Year in Review: The Top-Five Legal Developments of 2016

Here are our picks for the top-five most significant legal developments in the world of biosimilars in 2016:

5) Congress passed and President Obama signed the 21st Century Cures Act.  Among other things, the Act modifies the standards and review processes for FDA evaluation of applications to market new drugs, and increases the incentives for drug companies to develop treatments for rare diseases.

4) The Federal Circuit held in Amgen v. Apotex that the BPCIA’s 180-day notice of commercial marketing cannot begin until after a biosimilar applicant has received FDA licensure, and that the notice of commercial marketing provision is mandatory and enforceable by injunction, even for an applicant that has engaged in the patent dance.  The Supreme Court declined to review the Federal Circuit’s decision.  

3) The Supreme Court affirmed the Federal Circuit in Cuozzo Speed Technologies v. Lee.  In the first decision addressing the new PTAB proceedings established by the America Invents Act, the Court held that the Patent Trial and Appeal Board’s (PTAB) determination on whether to institute an inter partes review is not appealable in most cases and that the PTAB’s broadest reasonable interpretation standard in claim construction is proper.  

2) States continue to pass biosimilar substitution laws. As we reported here, here, here, and here, several states passed laws in 2016 that allow pharmacists to substitute for a brand name biological product a less expensive biosimilar product that has been deemed interchangeable by the FDA.

1) Amgen v. Sandoz worked its way toward the Supreme Court.  If the Supreme Court decides to hear the case, it could clarify important provisions of the BPCIA related to resolving patent disputes regarding biosimilar products.

In July 2015, the Federal Circuit held a) that the disclosure procedures set forth in subsection (l)(2)(A) of the BPCIA (the “patent dance”) are not mandatory and a biosimilar applicant can choose between either disclosing application and manufacturing information or not disclosing such information and instead facing an immediate infringement action from the reference product sponsor; and (b) that a notice of commercial marketing pursuant to subsection (l)(9)(A) of the BPCIA can be given only after FDA approval of the biosimilar product, effectively extending the reference drug’s exclusivity by 180 days.  In February 2016, Sandoz filed a petition for a writ of certiorari, asking the Supreme Court to review the Federal Circuit’s interpretation of the BPCIA’s “notice of commercial marketing” provision.  In March, Amgen opposed Sandoz’s petition and also filed a conditional cross-petition for certiorari, challenging the Federal Circuit’s ruling that the patent dance is optional. Several entities filed amicus briefs supporting Sandoz’s petition.  On December 7, the Solicitor General filed a brief recommending that the Supreme Court grant both Sandoz’s cert petition and Amgen’s conditional cross-cert petition regarding how to interpret the BPCIA, and also siding with Sandoz on the merits of the questions. The Solicitor General’s recommendation that the Court grant cert is a very strong indicator that the Court will grant the petition and cross-petition.

Stay tuned to Big Molecule Watch for further legal developments in the world of biosimilars.