Referred to the House Committee on the Judiciary.
The bill amends 35 U.S.C. to create a presumption that later-listed patents covering the same drug or biologic are treated as disclaimed for term beyond the first-expiring patent in certain FDA-related patent challenges, unless the patentee proves the later patents claim patentably distinct inventions or expressly disclaims term. It also requires the USPTO Director to review patent examination practices to reduce issuance of non-distinct drug or biologic patents and report findings and recommendations to the House Judiciary Committee within one year.
Liberal emphasizes faster generics and lower prices
Relative to its intended legislative type, this bill clearly identifies and addresses the statutory mechanism for preventing double patenting in the drug and biologic context by creating a presumption of disclaimer in specified proceedings and directing a USPTO procedural review.
The bill amends 35 U.S.C. to create a presumption that later-listed patents covering the same drug or biologic are treated as disclaimed for term beyond the first-expiring patent in certain FDA-related patent challenges, unless the patentee proves the later patents claim patentably distinct inventions or expressly disclaims term.
It also requires the USPTO Director to review patent examination practices to reduce issuance of non-distinct drug or biologic patents and report findings and recommendations to the House Judiciary Committee within one year.
Technically targeted but economically significant; strong industry resistance and legal complexity reduce prospects despite public appeal.
Relative to its intended legislative type, this bill clearly identifies and addresses the statutory mechanism for preventing double patenting in the drug and biologic context by creating a presumption of disclaimer in specified proceedings and directing a USPTO procedural review. It integrates directly with relevant statutory provisions and delegates a discrete review task to the PTO Director with a one-year reporting deadline.
Liberal emphasizes faster generics and lower prices
These are examples from the analysis, not a ranked list of the most-affected groups.
Liberal emphasizes faster generics and lower prices
Generally supportive; views the bill as a targeted anti-evergreening measure to speed generic and biosimilar entry.
Sees it as a way to lower drug prices and increase competition while preserving protection for genuinely distinct inventions.
Cautiously supportive with reservations; appreciates competition gains but worries about legal uncertainty and unintended impacts on innovation.
Wants clear standards and an implementation plan to minimize disruptive litigation and preserve genuine incentives for new drugs.
Likely opposed; views the bill as weakening patent rights and investor protections for pharmaceutical innovation.
Concerned it creates presumptions hostile to patentees and risks reducing incentives for costly drug development.
Reached or meaningfully advanced
Reached or meaningfully advanced
Still ahead
Still ahead
Still ahead
Technically targeted but economically significant; strong industry resistance and legal complexity reduce prospects despite public appeal.
The bill has not accumulated any surfaced votes yet.
Liberal emphasizes faster generics and lower prices
Technically targeted but economically significant; strong industry resistance and legal complexity reduce prospects despite public appeal.
Relative to its intended legislative type, this bill clearly identifies and addresses the statutory mechanism for preventing double patenting in the drug and biologic context by creating a presumption of disclaimer in s…
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