Court began its 96-page opinion setting forth 54 pages of findings of fact. The Court noted that Accord Healthcare, Inc. had stipulated to infringement and relied solely on a defense of invalidity. Accord sought to prove at trial that the asserted claims were invalid for obviousness-type double patenting, obviousness, anticipation, indefiniteness, and/or improper reissue. Chief Judge Stark found that Accord failed to prove that any of the asserted claims of the patents-in-suit were invalid. Regarding obviousness-type double patenting, the Court recognized that it was an appropriate challenge, due to the patents having the same inventor and the earlier patent not serving as prior art for the latter, but held that the claims were “patentably distinct” and not invalid due to double patenting. Chief Judge Stark also went through the objective indicia of non-obviousness and found that all factors supported a finding of non-obviousness. He further found that the claims were not anticipated, nor were they indefinite. Finally, after going through the prosecution history, Chief Judge Stark found that the reissue (following a withdrawal due to the filing being one day late under the pre-American Inventors Protection Act of 1999 (“AIPA”) rules) was not an intentional surrender of the original priority date and that the AIPA’s new, extended period applied retroactively to fix the prior timing mistake. Thus, the patent was not invalid due to improper reissue.

Key Points: This post-trial decision is an example of the careful analysis that goes into post-trial ANDA opinions. Chief Judge Stark’s decision was issued about six months after post-trial briefing closed and eight months after trial ended. During that time, the Court held two teleconferences regarding the regulatory stay and the pending PTO/PTAB actions on the patents.

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