What We're Reading: Gilead Dealt Patent Setback; Merck Spins Off Businesses; Governors' Medicaid Worries

February 6, 2020
AJMC Staff

The Patent Trial and Appeals Board delivered a setback to Gilead Sciences, rejecting its attempt to invalidate a pair of Truvada patents owned by the CDC; Merck is spinning off some businesses in order to focus on its oncology drug pembrolizumab, including its biosimilars operations; Republican and Democratic governors are worried that a proposed CMS fiscal accountability rule for Medicaid will reduce access to healthcare.

Patent Board Denies Gilead's Truvada Patent Challenge

The Patent Trial and Appeals Board (PTAB) delivered a setback to Gilead Sciences this week, rejecting its attempt to invalidate a pair of Truvada patents owned by the CDC. PTAB ruled that the company failed to show it was likely to win its argument, STAT reported. The patents helped fund academic research regarding HIV prevention that laid the foundation for pre-exposure prophylaxis therapy. The ruling comes 3 months after HHS sued Gilead, claiming it infringed on government patents for a pair of HIV drugs and refused to reach a licensing deal.

Merck Spinning Off Businesses to Focus on Keytruda

Governors Worried About Medicaid Cuts; CMS Proposes Medicare Advantage, Part D Changes

Merck said this week it is spinning off some businesses in order to focus on its oncology drug pembrolizumab (Keytruda). Among them: the company's biosimilars operations, which it operates in partnership with Samsung Bioepis, The Center for Biosimlars reported. The new, as-of-yet unnamed company will also sell women's health products and older, off-patent medicines. The new company will have $6.5 billion in annual sales.Republican and Democratic governors are worried that a proposed CMS fiscal accountability rule for Medicaid will reduce access to healthcare, the Associated Press reported. Governors Kate Brown, D-Oregon, and Charlie Baker, R-Massachusetts, sent a letter to CMS Administrator Seema Verma on behalf of the National Governors Association warning that the rule could "lead to unintended consequences that would negatively impact Medicaid beneficiaries across the country." CMS has said the rule is intended to increase transparency; one study said that the latest proposal, which comes after efforts by the Trump administration to impose work requirements and block grants, could lead to cuts of $37 billion to $49 billion a year in total Medicaid spending. Separately, on Wednesday, CMS released proposed changes to Medicare Advantage and Part D benefits, including changes for beneficiaries with end-stage renal disease.