Allergan, Inc. and Duke University v. Sandoz, Inc. (Akorn, Hi-Tech Pharm., Apotex)

Docket No. 2016-1085, -1160

March 17, 2017


Brief Summary: DC finding of collateral estoppel and obviousness for asserted claims affirmed but reversed as to the unasserted claims of the Allergan’s ‘953 patent (“Sandoz, Inc. has not shown a continuing case or controversy….”) The FC panel also explained it “did not change the applicable legal standard” with Allergan II (FC 2014) but only “repeated” and applied that of In re Katz (CCPA 1982) (see FN2: “This court has not determined whether the Katz standard applies to reviews of prior art under the AIA’s § 102, nor does either party ask us to do so here.”).

Summary: Allergan appealed DC dismissal of its infringement case against Sandoz (“Allergan IV”) with prejudice based on collateral estoppel and obviousness determination. Six patents are involved, all generally relating to “a topical solution to treat hair loss or reduction” using bimatoprost (US 7,388,029; 7,351,404; 8,263,054; 8,038,988; 8,101,161; and 8,926,953 (all CONs of the ‘404 patent)). In “Allergan I”, the DC found in favor of Allergan regarding the ‘029 and ‘404 patents. In “Allergan II”, the FC reversed the DC, invalidated the ‘404 patent as obvious, and vacated the injunction against Sandoz. Following Allergan II, the DC granted Apotex’s motion for judgment on the pleadings and Allergan moved to dismiss its claims against the other defendants (Allergan III). While these suits were pending, Allergan’s application for the ‘953 patent was pending at the PTO and it submitted “ex parte declarations to the Examiner related to two prior art references used to invalidate the ‘404 patent.” These were “intended to show that one of the inventors…was an author oof the prior art references such that the references were no longer prior art under” § 102(a) and the ‘953 patent issued afterward (“one’s own work is not prior art under § 102(a) even though it has been disclosed to the public in a manner or form which otherwise would fall under § 102(a)” (citing In re Katz (CCPA 1982) and § 3(b)(1) of the AIA (enacted in 2011; ‘953 effective filing date in 2013) but noting in FN2: “This court has not determined whether the Katz standard applies to reviews of prior art under the AIA’s § 102, nor does either party ask us to do so here.”) The FC panel explained that the law of the regional circuit is applied to collateral estoppel (CE) reviews as these “are not unique to patent issues” (Soverain Software, FC 2015) and, therefore, the decision was reviewed de novo (Tuttle, 4th Cir. 1999) in view of the 4th Circuit’s definition of the five elements of CE (Sedlack, 4th Cir. 1998; Collins, 4th Cir. 2006) and FC precedent (Aspex Eyewear, FC 2013). Allergan argued CE should not apply here because “the issue sought to be precluded is [not] identical to one previously litigated”, “the issue was [not] actually determined in the prior proceeding”, and it did not have “a full and fair opportunity to litigation the issue in the previous forum.” The FC panel agreed with the DC that the asserted claims “are substantially similar to the invalidated claims” and “any differences…do not materially alter the question of invalidity” (Ohio Willow Wood, FC 2013). The FC panel also found the issue of “darkness” in the claims “was actually determined in Allergan I and Allergan II” (e.g., “discussed in the claim construction proceedings for the ‘404 patent” (Brain Life, FC 2014 (not discussed where “[n]either party request that any terms off the…method claims…be construed”)). Regarding a fair opportunity to litigate, Allergan argued it did not since the FC, with Allergan II, “changed the legal standard under § 102(a) by adding a requirement that the inventor be ‘responsible for directing the production of the publication’” but the FC panel disagreed (Allergan did not explain why it did not address this alleged change with the DC and the FC “did not change the applicable legal standard” but only “repeated” and applied that of Katz (CCPA 1982)). However, the FC panel also reversed the DC’s order granting CE and finding the entire ‘953 patent invalid, incuding unasserted claims since “Sandoz, Inc. has not shown a continuing case or controversy” regarding those claims (“[a]s in prior cases in which we have found unasserted claims not invalidated”, citing MedImmune, US 2007 and Carroll Touch, FC 1993).

This entry was posted in Anticipation (35 USC 102), Article III disputes, Collateral estoppel, Issue Preclusion, Obviousness. Bookmark the permalink.

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