Here is an update on activity in cases pending before panels of the Federal Circuit where the case involves at least one amicus brief. We keep track of these cases in the “Other Cases” section of our blog. Today with respect to these cases we highlight two new response briefs, one in a case raising questions related to whether a district court erred in denying a motion to intervene and to unseal court records and another in a patent case involving a challenge to a district court’s injunction requiring the delisting of patents from the Food and Drug Administration’s Orange Book; two new reply briefs, one in a patent case raising questions related to eligibility, claim construction, and infringement and another in a patent case raising questions related to eligibility; and five new amicus briefs in the patent case challenging the delisting of patents from the Orange Book. Here are the details.
New Responses
Since our last report, two response briefs have been filed.
Entropic Communications, LLC v. Charter Communications, Inc.
In its opening brief, the Electronic Frontier Foundation argued a district court erred in denying its motion to intervene and to unseal court records. It contended “[n]either controlling law nor the record support the district court’s conclusion that Charter and Entropic would be prejudiced by EFF’s intervention.” It maintained the district court’s denial of EFF’s motion to unseal should be reversed because “the court failed to acknowledge, much less apply, the Fifth Circuit’s law protecting public access to judicial records; it failed to conduct a document-by-document and line-by-line review of the materials before sealing them; and it never articulated specific countervailing interest that overrode the public’s right of access.” Finally, it rejected the district courts interpretation of a local rule as justification for its sealing practices, arguing it “conflict[s] with Fifth Circuit law protecting the public’s right of access.”
Since our last report, Charter Communications filed its response brief. It argues that, because “the motion to intervene was filed after the case was dismissed, EFF is not harmed by the district court’s denial of its motion to intervene and unseal records. Charter Communications points out the magistrate judge’s Report and Recommendation “is entirely unredacted and summarizes key issues’ for the public, and that there were no ‘unusual circumstances’ that militate in favor of a determination of timeliness.” Charter also contends the district court did not abuse its discretion because the “local rule clearly allows parties to file under seal when the district court has already granted authorization to seal confidential information designated under a protective order.”
Teva Branded Pharmaceutical Products R&D v. Amneal Pharmaceuticals of New York
In this patent case, Teva Branded Pharmaceutical Products R&D and Teva Pharmaceuticals USA challenge a district court’s injunction requiring them to delist five patents from the Food and Drug Administration’s Orange Book. In their opening brief, they argued “[t]he district court’s decision misapplies settled law making clear what it means to ‘claim’ a product: if the patent reads on the drug product, it ‘claims the drug’ as the statute uses that phrase.” In their view, [t]he district court’s statutory interpretation likewise disregards the applicable statutory definition of the term ‘drug,’ which includes not just any ‘article’ that treats an illness or affects the body’s functioning, but also any ‘component’ of such an ‘article.’” The appellants seek reversal of the injunction and allowing the litigation “to proceed as an ordinary Hatch-Waxman case.”
Since our last report, Amneal Pharmaceuticals filed its response brief. In it, it argues that “the Listing Statute is properly construed to permit listing a “drug product” patent in the Orange Book only if it has at least one claim requiring the active ingredient of the NDA to be present in the claimed invention.” It further argues that “[t]he Asserted Patents do not qualify under the Listing Statute for inclusion in the Orange Book” because “none qualify for listing as a ‘drug product’ patent that ‘claims the drug for which [Teva] submitted the application.'”
New Replies
Since our last report, two reply briefs have been filed.
Arendi S.A.R.L. v. Oath Holdings Inc.
In this patent case, Arendi filed an opening brief seeking reversal of three determinations by the district court “that led to judgments in Google’s and Oath’s favor on Arendi’s claims against them for patent infringement.” Arendi first contended that its patents “are patent-eligible because they reach improvements in computer functionality.” It further argued that “the district court misconstrued the terms ‘document’ and ‘while it is electronically displayed,’” which led the court to “import[] limitations from the specifications.” Finally, it claimed, “the court erred in granting summary judgment of no direct infringement” because “Oath made, sold or offered for sale infringing computer readable mediums.”
In Oath Holdings’ response brief, two appellees argued “Arendi lacks evidence of direct infringement, and cannot overcome dispositive evidence, including their own expert’s admissions, that Oath apps alone do not directly infringe the asserted claim.” Another appellee in this case, Google, filed its own response brief arguing that, because “Arendi has failed to challenge invalidity on appeal, its noninfringement argument (based on construction of the term ‘document’) provides no basis for disturbing” the judgment with respect to one patent.
Since our last report, Arendi filed its reply brief, arguing that the district court “entered final judgment in Google’s favor based only on the jury’s non-infringement verdict.” Therefore, it claims, “the jury’s invalidity finding cannot provide this Court an alternative basis for affirmance.” Additionally, Arendi states its “asserted claims are patent-eligible because they improve computers as tools.”
REGENXBIO Inc. v. Sarepta Therapeutics, Inc.
In this patent case, REGENXBIO Inc. and the Trustees of The University of Pennsylvania challenge a grant of summary judgment of invalidity by a district court. They argued in their opening brief that, “[f]or claims directed to compositions that incorporate features based on natural products, the patent eligibility analysis focuses on whether the claimed composition is ‘markedly different’ from any natural product.” They further contended that, “[u]nder that standard, the undisputed facts demonstrate that the cultured host cells of the . . . patent claims are markedly different from any natural product in both structure and function.” They argued that, “even though the facts were undisputed, the district court’s decision rests on unsupported and erroneous factual inferences that Sarepta invited the district court to draw in its favor.”
In its response brief, Sarepta Therapeutics argued the “Asserted Claims do not reflect the creation of a ‘new’ composition with ‘markedly different characteristics.’” It contended that “structural differences resulting from the isolation of the rh.10 sequences from the surrounding genetic material–such as the breaking of chemical bonds–are not sufficient for patent eligibility.”
Since our last report, REGENXBIO filed its reply brief. There, it argues the district court’s finding of patent ineligibility “fails to follow cases from this Court and the Supreme Court, including Chakrabarty and Myriad.” Although the court “cited the ‘markedly different’ standard from Chakrabarty,” REGENXBIO continues, “it failed to properly apply it.” The reply brief further argues that “Sarepta’s failure to consider all claim limitations is fatal to its arguments that the claims recite an unpatentable natural product.”
New Amicus Briefs
Finally, five amicus briefs have been filed since our last report.
Teva Branded Pharmaceutical Products R&D v. Amneal Pharmaceuticals of New York
Five amicus briefs were filed in one of the patent cases discussed above involving a challenge to a district court’s injunction requiring the delisting of five patents from the FDA’s Orange Book. The following parties filed amicus briefs all supporting affirmance:
- 52 Professors Of Law, Economics, and Medicine
- Sandoz Inc.
- The Federal Trade Commission
- 14 Professors Of Medicine and Law
- Deva Holding A.S.