Here are our picks of some legal developments to keep an eye out for in the new year:
- Federal Circuit Decisions on Bevacizumab and Trastuzumab Preliminary Injunctions: Appeals are pending on the District of Delaware’s denial of preliminary injunctions in cases brought by Genentech against Amgen regarding Amgen’s bevacizumab and trastuzumab biosimilar products. The Delaware decisions paved the way for Amgen’s launches of both biosimilar products over the summer. Decisions in the appeals could provide significant guidance on the circumstances in which it is appropriate for a preliminary injunction to be granted to bar a biosimilar launch and the requirements (if any) for providing notice of commercial marketing as to approved supplemental aBLAs.
- Insulin to Be Regulated Under the BPCIA: Beginning on March 23, 2020, the FDA will begin to accept aBLAs for biosimilar insulin products referencing previously approved insulin products. Prior to this date, insulin products have been approved pursuant to New Drug Applications and, thus, insulin generics were not eligible for approval as aBLAs. In 2020, watch out for the first insulin aBLAs.
- Constitutional Challenge to the Affordable Care Act: As we reported, the Northern District of Texas ruled in a case brought by several states that the individual mandate of the Affordable Care Act is unconstitutional, that the remaining provisions of the ACA are not severable from the mandate provision, and that the entirety of the ACA (which includes the BPCIA) is therefore invalid. The Fifth Circuit has since affirmed the district court’s finding that the individual mandate is unconstitutional, now that the tax on the uninsured has been removed from the law by Congress. The Fifth Circuit remanded, however, for further analysis by the district court as to whether the mandate provision of the ACA is severable from the rest of the law. Watch out for further decisions on the issue in 2020.
- Continued Constitutional Challenges to IPRs: In 2019, the Federal Circuit held that application of the IPR procedure to patents issued prior to the enactment of the America Invents Act, which created IPRs, is constitutional. The issue has come up in several cases and there will likely be further appeals to the Supreme Court, particularly given that the Court appeared to invite appeal on this issue in a prior decision. Further appellate activity in the Arthrex case, concerning the constitutionality of the appointment of PTAB judges, may also affect pending IPRs and pending appeals from PTAB decisions in IPRs.
- Potential Legislation on Drug Pricing and Patent Issues: 2019 saw a lot of activity in Congress with many bills introduced that, if enacted, could bring changes to the pharmaceutical and biologics industry and related patent litigations. Bills were introduced covering a wide range of issues, including patent listings in the Purple Book, coverage for biosimilars in Medicare Advantage plans, increased reimbursement rates for biosimilars under Medicare Part B, and antitrust liability for “product hopping” and “patent thickets.” We’ll be watching in 2020 for further action on these and other proposals.