What changed between these versions
v2 introduces substantive changes to the disclosure requirements for drug and biological product applications, primarily by clarifying the scope of trade secret protections for information shared with the USPTO and adding a new restriction on who can assert a non-disclosure defense in patent infringement actions. The bill also corrects an erroneous cross-reference and renumbers a key paragraph with corresponding updates.
Overview
A handful of substantive changes concentrated within the disclosure and enforcement sections of the bill. · v2 clarifies and narrows certain protections while also introducing a new restriction on the applicability of a defense against patent infringement actions, representing a refinement of the bill's original intent with a new policy carve-out.
The most significant change in v2 is the addition of a condition that prevents 'covered foreign persons' from asserting a non-disclosure defense in drug patent infringement actions. Additionally, v2 modifies the provisions regarding the protection of trade secret and confidential information submitted to the United States Patent and Trademark Office (USPTO), explicitly allowing the USPTO to disclose information deemed necessary for the public to understand patent claims. A technical renumbering of a key paragraph and a correction of an erroneous cross-reference were also implemented.
Major additions
v2 adds a new condition to the non-disclosure defense against patent infringement actions. This condition specifies that the defense is not available if the person asserting it is a 'covered foreign person,' as defined in section 809 of the Defense Production Act of 1950.
This addition significantly narrows the applicability of the non-disclosure defense, preventing certain foreign entities from using it. This could impact the strategic options for generic drug manufacturers or biological product developers who are foreign entities in patent disputes, potentially reducing their leverage against patent holders.
Modifications
This is a technical renumbering that does not alter the substance of the disclosure requirements for drug application sponsors. All subsequent references to this paragraph are updated accordingly, ensuring internal consistency.
Before
v1 added a new paragraph (7) to Section 505(b) of the Federal Food, Drug, and Cosmetic Act, establishing disclosure and certification requirements for drug application sponsors regarding patent information shared with the FDA and USPTO.
After
v2 renumbers the newly added paragraph from (7) to (8) within Section 505(b) of the Federal Food, Drug, and Cosmetic Act, maintaining the same disclosure and certification requirements for drug application sponsors.
This modification narrows the scope of trade secret and confidential information protection for data submitted to the USPTO. It explicitly grants the USPTO discretion to make public information it deems necessary for understanding patent claims, potentially increasing transparency but also potentially exposing proprietary data that was previously protected. This could affect drug sponsors' willingness to submit certain information or their competitive position.
Before
v1 stated that information submitted to the USPTO to fulfill disclosure requirements, which would not otherwise be submitted, 'shall remain subject to application protections for trade secret or confidential information or financial information as if the information were held by the Food and Drug Administration.'
After
v2 clarifies that such information 'shall remain subject to protections for trade secret or confidential information or financial information applicable to such application as if the information were held by the Food and Drug Administration, except that such protections shall not apply to information that the United States Patent and Trademark Office determines necessary for the public to understand the scope of patent claims granted.' It also slightly rephrases the instruction for the USPTO to update regulations.
This is a direct consequence of the renumbering of paragraph (7) to (8) and has no independent operative impact beyond maintaining internal consistency within the Federal Food, Drug, and Cosmetic Act.
Before
v1 required certifications related to 'applicable patent (as defined in paragraph (7)(C))'.
After
v2 updates the reference to 'applicable patent (as defined in paragraph (8)(C))'.
Similar to the drug application changes, this modification narrows the scope of trade secret and confidential information protection for biological product data submitted to the USPTO. It grants the USPTO discretion to disclose information necessary for understanding patent claims, potentially affecting biological product sponsors' proprietary information and competitive strategies.
Before
v1 stated that information submitted to the USPTO for biological product applications 'shall remain subject to application protections for trade secret or confidential information or financial information as if the information were held by the Food and Drug Administration.'
After
v2 clarifies that such information 'shall remain subject to protections for trade secret or confidential information or financial information applicable to such application or license as if the information were held by the Food and Drug Administration, except that such protections shall not apply to information that the United States Patent and Trademark Office determines necessary for the public to understand the scope of patent claims granted.' It also slightly rephrases the instruction for the USPTO to update regulations.
This modification updates the cross-references to align with the renumbering of paragraph (7) to (8) and specifies the exact sub-clauses for the required certifications. This ensures that the FDA's enforcement authority remains correctly linked to the updated disclosure requirements, without changing the fundamental scope of the prohibited act.
Before
v1 specified that failure to submit certifications required under 'section 505(b)(7) of this Act or section 351(a)(2)(F) of the Public Health Service Act' constitutes a prohibited act.
After
v2 updates the references to 'section 505(b)(8)(A)(i) of this Act or section 351(a)(2)(F)(i)(I) of the Public Health Service Act'.
This modification corrects an error in v1 where the non-disclosure defense for biological products referenced the wrong subparagraph for the definition of 'applicable patent'. By correcting the reference to subparagraph (F)(iii), v2 ensures that the defense mechanism correctly targets the intended patents, clarifying the scope of the defense for biological products. This change ensures the legal mechanism functions as intended.
Before
v1 defined 'applicable patent' for the non-disclosure defense by referencing 'paragraph (7)(C) of section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) or subparagraph (F)(ii) of section 351(a)(2) of the Public Health Service Act (42 U.S.C. 262(a)(2)))'. Note that subparagraph (F)(ii) in v1 defined 'information material to patentability', not 'applicable patent'.
After
v2 updates the definition of 'applicable patent' for the non-disclosure defense by referencing 'paragraph (8)(C) of section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) or subparagraph (F)(iii) of section 351(a)(2) of the Public Health Service Act (42 U.S.C. 262(a)(2)))'. Subparagraph (F)(iii) in v2 correctly defines 'applicable patent'.
Scope
Meaningful expansion or narrowing — Changes are concentrated within the core operative sections related to disclosure requirements and enforcement, specifically Section 2 of the bill. — v2 introduces a meaningful narrowing of the patent information protection and adds a new restriction on the availability of a patent infringement defense, representing a shift towards greater transparency (for USPTO) and protection against certain foreign entities (for patent holders). — The renumbering changes affect multiple cross-references throughout the bill, ensuring internal consistency. The new condition on the patent infringement defense directly interacts with the existing framework for challenging drug patents.
Impact analysis
Drug and biological product sponsors/holders
Procedural change with potential for negative impact on proprietary information control.
Their submitted trade secret and confidential information to the USPTO is now subject to an explicit exception, allowing the USPTO to disclose information necessary for the public to understand patent claims.
Entities asserting a non-disclosure defense in drug patent infringement actions who are 'covered foreign persons'
Negative impact, as a legal defense is removed.
They are now explicitly barred from asserting the non-disclosure defense, which was previously available to all persons under v1.
United States Patent and Trademark Office (USPTO)
Procedural change, clarifying authority.
The USPTO is explicitly granted discretion to determine what information is necessary for the public to understand patent claims and to disclose it, even if it's trade secret or confidential.