Here is an update on recent en banc activity at the Federal Circuit in patent cases. Two new petitions have been filed. One raises questions related the substantial evidence standard for review of decisions of the Patent Trial and Appeal Board and the test for analogous art. The other raises a question related to after-arising technologies and the written description and enablement requirements. In addition, a response has been filed to a petition raising a question related to what patents must be listed in the Orange Book, along with three new amicus briefs supporting the petition in that same case. Here are the details.
New Petitions
Since our last update, petitioners have filed two new en banc petitions.
In Maxell, Ltd. v. Amperex Technology Limited, Maxell raised the following questions:
- “Whether objectively incorrect statements of fact regarding the challenged patent and the prior art reference can provide substantial evidence for findings of the Patent Trial and Appeal Board.”
- “Whether the test for analogous art should include the panel’s ‘analogous element’ test—separate from the established same-field-of-endeavor and reasonable-pertinence tests—looking only for a similar element in the challenged patent and the prior art reference, regardless of how, or the purpose for which, that element is used.”
In Novartis Pharmaceuticals Corp. v. Torrent Pharma Inc., MSN Pharmaceuticals raised the following question:
- “Whether, if patent claims are construed to cover (or embrace, include, encompass, etc.) later-arising technology—as Novartis argued below and the district court adopted—the patent must describe and enable such later-arising technology under 35 U.S.C. § 112(a) (35 U.S.C. § 112 ¶ 1 (pre-AIA)).”
New Response
In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, Amneal filed a response to Teva’s en banc petition. The petition asked the following question:
- “This case presents a question that is fundamental to the Hatch-Waxman framework: what patents must be listed in the Orange Book?”
Now, in its response, Amneal argues Teva’s petition should be denied. First, Amneal suggests “the panel correctly held that none of the asserted pure device patents ‘claims the drug for which the applicant submitted the [abbreviated new drug] application.'” Amneal, moreover, argues the panel properly exercised judicial restraint, and that en banc rehearings “are not a mechanism for answering hypothetical questions or rendering advisory opinions.” Next, Amneal contends, none of Teva’s arguments hold water because “the FDA has never policed the Orange Book.” Additionally, it argues, Teva’s petition “is premised on the fallacy that the panel decision requires patents to recite the active ingredient by name,” but, it continues, the panel did not hold as such. Amneal characterizes Teva’s argument as “boil[ing] down to little more than unsupported claims that the sky is falling on the Hatch-Waxman Act and pharmaceutical industry.” Moreover, Amneal argues, the court should reject Teva’s argument that the panel decision conflicts with the law of indefiniteness because the panel decision does not address it. Finally, it maintains, Teva’s “summary re-hash of its proposed constructions of ‘claims’ and ‘drug'” are “taken and defined outside the context” of the relevant statutes.
New Amicus Briefs
Since our last update, three new amicus briefs have been filed in Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the case discussed above. One of the amicus briefs supports Teva’s petition; the other two do not support either party but support rehearing.
- In its amicus brief, Sanofi challenges the panel’s decision. Sanofi argues the panel’s interpretation of “the listing provision to require Teva to delist patents on the device component . . . is wrong” because it “conflicts with precedent, disregards the controlling definition of ‘drug,’ ignores FDA’s long-held views, and unsettles the industry’s understanding of the statutory framework.” Additionally, Sanofi suggests, the panel’s decision “could even be misread as excluding genus patents.” Sanofi warns the panel’s decision “threatens to upset the Hatch-Waxman regime on which innovative and generic manufacturers have come to rely for over 40 years.”
- In its amicus brief, PhRMA and BIO take no position on whether “Teva’s patents that ‘focus’ on ‘device components’ of an inhaler fall within the scope of the statutory obligation to identify and list any patent that ‘claims the drug’ and ‘is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent.'” But, they argue, “the panel opinion’s interpretive analysis reflects certain foundational errors that overcomplicate what should be a straightforward statutory inquiry.” PhRMA and Bio call for the court “to revisit its statutory analysis and to further underscore that the ultimate holding in this case is limited to the narrow question presented by Teva’s patents.”
- In its amicus brief, AstraZeneca argues “ambitious litigants could seek to extend the panel’s decision to other broad categories of patents . . . [b]ecause the panel did not limit its reasoning to the patents at issue.” AztraZeneca further warns that, “[i]f uncertainty about the scope of the panel’s decision were to cause [new drug application] holders not to list these patents in the Orange Book . . . the established Hatch-Waxman system for the orderly resolution of patent disputes would be threatened.” AstraZeneca supports en banc rehearing to address “the uncertainty the panel decision has created.”