As we close out another calendar year, we look back at the top legal developments of 2020 that could influence the market for biologics and biosimilars. While there were a number of case-specific decisions this past year that, undeniably, impacted the availability of biosimilars in the market, the five legal decisions and developments below will likely impact the legal strategy in the biosimilars space in 2021 and moving forward.
1. While the “Consolidated Appropriations Act” enacted just days ago on December 27 was focused on much more than biosimilars, it did contain two provisions which will undoubtedly impact the development of biosimilars moving forward. Most notably, the Act requires FDA to create a searchable, electronic database of biologics approval and to update it with patent information provided to the Reference Product Sponsor during the patent dance process. This moves the BPCIA one step closer to an “Orange Book” like system for patent information and will provide follow-on biosimilar developers with invaluable information regarding the patent landscape for an approved biologic. It remains to be seen how this change will further facilitate the development of multiple biosimilar products for a particular branded biologic.
2. In a precedential yet divided decision, the Federal Circuit Court of Appeals upheld the decision of the U.S. District Court for the District of New Jersey that patents covering ENBREL were valid and enforceable. As the first decision of the appellate court addressing substantively validity issues brought in a district court biosimilar patent challenge, it analyzed issues relating to ownership rights and obviousness-type double-patenting, written description, and obviousness, concluding, as the district court did below, that the challenged patents were not shown to be invalid.
3. In a case addressing the requirements of the notice of commercial marketing provision of the BPCIA, the Federal Circuit Court of Appeals upheld the denial of a motion for a preliminary injunction by the U.S. District Court of the District of Delaware that allowed for Amgen’s launch of its bevacizumab biosimilar (MVASI). Siding with biosimilar makers, the Federal Circuit held that a “biosimilar applicant that has already provided Section 262(l)(8)(A) notice regarding its biological product need not provide another notice for each supplemental application concerning the same biological product.” This decision by the Federal Circuit Court of Appeals came on the heels of an earlier decision by the same court to affirm without opinion pursuant to Federal Circuit Rule 36 the District of Delaware court’s denial of a separate motion for a preliminary injunction to preclude Amgen from launching its biosimilar KANJINTI (trastuzumab-anns).
4. For many brand biologic and biosimilar developers that have focused on AbbVie’s so-called “patent thicket” strategy surrounding its blockbuster product HUMIRA, the decision of the U.S. District Court for the Northern District of Illinois dismissing an antitrust complaint relating to that conduct is informative of the types of strategies that may be used to protect market exclusivity in the biologic space. Plaintiffs had alleged that AbbVie improperly exercised monopoly power over the market for adalimumab, both by amassing and enforcing a large patent estate (a so-called “patent thicket”) and by settling patent litigations with biosimilar manufacturers such that earlier entry in the European market was traded for delayed market entry in the United States. Plaintiffs alleged that these practices amount to a scheme to violate federal and state antitrust laws. But the Court ruled that the allegations, even if true, would not amount to an antitrust violation.
5. Finally, in the year that transitioned certain products from NDAs to BLA licenses, the so-called “deemed to be a license” provision of the BPCIA which finally arrived in March of this year, Congress made a number of clarifications regarding that transition, including the definition of a “biologic” in the Further Consolidated Appropriations Act of 2020 (“FCAA”). Among other things, the FCAA enacted statutory provisions that allowed FDA to continue reviewing applications for biological products that were filed before March 23, 2019 and remain pending as of March 23, 2020. The impact of that change in law meant that the 505 (b)(2) NDA submitted by Mylan for a follow-on insulin glargine product referencing LANTUS could continue to be reviewed for approval as an NDA by the FDA, without having to be refiled as a BLA. FDA approved Mylan’s insulin glargine product in June 2020. Also noteworthy, the FCAA enacted laws intended to mitigate concerns over reference product sponsors refusing to provide samples to generic/biosimilar developers, as a parallel to the earlier enacted CREATES Act.
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