The gist

Creates a patent 'safe harbor' so generic and biosimilar drug makers can sell medicines with labels that exclude still-patented uses, without being sued for infringement.

Who wins, who loses

• Wins: generic drugmakers, biosimilar companies, patients and insurers paying for prescriptions.
• Loses: brand-name pharmaceutical companies relying on method-of-use patents to extend monopoly pricing.

What it does

• Amends Section 271 of US patent law to shield 'skinny label' generics from direct, induced, or contributory infringement claims.
• Protects applications filed under Food and Drug Administration (FDA) pathways 505(j), 505(b)(2), and 351(k) biosimilars.
• Safe harbor applies only if labeling and marketing avoid mentioning the patented use.
• Applies retroactively to pending lawsuits and past conduct.

Why should I care?

Supporters say skinny labels keep generics cheap and Americans already overpay for medicine compared to other countries. Critics argue weakening method-of-use patents discourages drug companies from researching new uses for existing medicines. An alternative being debated: tighter FDA labeling rules instead of patent law changes. Where do you land? Vote below and use "Tell Your Rep" to make sure your voice reaches Congress.