The Courts

Answering the calls of congressional Republicans, FDA is siding with the food industry in a lawsuit seeking to stop New York City's menu labeling regulation from being enforced until FDA implements its national standard.

The U.S. Court of Appeals for the Third Circuit dismissed an appeals claim from a secular anti-abortion group that sought exemption from the Affordable Care Act's mandate that employers cover all FDA approved contraceptive services with no cost-sharing.

A federal district court will allow a lawsuit calling for a right for beneficiaries to appeal placement under observation during a hospitalization to proceed as a class action suit, and the Center for Medicare Advocacy and Justice in Aging project hundreds of thousands of beneficiaries are likely to be members of such a class.

Adding a new twist to the ongoing saga over the ACA's cost-sharing reduction payments that President Donald Trump is threatening to withhold from insurers, a federal court on Tuesday said a group of Democratic attorneys general may intervene in the House GOP's high-profile suit against the Obama administration for making the payments absent a congressional appropriation.

House Republicans and the Department of Justice in separate filings Monday asked the DC Court of Appeals to reject a motion by Democratic attorneys general to intervene in the ACA cost-sharing reduction case.

Despite the Supreme Court’s recent ruling that an injunction cannot be used to compel participation in the so-called biosimilar patent dance, one retired district court judge recently argued that this information will still be exchanged during discovery given that courts will develop local rules to compel information exchange, in an effort to ensure that declaratory-judgment actions can move forward.

In the wake of the U.S. Supreme Court remanding portions of the closely-watched Amgen v. Sandoz biosimilar pathway case back to the federal circuit, Sandoz is asking the circuit court to further remand the lawsuit to the California district court.

The U.S. Supreme Court agreed last week take up a case that will determine the constitutionality of the patent office’s inter partes review process -- an administrative procedure for challenging patents that some drug industry stakeholders have said undermines the drug pipeline and unfairly uses a lower standard for reviewing patents than that used by a district court.

Amgen's pediatric exclusivity lawsuit against FDA was stayed after the agency agreed to reconsider its May 22 decision not to grant pediatric exclusivity to Amgen's Sensipar, a drug to treat secondary hyperparathyroidism.